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LICENSEE NEWSLETTER

NUREG/BR-0117, No. 11-04 Fall 2011

Oce of Federal & State Materials &

Environmental Management Programs

INSIDE THIS ISSUE

FSME Turns Five.............................. 1

Source Material ............................. 2

Welcome........................................... 2 

From the Desk 

of the Director ................................ 3

Farewell............................................. 4 

Advisory Committee 

on the Medical Uses 

of Isotopes Meets.......................... 4

Interagency Jurisdictional 

Working Group............................... 4

Significant Enforcement

Actions.............................................. 5

Generic Communications 

Issued................................................. 6

Significant Events.......................... 6

Selected Federal Register 

Notices............................................... 8

To Our Readers............................... 8

On October 1, 2006, the 

U.S. Nuclear Regulatory 

Commission (NRC) 

reorganization plan became 

effective that established the 

Office of Federal and State 

Materials and Environmental 

Management Programs (FSME) 

and restructured the Office of 

Nuclear Material Safety and 

Safeguards (NMSS). The new 

office, FSME, was created by 

merging the former Office 

of State and Tribal Programs 

with two of the technical 

divisions from the old NMSS. 

The Commission felt that this 

would “provide for effective 

organizational focus” for 

several major areas, including 

the nation’s fuel cycle strategy 

and the acknowledged 

“increasing contribution 

of Agreement States in the 

regulation of radioactive 

materials.” The reorganization 

was designed to “elevate the 

visibility of State and Tribal 

programs to a major program 

office level.” The Commission 

directed the new office to 

“remain engaged with the 

States to strengthen their 

roles in the National Materials 

Program to make it a truly 

national program.”

Now here we are in late 2011. 

Five years have passed since 

the inception of FSME; we 

cannot believe it has been 

that long. Many members of 

the original FSME leadership 

team have moved into other 

endeavors, but the primary 

mission of this office has 

not changed. FSME remains 

committed to effective 

regulation of nuclear materials 

and protection of the health 

and safety, environment, and 

security of the materials we 

regulate. We strive to do this 

through our partnerships 

with the other NRC offices, 

especially the regions, and 

with an appreciation for the 

regulatory excellence of the 

37 Agreement States. We 

also make every effort to be 

an effective liaison for Tribal 

issues and a place where 

concerns from the States or 

members of the public can be 

addressed. 

FSME TURNS FIVE
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Our full office name is 

admittedly quite a mouthful. 

But most important, we 

are quite proud of what 

we’ve accomplished in the 

past half-decade. With that 

said, we recognize that 

nobody is perfect and that 

all organizations need to 

continue to look for areas 

in which they can improve. 

Although we do selfassessments periodically, we 

also encourage your thoughts 

about whether or not you 

believe we are meeting our 

mission objectives or your 

ideas for ways we could get 

better. We want to know your 

thoughts, so tell us. We are 

waiting to hear from you.

The FSME Staff

SOURCE MATERIAL

On July 26, 2010, the NRC 

published a proposed rule 

on the distribution of source 

material in the Federal Register 

(75 FR 43425) for public 

comment. The rulemaking 

would 

provide 

the NRC 

with more 

complete 

and timely 

information on the types 

and quantities of source 

material distributed for use 

either under exemption or by 

general licensees. In addition, 

the NRC proposed to modify 

the existing possession and 

use requirements of the 

general license for small 

quantities of source material in 

Title 10 of the Code of Federal 

Regulations (10 CFR) 40.22, 

“Small Quantities of Source 

Material,” to better align the 

requirements with current 

health and safety standards. 

Finally, the proposed rule 

would revise, clarify, or delete 

certain source material 

exemptions from licensing. 

The rule is expected to impact 

manufacturers and distributors 

of certain products and 

materials containing source 

material and certain persons 

using source material under a 

general license. On November 

18, 2010, the NRC published in 

the Federal Register 

(75 FR 70618) a notice to 

extend the comment period 

to February 15, 2011. The NRC 

provided the extension to 

allow members of the public 

time to review the related 

guidance that was published 

in the Federal Register 

(76 FR 1100) for comment 

on January 7, 2011. The 

NRC received 14 comment 

letters from 9 commenters 

representing private 

individuals, industry groups, 

and individual companies. 

All comments are publicly 

available on regulations.gov 

under docket 

 NRC-2009-0084. The 

comments all opposed 

various aspects of the 

rulemaking and stated 

concerns about the impacts 

on analytical laboratories, 

the costs resulting from 

new distribution licenses 

and proposed reductions 

in possession limits, and 

the burden associated with 

reporting. Many of the 

commenters were concerned 

that the burdens were not 

justified by the risks. The 

commenters also identified 

many areas for which they 

believed additional guidance 

is necessary. The working 

group is currently analyzing 

the comments and evaluating 

the impacts of the proposed 

rule. 

(Contact: Gary Comfort, 

FSME, 301-415-8106 or e-mail 

Gary.Comfort@nrc.gov)

WELCOME 

The FSME staff would like 

to welcome Mr. Brian J. 

McDermott, the former 

Acting Director, Division 

of Security Policy, Office of 

Nuclear Security and Incident 

Response (NSIR), as the new 

Director, Division of Materials 

Safety and State Agreements, 

FSME, which was effective in 

October 2011. 

Mr. McDermott joined the 

NRC in 1990 as a reactor 

engineer intern. After 

graduation from the 

intern program, he served 

in Region I as a Reactor 

Engineer, Resident Inspector, 

at Susquehanna Steam 

Electric Station, and as a 

Mr. Brian McDermott
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The summer edition of this newsletter contained a brief 

article on page 4 announcing that I had been named as 

the new Director of FSME. It summarized my previous 

assignments within the NRC and my educational and 

military background, so I will not repeat any of that here. 

Instead, I’d like to use this space to tell you how enthusiastic 

I am about joining the FSME team, an organization that 

has earned a reputation for regulatory excellence since the 

office was formed in 2006. This reputation for excellence 

can be attributed to many things, including the hardworking staff and expanded leadership team, which is 

composed of the Branch Chiefs and divisional and office 

leadership. The successes are also closely tied to the 

leadership of my predecessor, Charlie Miller, his former 

Deputy Director, George Pangburn, and our current Deputy 

Director, Cindi Carpenter. 

From my days in both Headquarters and the regions, I know that all regulators are only as good as the 

licensees they regulate. In FSME’s case, we share that regulatory responsibility with 37 Agreement States. 

In fact, 20,000 of the 23,000 nuclear materials users are under State regulatory purview. I intend to rely 

heavily on the States as our partners, and I strive to communicate early and often to move us closer to a 

true “national materials program.” 

The reason that I am so eager to join FSME is because I know that this office deals with many different 

issues and a broad array of challenges. For example, we must continue to make progress on the 

information technology issues associated with development of an Integrated Source Management 

Portfolio. We will continue to address complex low-level-waste issues such as blending, depleted uranium, 

and changes to 10 CFR Part 61, “Licensing Requirements for Land Disposal of Radioactive Waste.” We have 

uranium recovery applications to review from a safety and environmental perspective. We will strive 

to keep our rulemaking actions on schedule while also providing ample opportunities for stakeholder 

viewpoints to be heard and addressed. 

I am a firm believer in the importance of all of the NRC values, which are located at http://www.nrc.gov/

about-nrc/values.html. Of these, I hold openness and integrity most dearly. I commit to all of you that 

FSME will model these values and take them into account during the course of our daily duties. 

Thanks to all of you for your solid record of safety. Let’s continue to work together to ensure the public 

health and safety and protection of the environment in all operations involving regulated nuclear materials.

Mark A. Satorius, Director

from the desk of

the director
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Mr. Robert J. Lewis

Senior Resident Inspector 

at Vermont Yankee Nuclear 

Power Station. He has held 

a number of progressively 

more responsible positions 

in Region I and NSIR. Mr. 

McDermott received 

a bachelor’s degree in 

nuclear engineering from 

Pennsylvania State University 

and a Master of Business 

Administration degree from 

Franklin College. 

The FSME staff is looking 

forward to working with Mr. 

McDermott.

FAREWELL

The FSME staff would like 

to congratulate Mr. Robert 

J. Lewis, the former Acting 

Deputy Director, FSME, for 

his recent appointment as 

the new Director, Division of 

Preparedness and Response, 

NSIR, which was effective in 

October 2011.

The FSME staff wishes Mr. 

Lewis all the best in his

new position.

ADVISORY COMMITTEE 

ON THE MEDICAL USES OF 

ISOTOPES MEETS

The Advisory Committee on the 

Medical Uses of Isotopes (ACMUI) 

advises the NRC on policy and 

technical issues that arise in 

the regulation of the medical 

uses of radioactive material 

in diagnosis and therapy. The 

ACMUI membership includes 

health care professionals from 

various disciplines who comment 

on changes to NRC regulations 

and guidance, evaluate certain 

nonroutine uses of radioactive 

material, and bring key issues to 

the attention of the Commission 

for appropriate action. On 

September 22, 2011, ACMUI 

met for two consecutive days 

at NRC Headquarters to discuss 

issues such as the Cardiogen 

generators, the NRC Medical 

Rulemaking Workshops, and the 

Permanent Implant Brachytherapy 

Subcommittee report. The next 

ACMUI meeting will take place at 

NRC Headquarters on 

April 16–17, 2012.

(Contact: Sophie Holiday, 

FSME, 301-415-7865 or e-mail 

Sophie.Holiday@nrc.gov)

INTERAGENCY 

JURISDICTIONAL 

WORKING GROUP

The Interagency Jurisdictional 

Working 

Group (IJWG) 

was initially 

established 

in 2001 to 

determine the 

best approach to delineating 

the responsibilities of the NRC 

and other Federal agencies 

and States with regard to 

low-level source material 

and materials containing less 

than 0.005 percent by weight 

concentration of uranium 

and/or thorium. In 2003, the 

IJWG recommended that 

the NRC’s jurisdiction should 

be limited to uranium and 

thorium that are extracted 

or purposely concentrated 

for their chemical, physical, 

or radiological properties. 

This would include source 

material used in the nuclear 

fuel cycle. However, at that 

time, the Commission decided 

to defer further activities 

of the IJWG. In 2006, the 

Commission directed the 

NRC staff to reassemble the 

IJWG to determine if the IJWG 

continued to support the 

original recommendation. In 

subsequent deliberations, 

the IJWG voiced continued 

support for the overall 

recommendation, but some 

members wanted to see the 

actual legislative proposal 

before committing the 

support for their agency or 

organization. The Commission 

has decided that the NRC 

should prepare and, upon the 

Commission’s approval, submit 

a legislative proposal through 

the Office of Management and 

Committee members (left to right): 

Dr. William Van Decker, Dr. James Welsh, 

Dr. Bruce Thomadsen, Ms. Laura Weil, 

Dr. Milton Guiberteau, Dr. Leon Malmud, 

Mr. Steve Mattmuller, Dr. Pat Zanzonico, 

Dr. Susan Langhorst, Dr. Orhan Suleiman, 

Dr. John Suh, and Dr. Christopher Palestro.
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Budget. On the basis of this 

path forward, the Commission 

has determined that the IJWG 

has successfully completed its 

objectives and has decided to 

conclude the working group. 

(Contact: Gary Comfort, FSME, 

301-415-8106 or e-mail 

Gary.Comfort@nrc.gov)

SIGNIFICANT 

ENFORCEMENT ACTIONS

The NRC issued 

the following 

significant actions 

for failure to 

comply with regulations.

Del Valle Group (EA-11-009)

On May 11, 2011, the NRC 

issued a Notice of Violation 

to Del Valle Group (DVG) for 

a Severity Level III violation 

involving the failure to obtain 

authorization in a specific NRC 

license to own and possess 

three portable moisture 

density gauges, as required by 

10 CFR 30.3(a). Specifically, 

from November 30, 2008, 

through October 28, 2010, 

DVG owned or possessed 

byproduct material (discrete 

radium-226 sources contained 

in three portable moisture 

density gauges) without 

authorization in a specific 

or general license issued 

in accordance with NRC 

regulations. 

Luzenac America, Inc. 

(EA-11-022)

On July 7, 2011, the NRC 

issued a Notice of Violation 

and Proposed Imposition of 

Civil Penalty in the amount of 

$8,500 to Luzenac America, 

Inc., for a Severity Level III 

violation involving the failure 

to transfer a device containing 

byproduct material to a 

licensee authorized to receive 

it, as required by

10 CFR 31.5(c)(8)(i). 

Specifically, as of 

December 2, 2010, Luzenac 

transferred a fixed nuclear 

gauge containing byproduct 

material to a recycling 

company that was not 

authorized to receive it.

Medical

Mercy Hospital (EA-11-094)

On June 8, 2011, the NRC 

issued a Notice 

of Violation to 

Mercy Hospital 

for a Severity 

Level III violation 

involving 

the failure to 

develop, implement, and 

maintain written procedures 

to provide high confidence 

that each administration is in 

accordance with the written 

directive as required by 

10 CFR 35.41(a). Specifically, 

between June 18, 2008, and 

February 23, 2011, the licensee 

performed approximately 

200 high-dose-rate remote 

afterloader administrations 

requiring written directives 

and failed to develop written 

procedures to provide 

high confidence that each 

administration was in 

accordance with the written 

directive. 

Henry Ford Macomb 

Hospital (EA-11-088)

On June 24, 2011, the NRC 

issued a Notice of Violation 

to Henry Ford Macomb 

Hospital for a Severity Level III 

violation involving the failure 

to develop, implement, and 

maintain written procedures 

to provide high confidence 

that each brachytherapy 

treatment was in accordance 

with the written directive as 

required by 10 CFR 35.41(a). 

Specifically, as of 

December 9, 2010, the 

licensee’s procedure did not 

include steps to verify that the 

transfer tube assembly used at 

the time of the administration 

was the same length as the 

one identified in the treatment 

plan implementing the written 

directive. As a result, four 

patients received radiation 

doses to areas not included 

within the planned treatment 

area.

Charleston Radiation 

Therapy Consultants, PLLC 

(EA-11-115)

On June 30, 2011, the NRC 

issued a Notice of Violation to 

Charleston 

Radiation 

Therapy 

Consultants, 

PLLC (CRTC) 

for a Severity 

Level III 

violation 

involving the 

failure to meet the physical 

presence requirements 

of 10 CFR 35.615(f)(2) 

during high dose radiation 

treatments. Specifically, on 

an indeterminate number 

of occasions on and before 

April 28, 2011, neither 

a CRTC authorized user 

nor a physician under the 

supervision of an authorized 

user was physically present 

during the entire duration of 

patient treatments involving 

the high-dose radiation unit.
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Bozeman Deaconess 

Hospital (EA-10-258)

On July 8, 2011, the NRC 

issued a Confirmatory Order 

(effective immediately) 

to Bozeman Deaconess 

Hospital (BDH) to confirm 

commitments made as 

a result of an alternative 

dispute resolution settlement 

agreement. 

During the 

inspection and 

investigation, 

the NRC 

identified 

two willful violations. The 

violations involved the failure 

to secure licensed materials 

from unauthorized removal or 

access as required by 

10 CFR 20.1801, “Security 

of Stored Material,” and to 

control and maintain constant 

surveillance of licensed 

material as required by 

10 CFR 20.1802, “Control of 

Material Not in Storage.” In 

response to these violations, 

BDH requested an alternative 

dispute resolution and agreed 

to take a number of actions 

as part of this Confirmatory 

Order. BDH agreed to provide 

training by an independent 

third-party organization to 

hospital staff and managers 

involved in NRC-licensed 

activities, modify the internal 

requirements for new workers’ 

initial and annual refresher 

training, develop and 

implement a procedure that 

allows hospital employees and 

contractors to raise radiation 

safety concerns to hospital 

management, and pay a civil 

penalty in the amount of 

$3,500. 

Information about the NRC’s 

enforcement program can be 

accessed at http://www.nrc.

gov/about-nrc/regulatory/

enforcement/current.html.” 

Documents related to cases 

can be accessed through the 

NRC’s Agencywide Document 

Access and Management 

System (ADAMS) at http://

www.nrc.gov/reading-rm/

adams.html. 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 to 

PDR.Resource@nrc.gov.

(Contact: Michele Burgess, 

FSME, 301-415-5868 or e-mail 

Michele.Burgess@nrc.gov)

GENERIC 

COMMUNICATIONS 

ISSUED

The following are 

summaries of NRC generic 

communications issued 

by FSME. If any of these 

documents appears relevant 

to your needs and you have 

not received it, please call 

one of the technical contacts 

listed below. The Web address 

for the NRC library of generic 

communications is http://

www.nrc.gov/reading-rm/doccollections/gen-comm.

REGULATORY ISSUE 

SUMMARIES

The NRC provides a regulatory 

issue summary (RIS) as an 

informational document 

used to 

communicate 

with the 

nuclear 

industry on a 

broad spectrum of matters.

On September 29, 2011, 

the NRC issued RIS 2011-

11, “Regarding Long-Term 

Surveillance Charge for 

Conventional or Heap Leach 

Uranium Recovery Facilities 

Licensed under 10 CFR Part 40.” 

The RIS reiterated NRC policy 

on the long-term surveillance 

charge for applicable uranium 

recovery facilities. 

(Technical Contact: Dominick 

Orlando, FSME, 301-415-6749 

or e-mail 

Dominick.Orlando@nrc.gov)

(General Contact: Angela R. 

McIntosh, FSME, 301-415-5030 

or e-mail 

Angela.McIntosh@nrc.gov)

SIGNIFICANT EVENTS

Treatment to 

Wrong Lobe of 

the Liver 

Date and Place: July 7, 2011, 

Madison, Wisconsin 

Event Details: The licensee 

reported that a patient 

was administered 1.05 GBq 

(28.38 mCi) of yttrium-90 

microspheres (MDS Nordion 

model TheraSpheres) on

July 7, 2011, to the wrong 
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lobe of the liver 

as documented 

on the written 

directive. The 

patient was 

prescribed to 

receive 1.04 

GBq (28.11 mCi) 

to the left lobe 

of the liver for multinodular 

heap-to cellular cancer. A 

treatment plan was created for 

the left lobe, but, during the 

procedure, the right lobe was 

treated with the prescribed 

dose for the left lobe.

Dose Administered to Wrong 

Patient 

Date and Place: July 8, 2011, 

Denver, Colorado

Event Details: The licensee 

reported that a patient was 

administered 3.7 GBq (100 

mCi) of iodine-131, instead of 

the prescribed 

dose of 0.74 

GBq (20 mCi), 

for Grave’s 

Disease. The 

3.7 GBq (100 

mCi) dosage was intended 

for another patient. The 

patient was discharged from 

the hospital before the error 

was discovered. The patient’s 

physician and the patient 

were notified of the error. The 

patient was given additional 

instructions about his contact 

with members of the public.

Overexposure Resulting in 

Deterministic Effects 

Date and Place: 

September 19, 2011, Port 

Lavaca, Texas 

Event Details: The licensee 

reported that a radiography 

trainee received an exposure 

to his right hand. It was 

determined that the trainee 

had removed the guide tube 

from the exposure device 

(Amersham model 660-D) with 

his bare hand and saw that 

the 2.7 TBq (73 Ci) iridium-192 

source was protruding from 

the device. The 

individual’s 

fingers had 

observable 

deterministic 

effects, including 

blistering of 

the thumb, 

index, and middle fingers. 

These effects correspond to 

a dose range between 20 

and 30 Gy (2,000 and 3,000 

rads). The trainee’s wholebody dosimeter was sent for 

immediate processing, and 

the results revealed that the 

trainee had received a dose of 

14 mSv (1.4 rem). The trainee 

is receiving treatment at a 

local hospital. The licensee has 

conferred with the Radiation 

Emergency Assistance Center/

Training Site concerning this 

event.

Overexposure to Workers 

during Irradiator Source 

Exchange 

Date and Place: 

October 8, 2011, Raritan, 

New Jersey 

Event Details: The licensee 

reported a potential radiation 

overexposure event involving 

three radiation workers. The 

three workers were contracted 

to load a 44.77 TBq (1,210 Ci) 

cobalt-60 source assembly 

(International Isotopes Idaho) 

into an MDS Nordion model 

Gammacell 220 irradiator 

at the licensee’s facility. 

During the procedure, the 

8-inch tall source assembly 

was somehow dislodged 

from its shielded 

position, so that 

approximately 

4 inches of the 

assembly were 

exposed. In 

addition, the 

insertion tool 

prevented the workers from 

quickly reinserting the source 

assembly. The workers were 

able to shield the assembly 

using titanium. They then 

had to force the assembly 

into place and broke off 

the insertion tool. The 

cobalt-60 source was then 

confirmed to be in a shielded 

configuration and safely 

secured. The total time that 

the source was unshielded 

was estimated to be between 

25 and 30 seconds. The 

two workers loading the 

source received whole-body 

exposures of 17.5 and 17.2 

cSv (rem); and their extremity 

exposures were determined 

to be 61.6 and 101.3 rad, 

respectively. They were 

wearing thermoluminescent 

dosimeters and ring badges. 

The third worker received a 

whole-body dose of 11.4 cSv 

(rem). Four additional workers 

were in attendance during the 

attempted source exchange. 

Their estimated whole-body 

exposures ranged between 1.5 

cSv (rem) and 3.5 cSv (rem). 

(CONTACT: Angela R. 

McIntosh, FSME, 301- 415-

5030 or e-mail Angela.

McIntosh@nrc.gov)
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In our attempt to keep the FSME Licensee Newsletter relevant, we welcome useful and informative 

feedback on the contents of the newsletter. If you would like to suggest topics, please contact 

Vanessa Cox or Gwendolyn Davis from FSME Rulemaking Branch A. Ms. Cox may be contacted at 

301-415-8342 or e-mail Vanessa.Cox@nrc.gov. Ms. Davis may be contacted at 301-415-8165 or e-mail 

Gwendolyn.Davis@nrc.gov. In addition, to ensure proper delivery of the FSME Licensee Newsletter 

and to prevent any interruption of service, please report any address changes to Ms. Cox at 

FSME_Newsletter@nrc.gov. 

Please send written correspondence to the following address: 

Vanessa Cox, Editor 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

CITATION SUBJECT CONTACT PUBLISHED

76 FR 58543

“Draft Policy Statement on Volume 

Reduction and Low-Level Radioactive Waste 

Management” (Reopening of comment 

period)

Donald Lowman, FSME, 

301-415-5452 or e-mail

Donald.Lowman@nrc.gov September 21, 2011

76 FR 60935

“Notice of Application from ExxonMobil 

Corporation, Highland Uranium Mine 

and Millsite, To Amend Existing Alternate 

Concentration Limits and Extend the NRC 

Long-Term Surveillance Boundary with 

Respect to Materials License SUA 1139” 

(Notice of amendment and opportunity to 

provide comments, to request a hearing, and 

to petition for leave to intervene)

Thomas McLaughlin, 

FSME, 301-415-5869, fax 

number 301-415-5369, or 

e-mail

Thomas.McLaughlin@nrc.

gov

September 30, 2011

SELECTED FEDERAL 

REGISTER NOTICES