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LICENSEE NEWSLETTER

NUREG/BR-0117, No. 12-01 Spring 2012

Oce of Federal & State Materials &

Environmental Management Programs

INSIDE THIS ISSUE

Region IV Office Relocation....... 1

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

General License

Restriction Rule.............................. 2 

From the Desk

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

Significant Enforcement

Actions ............................................. 4 

Generic Communications

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

Significant Events.......................... 7

Selected Federal Register 

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

To Our Readers............................... 9

On December 19, 2011, 

NRC’s Region IV office 

officially relocated to a 

new location in Arlington, 

Texas. The new location 

is approximately 1 mile 

from the previous location. 

Among other enhancements, 

the new location provides 

improved spaces for public 

meetings, upgraded 

technological infrastructure, 

expanded emergency 

response capabilities, and 

accommodated design for 

current as well as anticipated 

future needs of the Region IV 

staff. 

Effective immediately, the 

Region IV physical address/

mailing address is: 

U.S. Nuclear Regulatory 

Commission-Region IV1600 

East Lamar Boulevard

Arlington, Texas 76011-4511 

The Region IV toll-free 

telephone number was 

unaffected by the office 

relocation and remains at 

(800) 952-9677.

To reach a member of the 

Region IV staff, one can 

dial the toll-free telephone 

number provided above 

and follow the prompts. 

Additionally, one can dial 

the new Region IV main 

switchboard telephone 

number at (817) 200-1100

and follow the prompts. 

Often, NRC licensees and 

other stakeholders are 

accustomed to contacting 

Region IV staff members 

directly either by telephone 

or submitting documents 

by facsimile. With very few 

exceptions, the Region IV 

office relocation resulted in 

a telephone prefix change 

for Region IV staff’s landline telephone and facsimile 

lines from the previous 

telephone exchanges [(817) 

860-8XXX and (817) 276-

6XXX] to a new exchange 

817-200 -1XXX, where XXX is 

the 3-digit extension for the 

Region IV staff member. For 

example, the new facsimile 

number that can be used 

to send reciprocity requests 

and materials licensing 

amendments is (817) 200-

1263, where 263 was the 

existing 3 digit extension 

for the facsimile device. In 

the event of any difficulty 

in reaching a Region IV staff 

member using the new 

REGION IV OFFICE RELOCATION
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telephone exchange, please 

dial the main switchboard 

number or the toll-free 

number and follow the 

prompts.

Cellular telephone numbers 

as well as e-mail addresses 

for Region IV staff were 

unaffected by the office 

relocation. 

(Contact: Dr. Janine F. Katanic, 

FSME, 817-200-1151 or 

Janine.Katanic@nrc.gov)

WELCOME 

The FSME staff would like to 

welcome Ms. Tamara Powell 

as the new FSME Allegation 

Coordinator. 

Ms. Powell joined the 

NRC in 2000 as a summer 

hire in Incident Response 

Operations, while attending 

the University of Maryland. 

In 2001, Ms. Powell joined 

the Division of Fuel Cycle 

Safety and Safeguards, Office 

of Nuclear Material Safety 

and Safeguards as a General 

Engineer in the Mixed Oxide 

Branch.

Since 2004, she has worked 

in the Technical Support 

Branch as a Nuclear Process 

Engineer. She is one of a few 

staff members in the agency 

that has qualified as both a 

nuclear criticality safety (NCS) 

reviewer and NCS inspector. 

She was also the first female 

to qualify as an NCS inspector. 

Ms. Powell received a 

Bachelor of Science degree in 

nuclear engineering from the 

University of Maryland and a 

graduate certificate in nuclear 

criticality safety from the 

University of Tennessee. 

The FSME staff is looking 

forward to working with 

Ms. Powell.

GENERAL LICENSE 

RESTRICTION RULE

On January 25, 2012, the NRC 

published a withdrawal of 

proposed rule and closure of 

petition for rulemaking notice 

in the Federal Register (77 

FR 3640). The NRC is closing 

the petition for rulemaking 

(PRM-31-5) submitted by the 

Organization of Agreement 

States, Inc. The petition 

requested that the NRC 

amend its regulations to 

strengthen the regulation 

of radioactive materials by 

requiring a specific license for 

higher-activity devices that 

are currently available under 

a general license, and change 

the compatibility designation 

of applicable regulations 

from category B to category 

C. The petition also addresses 

a request filed by the Florida 

Department of Health, 

Bureau of Radiation Control, 

to change the compatibility 

category of a certain part of 

the applicable regulation from 

category B to category C. In 

response to the petition, the 

NRC developed a proposed 

rule that would have changed 

the compatibility of the 

applicable regulations, 

and would have limited 

the quantity of byproduct 

material contained in a 

generally-licensed device 

to below one-tenth of 

the International Atomic 

Energy Agency Category 

3 thresholds. After further 

review, the NRC has decided 

to withdraw the proposed 

rule and to change the 

compatibility designation of 

the applicable regulations 

from category B to category C. 

(Contact: Solomon Sahle, 

FSME, 301-415-3781 or 

Solomon.Sahle@nrc.gov)

Ms. Tamara Powell
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Having been on-board as the FSME Director only since the 

end of October, I have had just a short time to get familiar 

with the responsibilities of this office. Already I see my 2012 

calendar is filling up with a series of important Commission 

briefings, topical meetings, reviews of papers on which 

the Commission will be voting, and a series of trips and 

speeches. 

Having previously been a Regional Administrator, I am 

use to a full slate of activities and major responsibilities. 

However, the breadth of FSME topics is a bit surprising 

to me. For example, in 2012 FSME will play a leading or 

supporting role in numerous Commission briefings, and 

policy papers related to low-level waste regulation; the 

nuclear medical program; materials security; safety culture; 

radiation protection standards; materials control and 

accounting regulations; data collection issues associated 

with released nuclear medicine patients; transportation 

standards; site remediation; and Agreement State adequacy and compatibility. This is just a partial list.

Clearly, we will be involved in a wide range of topics and issues. In nearly all of the above areas, FSME staff 

and management have been, or will be, receiving comments and input from all interested stakeholders, 

including other regulators, the regulated communities, the affected localities, including the States and 

Tribes, and members of the general public. Whenever we brief our Commission, we strive to assemble 

panels with representative cross-sections of stakeholders, with the primary goal of giving our Commission 

a full understanding of the issues and options from various perspectives.

As a interested reader of this newsletter, you know the numerous ways to make your voice heard on the 

issues that most concern you. The FSME staff includes comment periods in proposed rulemakings and 

conducts meetings around the country on complex rulemakings and major policy papers to receive input. 

Once Commission policy-decisions are reached, FSME usually issues parallel guidance to affected licensees 

and may supplement that with regional workshops to ensure a common understanding of the key 

implementation issues. The FSME and NRC public Web sites are good sources for this type of information.

I wish everyone a happy new year as we work together to protect public health and safety, the 

environment, and ensure the security and control of nuclear materials. 

Mark A. Satorius, Director

from the desk of

the director
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SIGNIFICANT 

ENFORCEMENT 

ACTIONS

The NRC issued the following 

significant actions for failure 

to comply with regulations.

Warner Brothers, LLC (EA11-209)

On November 8, 2011, the 

NRC issued a Notice of 

Violation to Warner Brothers, 

LLC, for a Severity Level III 

violation involving the failure 

to file NRC Form 241, “Report 

of Proposed Activities in NonAgreement States,” at least 

3 days prior to engaging in 

licensed activities within NRC 

jurisdiction, as required by 

10 CFR 150.20, “Recognition 

of Agreement State Licenses.” 

Specifically, on December 6, 

2006, and July 7, 2008, Warner 

Brothers LLC, which only 

holds a Massachusetts license, 

used a portable gauge 

containing a sealed source at 

temporary jobsites within the 

State of Connecticut, without 

obtaining a specific license 

issued by the NRC or filing 

NRC Form 241 with the NRC, 

as required.

Escanaba Paper Company 

(EA-11-061)

On October 17, 2011, the NRC 

issued a Notice of Violation to 

Escanaba Paper Company for 

a Severity Level III violation 

involving the failure to 

ensure that only persons 

specifically licensed by the 

NRC or an Agreement State 

perform services involving 

the dismantling and nonroutine maintenance or repair 

of components related to the 

radiological safety of a gauge. 

Specifically, on

May 9, 2011, the licensee 

performed non-routine 

maintenance on a fixed 

level gauge by using a rod 

to change the position of 

the shutter, contrary to NRC 

License No. 21-17630-01, 

Condition 17.B. The licensee 

was not specifically licensed 

by the NRC or an Agreement 

State to perform this service.

Associated Specialists, Inc. 

(EA-11-179)

On September 21, 2011, 

the NRC issued a Notice 

of Violation to Associated 

Specialists (ASI), Inc., for 

Severity Level III violations 

involving the licensee’s failure 

to: (1) limit operation with a 

temporary radiation safety 

officer (RSO) to a period of 

60 days, in accordance with 

10 CFR 35.24(c); and (2) 

ensure that its authorized 

user (AU) provided adequate 

supervision to licensee 

staff who were involved 

in the receipt, possession, 

use, transfer or preparation 

of byproduct material in 

accordance with 10 CFR 35.27. 

Specifically, after ASI’s RSO left 

the company on

June 8, 2010, the AU 

functioned as the temporary 

RSO until October 13, 2010, 

a period greater than 60 

days. From August 16, 2009, 

until April 19, 2011, the 

AU had limited oversight 

of the program, such that 

ASI personnel under the 

supervision of the AU had 

not spoken to him and had 

not received instructions 

associated with ASI’s 

written radiation protection 

procedures, NRC regulations, 

ASI’s license conditions, 

and the requirement that 

supervised individuals 

follow the instructions of the 

supervising authorized user 

for medical uses of byproduct 

material.

Carmeuse Lime, Inc. 

(EA-11-145)

On September 2, 2011, 

the NRC issued a Notice of 

Violation to Carmeuse Lime, 

Inc., for three Severity Level III 

violations. The first violation 

involved the failure to have 

the individual specifically 

authorized by Condition 12.A 

of the license to fulfill the 
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duties and responsibilities as 

the radiation safety officer. 

Specifically, the individual left 

the company in 2007, and the 

licensee failed to appoint a 

new radiation safety officer 

and amend its license. The 

second violation involved the 

failure to conduct a physical 

inventory every 6 months, or 

at other intervals approved 

by the NRC, to account for all 

sealed sources and/or devices 

received and possessed under 

the license as required by 

Condition 15 of the license. 

The third violation involved 

the failure to test each gauge 

for the proper operation 

of the on-off mechanism 

(shutter) and indicator, if any, 

at intervals not to exceed 

6 months or at intervals 

specified in the certificate of 

registration as required by 

Condition 16.B of the license. 

Professional Service 

Industries, Inc. (EA-10-161)

On August 18, 2011, the 

NRC issued an Immediately 

Effective Confirmatory 

Order to Professional 

Service Industries (PSI), Inc., 

confirming commitments 

reached as part of an 

alternative dispute resolution 

mediation settlement 

agreement. The NRC 

identified eight apparent 

safety violations as well as 

apparent security violations 

involving the performance 

of industrial radiography in 

the Rock Springs, Wyoming, 

area. In addition, the NRC 

indicated that willfulness on 

the part of an office manager 

and a radiographer appeared 

to have been a factor in two 

of the apparent violations. 

PSI made no admission that 

they deliberately violated any 

NRC requirement. As part of 

the agreement, PSI agreed 

to take several corrective 

actions involving increased 

management oversight and 

individual accountability 

including, but not limited 

to: (1) developing and 

implementing a disciplinary 

program managed by the 

corporate staff that provides a 

graded approach for radiation 

safety and security infractions; 

(2) enhanced routine and 

refresher training for staff; 

(3) annual safety culture 

training for radiation safety 

officers; (4) enhanced annual 

audits of the radiation safety 

program; and (5) advance 

notification if PSI will be 

working in NRC jurisdiction 

under reciprocity. PSI also 

agreed that a Confirmatory 

Order with a Notice of 

Violation and $15,000 civil 

penalty would be issued 

in order to avoid further 

action by the NRC. Prior 

to any enforcement action 

by the NRC, the licensee 

voluntarily terminated its 

NRC license for radiography 

but maintains Agreement 

State licenses for radiography 

and an NRC license for other 

non-radiographic, regulated 

activities. 

U. S. Department of the 

Army (EA-10-129)

On August 1, 2011, the NRC 

issued a 

Notice of 

Violation 

to the 

Department 

of the Army 

(Army) for 

a Severity 

Level III violation involving the 

failure to implement 10 CFR 

40.3, “License Requirements.” 

Specifically, from April 1978, 

when NRC license SUB-459 

expired, to the present, the 

Army continued to possess 

depleted uranium (DU) 

associated with the Davy 

Crockett weapons system in 

the form of spent fragments 

of spotting rounds (obtained 

from 1962 to 1968, and 

expended prior to 1968) at 

firing ranges located at the 

Army’s two installations in 

Hawaii, Schofield Barracks 

and Pohakuloa Training 

Area. In addition to the two 

installations in Hawaii, the 

Army has also identified 

the presence of spent DU 

spotting rounds at other Army 

installations across the United 

States. 

 Medical

William Beaumont Hospital 

(EA-11-163)

On September 2, 2011, 

the NRC issued a Notice of 

Violation to William Beaumont 

Hospital for a Severity Level III 

violation involving the failure 

to develop written procedures 

to provide high confidence 

that each administration was 
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in accordance with the written 

directive as required by 

10 CFR 35.41(a). Specifically, 

as of May 5, 2011, the 

licensee’s written procedures 

for yttrium-90 treatments did 

not specify how personnel 

should administer a treatment 

using a fine bore catheter 

and a high concentration 

of microspheres in order to 

prevent blockage within the 

catheter. 

Crittenton Hospital 

(EA-11-165)

On September 2, 2011, 

the NRC issued a Notice 

of Violation to Crittenton 

Hospital for a Severity Level III 

violation involving the failure 

to develop written procedures 

to provide high confidence 

that each administration was 

in accordance with the written 

directive as required by 

10 CFR 35.41(a). Specifically, 

between September 2009 and 

January 2011, the licensee 

failed to address in its written 

procedure the need to verify 

that the step size used in the 

treatment plan was correctly 

translated into the high 

dose rate remote afterloader 

unit. As a result, the device’s 

control unit default step size 

of 2.5 mm was used instead 

of the 5 mm used in the 

treatment planning system. 

Liberty Hospital (EA-11-109)

On July 22, 2011, the NRC 

issued a Notice 

of Violation 

to Liberty 

Hospital for a 

Severity Level 

III violation 

involving the failure to 

develop written procedures to 

provide high confidence that 

each administration was in 

accordance with the written 

directive as required by 

10 CFR 35.41(a). Specifically, 

as of October 6, 2010, the 

licensee’s procedure did not 

require the position of the 

prostate to be verified prior to 

seed placement. As a result, 

the prostate received 16.9 

Gray (Gy) as opposed to the 

prescribed dose of 125 Gy.

 Individual 

Actions

Christopher A. Moore 

(IA-11-037) 

On November 9, 2011, the 

NRC issued a Notice of 

Violation to Christopher A. 

Moore, former Radiation 

Safety Officer at Cardinal 

Health PET Manufacturing 

Services, Inc., in St. Louis, 

Missouri, for a Severity 

Level III violation involving 

10 CFR 30.10, “Deliberate 

Misconduct.” Specifically, 

on June 16, 2010, Mr. Moore 

caused Cardinal Health PET 

Manufacturing Services, 

Inc., an applicant for an NRC 

license, to be in violation of 

10 CFR 20.1502(a)(1) which 

requires that a licensee 

(in this case, an applicant) 

monitor the occupational 

exposure to adults, who are 

likely to receive, in 1 year 

from sources external to 

the body, a dose in excess 

of 10 percent of the limits 

in 10 CFR 20.1201(a). The 

nature of Mr. Moore’s position 

made him subject to 10 CFR 

20.1502(a)(1). However, 

Mr. Moore deliberately 

removed his extremity (ring) 

dosimetry on two separate 

occasions prior to handling a 

chemical cartridge containing 

approximately 4 curies of 

fluorine-18.

The NRC’s enforcement 

program can be accessed at 

http://www.nrc.gov/aboutnrc/regulatory/enforcement/

current.html under 

”Recently Issued Significant 

Enforcement Actions.” 

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 

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 
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listed below. The Web address 

for the NRC library of generic 

communications is http://

www.nrc.gov/reading-rm/

doc-collections/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 January 17, 2012, the 

NRC issued RIS 2012-01, 

“Availability of Safety Culture 

Policy Statement.” The RIS 

informed the addressees 

of the availability of the 

Commission safety culture 

policy statement. 

(Contact: Cindy Flannery, 

FSME, 301-415-0223 or 

Cindy.Flannery@nrc.gov)

(General Contact: 

Angela R. McIntosh, FSME, 

301-415-5030 or

Angela.McIntosh@nrc.gov) 

SIGNIFICANT EVENTS

Radiation 

Therapy Dose 

Administered 

to Pregnant 

Patient

Date and Place: 

October 6, 2011, 

Wynnewood, Pennsylvania 

Event Details: The licensee 

reported that a pregnant 

patient received 2.73 GBq 

(73.7 mCi) of iodine-131 for 

thyroid therapy treatment on 

October 6, 2011. The patient 

had taken a pregnancy test on 

October 5, 2011, and results 

were negative. The patient 

discovered she was pregnant 

and contacted the licensee on 

October 26, 2011. It was 

determined that the embryo/

fetus was 10 days old at 

the time of treatment. 

The estimated dose to 

the embryo/fetus is 17.4 

cSv (rem). The State of 

Pennsylvania performed a 

reactive inspection to review 

the licensee’s procedures 

and investigate the event. 

No corrective actions were 

required beyond current 

practices.

Medical Event Involving 

High Dose Rate Remote 

Afterloader 

Date and Place: 

January 6, 2012, Toledo, Ohio

Event Details: The licensee 

reported a medical event 

involving a high dose rate 

afterloader (Varian, serial 

#VS0054) containing a 148.37 

GBq (4.01 Ci) iridium-192 

source. The patient was 

thought to have received 

four treatments to the cervix; 

each fraction prescribed 

400 cGy (rad). The physician 

noticed reddening of the 

skin to the upper thigh 

during examination on 

January 6, 2012. The licensee 

investigated the equipment 

and identified a constriction 

(corrosion) in the entry of 

the tandem used in the 

Fletcher Suite Device, where 

the device narrows at the 

end. It is believed that during 

the fourth fraction, when 

the catheter was inserted 

into the tandem, it snagged 

on the constriction causing 

the starting point of the 

source to be displaced by 9 

cm. Preliminary calculations 

indicate a skin dose of 1,251 

cGy (rad) to the right thigh 

and 1,273.9 cGy (rad) to the 

left, when no skin dose was 

intended. The dose to the 

treatment site during the 

fourth fraction was 194.2 cGy 

(rad) instead of the prescribed 

400 cGy (rad). The total dose 

to the treatment site from all 

four fractions was 

1,394.2 cGy (rad) instead of 

the prescribed 1,600 cGy (rad). 

The patient and referring 

physician were notified of the 

event. The licensee stated 

that the catheter used prior 

to the procedure is no longer 

made by Varian. The licensee 

was using a replacement 

catheter that was slightly 

larger in diameter and thicker 

than the original. The old 

catheter did not get caught 

on the constriction in the 

tandem, but the new catheter 

did. The licensee’s corrective 

actions included marking 

the new catheters to provide 

a visual indication of full 

insertion into the tandem

(General Contact: 

Angela R. McIntosh, FSME, 

301-415-5030 or 

Angela.McIntosh@nrc.gov)
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CITATION SUBJECT CONTACT PUBLISHED

76 FR 70913

“Retrospective Review Under Executive 

Order 13579”

(Initial plan for retrospective analysis of 

existing rules)

Cindy Bladey, ADM, 

301-492-3667 or 

Cindy.Bladey@nrc.gov November 16, 2011

76 FR 72082 “Miscellaneous Administrative Changes” 

(Final rule)

Angella Love Blair, ADM, 

301-492-3671 or

Angella.Love-Blair@nrc.gov

November 22, 2011

76 FR 76327

Installation of Radiation Alarms for 

Rooms Housing Neutron Sources” 

(Petition for rulemaking; request for 

comment)

Cindy Bladey, ADM, 

301-492-3667 or 

Cindy.Bladey@nrc.gov December 7, 2011

76 FR 76625

“Association of State and Territorial Solid 

Waste Management Officials; Denial of 

Petition for Rulemaking” (Petition for 

rulemaking; denial)

Gregory Trussell, FSME, 

301-415-6445 or 

Gregory.Trussell@nrc.gov

December 8, 2011

76 FR 77431

Decommissioning Planning During 

Operations” (Draft regulatory guide to 

request comments)

James C. Shepherd, FSME, 

301-415-6712 or 

James.Shepherd@nrc.gov

December 13, 2011

77 FR 3640

Withdrawal of Proposed Rule and 

Closure of Petition for Rulemaking: 

Organization of Agreement States and 

Florida Department of Health, Bureau 

of Radiation Control” (Withdrawal of 

proposed rule and closure of petition for 

rulemaking)

Solomon Sahle, FSME

301-415-3781, or 

Solomon.Sahle@nrc.gov January 25, 2012

SELECTED FEDERAL 

REGISTER NOTICES
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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 Vanessa.Cox@nrc.gov. 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 

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


UNITED STATES 

NUCLEAR REGULATORY COMMISSION

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