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LICENSEE NEWSLETTER

NUREG/BR-0117, No. 11-02 Spring 2011

Office of Federal & State Materials &

Environmental Management Programs

INSIDE THIS ISSUE

The 23rd Annual Regulatory 

Information Conference.............. 1

The NRC Blog .................................. 2

From the Desk of the 

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

Welcome and Farewell ................ 4

Decommissioning Financial 

Assurance......................................... 4

Safety Culture ................................. 5

Revisions to Medical 

Use Regulations............................. 6

Public Workshops on Medical 

Event Definition and Other 

Rulemaking Issues ....................... 7

Equipment Failure Causes Public 

Radiation Exposure....................... 7

Significant Enforcement 

Actions.............................................. 8

Generic Communications 

Issued...............................................10

Significant Events........................10

Selected Federal 

Register Notices...........................12

On March 8-10, 2011, the NRC 

held the 23rd Annual Regulatory 

Information Conference (RIC) 

at the Bethesda North Marriott 

Hotel and Conference Center 

in Rockville, MD. The 3-day 

conference was sponsored by 

the Office of Nuclear Reactor 

Regulation (NRR) and the Office 

of Nuclear Regulatory Research 

(RES). This year, the RIC drew 

rave reviews as the best attended 

conference to date. More than 

3,000 attendees from the nuclear 

industry, Congress, international 

agencies and members of the 

public gathered to discuss nuclear 

safety and security topics and 

significant regulatory activities.

The RIC began with opening 

remarks from NRR Director Eric 

Leeds, the keynote address by NRC 

Chairman Gregory Jaczko, and 

remarks from Executive Director 

for Operations William Borchardt. 

Over the course of the conference, 

others speakers included 

Commissioner Kristine Svinicki, 

Commissioner George Apostolakis, 

Commissioner William Magwood, 

Commissioner William Ostendorff, 

and many other senior NRC 

managers and technical experts, as 

well as industry representatives. 

In his keynote address titled, 

“Meeting Our Mission in 

Challenging Times,” Chairman 

Jaczko stated that, “For the first 

time since 2007, we open the RIC 

with a Commission operating 

at full strength...The RIC is an 

invaluable forum for us to share 

information and exchange views 

about recent developments and 

emerging issues central to nuclear 

safety and security...I want to 

highlight priority number one at 

the NRC – the safety and security 

of the existing reactor fleet and 

nuclear materials. As I have 

mentioned in many speeches 

throughout the year, we cannot 

allow complacency to take root in 

our regulatory culture. Whether 

through the Institute for Nuclear 

THE 23RD ANNUAL REGULATORY 

INFORMATION CONFERENCE
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Power Operations’ (INPO) efforts, 

licensee initiatives, or agency 

diligence, safety must be the 

number one priority.”

In two of the many informative 

sessions, the FSME staff presented 

discussions on radiation 

protection and low-level waste 

management. The radiation 

protection session addressed 

topics that included; the effects of 

the International Commission on 

Radiation Protection Publication 

103 on 10 CFR Part 20; and current 

initiatives relating to cesium-137 

chloride sources. Also, the session 

included a presentation on the 

Nuclear Energy Agency’s viewpoint 

on emerging issues in radiation 

protection and the radiation 

protection program at the U.S. 

Environmental Protection Agency. 

The session slides can be access at: 

https://ric.nrc-gateway.gov/docs/

abstracts/SessionAbstract_5.htm. 

The low-level waste management 

session addressed the NRC’s 

current and planned activities 

to update regulations and 

guidance on the disposal of lowlevel radioactive waste (LLW). 

The presenters discussed the 

current issues related to new 

emerging waste streams, such 

as large volumes of depleted 

uranium, as well as proposed 

waste management techniques, 

including large-scale blending 

of LLW. Additionally, the session 

included a discussion of options 

that the staff is considering for 

revising LLW regulations in

10 CFR Part 61, “Licensing 

Requirements for Land Disposal 

of Radioactive Waste,” to make 

them more risk informed and 

performance based, so that 

they closely reflect current and 

expected LLW management 

practices. The session slides 

can be access at: https://ric.

nrc-gateway.gov/docs/abstracts/

SessionAbstract_11.htm.

The conference also included a 

variety of technical posters and 

tabletop presentations, and tours 

to the NRC’s Incident Response 

Center.

THE NRC BLOG

On January 31, 2011, the NRC 

launched a new communications 

tool, The NRC Blog. The NRC 

Blog was established to increase 

collaboration 

and interaction 

with the public, 

in support 

of the Open 

Government 

initiative. The blog is intended to 

serve as a vehicle for informing 

stakeholders, raising awareness 

about the agency and its mission, 

and providing opportunity to 

hear from the public. The blog 

features posts from the NRC staff 

about various topics of interest to 

the public, as well as moderated 

public comments. 

The Office of Public Affairs 

administers and maintains the 

blog, works with bloggers to 

ensure that they understand 

and follow blog procedures 

and style, suggests topics of 

interest as appropriate, reviews 

posts for policy and legal issues 

and appropriateness, and edits 

posts to ensure the use of plain 

language. 

The NRC Blog is attracting 

thousands of readers who want 

to know more about the agency. 

In the first month, over 22,000 

people accessed the blog which 

included 13 posts and 83 posted 

comments. 

The NRC Blog does not replace 

formal communications, such 

as Federal Register notices or 

meeting notices, and will not 

accept allegations or comments 

on rulemakings. The complete 

comment guidelines are available 

on the blog.

The NRC Blog can be accessed 

directly at: http://public-blog.

nrc-gateway.gov or by clicking on 

the blog icon on the NRC website. 

It can also be accessed on mobile 

devices such as smart phones by 

entering the Web site address in 

the mobile devices’ Web browser.
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For more than 31 years, I have worked at the NRC. In that 

time, I have served in a number of staff and management 

positions. Early in my career, I worked primarily in the 

reactor arena, serving as a project manager, technical 

assistant, and first line supervisor. Later, I was fortunate 

enough to serve in several management positions including 

emergency response and radiation protection, and served 

as a Deputy Director for Incident Response Operations. I 

was also given the opportunity to be the Deputy Director 

for spent fuel licensing and inspection activities. In other 

words, I was lucky enough to be involved in issues and 

projects involving most of what NRC regulates.

That being said, I have really enjoyed the past 8 years of 

my career. Within this timeframe, I was selected as the 

Director of the Division of Industrial and Medical Nuclear 

Safety, and in October 2006, was given the privilege of 

being the first Director of the new Office of Federal and State Materials and Environmental Management 

Programs (FSME). 

In these past years, the nuclear materials and waste management programs have really matured. I am 

proud of what we have all accomplished to enhance public health and safety and protect the environment. 

Most of the credit for this is due to the consistent and strong performance of over 20,000 Agreement State 

and NRC licensees, the States and regions who work closely with those licensees, and the general public 

who plays such an important role in helping us stay on the right track and telling us when we are overregulating or not doing enough. 

Now, it is time for me to step down. Before I do, I would like to thank the FSME staff and management. I 

will always carry fond memories of you with me. Moreover, when we started this office in 2006, I was 

concerned about how the cultures of several different organizations (the former Office of State and Tribal 

Programs, and several divisions of the Office of Nuclear Materials Safety and Safeguards) might mesh. That 

concern quickly abated as all of the FSME staff and our management team collaborated nicely and we soon 

developed our own office identity. 

As my career was drawing to a conclusion, I was asked by Bill Borchardt, our Executive Director of 

Operations, to lead one last time. Following the events in Japan at Fukushima, I delayed my departure 

in order to lead a Task Force to determine what lessons that we might learn from the event and provide 

recommendations to the Commission about insights regarding the U.S. Reactor fleet, including any 

changes that should be made. So, I have come full circle, ending my career at the NRC where it started, 

in reactors.

It is always tough to leave a place where you have cultivated so many strong affiliations and lasting 

friendships. But I take consolation in knowing that as I retire, I leave the program in good hands. As always, 

I know you will keep public health and safety, and protection of the environment at the forefront of all that 

you do. Farewell.

Charles L. Miller, Director

FROM THE DESK OF 

THE FSME DIRECTOR
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WELCOME

Ms. Deborah Jackson

The FSME staff would like to 

welcome Ms. Deborah Jackson as 

the new Deputy Director, Division 

of Intergovernmental Liaison and 

Rulemaking, which was effective in 

March 2011.

Ms. Jackson joined the NRC in 1987 

as a project engineer in the Office 

of Nuclear Reactor Regulation 

(NRR). She has held a number of 

progressively more responsible 

positions in NRR, the Office of 

Nuclear Regulatory Research, 

and the Office of Nuclear Material 

Safety and Safeguards. Prior to 

joining the NRC, Ms. Jackson 

worked as a design engineer 

and construction inspector for 

the nuclear power industry. 

Ms. Jackson graduated with a 

bachelor’s degree in mechanical 

engineering from Howard 

University. 

The FSME staff is looking forward 

to working with Ms. Jackson.

FAREWELL

Mr. Mark Thaggard

The FSME staff would like to 

congratulate Mr. Mark Thaggard, 

the former Deputy Director, 

Division of Intergovernmental 

Liaison and Rulemaking, for his 

recent appointment as the new 

Deputy Director for Emergency 

Preparedness, Division of 

Preparedness and Response, Office 

of Nuclear Security and Incident 

Response, which was effective in 

March 2011. 

Mr. Thaggard joined the NRC in 

1989 as a hydrologist in the Office 

of Nuclear Material Safety and 

Safeguards (NMSS). He has held 

a number of progressively more 

responsible positions in NMSS, 

FSME, and the Office of New 

Reactors (NRO). Prior to joining 

the NRC, Mr. Thaggard worked 

for the Southwest Florida Water 

Management District and the U.S. 

Geological Survey. Mr. Thaggard 

received a bachelor’s degree in 

geology from the University of 

South Florida, a master’s degree 

in environmental science from the 

University of South Florida, and 

another master’s degree in applied 

mathematics and environmental 

engineering from John Hopkins 

University. 

The FSME staff wishes Mr. 

Thaggard all the best and knows 

that he will succeed in his new 

position.

DECOMMISSIONING 

FINANCIAL ASSURANCE

The Commission 

has approved 

a final rule 

to improve 

decommissioning 

planning and reduce the likelihood 

that a facility operating under its 

jurisdiction will become a “legacy 

site.” A legacy site is a common 

term used for a facility with an 

owner who cannot complete 

the decommissioning work for 

financial reasons. The final rule 

should be published in the Federal 

Register in late spring of 2011, after 

the Office of Management and 

Budget completes its review.

To reduce the number of future 

legacy sites and enhance 

assurance that adequate 

funding will be available for 

decommissioning each site, the 

final rule clarifies the actions 

that the licensees are required 

to perform during operations 

to minimize contamination 

of the site, and keep doses as 

low as reasonably achievable 

(ALARA) before, during, and after 

the decommissioning process. 

Licensees are already required 

by existing regulations to apply 

operating procedures and controls 

during facility operations to 

evaluate potential radiological 

hazards and minimize and control 

waste generation, consistent with 

ALARA principles. 
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The new rule clarifies that 

these ALARA principles require 

all licensees to conduct their 

operations to minimize the 

introduction of residual 

radioactivity into their sites, 

including subsurface soil and 

ground water. Currently,

10 CFR 20.1406 requires 

only applicants for standard 

reactor design certifications, 

standard design approvals, and 

manufacturing licenses to describe 

in their applications how their 

facility designs will “minimize, 

to the extent practicable, 

contamination of the facility 

and the environment, facilitate 

eventual decommissioning, 

and minimize, to the extent 

practicable, the generation of 

radioactive waste.” The new rule 

will amend this provision to apply 

it not only to those applicants, 

but to licensees with operating 

reactors and materials facilities as 

well. 

Certain 

operational 

events, such 

as slow, longterm leaks, 

particularly those causing 

subsurface soil and groundwater contamination, can 

significantly increase the cost of 

decommissioning. To assure that 

a facility’s decommissioning fund 

will adequately cover these costs, 

the owner must have a reasonably 

accurate estimate of the extent of 

residual radioactivity at the facility 

site. 

Currently, 10 CFR 20.1501(a) 

requires licensees to conduct 

radiation surveys that “may be 

necessary” and are “reasonable 

under the circumstances” to 

“evaluate the magnitude and 

extent of radiation levels; ... 

[c]oncentrations or quantities of 

radioactive material; and; ... [t]he 

potential radiological hazards.” The 

new rule will revise this provision 

by replacing its undefined term 

“radioactive material” with “residual 

radioactivity,” a term already 

defined in 10 CFR Part 20 to include 

subsurface contamination within 

its scope. 

When the new rule takes effect, 

both 10 CFR 20.1406(c) and

10 CFR 20.1501(a) will incorporate 

the term “residual radioactivity” to 

include subsurface contamination. 

These changes serve to reinforce 

the intended link between 

minimizing contamination and 

conducting surveys. Also, they 

are consistent with NRC policy 

that licensees conduct operations 

to minimize waste generation, 

which will later facilitate the 

decommissioning of the site. This 

clarification may require some 

licensees to perform site surveys 

to determine whether residual 

radioactivity is present in the 

subsurface soil or groundwater. 

Moreover, the licensees will 

maintain records of these surveys 

for decommissioning purposes. 

The final rule will also impose 

tighter controls on the financial 

instruments used to provide 

assurance that adequate 

funding will be available to 

cover decommissioning costs. 

Decommissioning power reactor 

licensees, for example, will have 

to report additional information 

on spent fuel management and 

storage costs. Among other 

things, the rule will eliminate 

the escrow account and line 

of credit as approved financial 

assurance mechanisms. It will also 

modify other financial assurance 

requirements, including those 

on self-guarantee of future 

decommissioning funding. 

(Contact: Robert MacDougall, 

FSME, 301-415-5175 or e-mail: 

Robert.MacDougall@nrc.gov)

SAFETY CULTURE

On March 7, 2011, the Commission 

approved the publication of a 

policy statement on safety culture. 

This policy statement, along with 

two other policy 

statements, 

“Freedom of 

Employees 

in the Nuclear Industry to Raise 

Safety Concerns Without Fear of 

Retaliation” (61 FR 24336; 

May 14, 1996) and “Policy 

Statement on the Conduct of 

Nuclear Power Plant Operations” 

(54 FR 3424; January 24, 1989), 

describes the Commission’s 

expectations on safety culture and 

emphasizes the importance that 

the NRC places on the development 

and maintenance of a positive 

safety culture for all NRC-regulated 

activities. In addition to approving 

the safety culture policy statement, 

the Commission directed the NRC 

staff to ensure that the individuals 

and organizations performing 

regulated activities have the 

necessary support to effectively 

employ the policy statement 

as they deem appropriate. The 

safety culture policy statement is 

scheduled to be published in the 

Federal Register after it is reviewed 

by the Office of Management and 

Budget.

The policy statement describes 

the Commission’s expectation 

that individuals and organizations 

establish and maintain a positive 

safety culture commensurate 

with the safety and security 

significance of their activities and 

the nature and complexity of 

their organizations and functions. 

This includes all licensees, 
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certificate holders, permit holders, 

authorization holders, holders 

of quality assurance program 

approvals, vendors and suppliers 

of safety-related components, and 

applicants for a license, certificate, 

permit, authorization, or quality 

assurance program approval, 

subject to NRC authority. The 

policy statement defines nuclear 

safety culture as the core values 

and behaviors resulting from a 

collective commitment by leaders 

and individuals to emphasize 

safety over competing goals to 

ensure protection of people and 

the environment. This definition 

includes safety and security 

issues. The policy statement 

also includes a set of traits that 

describe important areas of a 

positive safety culture, while 

acknowledging that other traits 

may also be important in a positive 

safety culture. The safety culture 

policy statement notes that the 

traits were not developed for 

inspection purposes. The traits 

included in the policy statement 

are: (1) Leadership Safety 

Values and Actions, (2) Problem 

Identification and Resolution, 

(3) Personal Accountability, (4) 

Work Processes, (5) Continuous 

Learning, (6) Environment for 

Raising Concerns, (7) Effective 

Safety Communication, (8) 

Respectful Work Environment, 

and (9) Questioning Attitude. The 

policy statement indicates that it is 

the Commission’s expectation that 

all individuals and organizations 

performing or overseeing 

regulated activities involving 

nuclear materials should take 

the necessary steps to promote a 

positive safety culture by fostering 

these traits as they apply to their 

organizations.

Information on safety culture 

and NRC activities relating to 

safety culture can be found at 

the NRC’s safety culture Web site: 

http://www.nrc.gov/about-nrc/

regulatory/enforcement/safetyculture.html. 

(Contact: James Firth, FSME, 

301-415-6628 or e-mail: 

James.Firth@nrc.gov)

REVISIONS TO MEDICAL 

USE REGULATIONS

Expanded 10 CFR Part 35 

Rulemaking

The NRC has begun to work on 

major revisions to the regulations 

governing the medical use of 

byproduct material regulations in 

10 CFR Part 35. In 2002, the NRC 

revised the 

entire medical 

use regulations; 

however, the 

training and 

experience requirements were 

not finalized until 2005. The 

revisions focused on those medical 

procedures that posed the highest 

risk to workers and patients. They 

were structured to be more riskinformed and performance based. 

In implementing the regulations 

in 10 CFR Part 35, the NRC staff 

and Advisory Committee on the 

Medical Uses of Isotopes (ACMUI) 

identified 28 issues that should 

be considered in the rulemaking 

process. These issues include 

several regulatory or technical 

complexities (e.g., amending 

preceptor attestation requirements 

and allowing assistant/associate 

radiation safety officers on a 

medical use license). In addition 

to the 28 identified issues, the 

proposed “expanded” rule will 

consider issues that were raised 

in a petition for rulemaking, the 

Ritenour petition (PRM-35-20). 

The proposed rule is due to the 

Commission by March 2012 and 

the final rule by September 2013.

Medical Event Definition 

Rulemaking

On August 6, 2008, the NRC 

published in the Federal Register 

(73 FR 45635) for public comment 

a proposed rule to modify both the 

written directive (WD) requirements 

in 10 CFR 35.40(b)(6) and the 

medical event (ME) reporting 

requirements in 10 CFR 35.3045 

for permanent brachytherapy 

implants to 

convert the dose 

results from 

dose-based to 

activity-based. 

Most of the 57 

comment letters received were 

primarily not supportive of the 

rulemaking. In 2008, the NRC 

received a substantial number of 

MEs involving permanent implant 

brachytherapy. Based on staff’s 

evaluation and an independent 

NRC medical consultant’s analysis 

of those MEs, the staff concluded 

that a number of them would 

not be categorized as MEs under 

the proposed rule. This would 

be inconsistent with the original 

regulatory intent. 

Additionally, the evaluation 

of the circumstances and data 

from the MEs reported in 2008 

prompted the staff to reevaluate 

the regulations related to the 

training requirements and time 

frames for licensees to assess the 

dose to the permanent implant 

brachytherapy treatment site. In 

SECY-10-0062, “Reproposed Rule: 

Medical Use of Byproduct Material 

– Amendments/Medical Event 

Definitions,” dated 

May 18, 2010, the staff 

recommended that a revised 

proposed rule be published for 

public comment. 

In SRM-SECY-10-0062, dated 

August 10, 2010, the Commission 

disapproved the staff’s 
7

recommendation to publish the reproposed rule. The Commission 

directed the staff to work closely 

with the Advisory Committee 

on the Medical Uses of Isotopes 

(ACMUI) and the broader medical 

and stakeholder communities 

to develop an event definition 

that will protect the interests of 

patients and allow physicians the 

flexibility to take actions that they 

deem medically necessary, while 

continuing to enable the agency 

to detect failures in process, 

procedure, and training, as well as 

any misapplication of byproduct 

materials by authorized users. 

Additionally, the staff was directed 

to hold a series of stakeholder 

workshops to discuss issues 

associated with the ME definition. 

Please see the information on the 

planned workshops in the article 

below.

(Contact: Neelam Bhalla, FSME, 

301-415-6843 or e-mail: 

Neelam.Bhalla@nrc.gov, for 

rulemaking, and Michael Fuller, 

FSME, 301-415-0620 or e-mail: 

Michael.Fuller@nrc.gov, for the 

workshops)

PUBLIC WORKSHOPS 

ON MEDICAL EVENT 

DEFINITION AND OTHER 

RULEMAKING ISSUES

The NRC will hold a series of public 

workshops to solicit stakeholder 

input on topics associated with 

the medical event (ME) definition, 

including sections involving 

reporting and 

notifications 

of MEs for 

permanent 

implant 

brachytherapy and other medical 

issues that are currently being 

considered for rulemaking.

The facilitated workshops will 

specifically cover the following 

issues:

• definition of medical event 

associated with permanent 

implant brachytherapy,

• relaxation of preceptor 

attestation requirements and 

extension of grandfathering to 

certain certified individuals,

• inclusion of the associate/

assistant radiation safety officers 

(RSOs) on NRC medical licenses,

• addition of molybdenum 

breakthrough testing and 

reporting requirements, 

• consideration of other items 

under rulemaking as identified in 

the Federal Register Notice (FRN).

The first 2-day workshop will be 

held on June 20, 2011, in New York, 

NY. The NRC also plans to hold a 

second 2-day workshop in August 

2011 in Houston, TX. The specific 

dates and location will be posted 

at http://www.blsmeetings.net/

NRCMedicalRulemakingWorkshop/ 

when the information becomes 

available. Each of the meetings 

will include a panel of participants, 

who will be selected in a 

convening process to represent 

the diversity of stakeholders. In 

addition to the panel, the NRC 

is encouraging attendance and 

participation by all interested 

individuals. The meeting 

agenda will specifically include 

opportunities for viewpoints to 

be expressed from individuals in 

attendance who are not members 

of the panel. The NRC plans to 

transcribe the meetings.

The meeting notice was published 

in the Federal Register (76 FR 29171)

and provided background 

information, issues that have been 

identified, and questions that have 

been posed by the NRC staff for 

consideration.

Information about the specific 

meeting venues, hotel 

accommodations, and access to 

public transportation is available 

on the Location/Lodging page, 

http://www.blsmeetings.net/

NRCMedicalRulemakingWorkshop/

location.cfm. We encourage you to 

keep checking the workshop’s Web 

site, http://www.blsmeetings.net/

NRCMedicalRulemakingWorkshop/, 

for the most current agenda and 

links to subsequent documents 

as they become available. 

Documents relevant to the 

workshop will also be continually 

posted on this site.

(Contact: Varughese Kurian, 

FSME, 301-415-7426 or e-mail: 

Varughese.Kurian@nrc.gov)

EQUIPMENT FAILURE 

CAUSES PUBLIC 

RADIATION EXPOSURE

On March 4, 2011, the NRC 

provided an inspection report to 

a licensee 

regarding an 

inspection 

that was 

conducted 

in response to an event that 

involved a malfunctioning fixed 

nuclear gauge. On December 17, 

2009, the licensee reported the 

event to the NRC indicating that 

high radiation levels were found 

in the vicinity of a fixed gauge, 

Berthold Technologies model 

LB-7440-D, which contained a 

cesium-137 source with an activity 

of 150 mCi. The high radiation 

levels were discovered when a 

radiation worker approached the 

gauge location to prepare for its 

relocation. The worker used a 

radiation survey instrument to 
8

measure the exposure in the area 

and found a reading exceeding 

200 mrem/hr. Normally, these 

gauges only emit radiation levels 

less than 1 mrem/hr. Two other 

survey instruments were used to 

verify that the radiation readings 

were correct. The radiation worker 

moved the shutter actuator of 

the gauge to the closed position, 

but the radiation field did not 

change. Therefore, the radiation 

worker left the area and contacted 

an authorized gauge service 

provider, Berthold Technologies, 

who dispatched a service engineer 

to perform repairs. The service 

engineer removed the source head 

of the gauge and discovered that 

the source capsule had become 

unscrewed from the source 

holder and had fallen into the 

tapered cylindrical hole intended 

to provide a pathway for the 

radiation beam. It was determined 

that the source holder became 

detached due to the absence of 

the lock washer, which the Sealed 

Source and Device Registry (SSDR) 

required to be placed between 

the sealed source and the source 

holder. 

The licensee had the source heads 

inspected on the other 43 fixed 

gauges of the same model that 

they possessed and found that 35 

of the gauges were missing the 

required lock washer. However, 

none of the sealed sources in the 

35 gauges were detached. In 

1991, the gauges were purchased 

from and the sources were 

installed by Berthold Systems 

Incorporated (BSI), which is no 

longer in business. The sealed 

source and interior of the failed 

gauge had apparently not been 

inspected or serviced since the 

original purchase and installation 

that occurred in 1991. Therefore, 

the absence of the lock-washers 

was not known to the licensee 

until after the investigation into 

the event that occurred on 

December 17, 2009. It should 

be noted that the licensee also 

hired a consultant to perform a 

dose assessment of the workers in 

the area and determined that six 

individuals, who were not radiation 

workers, received estimated doses 

in excess of the 100 mrem per year 

regulatory limit for members of the 

public. The six individuals’ doses 

ranged from 109 to 146 mrem. 

No immediate health effects 

were believed to result from their 

exposure. 

Due to this event, the NRC 

searched its event database 

for any similar events with the 

Berthold Technologies model 

LB-7440-D fixed gauge. The NRC 

has not determined that there is 

a generic issue or defect with this 

fixed gauge, but has determined 

that users of this gauge should 

be aware of this incident and the 

potential issues. More detailed 

information is discussed in NRC 

Inspection Report 03006794/2010-

001 dated March 4, 2011, 

(ML11066A002).

(Contact: Duane White, FSME, 

301-415-6272 or e-mail: 

Duane.White@nrc.gov)

SIGNIFICANT 

ENFORCEMENT ACTIONS

The NRC issued 

significant 

enforcement actions 

for failure to comply 

with regulations.

Carro & Carro Enterprises, Inc.

(EA-10-272)

On February 11, 2011, the NRC 

issued a Notice of Violation to 

Carro & Carro Enterprises, Inc. (CCE) 

for a Severity Level III violation 

involving CCE’s failure to obtain 

a specific NRC license to own 

and possess a portable moisture 

density gauge, which contained 

byproduct material. Specifically, 

from November 30, 2008, through 

June 28, 2009, CCE owned and/

or possessed byproduct material, 

a discrete radium-226 source 

contained in a portable moisture 

density gauge, without a specific 

license issued in accordance with 

NRC regulations. 

Superior Well Services, Ltd. 

(EA-10-077)

On February 8, 2011, 

the NRC issued an 

Immediately 

Effective Confirmatory Order to 

Superior Well Services, Ltd. (SWS) 

to confirm commitments made 

as a result of an Alternate Dispute 

Resolution (ADR) mediation 

session held on January 4, 2011. 

After receiving the NRC’s Notice 

of Violation and proposed civil 

penalty of $34,000 dated 

October 21, 2010, SWS requested 

an ADR to discuss the five 

violations that were categorized 

into two Severity Level (SL) III 

violations. The first SL III violation 

involved three violations related 

to the temporary loss of two 

radioactive well logging sources. 

The second SL III violation 

involved two violations related 

to the deliberate failure to 

conduct radiological surveys 

and the creation of inaccurate 

survey records. Prior to the ADR 

mediation session, SWS took a 

number of actions on their own 

to address the violations. These 

actions were intended to ensure 

that the corrective actions were 

effective and the lessons learned 

from these events were extended 
9

to the well logging industry. In 

recognition of these actions taken 

by SWS, as well as the corrective 

actions already taken, the NRC 

agreed to reduce the civil penalty 

originally proposed to $17,000. 

McConnell Dowell (American 

Samoa), Ltd. (EA-10-174)

On October 6, 2010, the NRC issued 

a Notice of Violation to McConnell 

Dowell (American Samoa), Ltd., 

for a Severity Level III violation 

involving the receipt, possession, 

and use of byproduct material 

without a specific or general 

license as required by 10 CFR 

30.3(a). Specifically, from 2008 to 

July 25, 2010, the licensee received, 

possessed and used two portable 

nuclear gauges in American 

Samoa, an area of exclusive Federal 

jurisdiction, without a specific 

license issued by the NRC. 

Chicago Testing Laboratory, Inc. 

(EA-10-113)

On August 24, 2010, the NRC 

issued a Notice of Violation to 

Chicago Testing Laboratory (CTL), 

Inc., for a Severity Level III violation 

involving the possession and use 

of byproduct material without a 

specific or general 

NRC license prior 

to conducting 

licensed activities in 

a non-Agreement 

State where the NRC 

maintains jurisdiction. Specifically, 

on multiple occasions between 

July 6, 2006, and August 30, 2009, 

CTL, an Agreement State licensee, 

possessed and used devices 

containing sealed sources in a 

non-Agreement State without a 

specific license. 

Medical

Sanford Medical Center

(EA-10-182)

On December 10, 2010, the NRC 

issued a Notice of Violation to 

Sanford Medical Center for a 

Severity Level III violation involving 

the failure to secure the high doserate remote (HDR) afterloader 

brachytherapy unit in accordance 

with License Condition 19.A 

and Section 3.3.1.1 of Standard 

Operating Procedure, NM-X2, 

“Radiation Safety Procedures for 

the Nucletron Microselectron 

HDR, Version 2.” Specifically, on 

June 15 through July 29, 2010, the 

licensee failed to secure the HDR 

afterloader unit from unauthorized 

use, removal or access from its 

storage area when the unit was 

not in use because a mechanical 

locking mechanism failed to 

function as designed, leaving the 

unit unsecured.

Bristol Hospital, Inc. (EA-11-008)

On February 17, 2011, 

the NRC issued a Notice 

of Violation to Bristol 

Hospital, Inc. for a Severity Level 

III violation involving the failure 

to notify the NRC Operations 

Center of two medical events, in 

accordance with 10 CFR 35.3045(c), 

which requires a report within the 

next calendar day of discovery. 

Specifically, on January 12, 2010, 

Bristol Hospital experienced two 

medical events involving patients 

receiving less than the intended 

prescribed dose during two 

different permanent prostrate 

brachytherapy seed implants. 

The administered doses differed 

from the prescribed doses by 50 

rem to an organ or tissue and the 

total doses differed by greater 

than 20% from the prescribed 

doses. As of March 1, 2010, Bristol 

Hospital personnel had information 

available to determine that those 

medical events had occurred on 

January 12, 2010, and should have 

therefore reported the events 

by March 2, 2010. However, the 

licensee did not verbally report 

the medical events to the NRC 

until June 2, 2010, when the NRC 

asked questions concerning the 

circumstances during an inspection.

Earth Engineers, Inc. (EA-10-062)

On June 28, 2010, the NRC issued 

a Notice of Violation to Earth 

Engineers, Inc., d.b.a. Heynen 

Engineers (EEI) for two Severity 

Level III violations. The first 

violation involved a failure to 

comply with the conditions 

of the NRC Order Revoking 

License, which was issued on 

June 4, 2009. Specifically, the 

licensee did not pay fees within 

30 days or transfer the licensed 

material to an authorized recipient 

within 60 days from the date of 

the Order. The second violation 

involved a failure to afford the 

NRC an opportunity to inspect 

the EEI facility, as required by 

10 CFR 19.14(a). Specifically, on 

October 7, 2009, the licensee did 

not provide the NRC access to 

the nuclear portable gauge to 

inspect the condition of the gauge. 

Between November 2, 2009, and 

January 27, 2010, the NRC made 

several attempts to contact the 

licensee, but the licensee did not 

provide access to the EEI facility. 

 Correction

In the 2010 winter edition of the 

FSME Licensee Newsletter, the 

company name of the significant 

enforcement action (EA-10-062) 

was erroneous stated. Earth 

Engineering, Inc. (EA-10-062) 

is retracted due to misprint of 

the licensee name.
10

Individual Actions

Mark M. Ficek (IA-10-028)

On September 2, 2010, the NRC 

issued an Order Prohibiting 

Involvement in NRC Activities 

(Effective Immediately) to Mr. Mark 

M. Ficek, president of Mattingly 

Testing Services, Inc., 

for multiple deliberate 

violations of NRC 

requirements and 

orders. The Order (IA-10-028) 

specified that Mr. Ficek was 

prohibited from engaging in all 

NRC-licensed activities for a period 

of 7 years, and that Mr. Ficek was 

required to notify the NRC upon 

initial involvement in NRC-licensed 

activities for an additional 3 years 

after the 7 year prohibition period 

expired. 

Specifically, the NRC found 

that Mr. Ficek, (1) failed to 

implement the requirements of 

Confirmatory Order (EA-08-271), 

which dispositioned a number 

of willful violations through 

alternative dispute resolution in 

2009, including conducting an 

assessment of the licensee’s safety 

programs and providing safety 

training to the licensee’s staff; (2) 

failed to establish and maintain 

a prearranged response plan 

with the local law enforcement 

agency (LLEA), as required by 

Increased Controls Order (EA-05-

090), Appendix B, Section IC-2(b); 

(3) provided false information 

material to an NRC inspector 

during a site visit on March 6, 2007, 

in violation of 10 CFR 30.10(a)(2), 

regarding the licensee’s effort to 

establish a prearranged response 

plan with the LLEA; (4) provided 

false information material to an 

NRC investigator while under oath 

on October 22, 2009, in violation 

of 10 CFR 30.10(a)(2), regarding 

the licensee’s effort to establish 

a prearranged response plan 

with the LLEA; and (5) violated 

the provisions of Confirmatory 

Order (IA-08-055) Section V.1 

which specified that Mr. Ficek was 

prohibited for 2 years from

the date of the Order

(March 6, 2009) from engaging in 

NRC-licensed activities. Although 

suspended from engaging in 

NRC-licensed activities for 2 years, 

Mr. Ficek (i) directed the activities 

of an NRC-required independent 

consultant; (ii) assumed the 

duties of the Radiation Safety 

Officer to determine the reporting 

requirements of an event involving 

a lost radiographic exposure 

device; (iii) applied, on behalf of 

the licensee, for reciprocity to 

use radioactive materials in an 

Agreement State pursuant to 

Mattingly’s NRC license; and (iv) 

continued to answer employees’ 

questions about radiation safety 

issues and purchased radiographic 

exposure devices.

The NRC’s enforcement program 

can be accessed at: http://www.

nrc.gov/about-nrc/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 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 Internet address for the NRC 

library of generic communications 

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

doc-collections/gen-comm.

Regulatory Issue Summary

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 25, 2011, the NRC 

issued RIS 2011-01, “NRC Policy 

on Release of Iodine-131 Therapy 

Patients Under 10 CFR 35.75 to 

Locations other than Private 

Residences,” to all NRC medicaluse licensees, NRC master 

material licensees, Agreement 

State Radiation Control Program 

Directors, and State Liaison Officers. 

(Technical Contact: Said Daibes, 

FSME, 301-415-6863 or e-mail: 

Said.Daibes@nrc.gov)

(General Contact: Angela McIntosh, 

FSME, 301-415-5030 or e-mail: 

Angela.McIntosh@nrc.gov)
11

SIGNIFICANT EVENTS

Administration of Iodine-131 to 

Embryo/Fetus

Date and Place: 

January 12, 2011, 

Portsmouth, 

Virginia

Event Details: The licensee 

reported that a pregnant patient 

received 3.7 GBq (100 mCi) of 

I-131 on January 12, 2011, from 

a thyroid ablation. She was given 

a pregnancy test just before 

the dose was administered and 

the result was negative. On 

January 27, 2011, it was determined 

that the patient became pregnant 

near the time of therapy. A dose 

calculation estimated that the dose 

to the embryo/ fetus was 21.3 cGy 

(rad).

Overdose of Y-90 Microspheres 

to Left Lobe of Liver

Date and Place: 

January 19, 2011, 

Philadelphia, 

Pennsylvania

Event Details: The 

licensee reported 

that a patient 

received 4.73 GBq 

(127.8 mCi) of Y-90 

microspheres (MDS Nordion Model 

TheraSpheres) to the left lobe of 

the liver, instead of the prescribed 

of 1.42 GBq (38.4 mCi). As a result, 

the left lobe of the liver received 

25,700 cGy (rad) instead of the 

intended 11,900 cGy (rad). The 

cause of the event was determined 

to be human error. There was a 

transcription error when the order 

form was prepared. The error 

was not recognized upon receipt 

of the Y-90, because the activity, 

as measured in a dose calibrator, 

was compared to the activity 

indicated on the order form rather 

than the activity on the written 

directive. The event may result in 

an increased risk of atrophy to the 

left liver lobe. Corrective actions 

included generating a computer 

spreadsheet that populates fields 

based on initial calculations, 

written directives, and order forms. 

In addition, several procedure 

modifications were implemented 

to ensure that the correct dosage is 

ordered and received.

Overdose of Y-90 Microspheres 

to Left Lobe of Liver

Date and Place: March 9, 2011, Ann 

Arbor, Michigan

Event Details: The licensee reported 

that a patient received a calculated 

dose of 15,940 cGy (rad) to the 

left lobe of the liver, instead of the 

prescribed dose of 7,440 cGy (rad). 

An authorized user (AU) planned 

two liver infusion treatments, using 

Y-90 microspheres (MDS Nordion 

Model Theraspheres), for a patient 

with unresectable hepatocellular 

carcinoma. The first treatment to 

the right lobe of the patient’s liver 

was successfully performed on 

December 15, 2010. The AU then 

ordered a 7,440 cGy (rad) dose for 

the left lobe of the patient’s liver. 

The medical physicist calculated a 

corresponding activity of 2.24 GBq 

(60.5 mCi) of Y-90 to be infused 

into the patient’s left liver lobe. 

However, in determining the Y-90 

activity needed, the physicist used 

the liver segment volumes for the 

right lobe and medial segment 

combined, instead of that for the 

left lobe. That error resulted in 

an over dose of approximately 

114.25% more than prescribed. 

Overdose of P-32 to Two 

Pediatric Patients

Date and Place: February 15, 2011, 

Dallas, Texas

Event Details: The licensee reported 

two medical events discovered 

as the result of a general chart 

review. The first event occurred 

approximately 4 months prior to 

the licensee’s report and the second 

event occurred approximately 

2 months prior to the licensee’s 

report. In the first event, the patient 

was administered a dose of 56,500 

cGy (rad) of P-32 

albumin, instead 

of the prescribed 

dose of 30,000 

cGy (rad). In the 

second event, the 

patient was administered a dose 

of 50,700 cGy (rad), instead of the 

prescribed dose of 20,000 cGy (rad). 

The doses were administered to 

tissue surrounding the extremity 

joints of the two patients. The 

licensee suspects that the 

radiopharmacy supplied incorrect 

concentrations of P-32. 

(Contact: Angela R. McIntosh, 

FSME, 301-415-5030 or e-mail: 

Angela.McIntosh@nrc.gov)
12

CITATION SUBJECT CONTACT PUBLISHED

76 FR 1100

Implementation Guidance for Distribution 

of Source Material to Exempt Persons and to 

General Licensees and Revision of General 

License and Exemptions; Draft Guidance 

Document for Comment 

Gary Comfort, FSME, 

301-415-8106 or e-mail: 

Gary.Comfort@nrc.gov

January 3, 2011

76 FR 6085

Draft Regulatory Guide, “Reporting and 

Recording Safeguards Events” (Notice of 

availability of draft guidance for public 

comment)

Phil Brochman, NSIR,

301-415-6557 or e-mail:

Phil.Brochman@nrc.gov

February 3, 2011

76 FR 6086

Draft Regulatory Guide “Applying for 

Enhanced Weapons Authority, Applying for 

Preemption Authority, and Accomplishing 

Firearms Background Checks under 10 

CFR Part 73” (Notice of availability of draft 

guidance for public comment)

Phil Brochman, NSIR,

301-415-6557 or e-mail: 

Phil.Brochman@nrc.gov

February 3, 2011

76 FR 6087

Draft Weapons Safety Assessment on the Use 

of Enhanced Weapons; Notice of Availability 

and Request for Comment

Phil Brochman, NSIR,

301-415-6557 or e-mail: 

Phil.Brochman@nrc.gov

February 3, 2011

76 FR 24831

Site-Specific Analyses for Demonstrating 

Compliance with Subpart C Performance 

Objectives (Notice of availability of 

preliminary proposed rule language and 

public meeting)

Andrew Carrera, FSME

301-415-1078 or e-mail:

Andrew.Carrera@nrc.gov

May 3, 2011

SUGGESTED FEDERAL 

REGISTER NOTICES
13

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

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