1

LICENSEE NEWSLETTER

NUREG/BR-0117, No. 09-04 Winter 2009

Office of Federal & State Materials &

Environmental Management Programs

INSIDE THIS ISSUE

Public Webpage on 

Low-Level Radioactive 

Waste and Source Disposal.....................1

Memorandum of Understanding 

with the Bureau of Land 

Management ...............................................1

NRC Licensee Inventory Reporting 

of Special Nuclear Material 

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

Safety and Security 

Culture............................................................2

From the Desk of the 

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

Significant Enforcement 

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

Generic Communications 

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

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

Selected Federal 

Register Notices...........................................8

Public Web Page on

Low-Level Radioactive

Waste and Source

Disposal

In a Staff Requirements 

Memorandum (SRM)-M090417, 

“Briefing on Low-Level Waste 

(LLW) Program, 9:30 a.m. and 

1:30 p.m., Friday April 17, 2009, 

Commissioners’ Conference Room, 

One White Flint North, Rockville, 

Maryland,” dated May 1, 2009, the 

Commission directed the NRC staff 

to work with the Organization of 

Agreement States and Conference 

of Radiation Control Program 

Directors to remind licensees of 

their regulatory responsibilities 

regarding the disposal of 

radioactive sources.

In response to the SRM, the FSME 

staff and a State of Washington 

representative developed a link 

on the FSME Web site to both 

address the disposal of radioactive 

sources and encompass many 

pertinent issues related to 

low-level radioactive waste 

(LLRW) disposal. The Web page 

places special emphasis on 

issues related to the disposal of 

LLRW or radioactive sources by 

materials licensees. The Web 

page consolidates information 

from existing NRC web pages 

into a single site that is easy to 

navigate. The Web page provides 

a definition for LLRW (such as 

what are unused and unwanted 

radioactive sources). The Web 

page also includes links on 

related topics such as acceptable 

methods of disposal for LLRW and 

radioactive sources, radioactive 

source recovery programs, decay 

in storage, transfer to authorized 

recipients, LLRW disposal sites, 

LLRW compacts, classes of LLRW, 

and who regulates LLRW. The 

LLRW and radioactive source Web 

page will be updated continuously 

in an effort to provide material 

licensees, stakeholders, and 

interested parties 

with the most recent 

regulations, guidance, 

and information on 

this most complex 

issue. This Web 

page was activated 

on January 29, 2010 

and can be found at 

http://nrc-stp.ornl.gov/

llrw.html.

(Contact: Michelle 

Beardsley, FSME, 

610-337-6942 

or e-mail: 

michelle.beardsley

@nrc.gov)

Memorandum of 

Understanding with

the Bureau of Land

Management

On November 30, 2009, 

the NRC and the Bureau 

of Land Management 

(BLM) signed a memorandum 

of understanding (MOU). The 

MOU provides an efficient means 

for both agencies to fulfill their 

National Environmental Policy 

Act (NEPA) requirements as they 

relate to NRC licensing actions and 

the BLM administration of public 

lands involving the development 

of uranium and thorium resources 

through in situ recovery (ISR). 

The MOU provides a framework 

for cooperation and coordination 

between the NRC and BLM that will 

encourage routine communication 

Classes

of

LLRW

Decayinstorage

Extended

storage

What is

LLRW?

Who

regulates

LLRW?

Who

generates

LLRW?

How can I

prevent/lessen the 

generation of 

LLRW?

How/Where

can I

dispose of

LLRW?

Transfer/

Shipment

Costs

Facilities and

Compacts

Regulation

and Guidance

What can I 

do with

Unwanted/

Disused

Radioactive

Sources?

Low-Level

Radioactive

Waste

(LLRW)
2

NRC Licensee Inventory 

Reporting of Special 

Nuclear Material and

Source Material

To all NRC 

licensees 

possessing 

1 gram or 

more of special 

nuclear material (SNM) (e.g., 

plutonium, uranium (U)-233 or 

U-235 contained in enriched 

uranium) or 1 kilogram or more 

of foreign obligated source 

material (SM) (e.g., natural 

uranium, depleted uranium or 

thorium) must report their physical 

inventory to the Nuclear Materials 

Management and Safeguards 

System (NMMSS) database 

annually. Moreover, licensees who 

possess between 1 gram and 350 

grams of SNM must report their 

physical inventory to the NMMSS 

database between January 1 and 

March 31 of each year. Licensees 

with more than 350 grams of SNM 

must continue reporting their 

physical inventory to NMMSS as 

previously performed, which is 

a minimum of once a year. To 

comply with the requirement 

to report a physical inventory, a 

licensee must complete and 

submit both a Material Balance 

Report (U.S. Department of Energy 

(DOE)/NRC Form-742) and a 

Physical Inventory listing 

(DOE/NRC Form-742c). These forms 

can be found on the NMMSS Web 

page at http://www.nmmss.com.

Licensees who possess 1 kilogram 

or more of foreign-obligated 

natural uranium, depleted uranium 

or thorium are also required to 

report their inventory of that 

material each year. In addition, 

some licensees must report 

their entire inventory of natural continued on page 4

at the national and local 

levels. Although the roles and 

responsibilities of the NRC 

and BLM are independent and 

separate, they have common 

elements that could be shared 

between the two agencies to 

save resources and time. The 

two agencies can implement the 

MOU when the NRC receives a 

license application, amendment, 

or renewal and BLM receives a plan 

of operations or a lease application 

for the same facility.

Implementation of the MOU will 

occur through meetings held 

to identify points of contact 

and to provide a forum for the 

exchange of data, analysis, and 

research. Both the NRC and BLM 

are committed to interagency 

coordination and are working to 

ensure that efficiencies are gained 

through using each agency’s area 

of expertise. The goal is that the 

first NEPA document issued for 

each in situ recovery site could be 

used as a reference for additional 

NEPA documents produced for 

that facility.

With the finalization of the MOU, 

greater cooperation between the 

agencies will be possible on the 

estimated 20 current and future 

applications that are on BLMmanaged lands. The maximum 

level of efficiency will be gained 

if applicants submit a plan of 

operations and an NRC license 

application simultaneously 

so that the timelines for the 

agencies’ NEPA reviews coincide 

and resources are aligned when 

the applications and plans are 

received.

(Contact: Alan Bjornsen, FSME, 

301-415-1195 or e-mail: 

Alan.Biornsen@nrc.gov)

uranium, depleted uranium or 

thorium to the NMMSS database 

each year. Licensees who may 

require additional clarification 

on reporting SM can find the 

information in Title 10 of the Code 

of Federal Regulations (10 CFR) 

40.64, “Reports,” and 10 CFR 150.17, 

“Submission to Commission of 

Nuclear Material Status Reports.” 

The links provided below will take 

you to the relevant regulations. 

Licensees can review and 

download copies of the relevant 

NRC regulations from the following 

links:

•	 Requirements for NRC licensees

to report inventories of SNM to 

the NMMSS database appear in 

10 CFR 74.13, “Material Status 

Reports,” at http://www.nrc.gov/

reading-rm/doc-collections/cfr/

part074/part074-0013.html 

•	 Requirements for NRC licensees

to report inventories of SM to 

the NMMSS database appear 

in 10 CFR 40.64 at http://

www.nrc.gov/reading-rm/

doc-collections/cfr/part040/

part040-0064.html 

•	 Requirements for Agreement

State Licensees to report 

inventories of SNM and SM to 

the NMMSS database appear 

in 10 CFR 150.17 at http://

www.nrc.gov/reading-rm/

doc-collections/cfr/part150/

part150-0017.html

(Contact: Brian Horn, NMSS, 

301-492-3122 or e-mail:

Brian.Horn@nrc.gov)

Safety and Security 

Culture

On November 6, 2009, the NRC 

published a draft safety culture 

policy statement in the Federal 

Register (74 FR 57525) for public 
3

In this quarter’s newsletter, I want to discuss safety culture. In 

recent years, the NRC has increased its focus on safety culture, 

and I see this emphasis continuing. The NRC considers safety 

culture as being important for ensuring safety, security, and 

the protection of the environment in the use of byproduct, 

source, and special nuclear materials. In general, we have 

found either weaknesses or deterioration in licensees’ safety 

culture at those facilities that have experienced problems 

with safety or security. A weak safety culture increases 

the likelihood of problems occurring and can increase the 

consequences of those problems that do occur. Because safety 

culture is a leading indicator of a licensee’s performance and 

has a bearing on public safety, the NRC has a responsibility to 

consider safety culture as part of its oversight responsibilities.

Although the phrase safety culture is being used more 

frequently today, it is not a new concept. On November 6, 

2009, the NRC published a draft policy statement on safety culture for public comment that will update and 

expand an existing policy statement that the NRC developed in 1989. Our goal is to make the policy statement 

more inclusive of the full range of activities regulated by the NRC and to better address security issues.

The draft policy statement introduces changes to the NRC’s definition of safety culture, defining it as “that 

assembly of characteristics, attitudes, and behaviors in organizations and individuals, which establishes that as 

an overriding priority, nuclear safety and security issues receive the attention warranted by their significance.” 

A strong safety culture is often described as having a “safety-first focus.” Characteristics of a strong safety culture 

include valuing safety over production, adhering to procedures, supporting conservative decision-making, 

maintaining a questioning attitude, and conducting problem identification and resolution. Many organizations 

have found that there is a strong business case to be made for emphasizing safety culture within their individual 

organizations because a “safety-first focus” can save money, create an environment where accidents are avoided, 

and provide other benefits.

The NRC expects licensees and other employers subject to our authority will establish and maintain a safetyconscious work environment in which employees are encouraged to raise safety concerns and feel free to raise 

concerns both to their own management and to the NRC without fear of retaliation. In a safety-conscious work 

environment, concerns are promptly reviewed, properly prioritized, appropriately resolved, and timely feedback 

is provided to those raising concerns. A safety-conscious work environment is an important part of a strong 

safety culture.

As the NRC proceeds to develop a final policy statement, the NRC also intends to develop a common definition 

of safety culture, and safety-culture-related language that can be used by the NRC, the Agreement States, 

licensees, and others involved with nuclear materials in the United States. To create such a common definition 

and terminology, the NRC will host several public workshops during the coming year. We hope that by 

developing a definition and terminology that can be widely used, we will make it easier for licensees to develop 

and maintain a strong safety culture. Information on the draft policy statement and the upcoming workshops 

can be found elsewhere in this newsletter. I look forward to reading your comments on the draft policy 

statement and to your participation in the upcoming workshops.

Charles L. Miller, Director

fromthedesk 

of the fsmedirector
4

these materials. Therefore, each 

licensee and certificate holder 

is responsible for developing 

and maintaining a positive 

safety culture which establishes 

that nuclear safety and security 

issues, as an overriding priority, 

receive the attention warranted 

by their significance. Therefore, 

licensees and certificate holders 

should foster a positive safety 

culture in their organizations and 

among individuals who oversee 

or perform regulated activities. 

However, as the regulatory agency, 

the NRC has an independent 

oversight role (through inspection 

and assessment processes) 

including addressing licensees’ and 

certificate holders’ performance 

related to areas important to 

safety culture. The draft policy 

statement indicates that the NRC 

will include the appropriate means 

to monitor safety culture in its 

oversight programs and internal 

management processes.

The NRC is 

planning to hold 

several public 

workshops on 

the draft policy statement and 

to develop safety-culture-related 

terminology that can be used by 

the NRC, the Agreement States, 

licensees, certificate holders, and 

others involved with the use of 

byproduct material. The NRC 

is seeking to use this common 

terminology in the development 

of a definition of safety culture 

and a high-level description of 

areas important to safety culture. 

On December 15, 2009 the NRC 

published and announced in the 

Federal Register (74 FR 66387) that 

it will conduct public workshops. 

The first workshop was scheduled 

for February 2-4, 2010, at or near 

the NRC Headquarters in Rockville, 

Maryland. Participation was also 

possible by teleconference and 

Internet connection. The NRC 

will consider public comments 

on the draft policy statement and 

from the workshops during the 

development of the final policy 

statement. Information on safety 

culture, the NRC activities relating 

to safety culture and the upcoming 

workshops can be found at the 

NRC’s safety culture website: 

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

regulatory/enforcement/safetyculture.html.

Additional information on the 

workshops can be found at 

the NRC Web site at http://

www.nrc.gov/public-involve/

public-meetings/index.cfm. If 

you are interested in attending 

the upcoming workshops, you 

may register with either of the 

following contacts: 

Alex Sapountzis (301-415-7822 or 

Alexander.Sapountzis@nrc.gov) or 

Maria Schwartz (301-415-1888 or 

Maria.Schwartz@nrc.gov).

(Contact: James Firth, FSME, 

301-415-6628 or e-mail: 

James.Firth@nrc.gov)

Significant

Enforcement

Actions 

The NRC issued significant 

actions to licensees, individuals, 

and non-licensees for failure to 

comply with a regulation.

Wal-Mart Stores, Inc. (EA-09-187) 

On October 28, 2009, the NRC 

issued a Notice of Violation to WalMart, Inc. (Wal-Mart) for a Severity 

Level III violation involving the 

failure to: (1) appoint an individual 

responsible for having knowledge 

of appropriate regulations and 

continued from page 2

comment, available for review 

at http://edocket.access.gpo.

gov/2009/pdf/E9-26816.pdf. 

The comment period is scheduled 

to close on March 1, 2010. The 

draft policy statement expands 

the Commission’s current policy 

on safety culture and provides 

the Commission’s expectations 

for individuals and organizations 

performing or overseeing 

regulated activities. The draft 

policy statement states that 

“it is the Commission’s policy 

that a strong safety culture is an 

essential element for individuals, 

both internal to the NRC and 

external, performing or overseeing 

regulated activities.” The draft 

policy statement proposes a 

revised definition of safety culture 

as “that assembly of characteristics, 

attitudes, and behaviors in 

organizations and individuals, which 

establishes that as an overriding 

priority, nuclear safety and security 

issues receive the attention 

warranted by their significance.” 

The changes in the definition were 

made (1) to produce a definition 

that is applicable to all licensees, 

certificate holders, and other 

organizations subject to NRC 

regulatory authority and (2) to 

clearly include security-related 

issues within the scope of the 

policy. 

The draft policy statement 

indicates that the Commission 

believes that, because licensees 

and certificate holders use or 

provide services related to the 

use of radioactive material, they 

bear the primary responsibility 

for safely handling and securing 
5

requirements to comply with 

the general license; (2) properly 

transfer and dispose of generally 

licensed devices; and (3) transfer 

generally licensed devices to 

another general licensee only 

if the devices remain in use at a 

particular location. Specifically, 

between October 2000 and 

January 2008, Wal-Mart did not 

appoint a radiation safety officer 

or other responsible individual 

to manage it’s general license 

program relative to tritium exit 

signs, improperly transferred or 

disposed of up to 2,462 tritium 

exit signs, and also transferred 

517 tritium exit signs from 

various Wal-Mart facilities to 

other Wal-Mart facilities, which 

were not authorized in a specific 

or general license.

Hematite Decommissioning 

Project (EA-09-084) 

On October 23, 2009, the NRC 

issued a Notice of Violation and 

Proposed Imposition of Civil 

Penalty in the amount of $16,250 

to Westinghouse Electric Company 

- Hematite Decommissioning 

Project for a Severity Level III 

violation involving the failure 

to implement 10 CFR 70.24 (a) 

requirements. Specifically, in 

March 2006, the licensee failed 

to maintain a criticality accident 

monitoring system which will 

energize clearly audible alarm 

signals when it removed the 

system from service without prior 

NRC authorization. In addition, 

the Notice of Violation included a 

second Severity Level III violation 

for which a civil penalty was not 

proposed, involving the failure 

to implement 10 CFR 70.9 (a) 

requirements. Specifically, on 

March 17, 2006, the licensee 

provided inaccurate information to 

the Commission when it informed 

the NRC that the Process buildings 

contained less than 250 grams of 

uranium-235, when in fact, as later 

determined in November 2008, 

the Process buildings contained 

an estimated 2,638 grams of 

uranium-235. This information 

was material to the NRC since it 

was used in part as the basis for 

granting a license amendment 

on June 30, 2006, revising the 

possession limits such that the 

criticality monitoring system could 

be disabled.

Langan Engineering & 

Environmental Services, Inc.

(EA-09-253) 

On October 13, 2009, the NRC 

issued a Notice of Violation 

to Langan Engineering & 

Environmental Services, Inc. 

for a Severity Level III violation 

involving the failure to control and 

maintain constant surveillance 

of licensed material as required 

by 10 CFR 20.1802. Specifically, 

on June 29, 2009, the licensee’s 

authorized user left unattended a 

portable moisture/density gauge 

in an unrestricted area for a short 

period of time. During the time 

that the licensee did not maintain 

control and constant surveillance 

of the gauge, it was damaged by 

construction equipment that was 

operating in the unrestricted area.

Medical 

Virtua Health System - 

West Jersey Hospital

(EA-09-212) 

On October 21, 2009, the NRC 

issued a Notice of Violation to 

Virtua Health System - West Jersey 

Hospital (Virtua) 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)(2).

Specifically, during patient setup 

on January 19, 2009, Virtua staff 

raised questions concerning the 

visualization and positioning of 

seeds in the prostate and there 

were no procedures to ensure 

resolution of the questions. As a 

result, all seeds were implanted 

outside the prostate.

Correction:

Ohio Valley Medical Center

(EA-09-182) 

On September 17, 2009, the 

NRC issued a Notice of Violation 

to Ohio Valley Medical Center 

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 (HDR) treatments. 

Specifically, on June 17, 2009 

and other occasions prior to 

that date, neither an authorized 

user (AU), nor a physician under 

the supervision of an AU and 

trained in the operation and 

emergency response for the unit, 

were physically present during 

continuation of HDR treatments. 

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 

Documents 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.
6

(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 one of these 

documents appears relevant to 

your needs and you have not 

received it, please call one of the 

technical contacts listed below. 

The Internet address for the NRC 

library of generic communications 

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

doc-collections/gen-comm. 

Bulletins 

None

Generic Letters 

None

Information Notices 

The NRC issues 

Information 

Notices (INs) 

to addressees 

to provide significant recently 

identified information 

about safety, safeguards, or 

environmental issues. Addressees 

are expected to review the 

information for applicability to 

their facilities and consider actions, 

as appropriate, to avoid similar 

problems. 

The NRC issued IN 2009-24, 

“Sources of Information 

Related to Potential Cyber 

Security Vulnerabilities” on 

October 13, 2009 to all holders of 

operating licenses or construction 

permits for nuclear power reactors 

or non-power (research or test) 

reactors under the provisions 

of Title 10 of the Code of Federal 

Regulations (10 CFR) Part 50, 

“Domestic Licensing of Production 

and Utilization Facilities; holders of 

operating licenses for Category I 

fuel cycle facilities, Category III fuel 

cycle facilities, conversion facilities, 

uranium recovery facilities, and 

enrichment facilities; holders of, 

and applicants for, combined 

licenses under the provisions 

of 10 CFR Part 52, “Licenses, 

Certifications, and Approvals for 

Nuclear Power Plants.” and holders 

of licenses for the following 

types of facilities undergoing 

decommissioning: nuclear power 

plants, non-power reactors, fuel 

cycle facilities, and uranium 

recovery facilities. 

(Technical Contact: F. Scot Sullivan, 

NSIR, 301-415-6107 or e-mail: 

Frederick.Sullivan@nrc.gov)

The NRC issued IN 2009-27, 

“Revised International Nuclear and 

Radiological Event Scale User’s 

Manual” on November 13, 2009 to 

all holders of an operating license 

or construction permit for a power 

reactor, test reactor or research 

reactor issued under 10 CFR Part 

50; holders of or applicants for 

an early site permit, standard 

design certification, standard 

design approval, manufacturing 

license, or combined license issued 

under 10 CFR Part 52 holders of 

a materials license, certificate, 

approval, or registration issued 

under 10 CFR Parts 30, 31 through 

36, 39, 40, 61, 70, 71, 72, and 76; 

and Agreement State Radiation 

Control Program Directors and 

State Liaison Officers. 

(Technical Contacts: 

Rebecca Sigmon, NRR, 

301-415-4018 or e-mail: 

Rebecca.Sigmon@nrc.gov

and Cynthia G. Jones, NSIR, 

301-415-0298 or e-mail: 

Cynthia.Jones@nrc.gov)

The NRC issued IN 2009-30, 

“Findings from the NRC Initiative 

to Assess Materials Licensees’ 

Compliance with the NRC 

Decommissioning Requirements” 

on November 6, 2009 to all NRC 

materials licensees, Agreement 

State Radiation Control Program 

Directors and State Liaison 

Officers. 

(Technical Contact: Mike McCann, 

Region III, 630-829-9856, or e-mail: 

Mike.McCann@nrc.gov)

Regulatory Issue Summaries 

The NRC provides 

Regulatory Issue 

Summary (RIS) as 

an informational 

document used to communicate 

with the nuclear industry on a 

broad spectrum of matters having 

generic applicability. It does not 

involve a request for action or 

information unless the request 

is voluntary. 

The NRC issued RIS 2009-14, 

“Licensing Approach for 

Uranium In Situ Recovery Facility 

Applications” on November 5, 

2009. The NRC issued this RIS to 

all holders of operating licenses 

for uranium in situ recovery (ISR) 

facilities and companies that 

have submitted applications to 

construct new ISR facilities or 

letters of intent to submit such 

applications; and to appropriate 

Agreement States for their 

information.

(Technical Contact: Bill Von Till, 

301-415-0598 or e-mail: 

Bill.VonTill@nrc.gov)

The NRC issued RIS 2009-15, 

“National Source Tracking System 

Annual Inventory Reconciliation” 

on December 3, 2009. The NRC 

issued this RIS to all licensees 
7

possessing Category 1 or 

Category 2 quantities of 

radioactive materials, Radiation 

Control Program Directors and 

State Liaison Officers.

(Contact: Angela R. McIntosh, 

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

Angela.McIntosh@nrc.gov)

Significant

Events

Event 1: Wrong 

Treatment Site 

Error Involving High Dose Rate 

Remote Afterloader

Date and Place: February 23, 2009, 

Pittsburgh, Pennsylvania

Nature and Probable Causes: 

Between February 23 and February 

27, 2009, the licensee reported that 

a female patient received a high 

dose rate mammosite treatment 

to the wrong site. The patient 

was to receive treatment twice a 

day for a total of 10 fractions with 

an expected dose of 3,400 cGy 

(3,400 rad) to the intended site. A 

dummy wire was inserted into the 

balloon to check and measure the 

tube length for dose calculations. 

A computerized tomography scan 

was performed daily to verify the 

position of the treatment site. 

After the treatment calculations 

were performed, reviewed, 

and approved, the treatment 

began on February 23, 2009. On 

February 27, 2009, a different 

therapy physicist was checking 

the patient’s charts and believed 

there may have been an error. 

On March 2, 2009, the original 

physicist checked the findings and 

discovered that there had been 

an error in the placement of the 

source during treatments. The 

source had not been fully inserted 

into the balloon, and was 3 cm 

from where it should have been. 

That incorrect source placement 

resulted in the tumor site only 

receiving 30% of the intended 

dose. An unintended site received 

the total treatment. The patient is 

being followed for any sequelae 

(pathological conditions) to the 

event. The oncologist discussed 

the event with the patient.

Event 2: Seed Displacement 

Results in Wrong Treatment 

Site Error

Date and Place: March 19, 2009, 

Voorhees, New Jersey

Nature and Probable Causes: 

On March 19, 2009, the licensee 

reported that I-125 seeds were 

implanted outside the target 

organ during a prostate seed 

brachytherapy implant procedure. 

The incident was discovered while 

the physicist conducted a post 

operative dosimetry analysis of the 

procedure. It was determined that 

none of the seeds were implanted 

in the prostate gland. The seeds 

retained their planned pattern 

grouping, with the superior 

end of the seed cloud being 

approximately 2 cm from the apex 

of the prostate gland. A dosimetric 

analysis of the computerized 

tomography (CT) image revealed 

all 93 seeds accounted for and 

a calculated dose to 90% of the 

target organ (prescription line) 

being 224 cGy (224 rad). The 

prescribed dose in the written 

directive was 14,500 cGy (14,500 

rad). The seeds appeared distal 

to the prostate and the dose 

appeared to have been maximally 

confined to soft tissue, including 

muscle and subcutaneous fat. A 

complete analysis was requested 

of the radiation oncologist, who 

was immediately informed. The 

license administrator and nuclear 

medicine manager were notified.

Event #3: Incorrect Isotope and 

Activity Ordered Resulting in 

Medical Event

Date and Place: December 29, 2008, 

New York (City Not Reported)

On December 29, 2008, a medical 

facility reported that a patient 

was prescribed 11.1 MBq (300 uCi) 

of I-123, but was administered 

72.5 MBq (1.96 mCi) of I-131. A 

referring physician requested 

an uptake study and scan to be 

followed by an I-131 therapy for 

thyrotoxicosis. The authorized 

user (AU) directed the secretary to 

schedule the uptake study using 

I-123. However, the secretary 

scheduled the patient for a whole 

body scan using I-131. On the day 

of the study, the nuclear medicine 

technologist took the patient’s 

history, which included the fact 

that she still had her thyroid. 

The technologist failed to seek 

clarification from the AU and did 

not review the AU’s approval. The 

technologist proceeded with the 

whole body study using the I-131. 

Upon discovery of the error, the AU 

had an uptake study performed. 

The AU notified the patient and 

referring physician. Results of the 

uptake study revealed that the 

patient was thyrotoxic. The AU 

prescribed a therapy dose of 370 

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

scheduling precipitated this event. 

The failure of the technologist to 

seek clarification and review the 

physician’s order caused the event. 

Corrective actions included a 

requirement for verification of the 

prescription by two technologists 

and the need to consult with 

the AU if there are any questions 

regarding the ordered procedure.

(Contact: Angela R. McIntosh, 

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

Angela.McIntosh@nrc.gov)
8

Selected Federal 

Register Notices 

List of Approved Spent Fuel 

Storage Casks: HI-STORM 100 

Revision 7 (AI71) (NRC-2009-0349), 

74 FR 52387, October 13, 2009.

(Contact: Neelam Bhalla, FSME, 

301-415-6843 or e-mail: 

Neelam.Bhalla@nrc.gov) 

Criminal Penalties: Unauthorized 

Introduction of Weapons (AI31) 

(NRC-2008-0458), 74 FR 52667, 

October 14, 2009.

(Contact: James E. Adler, OGC, 

301-415-1656 or e-mail: 

James.Adler@nrc.gov)

Draft Safety Culture Policy 

Statement: Request for Public 

Comments (NRC-2009-0485),

74 FR 57525, November 6, 2009.

(Contact: Alexander Sapountzis, 

OE, 301-415-7822 or e-mail: 

Alexander.Sapountzis@nrc.gov)

Draft Regulatory Guide: 

Issuance, Availability (DG-6008) 

(NRC-2009-0492), 74 FR 58318, 

November 12, 2009.

(Contact: Catherine R. Mattsen, 

FSME, 301-415-6264 or e-mail: 

Catherine.Mattsen@nrc.gov)

Administrative Changes: 

Clarification of the Location 

of Guidance for Electronic 

Submission and Other 

Miscellaneous Corrections (AI73) 

(NRC-2009-0397), 74 FR 62676, 

December 1, 2009.

(Contact: Angella Love Blair, ADM, 

301-492-3671 or e-mail: 

Angella.Love-Blair@nrc.gov)

State of Nevada; Denial of Portions 

of Petition for Rulemaking, 

Consideration of the Remaining 

Portions in the Rulemaking Process 

(NRC-2000-0026), 74 FR 64012, 

December 7, 2009. 

(Contact: Naiem S. Tanious, FSM E, 

301-415-6103 or e-mail: 

Naiem.Tanious@nrc.gov)

Unified Agenda of Federal 

Regulatory and Deregulatory 

Actions, 74 FR 64572, 

December 7, 2009.

(Contact: Michael T. Lesar, ADM, 

301-492-3663 or e-mail: 

Michael.Lesar@nrc.gov)

List of Approved Spent Fuel 

Storage Casks: HI-STORM 

100 Revision 7, Confirmation 

of Effective Date (AI71) 

(NRC-2009-0349), 74 FR 65679, 

December 11, 2009.

(Contact: Neelam Bhalla, FSME, 

301-415-6843 or e-mail: 

Neelam.Bhalla@nrc.gov)

Draft Technical Basis for 

Rulemaking Revising Security 

Requirements for Facilities Storing 

SNF and HLW; Notice of Availability 

and Solicitation of Public 

Comments (NRC-2009-0558),

74 FR 66589, December 16, 2009.

(Contact: Philip Brochman, NSIR, 

301-415-6557 or e-mail: 

Phil.Brochman@nrc.gov; or 

Rupert (Rocky) Rockhill, 

301-415-3734 or e-mail: 

Rupert.Rockhill@nrc.gov)

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