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LICENSEE NEWSLETTER

NUREG/BR-0117, No. 12-02 Summer 2012

Oce of Federal & State Materials &

Environmental Management Programs

INSIDE THIS ISSUE

Safety Culture Case Studies....... 1

The 24th Annual Regulatory 

Information Conference.............. 2 

FSME Staff Member Helping 

Others................................................ 2 

Transfer of Radioactive

Byproduct Materials .................... 2 

From the Desk

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

Significant Enforcement

Actions ...............................................7

Generic Communications

Issued .................................................9

Significant Events.......................... 9

Selected Federal Register 

Notices.............................................12

To Our Readers.............................13

The NRC has developed 

Safety Culture Case Studies to 

illustrate past events in which 

the presence or absence 

of a positive safety culture 

significantly contributed to 

the outcome of the event. The 

review of the circumstances 

and results of the 

investigations of these events 

are clear examples in which a 

positive safety culture helped 

to lessen consequences, 

and a weak safety culture 

contributed or exacerbated 

the causes and consequences 

of the event.

These case studies are 

learning tools. Those of 

us who are responsible for 

regulating or using radioactive 

material in a safe and secure 

manner should not become 

complacent and should be 

open to learning from the 

mistakes and problems others 

have faced in an effort to 

prevent recurrences. The 

case studies selected for this 

initiative represent a number 

of industries, including energy, 

construction, medical, and 

transportation.

The NRC has also developed 

a Safety Culture User Guide 

to help individuals and 

organizations apply lessons 

learned from the various 

case studies more effectively. 

The User Guide will provide 

readers with a better 

understanding of why a strong 

safety culture and safety-first 

focus are critically important. 

The NRC recommends that 

readers review the User Guide 

prior to reviewing the case 

studies.

Currently, the following four 

case studies are available 

on the NRC’s Safety Culture 

Web site at http://www.nrc.

gov/about-nrc/regulatory/

enforcement/safety-culture.

html:

•	Collision of Two Washington, 

D.C. Metropolitan Area Transit 

Authority Metrorail Trains

•	US Airways Flight 1549: Forced 

Landing On the Hudson

•	Partial Collapse of the Willow 

Island Cooling Tower

•	Upper Big Branch Mine 

Explosion - 29 Lives Lost

Additional case studies are 

under development and will 

be added to the Web site as 

they are completed.

SAFETY CULTURE CASE STUDIES
2

Also, the NRC’s Safety 

Culture Web site includes 

additional information about 

the safety culture policy 

statement including relevant 

background documents, 

safety culture brochure, 

Federal Register notices, and 

presentations made at public 

meetings, as well as other 

outreach activities.

(Contact: Cindy Flannery, 

FSME, 301-415-0223 or 

Cindy.Flannery@nrc.gov)

THE 24TH ANNUAL 

REGULATORY INFORMATION 

CONFERENCE

On March 13-15, 2012, the 

NRC held the 24th Annual 

Regulatory Information 

Conference (RIC) at the 

Bethesda North Marriott 

Hotel and Conference Center 

in Rockville, MD. The NRC’s 

Office of Nuclear Reactor 

Regulation (NRR) and Office 

of Nuclear Regulatory 

Research sponsored the 3-day 

conference. The RIC attracted 

more than 3,000 attendees 

from over 33 countries. 

The attendees included 

government, industry, 

international agencies and 

other interested stakeholders 

and members of the public 

who assembled to discuss 

nuclear safety and security 

initiatives and developments 

in the regulatory arena. 

NRC Chairman Gregory B. 

Jaczko delivered the keynote 

address, “Moving Forward for 

Safety.” NRC Commissioners 

Kristine L. Svinicki, George 

Apostolakis, William D. 

Magwood, and William C. 

Ostendorff also provided 

comments, along with Bill 

Borchardt, NRC’s Executive 

Director for Operations, and 

Eric Leeds, Director of NRR. 

The conference included 

sessions addressing the 

significant domestic 

and international issues 

associated with operating 

reactors, new and advanced 

reactors, fuel cycle facilities, 

nuclear security, safety 

research, and safety culture 

policies. One of the sessions 

discussed the Fukushima 

Dai-ichi accident and NRC’s 

response to lessons learned 

such as seismic and station 

blackout events, flooding and 

ventilation issues, emergency 

preparedness and incident 

response, as well as research 

and regulation of spent fuel 

storage, handling, and safe 

disposition from nuclear 

power reactors. The agenda 

also offered a broad variety of 

technical poster and tabletop 

presentations. 

FSME STAFF MEMBER 

HELPING OTHERS

The FSME staff is making a 

difference in the community. 

Mr. Gregory Suber, FSME 

Branch Chief, participated in 

a local high school’s Senior 

Mock Interview Day. The 

purpose of the event was to 

provide graduating seniors 

with an authentic interview 

experience before they leave 

high school. For many of 

the students, this was their 

first time participating in a 

professional interview, so 

this was a very meaningful 

experience for them. The 

event was sponsored by the 

School to Career Transition 

program. It was designed 

to fulfill a Maryland State 

graduation requirement to 

help prepare students for 

success in college and the 

world of work. 

TRANSFER OF RADIOACTIVE 

BYPRODUCT MATERIALS

From recent inquiries, the 

FSME staff has developed 

a discussion on the 

circumstances under which 

radioactive byproduct 

materials may be transferred 

to unlicensed persons, 

specifically to persons who 

are exempt from licensing 

under the Title 10 Code 

of Federal Regulations 
3

Now that I am settled into this position, I have had the 

opportunity to experience firsthand and appreciate the broad 

range of issues and programmatic responsibilities that FSME 

faces on a daily basis. Since my start in October 2011, we 

have accomplished a lot. A few of these accomplishments 

include preparing the final rule for the physical protection 

of byproduct material (10 CFR Part 37), providing 

recommendations to the Commission for policy and technical 

direction to revise radiation protection regulations and 

guidance, and providing recommendations to the Commission 

on regulatory changes to the medical event definition for 

permanent implant brachytherapy programs.

In addition to providing recommendations to the Commission, 

in late April 2012, the staff briefed the Commission on its 

recommendations to make a regulatory change to the medical 

event definition for permanent implant brachytherapy 

programs. I would like to take this time to thank the Advisory Committee on the Medical Uses of Isotopes and 

the broader medical and stakeholder community for their help in developing these recommendations. The 

collaborative effort used to develop these recommendations is another example of how important it is to work 

with our State partners to achieve a common goal. 

In early April 2012, the Organization of Agreement States and the Conference of Radiation Control Program 

Directors (CRCPD) briefed the Commission on several topics that are of great interest to the States. In late

April 2012, I attended NRC’s Agency Action Review Meeting (AARM); the AARM is an annual meeting where NRC 

senior managers meet to discuss NRC licensee performance and evaluate the process used by the agency to 

ensure the operational safety performance of nuclear licensees. Also, we just completed our annual assessment 

of the Agreement State program, and we appreciate the great work of our regulatory partners.

An open and collaborative relationship with our State partners is very important to me. As a reminder, the 

NRC, along with all Federal agencies, has implemented the Administration’s Open Government (OG) initiative. 

The NRC has an OG section on its public Web site at http://www.nrc.gov/public-involve/open.html. As part 

of this initiative, the agency has expanded the number of datasets made publicly available to enhance the 

transparency of what we do. We hope that you will take a moment to visit the site and provide comments on 

how the NRC and FSME can continue to operate in an open and transparent manner.

Certainly, we appreciate the support we received from the States, Health Physics Society, and CRCPD regarding 

NRC’s safety culture policy statement. We are pleased that these organizations have embraced this important 

initiative of outreach and education to emphasize safety over competing goals.

Thank you for all of your efforts to ensure the public health and safety and protection of the environment in all 

operations involving regulated nuclear materials.

Mark A. Satorius, Director

FROM THE DESK OF 

THE DIRECTOR
4

(10 CFR) 30.14, “Exempt 

Concentrations” and 

10 CFR 30.18, “Exempt 

Quantities.”

In 10 CFR Part 30, “Rules 

of General Applicability 

to Domestic Licenses of 

Byproduct Material,” the 

regulation contains a number 

of provisions that exempt 

the end user from licensing 

requirements, which are 

called “exemptions.” Among 

these are general materials 

exemptions which allow the 

use of many radionuclides in 

many chemical and physical 

forms subject to limits on 

activity, and which are 

specified in 10 CFR 30.14 and 

10 CFR 30.18.

Exempt Concentrations

Section 30.14 of 

10 CFR Part 30 provides 

an exemption from the 

requirements for a byproduct 

materials license 

to any person 

who receives, 

possesses, uses, 

transfers, owns 

or acquires 

products or 

materials 

containing byproduct material 

in concentrations not in excess 

of those listed in

10 CFR 30.70, “Schedule A--

Exempt Concentrations.” (Note, 

however, in paragraph (b) of 

this section, the exemption 

does not authorize the import 

of byproduct material or 

products containing byproduct 

material.)

Paragraph (c) of 10 CFR 30.14 

provides that a manufacturer, 

processor, or producer of a 

product or material is exempt 

from the requirements 

for a license to the extent 

that this person transfers 

byproduct material contained 

in a product or material in 

concentrations not in excess of 

those specified in 10 CFR 30.70 

and which was introduced 

into the product or material 

by a licensee holding a 

specific license issued by 

the Commission expressly 

authorizing such introduction. 

However, the exemption does 

not allow the manufacturer 

to transfer the byproduct 

material if contained in any 

food, beverage, cosmetic, 

drug, or other commodity or 

product designed for ingestion 

or inhalation by, or application 

to, a human being. Paragraph 

(d) of 10 CFR 30.14 specifies 

that no person may introduce 

byproduct material into a 

product or material knowing 

or having reason to believe 

that it will be transferred 

to persons exempt under 

this section or equivalent 

regulations of an Agreement 

State, except in accordance with 

a license issued by NRC under 

10 CFR 32.11, “Introduction of 

Byproduct Material in Exempt 

Concentrations into Products 

or Materials, and Transfer of 

Ownership or Possession: 

Requirements for License.”

Section 32.11 of 10 CFR 32, 

“Specific Domestic Licenses 

to Manufacture or Transfer 

Certain Items Containing 

Byproduct Material,” 

prescribes the requirements 

for the issuance of specific 

licenses (i.e., an Exempt 

or E-distribution license) 

to persons who introduce 

byproduct material in exempt 

concentrations into a product 

or material owned by or in 

the possession of the licensee 

or another and specifies the 

regulations governing holders 

of such licenses. Applicants 

for a 10 CFR 32.11 license need 

to have a possession license 

for the byproduct material. In 

addition, they must provide 

a description of the product 

or material; its intended use, 

method of introduction, 

initial concentration; control 

methods, estimated time 

interval between introduction 

and transfer, and estimated 

concentration at the time 

of transfer. Further, the 

applicant must provide 

reasonable assurance that the 

concentrations at the time 

of transfer will not exceed 

the limits, reconcentration 

is not likely, use of lower 

concentrations is not feasible, 

and the product or material is 

not likely to be incorporated in 

any food, beverage, cosmetic, 

drug or other commodity 

or product designed for 
5

ingestion or 

inhalation by, 

or application 

to, a human 

being. 

Sections 

32.12, 

“Records 

and Material 

Transfer Reports,” and 32.13, 

“Prohibition of Introduction,” 

of 10 CFR Part 32 apply to 

distributors of these products.

An example of a situation 

in which these regulations 

might be applied would 

be if an oil refinery wishes 

to conduct a tracer study 

within certain equipment 

to identify potential process 

problems or determine other 

process characteristics. In this 

example, a licensee, who holds 

a NRC E-distribution license 

and an NRC or Agreement 

State possession license and 

is specifically authorized to 

conduct tracer studies, which 

may be the refinery or another 

specifically licensed company, 

introduces a quantity of 

labeled tracer into the process 

equipment, which is diluted by 

the large volume of product, 

and takes product samples 

downstream to analyze 

for process characteristics. 

The “contaminated” 

product, which the licensee 

has confirmed contains 

concentrations less than the 

limits specified in 10 CFR 30.70, 

may then be transferred, under 

10 CFR 32.11, to unlicensed 

persons (exempt under 

10 CFR 30.14). Any person who 

subsequently receives and 

transfers the product following 

the initial transfer is also 

exempt under 

10 CFR 30.14.

Exempt Quantities

Section 30.18 of 

10 CFR Part 30 provides 

an exemption from the 

requirements for a byproduct 

materials license to the 

extent that such person 

receives, possesses, uses, 

transfers, owns or acquires 

byproduct material in 

individual quantities, each 

of which does not exceed the 

applicable quantity set forth 

in 10 CFR 30.71, “Schedule B.” 

(However, paragraph (e) of 

this section prohibits persons, 

for purposes 

of producing 

an increased 

radiation level, 

from combining 

quantities of byproduct 

material covered under 

the exemption so that the 

aggregate quantity exceeds 

the limits.)

It is important to note that 

paragraph (c) of 10 CFR 30.18, 

“Manufacture, Distribution 

and Transfer of Exempt 

Quantities of Byproduct 

Material: Requirements for 

License,” specifies that the 

exemption does not authorize, 

for purposes of commercial 

distribution, the production, 

packaging, repackaging, 

or transfer of byproduct 

material or the incorporation 

of byproduct material into 

products intended for commercial 

distribution. (The exemption in 

10 CFR 30.14 does not include this 

prohibition.) Paragraph (d) of 

10 CFR 30.18 prohibits persons, 

for purposes of commercial 

distribution, from transferring 

“exempt” quantities of 

byproduct material, knowing 

or having reason to believe 

that the byproduct material 

will be transferred to persons, 

except in accordance with a 

license issued by NRC under 

10 CFR 32.18. Section 32.18 

of 10 CFR Part 32 prescribes 

the requirements for the 

issuance of specific licenses 

(E-distribution licenses) 

to persons who wish to 

manufacture, process, 

produce, package, repackage, 

or transfer quantities of 

byproduct material for 

commercial distribution to 

persons exempt under 

10 CFR 30.18 or the equivalent 

regulations of an Agreement 

State. Paragraph (a) of 

10 CFR Part 32 requires 

applicants to have a 

possession license for the 

byproduct material. Paragraph 

(b) of 10 CFR Part 32 specifies 

that the byproduct material 

may not be contained in any 

food, beverage, cosmetic, 

drug, or other commodity 

designed for ingestion or 

inhalation by, or application 

to, a human being. Paragraph 

(c) of 10 CFR Part 32 specifies 

that the byproduct material 

must be in the form of 

processed chemical elements, 

compounds, or mixtures, tissue 

samples, bioassay samples, 

counting standards, plated 

or encapsulated sources, or 

similar substances, identified 

as radioactive and is intended 

to be used for its radioactive 
6

properties. The paragraph 

further stipulates that the 

byproduct material may not 

be incorporated into any 

manufactured or assembled 

commodity, product, or device 

intended for commercial 

distribution. Paragraph (d) 

of 10 CFR Part 32 requires 

the applicant to submit 

copies of prototype labels 

and brochures that must be 

included with the byproduct 

material when transferred.

Sections 32.19, “Conditions of 

licenses,” and 32.20, “Records 

and material transfer reports” 

of 10 CFR Part 32 also apply 

to commercial distributors of 

exempt quantities. Section 

32.19 of 10 CFR Part 32 sets 

forth license conditions that 

specify limits on transfer 

and what may constitute 

an individual “quantity.” 

This section also specifies 

container labeling criteria and 

other information that must 

accompany the product when 

transferred to an unlicensed 

person. Section 32.20 of 

10 CFR Part 32 requires 

licensees to maintain the 

records and 

describes 

the type of 

information 

that must 

be included in the reports 

that are submitted annually to 

NRC.

The most common products 

authorized for distribution 

under 10 CFR 32.18 are 

plastic encapsulated “check” 

or calibration sources which 

are used to verify radiation 

detection instrument 

operability. Although 

the term “commercial 

distribution” is not defined in 

the regulations, the term has 

been interpreted in guidance 

such that commercial transfer 

of a product refers to the 

introduction of a material into 

the marketplace, whether or 

not a charge is assessed for 

that distribution. Commercial 

benefit does not necessarily 

include a monetary exchange. 

An important difference to 

note regarding commercial 

distribution of exempt 

quantities is that, while the 

regulations in of 

10 CFR Part 30 for all other 

exempt products only require 

an NRC license for initial 

transfer of the products, (i.e., 

a license is not required for 

all subsequent transfers); 

all commercial transfers 

(including finished product 

retransfers) of exempt 

quantity products must be 

authorized by an NRC license. 

While commercial distribution 

must be authorized under a 

specific NRC license, section 

30.18 of 10 CFR 30 does allow 

licensees and others to make 

non-commercial transfers 

of byproduct material in 

individual 

quantities, each 

of which does 

not exceed the 

applicable quantity set forth in

10 CFR 30.71 to unlicensed 

individuals. The Statements of 

Considerations published in the 

Federal Register (35 FR 6426-6427; 

April 22, 1970), for the final rule 

established 10 CFR 30.18, which 

contains the following statement 

to clarify this allowance: 

“Persons holding an Atomic 

Energy Commission or an 

Agreement State byproduct 

material license authorizing 

manufacture, processing, 

or production of byproduct 

material are authorized under 

the exemption to make 

transfers, on a noncommercial 

basis, of exempt quantities of 

byproduct material possessed 

under the license, on an 

exempt basis. This provision is 

designed to accommodate the 

occasional transfers between 

laboratories of small quantities 

of byproduct material in tissue 

samples, bioassay samples, 

tagged compounds, counting 

standards, etc., which involve 

a negligible risks.” A typical 

example might be a hospital 

which transfers a tissue 

sample from a patient who 

had been treated for thyroid 

ablation with iodine-131 to 

an unlicensed pathology 

laboratory for testing after 

confirming that activity 

of iodine-131 in the tissue 

sample is less than the 

allowed limit.

Frequently, some confusion 

exists regarding exempt 

concentrations and quantities. 

Specifically, the misperception 

is that the limits create a 

“threshold” below which 

licensed material is no longer 

subject to licensing. This is 

an incorrect assumption. In 

addition, sections 30.11 and 

30.18 of 10 CFR Part 30 do not 

provide an authorization for 

a licensee to transfer licensed 

material at or below the limits 

specified in the regulations 
7

to an unlicensed person 

for disposal. Note that if a 

specific licensee receives an 

exempt quantity, product or 

material containing an exempt 

concentration, the license is 

subject to the requirements of 

10 CFR Part 20, “Standards for 

Protection Against Radiation,” 

(e.g., waste disposal). No 

exemption is allowed from the 

requirement of 

10 CFR Part 20 in 

10 CFR 30.14 or 10 CFR 30.18.

(Contact: Carrico, J Bruce, 

FSME, 301-415-7826 or 

JBruce.Carrico@nrc.gov)

SIGNIFICANT ENFORCEMENT 

ACTIONS

The NRC issued significant 

enforcement actions for failure 

to comply with regulations.

Humboldt Scientific, Inc. 

(EA-11-138) 

On March 8, 2012, the NRC 

issued a Notice of Violation 

to Humboldt Scientific, Inc. 

(HSI) for two Severity Level 

III problems. 

The problems 

involved a 

failure to obtain appropriate 

license authorization to 

export byproduct materials 

to restricted and embargoed 

destinations and a failure 

to submit annual reports 

of all americium shipments 

in accordance with 

10 CFR 110.54(b). Specifically, 

on May 6, 2005, May 7, 2008, 

June 26, 2008, and 

July 31, 2008, HSI exported 

americium-241 and cesium-137 

byproduct materials subject to 

NRC licensing jurisdiction, to 

embargoed destinations (i.e., 

Iraq and Sudan, respectively), 

without a specific license 

as required by 10 CFR 110.5. 

Even though americium 

exports were performed, HSI 

failed to make annual reports 

of americium exports for 

calendar years 2000-2009.

S&R Engineering S.E. 

(EA-11-098)

On January 13, 2012, the 

NRC issued a Notice of 

Violation and Proposed 

Imposition of a Civil Penalty 

in the amount of $14,000 to 

S&R Engineering (S&R) for a 

Severity Level (SL) III problem 

and two SL III violations. The 

SL III problem involved two 

violations: (1) S&R failed to 

comply with or respond to 

an NRC Order, as required by 

10 CFR 2.202(b); and (2) S&R 

provided information to the 

NRC that was not complete 

nor accurate as 

required by 

10 CFR 30.9(a). 

Specifically, as of 

January 13, 2012, 

S&R had not 

submitted an 

answer to the Order (which 

was required by November 

28, 2009), had not paid the 

license fee, and had not 

disposed or transferred their 

licensed nuclear material 

to an authorized recipient. 

On August 3, 2010, the S&R 

president informed the NRC 

that S&R had transferred its 

portable moisture density 

gauge containing radioactive 

sources to another NRC 

licensee when S&R still 

possessed the gauge. The 

two additional SL III violations 

involved S&R’s failure to afford 

the NRC an opportunity to 

inspect materials, activities, 

and records under the 

regulations as required by 

10 CFR 19.14(a) and S&R’s 

failure to use a minimum of 

two independent controls that 

formed tangible barriers to 

secure portable gauge from 

unauthorized removal, when 

the portable gauge was not 

under S&R’s direct control 

and constant surveillance as 

required by 10 CFR 30.34(i). 

Specifically, on August 3, 2010, 

S&R provided inaccurate 

information to the NRC about 

the location of licensed 

material, thereby preventing 

inspection of its licensed 

activities. The gauge had 

been stored in its shipping 

case, which was located in an 

unlocked closet of a locked 

S&R office, providing only one 

barrier.

Universal Product Concepts, Inc. 

(EA-11-222)

On January 9, 2012, the NRC 

issued a Notice of Violation 

and Proposed Imposition of 

a Civil Penalty in the amount 

of $7,000.00 to Universal 

Product Concepts, Inc. (UPC) 

for a Severity Level III problem. 

The problem involved two 

violations: (1) a willful 

transfer of smoke detectors 

containing byproduct material 
8

(americium-241) without an 

NRC license as required by 

10 CFR 30.3(a); and (2) an 

import of material into the 

United States without having 

the required license for 

possession of the material 

as required by 10 CFR 110.5. 

Specifically, from May to 

July 2010, UPC imported and 

transferred approximately 

19,423 smoke detectors 

containing byproduct material 

without the required NRC 

licenses authorizing such 

imports and transfers. 

Lincoln University of 

Missouri (EA-11-219)

On December 19, 2011, 

the NRC issued a Notice of 

Violation to Lincoln University 

of Missouri for a Severity Level 

III problem 

involving 

multiple 

violations 

of license 

conditions and NRC 

regulations. Specifically, 

the licensee failed to: (1) 

ensure that the individual 

named on the NRC license 

fulfilled the responsibilities 

of the radiation safety officer 

between May 2009 and 

August 18, 2011; (2) conduct 

a physical inventory every 

6 months to account for 

all sources and/or devices 

received and possessed 

under the license between 

May 2009 and August 8, 2011; 

(3) notify the NRC in writing 

within 60 days of no longer 

conducting principal activities 

for a period of 24 months; (4) 

maintain records of receipt 

of radioactive materials 

for as long as the material 

was possessed as well as 

maintain disposal records 

until termination of the NRC 

license; and (5) comply with 

the applicable requirements 

for performing leak tests 

and inventories of generally 

licensed devices. 

International Cyclotron, Inc. 

(EA-11-086)

On December 19, 2011, 

the NRC issued a Notice 

of Violation and Proposed 

Imposition 

of a Civil 

Penalty 

in the 

amount of 

$7000, and 

an Order suspending licensed 

activities within 60 days to 

International Cyclotron, Inc. 

(ICI), for a Severity Level III 

violation of 10 CFR 30.35. The 

violation involved ICI’s failure 

to provide a decommissioning 

funding plan. Specifically, on 

August 20, 2009, ICI was 

issued an NRC license 

authorizing the possession 

and use of unsealed 

byproduct material of 

applicable quantities set forth 

in Appendix B to 

10 CFR Part 30. ICI has not 

provided a decommissioning 

funding plan that contains a 

signed original of the financial 

instrument obtained to 

provide financial assurance for 

decommissioning, as required 

by 10 CFR 30.35. Based on 

ICI’s failure to fully and timely 

respond to requests for 

information, and compliance 

with NRC regulations, the NRC 

issued an Order Suspending 

Licensed Activities (Order). 

According to this Order, if ICI 

does not submit to the NRC an 

acceptable financial assurance 

instrument within 60 days 

of the date of the Order, ICI 

is required to suspend all 

activities authorized under its 

license. This Order will remain 

in effect until ICI submits a 

financial assurance instrument 

and the NRC informs ICI that 

the instrument is accepted.

MEDICAL

Cardinal Health PET 

Manufacturing Services, Inc. 

(EA-11-146)

On November 9, 2011, the 

NRC issued a Notice of Violation to Cardinal Health PET 

Manufacturing Services, Inc., 

for a Severity Level III violation 

involving the failure to monitor the occupational exposure 

to an adult who was likely to 

receive, in 1 year from sources 

external to the body, an extremity dose in excess of 5 rem as 

required by 10 CFR 20.1502(a)

(1). Specifically, on June 16, 

2010, a Cardinal Health PET 

Manufacturing Services em-
9

ployee removed his 

extremity (ring) 

dosimetry 

on two 

separate occasions prior to 

handling a chemical cartridge 

containing approximately 4 

curies of fluorine-18. 

Information about the NRC’s 

enforcement program can be 

accessed at http://www.nrc.

gov/about-nrc/regulatory/

enforcement/current.html. 

Documents related to cases 

can be accessed through 

the NRC’s Agencywide 

Document Access and 

Management System 

(ADAMS) at http://www.

nrc.gov/reading-rm/adams.

html. Help in using ADAMS 

is available by contacting 

the NRC Public Document 

Room staff at 301-415-4737

or 1-800-397-4209 or 

by sending an e-mail to 

PDR.Resource@nrc.gov.

(Contact: Michele Burgess, 

FSME, 301-415-5868 or 

Michele.Burgess@nrc.gov)

GENERIC COMMUNICATIONS 

ISSUED

The following are 

summaries of NRC generic 

communications issued 

by FSME. If any of these 

documents appears relevant 

to your needs and you have 

not received it, please call 

one of the technical contacts 

listed below. The Web address 

for the NRC library of generic 

communications is http://

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

REGULATORY ISSUE 

SUMMARIES

The NRC provides regulatory 

issue summaries (RIS) as an 

informational 

document 

used to 

communicate with the nuclear 

industry on a broad spectrum 

of matters. 

On March 20, 2012, the NRC 

issued RIS 2012-04, “Notice 

of Revision to the Criteria for 

Identifying Materials Licensees 

for Discussion at the Agency 

Action Review Meeting,” to 

all NRC materials licensees, 

including fuel cycle facilities 

and master material licensees, 

all Agreement State Radiation 

Control Program Directors, 

and State Liaison Officers. 

The RIS informed addressees 

that the NRC has revised the 

criteria for identifying nuclear 

material licensees, including 

Agreement State licensees, 

with significant performance 

problems for discussion at the 

NRC’s Agency Action Review 

Meeting. 

(Contact: Duane White, FSME, 

301-415-6272 or 

Duane.White@nrc.gov)

On April 16, 2012, the NRC 

issued RIS 2012-06, “NRC 

Policy Regarding Submittal of 

Amendments for Processing 

of Equivalent Feed at 

Licensed Uranium Recovery 

Facilities,” to all holders of NRC 

operating licenses for water 

treatment, companies that 

have submitted applications 

to construct all types of new 

uranium recovery facilities 

(conventional mills, heap 

leach facilities, and in situ 

recovery facilities), Radiation 

Control Program Directors, 

and State Liaison Officers. The 

RIS provided guidance on the 

impact that the processing of 

alternative feed may have for 

individual licensees.

(General Contact: Angela R. 

McIntosh, FSME, 301-415-5030 

or Angela.McIntosh@nrc.gov)

SIGNIFICANT EVENTS

Misidentification of Source 

Location Resulting in Under 

Dose During HDR 

Date and Place: 

January 5, 2012, 

Great Falls, 

Montana

Event Details: 
10

During administration of high 

dose remote (HDR) afterloader 

brachytherapy 

using an Ir192 (234.728 

GBq (6.344 

Ci) source, 

the patient 

received only 

about 10 

percent of the prescribed 700 

cGy (rad) dose for treatment 

of esophageal cancer. The 

location of the source was 

tracked by a radiographically 

opaque marker near the 

source. In this case, the end 

of the catheter also appeared 

somewhat radiographically 

opaque and was mistaken for 

the source location. When 

the nasogastric tube and 

the catheter were removed 

as a unit at the end of the 

procedure, it was discovered 

that the catheter was not 

advanced to the end of the 

nasogastric tube. As the 

result of an investigation, it 

was determined that the dose 

was delivered to a location 

29 centimeters proximal to 

the end of the catheter and 

resulted in 1,000 cGy (rad) 

to a 4 centimeters length 

of tissue in the nasal and 

nasopharyngeal sinus area. 

The physician and patient 

were notified of the event. 

The patient was scheduled for 

an anatomical examination to 

assess the presence of adverse 

effects; however, no adverse 

health effects are anticipated. 

Corrective actions included 

procedure modification 

such that catheter length 

measurements are performed 

prior to treatment and the 

catheter and nasogastric 

tube are introduced to the 

patient as a unit. Also, the 

entire length of the catheter 

will be visible in computer 

tomography scans during all 

HDR procedures. An NRCcontracted medical consultant 

agreed with the hospital’s 

analysis of this event. 

Erroneous Treatment 

Parameter Resulting in 

Under Dose During HDR 

Date and Place: 

January 16, 2012,

Sioux Falls, South Dakota

Event Details: During 

administration of high dose 

remote (HDR) afterloader 

brachytherapy using a SenoRx 

Contura 

multicatheter 

applicator, 

the patient 

received approximately 50 

percent of the prescribed dose 

in 2 of the 10 fractions. The 

treatment parameter length 

entered was 10 cm less than 

calculated. The correct length 

was entered for the second 

fraction; however, after the 

third fraction on 

January 17, 2012, it was 

discovered that the original 

incorrect treatment plan 

had been inadvertently 

re-selected. Two additional 

fractions were added and 

the treatment plan was 

modified to achieve the 

total dose specified in 

the written directive. The 

licensee’s medical consultant 

determined that the patient 

received approximately 2,720 

cGy (rad) of unintended skin 

dose. Corrective actions 

included procedure revision, 

personnel training, and 

organizational changes.

Patients Switched In Y-90 

Microsphere Administration

Date and Place: 

January 19, 2012,

Philadelphia, Pennsylvania

Event Details: The licensee 

reported that two patients 

received different Y-90 

microsphere (Sirtex Medical 

model SIR-Spheres) doses 

than prescribed. Both patients 

were scheduled to be treated 

on the same day, close in time. 

The worksheets were switched 

and each patient received the 

other patient’s dose. The first 

patient reached stasis before 

receiving the full amount 

and received a dose 35 

percent above the originally 

prescribed dose and was 

administered 513 MBq (13.86 

mCi) instead of the prescribed 

381.1 MBq (10.3 mCi). The 

second patient received 

56% less than prescribed or 

329.3 MBq (8.9 mCi) instead 

of the prescribed 751.1 MBq 

(20.3 mCi). The cause of the 

event was determined to be 

human error. To compensate 

for the error, the licensee 

administered a higher dose 

than planned to the second 

patient, during the next 

scheduled treatment. Written 

procedures were developed 

and implemented to both 

minimize the chance of errors 
11

occurring in the microsphere 

dose preparation process 

and to identify and correct 

any such errors prior to 

administration. 

Patient Switch Results In 

Y-90 Under Dose 

Date and Place: 

February 2, 2012, Murray, UT

Event Details: The licensee reported that 

a patient 

prescribed 

to receive 

5.32 GBq 

(143.78 

mCi) of Y-90 microspheres 

(MDS Nordion model TheraSpheres) for a treatment dose 

of 12,000 cGy (rad) received 

another patient’s microsphere 

treatment. Two patients were 

at the facility to receive microspheres at the same time. 

The first patient received the 

second patient’s intended 

dose or 1.77 GBq (47.84 mCi). 

The error was identified prior 

to the second patient receiving treatment.

Unintended Organs Dosed 

During Y-90 Microsphere 

Treatment 

Date and Place: 

February 2, 2012,

Minneapolis, Minnesota 

Event Details: The licensee 

reported that a patient 

received dose to unintended 

organs during a liver 

treatment that involved 

1.55 GBq (41.89 mCi) of Y-90 

microspheres (Sirtex Medical 

model SIR-Spheres). The 

infusion procedure went 

according to plan. After 

accounting for normal loss 

within the delivery system, 

the final administered activity 

was 1.53 GBq (41.35 mCi). 

However, follow-up scans 

revealed that some of the 

microspheres were not in 

the liver. After investigation 

on February 6, 2012, it 

was determined that an 

estimated 10 to 15 percent 

of the microspheres were in 

the spleen, gastric fundus, 

and duodenum. The patient 

and the ordering physician 

were informed. From 

further investigation and 

the single-photon emission 

computed tomography 

(SPECT CT) imaging results, 

the following calculations of 

the administered activities 

and estimated doses were 

discovered: 83.9 percent to 

the liver for a dose of 53 Gy 

(5,300 rad); 5.8 percent to the 

gastric fundus for a dose of 44 

Gy (4,400 rad); 9.3 percent to 

the spleen for a dose of 35 Gy 

(3,500 rad); and 1percent to 

the duodenum for a dose of 

35 Gy (3,500 rad). These dose 

estimates have uncertainties 

of at least 20 percent 

with local concentrations 

and doses that may be 

significantly higher. Maximum 

concentrations per pixel in the 

SPECT images were as much 

as 50 percent higher than 

the average concentration. 

After a detailed investigation, 

the licensee was unable 

to identify any procedural 

failures or human errors 

that may have produced the 

event. This event may result 

in unintended, permanent 

functional damage and some 

form of medical intervention, 

which is likely. The patient 

was administered the radioprotective pharmaceutical 

Amifostine and will be 

monitored weekly to 

determine the extent of 

damage to the unintended 

organs. The RSO will provide 

periodic updates regarding 

the status of the patient to 

the State. 

(General Contact: Angela R. 

McIntosh, FSME, 301-415-5030 

or Angela.McIntosh@nrc.gov)
12

CITATION SUBJECT CONTACT PUBLISHED

77 FR 8078

Unified Agenda of Federal Regulatory

and Deregulatory Actions 

(Semiannual regulatory agenda)

Cindy Bladey, ADM, 

301-492-3667 or 

Cindy.Bladey@nrc.gov February 13, 2012

77 FR 8751

Guidance for Decommissioning

Planning During Operations

(Draft regulatory guide; reopening of 

comment period)

James C. Shepherd, FSME,

301-492-6712 or 

James.Shepherd@nrc.gov. February 15, 2012

77 FR 10401

Low-Level Radioactive Waste

Management Issues

(Public meeting; request for

comment)

Michael P. Lee, Ph.D., FSME, 

301-415-6887 or 

Mike.Lee@nrc.gov; or

Tarsha Moon, FSME, 

301-415-6745 or 

Tarsha.Moon@nrc.gov

February 22, 2012

SELECTED 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 

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

WASHINGTON, DC 20555-0001

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