U.S. Nuclear Office of Nuclear NUREG/BR-0117

Regulatory Material Safety No. 06-03

Commission and Safeguards September 2006

NMSS Licensee Newsletter

Contents	 Page

1.	 Louisiana Energy Services Gas

Centrifuge Uranium Enrichment

Facility License Issued ......................................1

2.	 Clarification Of Work Experience in

Medical Use Of Byproduct Material .................2

3.	 Availability Of Radioactive Seed

Localization Guidance ......................................2

4.	 The Energy Policy Act (EPAct), Section 656,

“Secure Transfer of Nuclear Material,” and

Section 652, “Fingerprinting and Criminal

History Record Checks”....................................3

5.	 Ensuring the Completeness and

Accuracy of Attestations for

Recognizing Authorized Individuals..................4

6. Proposed Rule: Regulatory Improvem

to the Nuclear Materials Management and

Safeguards System.............................................5

7. Meeting Summary and Availabi

of Meeting Material from Fuel Cycle

Information Exchange 2006 (FCIX 2006).........6

8. High-Level Waste Repository Sa

Knowledge Management Program....................7

9. What’s New In the Medical 

Licensee Toolkit.................................................8

10. Generic Communications Issued .....................

11. Significant Events.............................................

12. Significant Enforcement Actions.....................

13. Selected Federal Register Notices.................. 

LOUISIANA ENERGY SERVICES GAS 

CENTRIFUGE URANIUM ENRICHMENT 

FACILITY LICENSE ISSUED

On December 15, 2003, Louisiana Energy Services

(LES) submitted a license application for a proposed

gas centrifuge uranium enrichment plant to be

located in Lea County, New Mexico. LES proposed

to use gas centrifuge technology developed by

Urenco in Europe. Urenco has been operating g

centrifuge enrichment facilities for over 30 years in

the United Kingdom, the Netherlands, and Germany.

The proposed plant would have a capacity of 3

million Separative Work Units and would produce

enrichments up to 5 percent uranium-235.

On June 15, 2005, staff completed its safety and

environmental reviews and issued its “Safety

Evaluation Report for the National Enrichment

Facility in Lea County, New Mexico,” NUREG1827, and the “Final Environmental Impact

Statement for the Proposed National Enrichment

Facility in Lea County, New Mexico,” NUREG1790. After completion of contested and mandato

hearings before the Atomic Safety and Licensing

Board (ASLB), the license was issued on June 23,

2006. This licensing action was completed with

the 30-month schedule set out by the Commission.

In response to a January 30, 2004, notice offering

an opportunity to intervene in the proceeding,

petitions were submitted by: (1) the New Mexi

Environment Department; (2) the New Mexico

Attorney General; and (3) Nuclear Information and

Resource Service (NIRS) and Public Citizen (PC)

(combined petition). The contentions that we

admitted were in the areas of: (a) LES’ proposed

radiation protection program, (b) disposal cost

estimates, (c) impacts on ground and surface water,

(d) impact on water supplies, (e) depleted uranium

storage and disposal, (f) decommissioning costs,

(g) need for the facility, and (h) natural gas pipeline

accidents. In August 2005, the New Mexi
2

agencies settled with LES and withdrew from the

proceeding. Under the agreement, LES agre

to limits for storage of depleted uranium, a

overfunding the decommissioning funding plan. T

ASLB held evidentiary hearings on the contentions

in February 2005, October 2005, and February 2006.

In addition to the contested hearing on the admitted

contentions, uranium enrichment facility licensing

actions also require a mandatory hearing in which

the ASLB evaluates whether the U.S. Nuclear

Regulatory Commission (NRC) staff ’s safety

and environmental reviews are adequate. T

evidentiary part of the mandatory hearing was held

in March 2006.

On May 31, 2006, the ASLB issued its final

decisions on the contested hearing in favor of LES

and the NRC staff. On June 23, 2006, it issued i

decision on the mandatory hearing, finding that the

NRC staff had performed adequate environmental

and safety reviews. Based on these decisions, 

June 23, 2006, the staff issued a license to LES to

construct and operate the gas centrifuge uranium

enrichment facility. On June 12, 2006, NIRS/

appealed the contested hearing decision to the

Commission.

LES now plans to begin construction of its plant

in August 2006 and begin operations in late 2008.

Full-capacity operation is expected in 2013. At th

time, LES has sold over 80 percent of its planned

capacity for the first 10 years of operation.

(Contact: Timothy C. Johnson, Office of Fu

Cycle Safety and Safeguards, 301-415-7299,

e-mail: tcj@nrc.go

CLARIFICATION OF WORK 

EXPERIENCE IN MEDICAL USE OF 

BYPRODUCT MATERIAL

Paragraph (c)(1) of 10 CFR 35.290, “Training

for imaging and localization studies,” requires

physicians seeking approval as authorized users

of unsealed byproduct material for imaging and

localization studies to complete classroom and

laboratory training and supervised work experien

in specific topics and tasks. Similar training

specifications are outlined in 10 CFR 35.190(c)(1)

and 35.390(b)(1).

The NRC and its Advisory Committee on the

Medical Uses of Isotopes believe that hands-on

work experience forms a critical cornerstone of

any complete radiation safety program. T

individuals seeking approval as authorized users

for the medical use of byproduct material must

demonstrate hands-on work experience where they

perform the tasks listed in the regulations describing

the supervised work experience requirements. Me

observation is insufficient to fulfill this requirement.

For example, 10 CFR 35.290(c)(1)(ii)(F) requires

individuals seeking approval as authorized

users to demonstrate work experience involving

“administering dosages of radioactive drugs to

patients or human research subjects.” In th

case, applicants must personally administer the

dosage to the patient. Similarly, under 10 C

35.290(c)(1)(ii)(G), applicants must physically elute

the generator system, perform the measuring and

testing of the eluate, and process the eluate with

reagent kits to prepare radioactive drugs.

Licensees are encouraged to refer to 10 CFR Part 35

for additional detail on these training requirements.

(Contact: Cindy Flannery, Office of Nucle

Material Safety and Safeguards, 301-415-0223;

e-mail: cmf@nrc.go

AVAILABILITY OF RADIOACTIVE SEED 

LOCALIZATION GUIDANCE

Recently, guidance was developed for a 10 CFR

35.1000 medical-use procedure called radioactive

seed localization. The purpose of radioactive se

localization of non-palpable lesions (i.e., an area of

suspicious tissue detected by mammography that

needs further evaluation) is to localize suspicious

tissues for excision with the use of radioactive seeds.

This technique uses radioactive seeds previously

approved for brachytherapy. Typically, iodine125 and palladium-103 seeds between 7.4 - 11

megabecquerel (200 – 300 mCi)/seed are implanted

into a breast lesion using a standard 18-gauge

needle. These seeds are normally implant

within mammography or ultrasound suites and

removed within surgical suites between 2 and 5

days post implantation. The radioactive seed(

are located with appropriate instrumentation (using

a technique similar to sentinel lymph node biopsy

and radioguided parathyroidectomy) and surgically

removed with minimal injury to non-affected

tissue. The seed(s) may be removed from t

tissue specimen in surgery, or the tissue specimen

containing the seed(s) can be sent to pathology for

removal of the seed and analysis of the tissue. T

seed or seeds are then disposed of in accordance

with 10 CFR 35.92 or the equivalent Agreement

State regulations.
3

The guidance is available at any one of the following

websites:

•	 NRC’s medical user’s Licensee Toolkit at http://

www.nrc.gov/materials/miau/ med-use-toolkit.

html;

•	 NRC’s Office of State and Tribal Programs

website at http://nrc-stp.ornl.gov/materials. html;

and

•	 The Organization of Agreement States website at

http://www.agreementstates.org/whatsnew.html.

Licensees desiring to use radioactive seed

localization must submit an amendment request for

this 10 CFR 35.1000 medical use to the appropriate

NRC regional office.

(Contact: Donna-Beth Howe, NMS

301-415-7848; e-mail: dbh@nrc.go

THE ENERGY POLICY ACT (EPAct), 

SECTION 656, “SECURE TRANSFER of 

NUCLEAR MATERIAL,” and SECTION 

652, “FINGERPRINTING and CRIMINAL 

HISTORY RECORD CHECKS”

On August 8, 2005, the President signed the EPAct

of 2005 into law. In the legislation, two section

656 and 652, relate to fingerprinting and background

checks.

During the Section 656 rulemaking, recently issued

as a proposed rule, the Commission has determined

that manifest requirements are already covered by

existing Department of Transportation (DOT) and

NRC regulations. In addition, it was determin

that the most appropriate and comprehensive

approach for establishing requirements for

security background checks is part of the broader

considerations of NRC’s planned rulemaking

to implement Section 652 of the EPAct. T

individuals referred to under Section 656 are a

subgroup (i.e., those transferring radioactive material

pursuant to an export or import license) of the

larger group of individuals at a licensed facility,

that have unescorted access to radioactive material,

who would ultimately be included under a Section

652 rulemaking. The goal of the Section 6

rulemaking is to develop requirements for access

that are coherent, and use a graded approach for the

wide range of licensees impacted by Section 652.

Individuals affected in this section are those who

might import or export radioactive material. Secti

652 will also address the need for coordinat

consideration of appropriate exceptions for domestic

import/export transport.

Additionally, as noted in Section 656, the

Commission is proposing to amend its regulations

to except from the security background che

requirements of Section 170I of the Atomic Energy

Act (AEA), as amended, licensees who have not

received NRC Orders restricting unescorted access

to radioactive materials based on background

checks for trustworthiness and reliability that

include fingerprinting and criminal history record

checks. As of May 2006, Orders issued regardi

unescorted access to radioactive materials have

only been based on background checks that do not

include fingerprinting. However, it is anticipat

that Orders restricting access based on fingerprinting

and criminal history record checks will be prepared

for certain licensees. Under this proposed rul

those licensees who did not receive Orders for

both fingerprinting and background checks would

be excepted from the security background check

requirements of Section 170I of the AEA .

The current schedule for the rulemaking to

implement Section 652 calls for issuance of a

proposed rule in late 2007, and a final rule in late

2008. While the more comprehensive Section 6

rulemaking is being conducted, the combination

of NRC’s system of Orders to a broad range of

licensees setting conditions for access to radioactive

material, as well as the system of security

regulations under the Department of Homeland

Security and the DOT for transport personnel,

provide adequate protection of the common defense

and security, as they relate to persons accompanying

and receiving material.

The rulemaking package for Section 656 was

provided to the Commission on June 20, 2006,

in SECY-06-0139. This draft version of the ru

was placed on NRC’s RuleForum website for

information on July 6, 2006. On August 30, 200

the proposed rule on Section 656 was issued in the

Federal Register for public comment (71FR51534).

The public comment period closes on September 29,

2006. It is anticipated that a final rule implementi

Section 656 will be issued in late 2006. NRC sta

is currently preparing the technical basis to support

implementation of Section 652 of the EPAct. 

noted above, it is anticipated that a proposed rule

will be issued in late 2007, and a final rule is

anticipated in late 2008.

(Contact: Frank Cardile, Office of Nucle

Material Safety and Safeguards, 301-415-6185,

e-mail: fpc@nrc.go
4

ENSURING THE COMPLETENESS 

AND ACCURACY OF ATTESTATIONS 

FOR RECOGNIZING AUTHORIZED 

INDIVIDUALS

The regulations in 10 CFR Part 35 identify two

main pathways for individuals seeking recognition

as an authorized individual (i.e., authorized user,

authorized medical physicist, radiation safety

officer, or authorized nuclear pharmacist). T

first pathway, the board certification pathway, is for

individuals who have received certification from

a board whose certification process is recognized

by the NRC. The other, referred to as the alterna

pathway, involves demonstration directly to the NRC

of the completion by the individual of the training

and experience requirements specified in the rule for

the particular authorization being sought.

For an individual to gain status as an authorized

individual under the board certification pathway, the

combined efforts of the certification boards, training

Program Directors, preceptors, and the proposed

authorized individual are needed. NRC realizes a

appreciates that the vast majority of certification

boards, training Program Directors, preceptors, and

proposed authorized individuals strive to ensure that

proposed authorized individuals have completed the

required training and supervised work experience

that is necessary for continued protection of the

public health and safety. Nevertheless, N

staff wishes to remind all of these parties of their

individual roles in assuring truthful complete and

accurate representations.

A certificate issued to an individual by a certification

board with a recognized certification process

indicates that an applicant is qualified to be

designated by NRC as an authorized individual.

The certificate is relied upon by NRC in making

a regulatory decision. It is a representation 

NRC that the individual has completed training

and supervised work experience that includes all

of the hours, in all of the topics, specified by NRC

regulations. Such statements must be complete a

accurate in all material respects.

Certification boards recognized by the NRC should

ensure that all candidates for certification fulfill

NRC’s certification pathway training and experience

requirements. It is the role of the Program Directo

of the various training programs (e.g., radiology,

nuclear medicine, radiation oncology), to assure that

information supplied to the certification boards about

training and experience completed by applicants

for certification is accurate. Similarly, NRC reli

on the truthful and accurate attestations of the

preceptors for individuals seeking authorization

under the board certification and the alternate

pathways.

If a certification board becomes aware of training

programs that are not including all the topics, or

specified training time, or actual supervised work

experience that is necessary for the certification

candidates to meet the necessary NRC certification

pathway training and experience requirements, the

certification board should deny certification to these

individuals, until they complete the required training

and experience. Furthermore, for training progra

that are residency programs, the certification

board should consult with the Residency Review

Committee if the certification board becomes aware

of any inadequacy of training in those programs.

Each training Program Director and preceptor who

verifies the training and experience for a proposed

authorized individual must, to the best of his or

her professional ability and judgment, determine

that the candidate has actually received the training

and supervised work experience claimed. Progr

Directors and preceptors are encouraged to take

reasonable measures to ensure that proposed

authorized individuals have completed all of the

required training and supervised work experience

(e.g., contacting individuals providing the training

and supervised work experience). Further, propos

authorized individuals must provide complete and

accurate documentation of their own training and

experience, and should cooperate in the attestation

process so that the Program Director and preceptor

will have a thorough understanding of the specific

training and experience that the proposed authorized

individual has received.

Cognizant persons (e.g., Certification Boards,

Program Directors, preceptors) should notify NRC

if they become aware of any proposed authorized

individual who is misrepresenting his or her own

training and supervised work experience, or of

any other Program Director or preceptor who is

making inaccurate attestations about the completion

of training and supervised work experience. False

attestations and misrepresentations may cause a

violation of 10 CFR 30.9 or 30.10, and violate 18

U.S.C 2001.

(Contact: Cindy Flannery, Office of Nucle

Material Safety & Safeguards, 301-415-0223;

e-mail: cmf@nrc.go
5

PROPOSED RULE: REGULATORY 

IMPROVEMENTS TO THE NUCLEAR 

MATERIALS MANAGEMENT AND 

SAFEGUARDS SYSTEM 

The Nuclear Regulatory Commission (NRC)

is proposing to amend its regulations related to

licensee reporting requirements for source material

and special nuclear material (SNM) to the Nuclear

Materials Management and Safeguards System

(NMMSS). The amendments are needed to impro

the accuracy of material inventory information

maintained in the NMMSS. The annual report

requirements would be new requirements for

licensees that possess 350 grams or less, of SNM.

However, the proposed changes would reduce some

reporting burden on licensees subject to current

reporting requirements. The NRC expects to publi

the proposed rule for comments, in early 2007.

The NMMSS is the national database used in the

United States by NRC licensees, Agreement State

licensees, and U.S. Department of Energy (DOE)

contractors, to report the possession of certain

SNM and source material. The NRC reporti

requirements related to the NMMSS are primarily

contained in 10 CFR Parts 40, 72, 74, 75, 76, and

150. Using licensee submittals, the NMM

database serves two important functions: meeting

international reporting obligations, and assisting

in the oversight of licensee material control and

accounting (MC&A) programs required by 10 CFR

Parts 40, 72, 74, 75, and 150.

PROPOSED AMENDMENTS

The following sections summarize the significant

proposed changes to the regulations in 10 CFR Par

40, 72, 74, and 150.

Special Nuclear Material Status Reports

Current: licensees are required by 10 CFR 74.1

to report annual SNM inventories to the NMMSS,

only if they are authorized to possess more than 350

grams of SNM.

Proposed: would require annual reporting 

licensees that possess 1 gram or more of SNM.

Submission of material balance reports for licensees

possessing less than 350 grams, no later than March

31 of each year.

Special Nuclear Material Transaction Reports 

Current: licensees are required by 10 CFR 74.15(

to report to the NMMSS whenever they transfer or

receive one gram or more of SNM.

Proposed: would also require reporting to t

NMMSS whenever a licensee makes an on-site

adjustment to the SNM inventory by 1 gram or

more. (The inventory adjustments may be due

to decay, normal operational losses or accidental

losses.)

Source Material Transaction Reports

Current: 10 CFR 40.64(a) requires submission 

a Nuclear Material Transaction Report whenever

a licensee transfers, receives, imports, exports or

adjusts the inventory of foreign obligated source

material by one kilogram or more.

Proposed: would also require reporting when

licensee uses 1 kilogram or more of source material

in enrichment services, downblend material initially

enriched in the U-235 isotope to 10 percent or more, or

mixed oxide fuel fabrication, regardless of obligation.

Source Material Status Reports

Current: 10 CFR 40.64(b) requires annual sour

material inventory reports of foreign obligated

source material for licensees authorized to possess

more than 1000 kilograms of source material.

Proposed: would require annual reporting f

licensees that possess1 kilogram or more of foreign

obligated source material.

Reconciliation of Submitted Inventories

Current: reconciliation of NMMSS values a

licensee inventories is in the guidance documents,

not in the regulations.

Proposed: would require licensees to reconcile a

inventory discrepancies identified by the NRC in the

NMMSS database within 30 days of submission of

licensee inventory information.

Reduction in Reporting Requirements for

Material Shipments

Current: licensees who export reportable quantiti

of SNM or source material file both the shipper’s

and receiver’s information on two separate forms

when exporting nuclear material.
6

Proposed: licensees would be required to file on

the shipper’s information form unless a significant

shipper/receiver difference, or, a theft or diversion

is identified. This proposed change in reporting

requirement would reduce the licensees’reporting

burdens when shipping nuclear materials without

significantly impacting the quality of the information

reported to the database.

Upon Commission approval, the proposed rule

will be published in the Federal Register for public

comments.

(Contact: Neelam Bhalla, Nuclear Material Safe

and Safeguards, 301-415-6843, e-mail: nxb@nrc.gov)

MEETING SUMMARY AND 

AVAILABILITY OF MEETING MATERIAL 

FROM FUEL CYCLE INFORMATION 

EXCHANGE 2006 (FCIX 2006)

The Nuclear Regulatory Commission (NRC) hosted

a seminar on August 30 and 31, 2006 to provide

an opportunity for licensees, NRC staff, and other

stakeholders to exchange information and discuss

issues of interest pertaining to the regulation of

NRC-regulated fuel cycle facilities.

The seminar was held in Rockville, Maryland,

at the Universities of Maryland at Shady Grove

Campus Auditorium and was open to the public.

The meeting notice and agenda can be found on the

NRC Public Meeting web site: http://www.nrc.go

public-involve/public-meetings/index.cfm.

Ninety four persons attended the meeting. T

agenda items and presenters are listed below:

August 30, 2006

Safety Culture Importance of Safety Culture and

Lessons Learned from Various Events

Martin Virgilio, N

Industry Perspectives

Marvin Fertel, NEI

The Future of the Fuel Cycle Industry

Joseph Giitter, NRC

Global Nuclear Energy Partnership (GNEP):

Closing the Fuel Cycle While Reducing

Proliferation Risk

David Henderson, DOE

Status Report of Current NRC Fuel Cycle Related

Initiatives: Security, Emergency Preparednes

Licensee Performance and Evaluation, Enforcement

Policy Changes and ISG-02

Robert Pierson, NRC

Revisions to the Fuel Facility Inspection Program

and Procedures: Planned Changes to Inspecti

Manual Chapter (IMC) 2600, IMC 610, and Safe

Inspection Procedures

Dr. William Travers, NRC

Douglas Collins, NRC

Fuel Cycle Security Activities: What Lies Ahead f

Fuel Cycle Facilities from a Security Point of View

Robert Caldwell, NRC

Inspection and Enforcement Comments from the

Fuel Cycle Industry

Randy Shackelford, NFS

Stakeholder Evaluation of Fuel Cycle Regulation

Joseph Giitter, NRC

Risk-Informed Decision-Making Process and Risk

Guidelines for NMSS

Dr. Dennis Dam

Global Perspective of the Radiation Health Impact

from the Fuel Cycle

Dr. Judith Johnsrud, Sierra Club

GNEP is a REALLY Bad Idea

Kevin Kamps, Nuclear Information and Resource

Service (NIRS)

Impact of Increased Nuclear Energy in Domestic

Energy Generation

Dr. David Manut

Manuta Chemical Consulting Inc.

August 31, 2006

ISA Summary Reviews, Lessons Learned and Best

Practices: Lessons Learned by the NRC and Wh

“Best Practices” Were Demonstrated From Review

of ISA Summaries

James Smith, NRC

License Renewal Procedures New Draft ISG Under

Development by the NRC to Address License

Renewal Procedures Related to the New Subpart H

Steven Schilthelm, BWXT

Nick Baker, NRC
7

Databases and IROFS Tracking Systems:

Discussion on AREVA’s Experience In Using

Computer Systems for IROFS Tracking

Robert Link, AREVA NP

Status of 10 CFR 70.72 Rulemaking Update on NRC

Rulemaking and Guidance Development Efforts

Related to 10 CFR 70.72(c)(2)

Melanie Galloway, NRC

International Guidance Documents: Summary 

Recent NEA Guidance Documents and a Discussion

of How the IAEA Prepares Safety Guides,

Requirement Documents, and Standards and the

Relevance of These Documents to NRC Licensees

Robert Pierson, NRC 	 Yawar Faraz, N

Boundaries of IROFS: How LES and Oth

Licensees Have Developed Procedures Specific for

Developing IROFS Boundary Packages

Stan Day, LES

Overview and Experience Under the NRC’s New

Hearing Process by Fuel Cycle Applicants and

Licensees

Overview of the NRC’s New Hearing Processes

Based Upon Experience With Duke, Cogema, Stone

& Webster’s Mixed-Oxide Fuel Fabrication Facility

and USEC Inc.’s American Centrifuge Plant

Overview of the Hearing Process in the Context

of the Recent Issuance of a Combined License to

Construct and Operate Louisiana Energy Services’

National Enrichment Facility

Donald Silverman

Morgan, Lewis & Bockius

James Curtiss, Winston & Strawn

Electronic copies of the presentations used at the

seminar can be obtained by contacting the staff

member listed below.

(Contact: James Smith, Project Manager, Fu

Cycle Safety and Safeguards, Special Projects

Branch Technical Support Section, 301-415-6459,

Fax: 301-415-5370, e-mail: jas4@nrc.go

HIGH-LEVEL WASTE REPOSITORY 

SAFETY KNOWLEDGE MANAGEMENT 

PROGRAM

The Division of High Level Waste Repository

Safety (HLWRS) in the Office of Nuclear Material

Safety and Safeguards (NMSS) is developing and

implementing a Knowledge Management strategy

for capturing and organizing key information to

support staff preparations for reviewing a potential

license for the Yucca Mountain high-level waste

repository. The HLWRS prelicensing revi

activities in the last two decades have resulted in

a large knowledge base of technical and process

information on Yucca Mountain. This includ

a variety of documents related to NRC review

processes (e.g., the Yucca Mountain Review Plan),

and interactions with DOE (e.g., Key Technical

Issues (KTI) agreements and DOE responses). 

addition, the HLWRS program employs a number

of subject matter experts (SMEs) with extensive

institutional knowledge of the HLW program at

the NRC and at the Center for Nuclear Waste

Regulatory Analysis (CNWRA) who may retire or

change jobs. As the projected license applicati

submission date draws closer, it is important for a

timely review to capture, recover, and disseminate

efficiently to current and new staff members key

relevant knowledge on issues, approaches, methods

and models developed over the years. 	 	

A phased, progressive approach is being used for

the HLWRS Knowledge Management (KM) and

Knowledge Transfer (KT) strategies. A suite 

issue tracking databases are being compiled that

are based upon a foundation of existing publicly

available HLW KTI documents. These prelimina

databases will be converted to XML databases to

provide broader accessibility and functionality

for the HLWRS and CNWRA staff. Web-bas

classification tools are being developed based on

in-depth knowledge of key scientific and engineering

issues at Yucca Mountain. For example, a taxono

that will be developed would be used as a dictionary

to index documents and allow precision searches in

different knowledge bases. The goal is to impro

staff productivity and assist the staff in conducting

a timely review of the potential license application

within the time frame specified in the Nuclear Waste

Policy Act.

Parallel to the above effort, the HLWRS continues

its extensive technical reviewer qualification training

program and anticipates supplementing the program

with a virtual community of practice (CoP) in the

NRC Knowledge Center (KC). A technical review

CoP was created in the KC, in which libraries of

reviewer qualification session assignments, study

guides and reading materials are organized and

maintained. Training sessions were conduct

to familiarize the division staff with the new

knowledge management platform and environment

in the KC. Other virtual communities, e.g.,

knowledge transfer working group CoP, are being

formulated and populated with knowledge bases.
8

Moreover, the staff plans to use the KC’s online

collaboration and project management features for

both the prelicensing and licensing phases of the

Yucca Mountain Project. The goal is to use the KC

as an HLWRS knowledge store and a vehicle for

efficient knowledge acquisition and dissemination.

The third aspect of the HLWRS KM and KT strategy

and effort is to capture, recover and disseminate

the knowledge of subject matter experts. New sta

is teamed up with SMEs to ensure the transfer of

knowledge as well as the eventual retention and

succession of project responsibilities. Knowled

transfer seminars are prepared and presented by

these SMEs. The seminar supporting materials are

added to HLWRS knowledge bases and will be

incorporated into the KC to become a searchable,

multimedia library of lessons learned. Additionall

consultant arrangements can be made with retired

SMEs, emphasizing knowledge transfer and

recovery, such activities would include interviews

with the SME in a format of questions and answers.

The important knowledge that can be obtained from

this process would be used in a lessons learned

library in the KC.

The HLWRS KM and KT efforts are being

coordinated with agency-wide efforts. As t

HLWRS continues to implement its knowledge

management and transfer strategy, teamwork and

contributions from all the staff are the essential

ingredients. A successful Knowledge manageme

strategy contributing to the mission of the agency

and individual division programs requires concerted

and coordinated efforts and integration into the

staff ’s routine business practices.

(Contact: Andrew C. Campbell, Ph.D., Division

High-Level Waste Repository Safety, 301-415-6897,

Fax: 301-415-5399, e-mail: acc@nrc.

WHAT’S NEW IN THE MEDICAL USES 

LICENSEE TOOLKIT 

The Medical Uses Licensee Toolkit (http://www.nrc.

gov/materials/miau/med-use-toolkit.html) has been

updated to include new links or new information

under the following two headings:

“Regulations and Medical Policy Statement”

(1) Correcting Amendment, Medical Use of

Byproduct Material—Recognition of Specialty

Boards; Correction, (71 FR 1926). This correct

10 CFR Part 35 by inserting a reference that was

inadvertently omitted in the final regulations

amending the Commission’s training and experience

requirements in 10 CFR Part 35 published in the

Federal Register March 30, 2005 (70 FR 16336).

The correction was related to authorized medical

physicists, authorized nuclear pharmacists, or

authorized users who could be recognized as

Radiation Safety Officers and was discussed in the

last NMSS Newsletter.

(2) Final Rule, 10 CFR Parts 1, 13, 20, 30, 32, 35,

40, 55, 70, 73, 110, and 140, (71 FR 15005) which

corrected several miscellaneous errors in the Code

of Federal Regulations (CFR), update the address for

Region III, and remove all references to Subpart J in

Parts 32 and 35.

(3) The Proposed NARM RULE published in the

Federal Register (71 FR 42952) which incorporates

the new definition of byproduct material into NRC’s

regulations.

“Other Guidance” 

(1) NRC recognized new medical specialty boards in

the “Specialty Boards Certification Recognized by

NRC” web page linked under this heading.

(2) Revised licensing guidance for 10 CFR 35.1000

sealed sources and devices to reflect that Proxima

Therapeutics was purchased by Cytyc Corporation

and the name of the product manufacturer has

changed to Cytyc Surgical Products. The guidan

also clarifies that the Cytyc Surgical Products’

Gliasite Spectrum System is not covered by the

guidance. Applicants who intend to use the n

Gliasite Spectrum System need to contact the

appropriate NRC Regional office for assistance.

(3) Revised licensing guidance for 10 CFR 35.1000

sealed sources and devices to reflect that the Novoste

Intervascular brachytherapy products were bought

by Best Vascular, Inc., and the product name has

changed accordingly.

(4) Revised licensing guidance for 10 CFR 35.1000

sealed sources and devices to add a new 35.1000

medical use - “Iodine125 and Palladium-103

Low Dose Rate Brachytherapy Seeds Used for

Localization of Non-Palpable Lesions.”

(Contact: Donna-Beth Howe, NMS

301-415-7848; e-mail: dbh@nrc.go
9

GENERIC COMMUNICATIONS ISSUED 

(June 1, 2006 - August 31, 2006)

The following are summaries of U.S. Nuclear

Regulatory Commission (NRC) generic

communications. If one of these documents appea

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/. Please note that th

address is case-sensitive and must be entered exactly

as shown. If you have any questions or commen

about generic communications in general, please

contact Angela R. McIntosh, (301) 415-5030, or by

e-mail: arm@nrc.gov.

Bulletins (BLs)

None.

Generic Letters (Gls)

None.

Information Notices (INs)

IN 2006-11, “Applicability of Patient Intervention

in Determining Medical Events for Gamma

Stereotactic Radiosurgery and Other Therapy

Procedures,” was issued on June 12, 2006. This 

was issued to all medical licensees.

(Technical contact: Ronald E. Zelac, PhD, NMS

301-415-7635; e-mail: rez@nrc.gov)

IN 2006-12, “Exercising Due Diligence When

Transferring Radioactive Materials,” was issued

on July 6, 2006. This IN was issued to all materi

licensees.

(Technical contact: Joseph DeCicco, PhD, NMS

301-415-7833; e-mail: jxd1@nrc.go

IN 2006-13, “Ground-water Contamination Due

to Undetected Leakage of Radioactive Water” was

issued on July 10, 2006. This IN was issued to a

holders of operating licenses for nuclear power and

research and test reactors including those who have

permanently ceased operations and have certified

that fuel has been permanently removed from the

reactor, and those authorized by Title 10 of the Co

of Federal Regulations Part 72 licenses to store spent

fuel in water-filled structures.

(Technical contacts: Timothy Frye, NRR, 30

415-9676, e-mail: tjf@nrc.gov; Marvin Mendonc

NRR, 301-415-2191, e-mail: mmm@nrc.gov; Jo

White, Region 1, 610-337-5114;

e-mail: jrw1@nrc.gov; or James Shepherd, NMS

301-415-6712, e-mail: jcs2@nrc.go

IN 2006-16, “Implementing Search Requirements

for Personnel, Packages and Material at NRCLicensed Facilities” was issued July 28, 2006. Th

IN was issued to all power reactors, category I

fuel cycle facilities, independent spent fuel storage

installations, conversion facility, and gaseous

diffusion plants. Note that the information notice

contains physical security information and is,

therefore, being withheld from public disclosure in

accordance with 10 CFR 2.390.

(Technical contact: F. Paul Peduzzi, NSIR, 301-41

5734, e-mail: fxp1@nrc.go

Regulatory Issue Summaries (RIS’)

RIS 2006-11, “Requesting Quality Assurance

Program Approval Renewals Online by Electronic

Information Exchange” was issued July 20, 2006.

This RIS was issued to all 10 CFR Part 71 quality

assurance program and certificate holders.

(Technical contacts: Frank Gee, NMSS, 301-41

7414; e-mail: fsg@nrc.gov; and John Skoczla

OIS, 301-415-7186, e-mail: jas1@nrc.go

(General contact: Angela R. McIntosh, NMSS, 30

415-5030; e-mail: arm@nrc.go

SIGNIFICANT EVENTS

(May 1, 2006 - August 30, 2006)

Event #1: Brachytherapy Overdose Event

Date and Place: May 9, 2006, Bozeman, Monta

Nature and Probable Causes: The licensee report

a medical event involving dose to an unintended site.

The incident was identified during the post-implant

CT scan of a prostate implant patient. A total 

88 iodine-125 seeds, with a total activity of 1.12

gigabecquerel (30.3 millicuries), was implanted.

However, three seeds were recovered after the

procedure. The CT scan confirmed that most of t

seeds were located in an area surrounding the urethra

instead of in the prostate. The licensee has estimat

that the radiation dose to the unintended site was
10

14,500 centigray (rad). The patient’s physician w

informed. The patient was informed and advis

of the possible side effects. The licensee wi

continue to investigate the incident. NRC Region 

dispatched an inspector to the licensee’s facility to

review the incident.

Event #2: Brachytherapy Overdose Event

Date and Place: July 10, 2006, Akron, Oh

Nature and Probable Causes: The licensee report

that a patient prescribed to receive a prostate seed

implant procedure received seeds with 27 percent

higher activity than intended. The licensee stat

that the default seed strength of the computer

planning system is specified in air kerma units.

However, the activity of the seeds was entered in

units of millicurie. When the seeds for this patie

were ordered, the activity was not changed to

millicurie. The patient was prescribed to recei

111 iodine-125 seeds, each with an activity of 14.58

megabecquerel (0.394 millicurie). The patie

was implanted with seeds that had an activity of

approximately 18.5 megabecquerel (0.5 millicurie)

each. The physician, patient, and the State of Oh

were notified of the incident on July 13, 2006. T

State Agency inspected the licensee’s facility on July

18, 2006.

Event #3: Brachytherapy Underdose Eve

Date and Place: June 5, 2006, Oklahoma City,

Oklahoma

Nature and Probable Causes: The licensee report

an administration that was 68 percent less than

prescribed during one of a series of brachytherapy

doses to a patient. The patient received 1

centigray (rad) instead of the prescribed 360

centigray (rad). This was the first use of the n

High Dose Remote (HDR) modality mammosite

treatment equipment. An iridium -192 sour

(Varian) with an activity of 222 gigabecquerel (6

curies) was used. The quality control (QC) 

the instrument was performed before the patient

treatment. The treatment plan was sent from t

dosimetry computer to the HDR control computer.

The computer, or personnel, chose the plan used

from the QC. The computer interpreted the pl

to mean that a particular amount of dose had

already been given. Inspection of computer recor

revealed that the exposure had been stopped during

treatment. The licensee informed the patient of t

dose discrepancy. Corrective actions taken by t

licensee included performing the QC activity in a

way that can’t be confused with the therapy. T

State of Oklahoma is sending an inspector to the site.

(Contact: Angela R. McIntosh, 301-415-5030, email: arm@nrc.

SIGNIFICANT ENFORCEMENT ACTIONS

The U.S. Nuclear Regulatory Commission’s (NRC’s)

enforcement program can be accessed via NRC’s

homepage [http://www.nrc.gov/] under “What We

Do.” Documents related to cases can be accessed 

[http://www.nrc.gov/], “Electronic Reading Room,”

“Documents in ADAMS.” ADAMS is the Agencywide Document Access and Management Syst

Help in using ADAMS is available from the NRC

Public Document Room, telephone: 301-415-4737

or 1-800-397-4209.

Hospitals

Hospital Andres Grillasca, Inc. (EA-06-125)

On July 21, 2006, a Notice of Violation was issued

for a Severity Level III violation, involving the

failure to implement written procedures to provide

high confidence that each patient treatment is in

accordance with the treatment plan and written

directive, and that both manual and computergenerated dose calculations are verified. As a resu

of the failure to verify that an High Dose Rate

(HDR) treatment was administered in accordance

with the written directive, a dose was calculated and

delivered to a depth of one centimeter rather than

the prescribed two centimeter depth, resulting in an

underdose of 57 percent.

Southside Community Hospital (EA-06-097)

On July 12, 2006, a Notice of Violation was

issued for a Severity Level III violation involving

the failure to perform surveys, or secure from

unauthorized removal, or limit access to six vials,

at least two of which contained radioactive material

in the form of iodine-131, sodium iodide. The vials

were subsequently disposed of as non-radioactive

waste on December 1, 2005.

IUPUI/Indiana University Medical Center 

(EA-06-095)

On July 10, 2006, a Notice of Violation was

issued for a Severity Level III violation involving

the licensee’s failure to develop, implement,
11

and maintain written procedures to provide high

confidence that each administration of NRC-licensed

material is in accordance with the written directive

of an authorized user physician, as required by

10 CFR 35.41, “Procedures for Administrations

Requiring a Written Directive.”

Community Hospitals of Indiana, Inc. (EA-06-101)

On July 10, 2006, a Notice of Violation was issued

for a Severity Level III problem involving the

failure to develop written procedures to provide

high confidence that each administration was in

accordance with a written directive. Specifically,

the licensee’s written procedure for high dose rate

(HDR) brachytherapy did not describe that the

HDR metal interface connector was to be attached

during treatment simulation to determine appropriate

location of the sources within the patient. 

addition, the licensee did not notify the NRC

Operations Center by the next calendar day after

discovery of the medical event.

Radiography

Southwest X-Ray Corporation (EA-06-014)

On May 25, 2006, a Notice of Violation was

issued for a Severity Level III violation involving

a radiographer’s assistant’s failure to wear a direct

reading dosimeter and personnel dosimeter, on the

trunk of his body during radiographic operations.

Portable Gauges

ECS Mid-Atlantic, LLC (EA-05-177)

On May 22, 2006, a Notice of Violation was issued

for a Severity Level III violation involving the

failure to secure from unauthorized removal, or

limit access to, a portable gauge containing licensed

material, while the gauge was in an unrestricted

area and not in storage; nor did the licensee control

and maintain constant surveillance of this licensed

material. While the gauge was unattended, it w

run over by a front end loader and destroyed.

(General Contact: Sally Merchant, Office 

Enforcement, 301-415-2747, e-mail: slm2@nrc.go

Eastern Shoshone & Northern Arapaho Tribes 

(EA-06-040)

On July 14, 2006, a Notice of Violation was issued

for a Severity Level III problem involving failure to

conduct operations so that the total effective dose

equivalent to individual members of the public

would not exceed 0.001 sievert (Sv) (0.1 rem) in a

year. Specifically a member of the public, working

in close proximity to the portable gauge storage area,

received a calculated dose in excess of 0.001 Sv

during calendar years 2000 and 2001. In additio

from March 2000 through May 2006, the licensee

failed to make, or cause to be made, surveys of

radiation levels in unrestricted and controlled areas

to demonstrate compliance with the dose limits for

individual members of the public as required. T

NRC is exercising enforcement discretion and is

refraining from issuing a civil penalty because the

licensee has transferred all NRC-licensed material to

an authorized recipient, and requested termination of

its NRC license.

SELECTED FEDERALREGISTER NOTICES

(June 1, 2006 – August 31, 2006)

10 CFR Part 73 [RIN 3150-AH94] “Relief From

Fingerprinting and Criminal History Records Check

for Designated Categories of Individuals.” 71 FR

33989, June 13, 2006.

(Contact: Jared K. Heck, Office of the Gener

Counsel, 301-415-1623, e-mail: jkh3@nrc.go

or Marjorie U. Rothschild, Office of the General

Counsel, 301-415-1633, e-mail: mur@nrc.go

10 CFR Parts 20 and 32 [RIN 3150-AH48]

“National Source Tracking of Sealed Sources ;

Proposed rule.” 71 FR 34024 June 13, 2006.

(Contact: Merri Horn, Office of Nuclear Materi

Safety and Safeguards, 301-415-8126, e-mail:

mlh1@nrc.gov)

“State of Rhode Island Relinquishment of Sealed

Source and Device Evaluation and Approval

Authority and Assumption by the Nuclear

Regulatory Commission.” 71 FR 3818

July 5, 2006.

(Contact: Jennifer C. Tobin, Office 

State and Tribal Programs, 301-415-2328,

e-mail: jct1@nrc.go

10 CFR Part 72 [RIN 3150-AH93] “ List

of Approved Spent Fuel Storage Casks:

NUHOMS[supreg]HD Addition; Withdrawal of

Direct Final Rule.” 71 FR 39520, July 13, 200

(Contact: Jayne M. McCausland, Office of Nucle

Material Safety and Safeguards, 301-415-6219, email: jmm2@nrc.go
12

10 CFR Part 110 [RIN 3150-AH88]

“Implementation of the Nuclear Export and Import

Provisions of the Energy Policy Act of 2005;

Correction.” 71 FR 40003, July 14, 200

(Contact: Michael T. Lesar, Office 

Administration, 301-415-7163 or Toll-Free:

1-800-368-5642, e-mail: MTL@nrc.go

10 CFR Parts 20, 30, 31, 32, 33, 35, 50, 61, 62,

72, 110, 150, 170, and 171[RIN 3150-AH84]

“Requirements for Expanded Definition of

Byproduct Material; Proposed rule.” 71 FR 4295

July 28, 2006.

(Contact: Lydia Chang, Office of Nuclear Materi

Safety and Safeguards, 301-415-6319, e-mail:

lwc1@nrc.gov)

10 CFR Part 36 [Docket No. PRM-36-01]

“American National Standards Institute N43.10

Committee; Denial of Petition for Rulemaking.”

71 FR 47751, August 18, 2006.

(Contact: Thomas Young, Office of Nucle

Material Safety and Safeguards, 301-415-5795,

e-mail: tfy@nrc.go

10 CFR Part 73 [RIN 3150-AH90] “Secure Transfer

of Nuclear Materials, Proposed rule.” 71 FR 5153

August 30, 2006.

(Contact: Frank Cardile, Office of Nucle

Material Safety and Safeguards, 301-415-6185,

e-mail: fpc@nrc.go

(General Contact: Michael K. Williamson, Office

of Nuclear Material and Safeguards, 301-415-6234,

e-mail: mkw1@nrc.gov)

NOTE TO READERS: In an attempt to ke

the NMSS Licensee Newsletter relevant, useful

and informative, feedback on the content of

the newsletter is welcome. Readers desiring 

contribute articles, self-explanatory diagrams,

suggestions for future articles, bulletins, web-site

postings, and other items of interest to the NMSS

Licensee Newsletter readership, should contact

Michael Williamson, from the Office of Nuclear

Materials Safety and Safeguards, Rulemaking and

Guidance Branch. Mr. Williamson may be contact

at (301) 415-6234 or mkw1@nrc.gov. In additio

to ensure proper delivery of the NMSS Licensee

Newsletter, please report any address changes to Mr.

Williamson to prevent any interruption of service.

Please send written correspondence and

requests to:

Michael K. Williamson, Editor

NMSS Licensee Newsletter

Office of Nuclear Material Safety and Safeguards

U.S. Nuclear Regulatory Commission

Two White Flint North, Mail Stop T-8 F3

Washington, D. C. 20555-0001


Printed

on recycled

paper

Federal Recycling Program
UNITED STATES

NUCLEAR REGULATORY COMMISSION

WASHINGTON, DC 20555-0001

 _______________

OFFICIAL BUSINESS