Contents	 Page

1.	 Reorganization of the Office of Nuclear

Material Safety and Safeguards

and Creation of the Office of Federal

and State Materials and Environmental

Management Programs.......................................1

2.	 Shaw AREVA MOX Services, Formerly

Duke Cogema Stone & Webster, Mixed

Oxide Fuel Fabrication Facility License

Application and Integrated Safety

Analysis Summary Submitted............................2

3.	 The Global Nuclear Energy Partnership............2

4.	 Recent Events in Gas Centrifuge........................3

5.	 Update of Consolidated Decommissioning

Guidance (NUREG-1757)..................................4

6.	 Consolidation of NRC’s

Decommissioning Program................................4

7.	 Clarifying Improvements to

10 CFR 70.72(c)(2)............................................4

8.	 Regulations for Emerging Technologies............5

9.	 Clarification of Dosage Categories for

Unsealed Byproduct Material Requiring

a Written Directive.............................................6

10.	 Clarification of the Training and Experience

Requirements in 10 CFR 35.396........................6

11.	 Improving Public Understanding of the

Risks Associated with Medical Events...............6

12.	 Dose Limit for Patient Release Under

10 CFR 35.75.....................................................7

13.	 Increased Controls: Answers 

Commonly Asked Questions..............................7

15.	 Rupture of Jammed Seeds in Mick Applicators

During Manual Brachytherapy Treatments

16.	 Generic Communications Issued........................8

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

18.	 Significant Enforcement Actions......................10

19.	 Selected Federal Register Notices ...................11

REORGANIZATION OF THE OFFICE 

OF NUCLEAR MATERIAL SAFETY 

AND SAFEGUARDS AND CREATION OF 

THE OFFICE OF FEDERAL AND STATE 

MATERIALS AND ENVIRONMENTAL 

MANAGEMENT PROGRAMS

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

two newest offices have begun operation. They are

a refocused Office of Nuclear Material Safety and

Safeguards (NMSS) and the newly created Office

of Federal and State Materials and Environmental

Management Programs (FSME).

The refocused NMSS will concentrate on the nuclear

fuel cycle, from uranium conversion and enrichment

to fuel manufacturing and high-level waste storage,

transportation, and disposal. The leadership of the

Office will continue to be Jack Strosnider, Director.

Other senior managers include E. William Brach,

Director of the Division of Spent Fuel Storage

and Transportation; Robert Pierson, Director of

the Division of Fuel Cycle Safety and Safeguards;

Lawrence Kokajko, Director of the Division of

High-Level Waste and Repository Safety; and Mark

Flynn, Director of the Program Planning, Budgeting,

and Program Analysis staff.

FSME is comprised of the former Office of State and

Tribal Programs, two technical divisions from the

former NMSS, and a small program support staff.

FSME is headed by Charles Miller as Director, with

George Pangburn as Deputy Director. Other seni

managers include Janet Schlueter, Director of the

Division of Materials Safety and State Agreements;

Dennis Rathbun, Director of the Division of

Intergovernmental Liaison and Rulemaking;

Larry Camper, Director of the Division of Waste

Management and Environmental Protection; and

Joseph Holonich, Director of the Program Planning,

Budgeting and Program Analysis staff.

Protecting People and the Environment

UNITED STATES NUCLEAR REGULATORY COMMISSION

LICENSEE NEWSLETTER

NUREG/BR-0117

No. 06-04

December 2006

Office of Nuclear Material Safety and Safeguards

Office of Federal and State Materials and Environmental Management Programs
2

The reorganization was approved by the

Commission in June to help the NRC meet

new challenges in the materials, waste, and

environmental areas. These challenges inclu

increases in the number of Agreement States, as

well as the expected applications for new nuclear

power plants, spent-fuel reprocessing plants, and

the high-level waste repository at Yucca Mountain.

The NRC’s Agreement State program has grown

to 34 States, with three more States negotiating for

Agreement State status. Agreement State stat

allows a State to regulate the industrial, academic,

and medical uses of radioactive materials within its

jurisdiction.

Martin Virgilio, Deputy Executive Director for

Materials, Waste, Research, State, Tribal and

Compliance Programs, said the reorganization will

help NRC meet these demands while maintaining

its ability to protect public health and safety and

the environment. You can read more about the

reorganization at http://www.nrc.gov/reading-rm/

doc-collections/news/2006/06-122.html.

The reorganization became effective October 1.

(Contact: Michael Williamson, Office of Feder

and State Materials and Environmental Management

Programs, 301-415-6234; e-mail: mkw1@nrc.go

SHAW AREVA MOX SERVICES, 

FORMERLY DUKE COGEMA STONE 

& WEBSTER, MIXED OXIDE FUEL 

FABRICATION FACILITY LICENSE 

APPLICATION AND INTEGRATED 

SAFETY ANALYSIS SUMMARY 

SUBMITTED 

On September 27, 2006, Duke Cogema Stone &

Webster (DCS) submitted a License Application

and Integrated Safety Analysis (ISA) summary for

a proposed Mixed Oxide Fuel Fabrication Facility

(MFFF) to be built near Aiken, South Carolina.

Under the U.S. Department of Energy’s (DOE)

Surplus Plutonium Disposition Program, DOE plans

to use Shaw AREVA MOX Services (formerly DCS)

as a contractor to convert approximately 34 metric

tons of surplus weapons-grade plutonium into mixed

oxide fuel to be used in commercial nuclear power

plants.

On November 07, 2006, the U.S. Nuclear Regulatory

Commission (NRC) sent a letter, to Shaw AREVA

MOX Services, requesting that certain information

submitted as proprietary in the ISA summary be

included in the License Application. In respon

to this letter, Shaw AREVA MOX Services sent

a revised License Application for NRC staff to

review, incorporating the information requested on

November 17, 2006.

At the time of this writing, the resubmitted

License Application and existing ISA summary

are undergoing a 45-day acceptance review. If t

License Application and ISA summary are deemed

acceptable, they will undergo a technical review.

Before the beginning of a technical review of the

License Application and ISA summary, there will

be a public meeting, near the site, to discuss the

staff’s plan for the review and to announce another

opportunity for a hearing.

DCS previously applied for and received

authorization to construct a MFFF. On April 1

2001, the NRC published a notice in the Federal 

Register (66FR19994), announcing that the NRC

had accepted an application for authority to construct

a MFFF from DCS. The notice also announced 

opportunity for a hearing on the DCS application.

On March 30, 2005, the NRC issued a Construction

Authorization (CA) to DCS for a MFFF located on

the Savannah River Site in South Carolina. T

NRC staff’s technical basis for issuing the CA is set

forth in NUREG-1821, “Final Safety Evaluation

Report on the Construction Authorization Request

for the Mixed Oxide Fuel Fabrication Facility at

the Savannah River Site, South Carolina.” T

results of the staff’s environmental review related

to the issuance of the CA are contained in NUREG1767, “Environmental Impact Statement on the

Construction and Operation of a Mixed Oxide Fuel

Fabrication Facility at the Savannah River Site,

South Carolina -- Final Report.”

(Contact: David Tiktinsky, Office of Nucle

Material Safety and Safeguards, 301-415-6195;

e-mail: dht@nrc.go

THE GLOBAL NUCLEAR ENERGY 

PARTNERSHIP

In February 2006, the U.S. government announced

the Global Nuclear Energy Partnership (GNEP) as

part of President Bush’s Advanced Energy Initiative

to reduce U.S. dependence on foreign sources of

energy. This major initiative is considering a n

approach to the recycling of spent nuclear fuel

using advanced technologies. These advanc

technologies would increase resistance to

proliferation, recover and reuse fuel resources, and

reduce the amount of waste. Under this partnershi

the U.S. Government will work with nations such

as Russia, Japan, the United Kingdom and France

which have advanced civilian nuclear energy

programs to expand the use of nuclear power,
3

consistent with the provisions in the Energy Policy

Act, Nuclear Power 2010, and other provisions that

have been passed.

In order to reduce nuclear waste, GNEP is

considering two recycling technologies, among

others: 1) Uranium Extraction Plus (UREX+); and 2)

pyroprocessing. UREX+ is an advanced version 

PUREX, which is an existing aqueous reprocessing

technology used internationally in France and in

the United Kingdom. UREX+ does not separa

plutonium from other long-lived radioactive

elements. The UREX+ process will separate spent

fuel into uranium, which can be stored for future

use or disposal as low-level waste. In additio

long-lived fission products, such as technetium,

and iodine, could be separated for disposal in the

proposed repository at Yucca Mountain. Short-liv

fission products, such as cesium and strontium,

could be extracted and prepared for decay-in-storage

until they meet the requirements for disposal as

low-level waste. Transuranic elements (plutoniu

neptunium, americium, and curium) separated from

the remaining fission products could be fabricated

into fuel for consumption in a fast neutron reactor.

Burning the transuranic elements will significantly

reduce the heat load to Yucca Mountain, reducing

the need for additional geological repositories this

century.

Pyroprocessing is a non-aqueous technology that is

based on electrochemical separation. This techniq

is used to remove uranium, plutonium and other

actinides from the spent fuel, while keeping them

mixed. This method prevents the plutonium to 

used directly in weapons. Pyroprocessing dissolv

spent fuel in a chloride salt that is hot enough

to melt, rather than water-based acid as used in

UREX+. This does not work well for the oxide fue

in thermal reactors, but it is ideal for metallic fuel

that may be used in fast-neutron reactors.

According to the U.S. Department of Energy (DOE),

reprocessed materials, which retain about 90 percent

of the energy content of primary fuel, can be burned

in Advanced Burner Reactors (fast-neutron reactors)

to produce even more energy. The advantage 

those fast reactors is that as they produce power

they are also able to consume transuranic elements,

potentially eliminating the need for their disposal at

Yucca Mountain.

The U.S. will co-sponsor a workshop with the

International Atomic Energy Agency (IAEA) and

other IAEA Member States in Vienna, Austria, on

Dec. 4-6, 2006, to discuss a program to design, build

and export grid-appropriate reactors to comply with

GNEP purposes. The aforementioned technologies

promise to bring the benefits of nuclear energy to

the world safely and securely, without all countries

having to invest in the complete fuel cycle process.

The DOE plans to work with the industry to design,

build and operate a Consolidated Fuel Treatment

Center (CFTC) consisting of a commercial-scale

Modular Prototype Integrated Recycle Facility

and a commercial-scale Prototype Advance Burner

Reactor. DOE also intends to retain the lead 

research and development in the Advance Fuel

Cycle Research Facility.

(Contact: Cinthya I. Román-Cueva

Office of Nuclear Material Safety and Safeguards,

301-415-8118; e-mail: cir1@nrc.go

RECENT EVENTS IN GAS CENTRIFUGE

Milestones continue to be reached in the area of

gas centrifuge (GC) uranium-enrichment facility

licensing. After issuing a license to Louisia

Energy Services for the National Enrichment

Facility in Hobbs, New Mexico this past June, the

staff has been working on several licensing actions

involving USEC Inc. (USEC). These licensi

actions continue a changeover from the current

uranium-enrichment technology used in the United

States (gaseous-diffusion process) to the gascentrifuge process.

On September 11, 2006, the U.S. Nuclear

Regulatory Commission (NRC) issued the Safety

Evaluation Report (SER), NUREG-1851, for the

proposed American Centrifuge Plant (ACP) to be

constructed and operated by USEC. In the SER,

NRC staff concluded that USEC demonstrated it has

adequate safety programs to construct and operate

the proposed facility.

The proposed ACP, to be located at the Portsmouth

Gaseous Diffusion Plant (GDP) site in Piketo

Ohio, would produce Uranium-235 (U-235) enriched

up to 10 weight percent by a gas centrifuge process.

If the license is approved, facility construction

would begin in 2007, and continue for 5 years

through, 2011. The proposed ACP would begin

initial production in 2009, and peak production

would be reached in 2011.

The final SER, and the recently completed

Environmental Impact Statement are the major NRC

staff reviews in the licensing process. There are 

contentions related to the facility before the NRC
4

Atomic Safety and Licensing Board. However,

mandatory hearing will take place early next year.

Recent advancements have also been made by

USEC’s Lead Cascade Facility (LCF), which was

licensed in early 2004. The LCF was authoriz

to introduce uranium hexafluoride gas (UF6) into

the system on August 23, 2006. Also located 

the Portsmouth GDP site in Piketon, Ohio, the

LCF is a gas centrifuge test facility intended to

provide operational information on the machines

and auxiliary systems as they would be used

in commercial application. The authorizati

to introduce UF6 was made after several

license conditions were satisfied. These licen

conditions required: (1) revising the Portsmou

GDP Emergency Plan to appropriately address

the LCF; (2) acceptance and execution of the

decommissioning funding mechanism; and

(3) NRC completion of an operational readiness

review, verifing that management measures to

ensure compliance with the performance

requirements of 10 CFR 70.61 had been

implemented, and confirming that the facility was

constructed and operated, safely in accordance with

license requirements.

For more information related to gas centrifuge

uranium-enrichment facility licensing, visit our

website at http://www.nrc.gov/materials/fuelcyclefac/gas-centrifuge.html.

(Contact: Brian W. Smith, Fuel Cycle, NMS

301-415-7457; e-mail: bws1@nrc.go

UPDATE OF CONSOLIDATED 

DECOMMISSIONING GUIDANCE 

(NUREG-1757)

The Division of Waste Management and

Environmental Protection (DWMEP) has completed

its update of NUREG-1757, “Consolidated

Decommissioning Guidance,” which provides

guidance for planning and implementing license

termination under the License Termination Rule (10

CFR Part 20, Subpart E). The staff has publish

revisions to Volumes 1 and 2 of this NUREG series.

The first volume is “Consolidated Decommissioning

Guidance: Decommissioning Process for Materia

Licensees” (NUREG-1757, Vol. 1, Rev. 2), which

provides guidance for planning and implementing

the termination of materials licenses. The seco

volume, “Consolidated Decommissioning Guidance:

Characterization, Survey, and Determination of

Radiological Criteria” (NUREG-1757, Vol. 2, Rev.

1), provides guidance for compliance with the

radiological criteria for termination of licenses.

The revised Volumes 1 and 2 include the finalized

guidance of NUREG-1757, Draft Supplement

1, which was published for public comment in

September 2005. The guidance is intended f

use by NRC staff, licensees, and others. All thr

volumes of NUREG-1757 are available at http://

www.nrc.gov/reading-rm/doc-collections/nuregs/

staff/sr1757.

(Contacts: Kristina Banovac, DWMEP, 301-41

5114; email: klb@nrc.gov, and Duane Schmid

DWMEP, 301-415-6919; email: dws2@nrc.go

CONSOLIDATION OF NRC’S 

DECOMMISSIONING PROGRAM

On October 1, 2006, the project management and

oversight responsibility for 14 decommissioning

Research and Test Reactors (RTRs), two

decommissioning power reactors, and two earlydemonstration reactors transferred from the Office

of Nuclear Reactor Regulation (NRR) to the Office

of Federal and State Materials and Environmental

Management Programs (FSME). Additionally, t

project management and oversight of uraniumrecovery facilities, including decommissioning

facilities, was also transferred to FSME. T

decommissioning activities were consolidated

into the Division of Waste Management and

Environmental Protection (DWMEP) as a result

of a Staff Requirements Memorandum requesting

the staff to evaluate further consolidating the

decommissioning program. Based on t

evaluation, the staff determined that consolidating

the decommissioning program would increase the

efficient and effective use of resources and further

concentrate the decommissioning technical expertise

in one organization. The Decommissioning a

Uranium Licensing Recovery Licensing Directorate

in FSME now provides decommissioning

project management and oversight activities

for complex materials sites, power reactors,

RTRs, and uranium-mill tailing sites in addition

to providing decommissioning programmatic

support to the regions and other offices involved in

decommissioning activities.

(Contact: Keith McConnell, DWME

301-415-7295; email: kim@nrc.go

CLARIFYING IMPROVEMENTS TO 

10 CFR 70.72(c)(2)

In a September 27, 2006, Federal Register notice

(FRN), the U.S. Nuclear Regulatory Commission

(NRC) published both a proposed Direct Final Rule

(DFR) and proposed rule to clarify a requirement
5

pertaining to items relied on for safety (IROFS),

under Title 10 Code of Federal Regulations (CFR)

Part 70. The proposed rulemaking corrected 

inconsistency in the regulations pertaining to IROFS.

The final rule would be effective by December 11,

2006, unless significant adverse comments on the

rule were had been received by October 27, 2006. 

significant adverse comments on the rule had been

received, then the proposed rule would be modified

to address the comments, and a final rule would be

published in a future FRN.

Questions had arisen about whether changes

involving licensee-identified IROFS that were not

needed to meet the performance requirements in 10

CFR 70.61 would require an equivalent replacement

of the safety function. Consistent with other par

of the regulation, the staff proposed adding the

phrase, ‘‘...and is necessary for compliance with the

performance requirements of 10 CFR 70.61’’to the end

of 10 CFR 70.72(c)(2). Thus, the proposed 10 C

70.72(c)(2) would be (newly added phrase in bold):

	 “The licensee may make changes to the site,

structures, processes, systems, equipment,

components, computer programs, and activities

of personnel, without prior Commission

approval, if the change . . . does not remove,

without at least an equivalent replacement of

the safety function, an item relied on for safety

that is listed in the integrated safety analysis

summary and is necessary for compliance with 

the performance requirements in §70.61.”

This revision clarified that if an IROFS were not

needed to meet the 10 CFR 70.61 performance

requirements, a licensee may remove or replace the

IROFS without NRC staff’s approval and without

showing equivalent replacement of the safety

function. This change did not affect IROFS need

to meet performance requirements. If a licens

intends to remove or replace an IROFS needed to

meet performance requirements, then the licensee

must obtain NRC staff pre-approval before making

the change, unless the licensee has demonstrated

with on-site documentation that the replacement or

removal of the IROFS could be done with equivalent

replacement of the safety function of the IROFS.

At around the same time that the FRN was

published, NRC published the associated Regulatory

Issue Summary (RIS) 2006-14 and Enforcement

Guidance Memorandum (EGM) 06-005. The R

informed the Part 70 licensees that the 10 CFR

70.72(c)(2) regulation was proposed to be changed,

whereas the EGM informed NRC inspectors how

to apply enforcement discretion between the times

when the FRN was published and when the rule

change became final.

No significant adverse comments on the rule were

received by October 27, 2006. So, on December 1

2006, the DFR became effective as a final rule. N

that the rule change was finalized, both the RIS and

EGM are not in effect. One comment was receiv

on the information in the FRN. Staff is developi

a 10 CFR 70.72(c)(2) implementation guidance

document called an interim staff guidance (ISG).

The Division of Fuel Cycle Safety and Safeguards

(FCSS)-ISG process includes industry and other

stakeholder participation in public meetings as well

as a comment/resolution process. The one comme

received on the information in the FRN will be

addressed as part of the FCSS-ISG process.

(Contact: Harry Felsher, Office of Nucle

Material Safety and Safeguards, 301-415-5521,

e-mail: hdf@nrc.go

REGULATIONS FOR EMERGING 

TECHNOLOGIES

The requirements for all new medical uses of

byproduct material, or radiation from byproduct

material, that are not specifically addressed in

subparts D through H of Title 10 Code of Federal

Regulations (CFR) Part 35 fall under the regulations

in10 CFR 35.1000. The information required 

applicants of 35.1000 medical uses is found in

10 CFR 35.12 “Application for license, amendment,

or renewal.” Section 35.1000 itself does n

include specific training and experience (T&E)

requirements for authorized users (AU) of emerging

technologies because the T&E necessary for the safe

use of byproduct material may be unique to each

new technology. The specific risks associated wi

these emerging technologies, additional regulatory

requirements, and the T&E requirements are

evaluated on a case-by-case basis. Although t

new medical use of byproduct material is regulated

under 10 CFR 35.1000, licensing guidance for

each specific 10 CFR 35.1000 use, including the

T&E requirements, is posted on the U.S. Nuclear

Regulatory Commission (NRC) web site under

the section “Other Guidance,” at http://www.nrc.

gov/materials/miau/med-use-toolkit.html. Licensi

guidance for emerging technologies will be modeled

on other medical uses with similar risk. License

interested in applying for authorizations for new

medical uses should submit applications to the

appropriate NRC Regional offices.

(Contact: Donna-Beth Howe, Office of Federal a

State Materials and Environmental Management

Programs, 301-415-7848; e-mail: dbh@nrc.go
6

CLARIFICATION OF DOSAGE 

CATEGORIES FOR UNSEALED 

BYPRODUCT MATERIAL REQUIRING 

A WRITTEN DIRECTIVE

Title 10 Code of Federal Regulations (CFR)

35.390, “Training for use of unsealed byproduct

material for which a written directive is required,”

establishes requirements for authorized users

(AU) of unsealed byproduct material for the uses

authorized under 10 CFR 35.300 “Use of unseal

byproduct materials for which a written directive

is required.” 10 CFR 35.390 requires a physici

seeking to become an AU for uses authorized

under section 35.300 to complete work experience

that includes administering dosages of radioactive

drugs to patients or human research subjects in at

least three cases in each of the categories for which

the individual is requesting AU status. There a

four dosage categories listed in paragraph 10 CFR

35.390(b)(1)(ii)(G):

(1)	 Oral administration of less than or equal to 1.22

gigabecquerels (Gbq) (33 millicuries) of sodium

iodide I-131, for which a written directive is

required;

(2)	 Oral administration of greater than 1.22 Gbq

(33 millicuries) of sodium iodide I-131;

(3)	 Parenteral administration of any beta-emitter,

or a photon-emitting radionuclide with a photon

energy less than 150 kiloelectron volt, for which

a written directive is required; and/or

(4)	 Parenteral administration of any other

radionuclide, for which a written directive is

required.

The U.S. Nuclear Regulatory Commission (NRC)

has received several inquiries from physicians

wishing to be authorized for all four categories.

Currently an AU can be licensed only for categories

1, 2, and 3, or any combination thereof. Exampl

of parenteral administrations that fall within the third

category include, but are not limited to, Strontium89, Phosphorus-32, Yttrium-90 (Zevalin® therapy),

Samarium-153, and non-sodium iodide-131 (e.g.

Bexxar® and MIBG therapies). NRC is not a

of any radiopharmaceutical administrations that fall

under the fourth category and therefore currently

does not authorize AUs for that category. Catego

3 was intended to include parenteral administrations

that were currently being performed at the time that

10 CFR 35.390 was promulgated. At the time th

10 CFR 35.390 was promulgated, there was no way

to predict what new therapies involving parenteral

administrations of unsealed byproduct material

would be developed in the future. Therefore, t

fourth category was included in the regulation to

cover these potential therapies, to avoid having to

again revise the requirements to address these new

therapies.

(Contact: Cindy Flannery, Office of Federal a

State Materials and Environmental Management

Programs, 301-415-0223; e-mail: cmf@nrc.go

CLARIFICATION OF THE TRAINING 

AND EXPERIENCE REQUIREMENTS IN 

10 CFR 35.396

Section 35.396, “Training for the parenteral

administration of unsealed byproduct material

requiring a written directive,” was specifically

developed for authorized users (AU) qualified

under other sections of Title 10 Code of Federal

Regulations (CFR) Part 35 who are seeking to

become AU’s under this section. The U.S. Nucle

Regulatory Commission (NRC) has received many

inquiries about whether paragraph (d) of 10 CFR

35.396 is a stand-alone criterion for one of the

training and experience (T&E) pathways. Secti

35.396 establishes three different T&E pathways for

a physician seeking to become an AU for parenteral

administration of unsealed byproduct material

requiring a written directive. The first pathwa

described in 10 CFR 35.396(a), is a stand-alone

criterion which permits an AU authorized under

10 CFR 35.390 for parenteral administrations (i.e.,

uses listed in §35.390(b)(1)(ii)(G)(3) or (4)), by his

or her training and experience, to be an AU under

10 CFR 35.396. Physicians seeking AU status 

the second or third pathways, described in 10 CFR

35.396(b) and (c), respectively, must also satisfy

the T&E requirement in paragraph (d) of 10 CFR

35.396. With regard to those pathways, the T

requirement described in 10 CFR 35.396(d) is not

a stand-alone criterion. Rather, paragraph (d) is 

additional requirement for the pathways described in

10 CFR 35.396(b) and (c). The T&E requiremen

established in 10 CFR 35.396 can be found on the

NRC web site at http://www.nrc.gov/reading-rm/

doc-collections/cfr/part035/part035-0396.html.

(Contact: Cindy Flannery, Office of Federal a

State Materials and Environmental Management

Programs, 301-415-0223; e-mail: cmf@nrc.go

IMPROVING PUBLIC UNDERSTANDING 

OF THE RISKS ASSOCIATED WITH 

MEDICAL EVENTS

Medical events (ME) are defined in Title 10 Code

of Federal Regulations (CFR) 35.3045, “Report
and notification of a medical event.” There ha

been indications to the U.S. Nuclear Regulatory

Commission (NRC), that members of the public

associate the occurrence of an ME with harm or

risk of harm to the patient or patients involved in an

event, which is not necessarily the case. In Ma

2004, the Commission directed the NRC staff to

provide recommendations on how to effectively

communicate the associated risks, if any, of MEs

to the public. The Commission also directed t

staff to involve NRC’s Advisory Committee on

the Medical Uses of Isotopes (ACMUI) in the

development of its recommendations.

In February 2005, the Commission approved the

NRC staff’s recommendations to improve public

understanding of the risks associated with MEs.

The staff’s recommendations were based on input

from the ACMUI.

The ACMUI recommended as a general “guiding

principle” that NRC consider MEs as a quality

assurance (QA) performance index, indicative of

technical or QA problems in accurately realizing

clinical intentions of authorized user (AU)

physicians, but not as an indicator of patient

harm, nor the probability of patient harm. N

endorses this “guiding principle.” The ACM

also suggested that NRC not disclose/release event

information to the public until the event has been

confirmed to be a reportable ME. In the interest 

openness and timeliness, information about events

involving medical use and reported as potential MEs

is released to the public by NRC when the event has

been confirmed to be an ME, or after 5 calendar days

have passed, whichever comes first. The ACM

also suggested footnoting each Event Summary

released, to the public as a reportable ME, to indicate

that dose thresholds in NRC’s ME definitions, if

exceeded, are not necessarily indicative of patient

harm. This measure has also been implemente

In summary:

1. 	 NRC’s ME definitions provide thresholds for

identifying events indicative of technical or QA

problems in accurately realizing the clinical

intentions (prescriptions) of AU physicians;

2. 	 Thresholds in NRC’s ME definitions, if

exceeded, are not necessarily indicative of

patient harm.

This summary has been incorporated into an NRC

fact sheet, available on the NRC public web site, at

http://www.nrc.gov/reading-rm/doc-collections/factsheets/risks-assoc-medical-events.html.

(Contact: Ronald Zelac, Ph.D., Office of Feder

and State Materials and Environmental Programs,

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

DOSE LIMIT FOR PATIENT RELEASED 

UNDER 10 CFR 35.75

The conditions under which licensees may authorize

the release from their control of individuals who

have been administered unsealed byproduct material

or implants containing byproduct material appear in

Title 10 Code of Federal Regulations (CFR) 35.75.

One of these conditions is that the total effective

dose equivalent (TEDE) to any other individu

from exposure to the released individual is not likely

to exceed 5 millisievert (mSv) (0.5 rem).

Although licensees typically use the 5 mSv (0.5 rem)

TEDE limit to other individuals for determining the

appropriateness of releasing a patient (or human

research subject) after a single administration or

application, the 5 mSv (0.5 rem) TEDE is an annual

limit on dose to other individuals. Thus, if multip

administrations or applications in a single year are

planned or are potentially anticipated for a patient,

the decision about releasing that patient after each of

the administrations must be based on the TEDE from

all administrations or applications in a calendar year

not exceeding 5 mSv (0.5 rem) for the maximally

exposed other individual.

The U.S. Nuclear Regulatory Commission’s position

for 10 CFR 35.75, that the 5 mSv (0.5 rem) TEDE

annual limit on doses to other individuals from

exposure to the released individual is an annual

limit, and that the total dose resulting from multiple

administrations to and multiple releases of an

individual within a given year must be taken into

consideration, will be discussed more fully in a

Regulatory Information Summary to be issued in

the near future, which can be found at http://www.

nrc.gov/reading-rm/doc-collections/gen-comm/regissues/2006/.

(Contact: Ronald Zelac, Ph.D., Office of Feder

and State Materials and Environmental Programs,

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

INCREASED CONTROLS: ANSWERS TO 

COMMONLY ASKED QUESTIONS

The U.S. Nuclear Regulatory Commission

(NRC) has identified fifteen radionuclides, and

combinations thereof, that, when possessed in

certain quantities, must be protected by the licensee

from theft, sabotage, or diversion. In order 

minimize risk to public health and safety, NRC
8

issued an Increased Controls (IC) Order [EA-05-

090] on November 14, 2005 to licensees that are

authorized to possess the quantities of radioactive

material identified in Table 1 of the Order, otherwise

known as “Radioactive Materials Quantities of

Concern.” The Order encompasses six gener

requirements that pertain to the security of Table

1 quantities. Licensees must implement the

requirements to ensure adequate protection of these

sources from malevolent use.

Though NRC and Agreement State licensees

have always been required to protect radioactive

material in their possession, several security

concepts behind the IC requirements may be new to

licensees. To help licensees interpret and apply t

IC requirements, NRC formed the Implementation

of Increased Controls Working Group (IICWG),

made up of NRC Headquarters and Regional staff,

and Agreement State representatives. The IIC

develops guidance to address questions that may

arise as regulators and licensees implement the

requirements of the Order. For this purpose, t

IICWG produced implementing guidance including

a series of questions and answers (Q&A). T

IICWG continues to answer new implementation

questions by means of a living supplemental Q&A

document. Licensees are encouraged to revi

this information to enhance their understanding

of the requirements and clarify issues involving

their IC program. Should there be need of furth

clarification, licensees may contact their respective

Agreement State agency or NRC Regional office for

assistance.

The IC Order and guidance documents can be

viewed on the NRC public website at http://www.

nrc.gov/reading-rm/doc-collections/enforcement/

security. The documents are located under t

heading “Holders of Material Licenses Authorized

to Possess Radioactive Material Quantities of

Concern.”

(Contact: Joshua Palotay, FSME/MSS

301-415-6231; e-mail: jxp5@nrc.gov, 

Christian Einberg, FSME/MSSA, 301-415-5422;

e-mail: cee1@nrc.go

RUPTURE OF JAMMED SEEDS IN MICK 

APPLICATORS DURING MANUAL 

BRACHYTHERAPY TREATMENTS

During the past 3 years, there have been at least six

cases in which Iodine-125 seeds ruptured during

prostate Brachytherapy treatments. Typically t

cause of the seed rupture is operator excessive

force applied to the seed cartridge in an attempt

to dislodge or implant seeds jammed in the MICK

applicator.

In 2005, NRC issued Information Notice 2005-

17, “Manual Brachytherapy Source Jamming”

for nation-wide distribution, and the Wisconsin

Department of Health and Family Services also

issued an Information Notice dated June 9, 2005,

for Wisconsin licensees. Users are advised N

to use force when attempting to remove jammed

seeds, and to follow the manufacturer’s instructions,

as provided in the user manual, when dislodging

jammed seeds. Also, Mick Radio-Nucle

Instruments, Inc. describes the proper dislodging

techniques on its website (http://www.micknuclear.

com).

Both Information Notices are available on the

NRC website at http://www.nrc.gov/reading-rm/doccollections/gen-comm/info-notices/2005/in200517.

pdf.

(Contact: Cindy Flannery, Office of Federal a

State Materials and Environmental Management

Programs, 301-415-0223; e-mail: cmf@nrc.go

GENERIC COMMUNICATIONS ISSUED

(Sep 1, 2006 - Nov 30, 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/readingrm/doc-collections/ en-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 Monica Orendi, (301) 415-3938, or by

e-mail: mlo1@nrc.go

Bulletins (BL)

None.

Generic Letters (Gl)

None.

Information Notices (IN)

None.
9

Regulatory Issue Summaries (RIS’)

RIS 2006-19 “Availability of Guidance on

Radioactive Seed Localization” was issued

September 14, 2006. This RIS was issued to a

NRC medical licensees.

(Technical contact: Donna-Beth Howe, FSM

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

RIS 2006-20, “Guidance for Receiving Enforcement

Discretion When Concentrating Uranium at

Community Water Systems” was issued September

14, 2006. This RIS was issued to all communi

water systems (CWS’), in NRC non-Agreement

States, that during the treatment of drinking water,

may accumulate and concentrate naturally occurring

uranium in media, effluents, and other residuals,

above 0.05 percent by weight. CWS’ operating

in Agreement States should contact their State

regulatory agency to determine what requirements

apply to their operations.

(Technical contacts: Michael Williamson, Offi

of Federal and State Materials and Environmental

Management Programs, 301-415-6234; e-mail:

mkw1@nrc.gov and Gary Comfort, Office 

Federal and State Materials and Environmental

Management Programs, 301-415-8106; e-mail:

gcc1@nrc.gov)

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, NMS

301-415-7414; e-mail: fsg@nrc.gov; a

John Skoczlas, OIS, 301-415-7186;

e-mail: jas1@nrc.go

(General Contact: Monica Orendi, FSM

301-415-3938; e-mail: mlo1@nrc.go

SIGNIFICANT EVENTS

Event #1: Lost radioactive see

Date and Place: October 4, 2006, Spokane,

Washington

Nature and Probable Causes: The licensee report

two damaged shipping packages containing cesium131 (Cs-131) cancer therapy seeds. The shippi

company discovered a flattened lead cap in its

Spokane, Washington, terminal. A partial label 

the cap indicated it came from one of two packages

containing 63 Cs-131 seeds with a total activity of

12.2 Gigabecquerels (GBq) (330 millicuries). T

second package was found crushed, but essentially

intact; all seeds were present and undamaged.

Scraps from the first package were found on the

runway and on the floor of an airport vehicle.

Washington Department of Health (DOH) personnel

responded to the scene, and the licensee also

dispatched a team to the site. DOH personnel we

able to recover three of the 63 seeds from the first

package. Several areas of radioactive contaminati

and radiation exposure were located, with the highest

level of contamination at 400 counts per minute, and

the highest level of exposure at approximately 25

milliroentgen per hour or 6.54 x 10-5 Coulombs per

kilogram per hour (C-kg-1-hr-1). Washington D

requested that the shipping company’s management

revise its hazardous material transportation-handling

procedures and provide refresher training to staff.

Event #2: Overexposure to Work

Date and Place: October 20, 2006, Cincinnati, Oh

Nature and Probable Causes: The licensee report

a contamination incident in its source-handling

facility. Two cesium 137 (Cs-137) sources fr

TN Technology fixed gauges were breached during

source disposal operations. One Cs-137 sour

with an activity of 0.41 Gigabecquerels (GBq) (11

millicuries (mCi)) was breached when an individual

cut into the source holder with a band-saw. T

other source had an activity of 0.96 GBq (26 mCi)

and was breached when the same individual drilled

into the source holder. Radioactive contaminati

was detected on the individual conducting the

source-removal operations and throughout the

source-handling area. The contaminated areas we

controlled-access areas within the facility. So

contamination escaped from the room under two

doors leading to the licensee’s gauge-manufacturing

area, but not into any unrestricted areas. T

contamination on the individual was estimated

at 0.37 GBq (10 mCi) and was located on the

individual’s clothing, hair, arms, and hands. T

individual was decontaminated on site and sent to

a local hospital as a precautionary measure. Th

was some residual contamination on the individual’s

finger tips; however, further scrubbing to remove the

contamination may have caused a breakdown of the

skin. The individual put on gloves in an attempt 

sweat out the residual contamination. Two urinalys

samples collected from the employee were negative.

The source-handling area was secured and closed

to all personnel over the weekend. Prelimina

surveys identified 14,000 to 500,000 disintegrations
10

per minute in large-sample wipe tests of walk-ways

in the manufacturing area. It was estimated th

approximately 0.37 GBq (10 mCi) of contamination

were involved in the source-handling area. T

licensee retained a decontamination contractor

and an Ohio Bureau of Radiation Protection

inspector visited the site to assess the contractor’s

decontamination efforts and to further investigate

the circumstances that caused the incident. T

contaminated employee received a whole-body

count, and the results revealed the presence of

133.57 Becquerels (3.61 nanocuries) in the lungs.

A second whole-body scan was scheduled for 2

weeks from the initial scan. Dose estimates will 

prepared by the licensee and its medical consultant

after urine samples have been analyzed. Correcti

actions taken by the licensee included generating

a new procedure for the removal of sources from

holders.

Event #3: Overexposure to Radioactive Was

Workers

Date and Place: November 1, 2006, Richlan

Washington

Nature and Probable Causes: The licensee report

possible radiation overexposures to four individuals.

The individuals were involved in separating

sources, lead pigs, and trash from drums. The tot

americium 241 (Am-241) activity from 12 drums

was manifested at 6.8 Gigabecquerels (GBq) (184

millicuries); however, only one drum was open at

the time of the incident. Work was being conduct

in a ventilated room within a waste-processing

building. Two workers inside the room we

wearing respirators and the supervisor, not wearing

a respirator, was immediately outside the room

directing the work. A contamination level abo

2 million disintegrations per minute was detected

in the room, and the building was evacuated. 

air sample in the area revealed an alpha activity of

0.37 microBecquerels per milliliter (μBq/ml) (0.001

picocuries per milliliter). The three workers we

taken to a survey area and found to be contaminated

on the face. Contamination was also found on t

respirators. The workers were decontaminated on

site. Air-sample-analysis results for a particula

sample in the building exhaust stack was 340.4

Becquerels per milliliter (Bq/ml) (9.2 nanocuries

per milliliter (nCi/ml)) gross alpha. The building

was decontaminated, and additional containment

tents were installed around the contaminated room.

Whole-body counts the next day revealed that the

supervisor received an intake of approximately

432.9 Bq (11.7 nCi) of Am-241, with an estimated

lung dose of 97.5 centisievert (cSv) (97.5 rem)

committed dose equivalent (CDE).

The supervisor also had an estimated dose to the

endosteal (white bone matter) of 95 cSv (95 rem)

CDE. The other two workers were given two lu

counts, with results of 248 and 188 Bq (6.7 and 3.2

nCi) for one, and 56 and 19 Bq (1.5 and 0.5 nCi) for

the other. A health physics technician working ne

the supervisor in the outer room was also counted

with a result of less than 33 Bq (0.9 nCi). All fo

workers were given chelating treatments.

(CONTACT: Ashley M. Tull 301-415-5294, FSM

e-mail: amt1@nrc.go

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

St. Peter’s University Hospital (EA-06-228)

On November 30, 2006, a Notice of Violation was

issued for a Severity Level III violation involving

the failure to secure licensed material from

unauthorized removal or access, and/or maintain

constant surveillance of licensed material that

was stored in a controlled or unrestricted area.

Specifically, on August 2, 2006, an High Dose

Reloader (HDR) unit containing Iridium-192 was

left unsecured and unattended in that the door to

the room housing the HDR was open and no staff

member was in the immediate vicinity to maintain

constant surveillance, contrary to 10 CFR 20.1801

and 10 CFR 20.1802.

St. Joseph Health Center (EA-06-188)

On October 20, 2006, a Notice of Violation was

issued for a Severity Level III violation involving

the administration of greater than 30 microcuries

of I-131 sodium iodide without a written directive

that was signed and dated by an authorized user.

Specifically, a technologist administered 5.4

millicuries of I-131 sodium iodide to a patient that

was scheduled to receive 15 microcuries of I-131

sodium iodide, without a written directive that

was dated and signed by an authorized user before

administering the I-131 sodium iodide dose.
11

Portable Gauges

H&G Inspection Company, Inc. (EA-06-021)

On October 24, 2006, a Confirmatory Order

(effective immediately) was issued to confirm

commitments made as part of a settlement

agreement. The licensee requested Alternati

Dispute Resolution following the NRC’s May 1,

2006, Notice of Violation and proposed imposition

of a civil penalty in the amount of $6,500. T

violation involved the willful failure to block

and brace a radiographic exposure device during

transport. As part of the agreement, H&G h

agreed to implement a comprehensive management

review and oversight program, and within one year,

to write and submit an article for publication by both

the American Society of Non-Destructive Testing

(ASNT) and the Non-Destructive Testing Managers

Association (NDTMA) addressing the value that

the new H&G management oversight program

adds to overall safe and effective operations. 

recognition of H&G’s extensive corrective actions,

the NRC agreed to reduce the civil penalty originally

proposed to $500.

Advantage Engineering, LLC (EA-06-214)

On October 18, 2006, a Notice of Violation was

issued for a Severity Level III violation involving

the failure by the authorized gauge operator to

control and maintain constant surveillance of a

portable nuclear gauge. Specifically, the gaug

which contained NRC-licensed radioactive material

(two radioactive sources), was damaged when it was

run over by a bulldozer after the authorized gauge

operator had left it unattended for approximately five

minutes at a job site.

Quaker Sales Corporation (EA-06-194)

On September 13, 2006, a Notice of Violation was

issued for a Severity Level III violation involving

the failure to control and maintain constant

surveillance of a portable nuclear gauge resulting in

damage to the gauge. Specifically, the gauge w

left unattended for approximately 5 minutes while

the gauge user was approximately 150 feet away

from the gauge. During the time the gauge was n

within the user’s line of sight, it was run over by a

bulldozer.

Triad Engineering, Inc. (EA-06-150)

On September 12, 2006, a Notice of Violation

(NOV) and Proposed Imposition of Civil Penalty

in the amount of $3,250 was issued. The NOV

cites two violations of NRC requirements. T

first violation involved the failure of the authorized

gauge user (AU) to properly block and brace the

gauge in the open bed of his pick-up truck, to secure

the gauge with two independent physical controls,

and to close the tailgate prior to leaving the field

office parking lot. The case containing the gau

fell off the truck onto a public street resulting in

the second violation, i.e., the failure to control and

maintain constant surveillance of licensed material

in an unrestricted area. After bystanders notified t

AU that his gauge had fallen off his truck, the AU

driver retraced his route and retrieved the gauge.

The container and the gauge were not damaged and

there was no radiation dose to members of the public

as a result of this event.

(General Contact: Sally Merchan

Office of Enforcement, 301-415-2747,

e-mail: slm2@nrc.go

SELECTED FEDERALREGISTER NOTICES

(September 1, 2006 – December 31, 2006)

10 CFR Parts 19, 20, and 50 [RIN 3150-AH40]

“Occupational Dose Records, Labeling Containers,

and the Total Effective Dose Equivalent; Proposed

rule.” 71 FR 55382, September 22, 2006.

(Contact: Stewart Schneider, Office of Nucle

Reactor Regulation, 301-415-4123, e-mail: sx

nrc.gov)

10 CFR Part 70 [RIN 3150-AH96] “Facility Change

Process Involving Items Relied on for Safety.” 71

FR 56344 September 27, 2006.

(Contact: Dr. Anthony N. Tse, Office of Federal a

State Materials and Environmental Management

Programs, 301-415-6233, e-mail: ant@nrc.go

10 CFR Part 72 [RIN 3150-AH98] “List of

Approved Spent Fuel Storage Casks: HI-STORM

100 Revision 3.” 71 FR 60659, October 16, 200

(Contact: Jayne M. McCausland, Office of Feder

and State Materials and Environmental Management

Programs, 301-415-6219, e-mail: jmm2@nrc.go

10 CFR Parts 2, 30, 40, 50, 52, 60, 63, 70, 71, 72,

73, 76, and 150 [RIN 3150-AH57] “Protection of

Safeguards Information; Proposed rule.” 71 

64004, October 31, 2006.

(Contact: Marjorie Rothschild, Office of the Gener

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

Bernard Stapleton, Office of Nuclear Security and
12

Incident Response,

301-415-2432, e-mail: bws2@nrc.go

10 CFR Part 35 [Docket No. PRM-35-20] “E.

Russell Ritenour, Ph.D.; Receipt of Petition for

Rulemaking.” 71 FR 64168, November 1, 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 and 32 [RIN 3150-AH48]

“National Source Tracking of Sealed Sources; Final

Rule.” 71 FR 65686, November 8, 200

(Contact: Merri Horn, Office of Federal a

State Materials and Environmental Management

Programs, 301-415-8126, e-mail: mlh1@nrc.go

10 CFR Part 72 [RIN 3150-AH93] “List

of Approved Spent Fuel Storage Casks:

NUHOMS[supreg] HD Addition.” 71 FR 7146

December 11, 2006.

(Contact: Jayne M. McCausland, Office of Feder

and State Materials and Environmental Management

Programs, 301-415- 6219, e-mail: jmm2@nrc.go

10 CFR Part 20 “Public Meeting on Consideration

of Rulemaking To Reduce the Likelihood of Funding

Shortfalls for Decommissioning Under the License

Termination Rule.” 71 FR 74847, December 1

2006.

(Contact: Kevin O’Sullivan, Office of Federal a

State Materials and Environmental Management

Programs, 301-415-8112, e-mail: kro2@nrc.go

10 CFR Part 72 [RIN 3150-AH98] “List of

Approved Spent Fuel Storage Casks: HI-STORM

100 Revision 3; Withdrawal of Direct Final Rule.”

71 FR 77586, December 27, 2006.

(Contact: Jayne M. McCausland, Office of Feder

and State Materials and Environmental Management

Programs, 301-415- 6219, email: jmm2@nrc.go

(General Contact: Alexandra Greene, Office 

Federal and State Materials and Environmental

Management Programs, 301-415-5288, e-mail:

amg1@nrc.gov)

NOTE TO READERS: In an attempt to ke

the NMSS-FSME Licensee Newsletter relevant,

useful and informative, feedback on the content

of the newsletter is welcome. Readers desiri

to contribute articles, self-explanatory diagrams,

suggestions for future articles, bulletins, web-site

postings, and other items of interest to the NMSSFSME Licensee Newsletter readership, should

contact Michael Williamson, from the Office of

Federal and State Materials and Environmental

Management Programs, Rulemaking Branch A.

Mr. Williamson may be contacted at (301) 415-6234

or mkw1@nrc.gov. In addition, to ensure prop

delivery of the NMSS-FSME 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-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 F3

Washington, D. C. 20555-0001