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

Regulatory Material Safety No. 05-01

Commission and Safeguards March 2005

NMSS Quarterly Newsletter

Contents Page

1. Security Requirements for Portable Gauges

Containing Byproduct Material ......................... 1

2. NRC’s Annual Report on the Status of

the Decommissioning Program.......................... 3

3. NMSS Participated in ISO Working Group

Session on Two International Standards for

Sealed Radioactive Sources ............................... 4

4. Spent Fuel Project Office Licensing

Process Conference ........................................... 5

5. Generic Communications Issued

(December 17, 2004 - March 1, 2005) ............... 5

6. Significant Events ............................................. 6

7. Significant Enforcement Actions ....................... 6

8. Selected Federal Register Notices

(December 15, 2004 - February 28, 2005) ......... 8

SECURITY REQUIREMENTS for PORTABLE

GAUGES CONTAINING BYPRODUCT

MATERIAL

Recent events in the nation and the world have

increased public interest in and sensitivity to the

frequency of theft of gauges containing nuclear

material. It is important to keep in mind that the

number of incidents of stolen gauges (about 50 out

of about 22,000 or less than one quarter of 1

percent) reported per year is small when compared

with the total number of gauges in use. The amount

of radioactive material used in a portable gauge is

also relatively small. The most commonly used

portable gauges contain two encapsulated sources: a

sealed gamma source containing 0.30 to 0.37

gigabecquerels (8 to 10 millicuries) of cesium-137

(Cs-137) and a sealed neutron source containing

1.48 to 1.85 gigabecquerels (40 to 50 millicuries) of

americium-241/beryllium (Am-241/Be).

To date, there have not been any reported incidents

of individuals suffering from a radiation injury or

overexposure associated with a stolen portable

gauge, but the potential exists for an individual to

receive a radiation exposure exceeding the

regulatory limits as a result of close contact with the

sealed source. The dose rate on the surface of a

typical portable gauge is about 0.2 millisievert per

hour (mSv/hr) [20 millirem per hour (mrem/hr)];

and the dose rate on the source is more than 10

mSv/hr (1,000 mrem/hr).

Furthermore, it is also a concern if a portable gauge

is abandoned in the environment or recycled in a

steel mill. Many landfills and recycling facilities

are now equipped with radiation monitors;

therefore, radioactive sources are often detected and

removed early in the process. Granted, the potential

for radioactive material to enter a metal recycling

plant is small, but the cost for cleanup is large if

such an event occurs. For example, in 2001, a

radioactive source was melted in a steel mill in

Florida. The metal recycling plant was shut down

for more than a month, and the cost for cleanup was

more than $10 million.

Citing the reasons above, the U.S. Nuclear

Regulatory Commission (NRC) believed that

existing regulatory controls were insufficient to

reduce the current rate of stolen gauges. NRC has

issued several Information Notices (INs) to remind

licensees of their responsibilities concerning the

security of portable gauges, but the number of

reported incidents has not significantly decreased.

In order to protect the public from the potential

health and safety risks caused by lost or stolen

gauges, and to enhance public confidence, it is

prudent to require additional controls to reduce the

number of stolen portable gauges.

Based on the number of portable gauges in

operation and the number of licensees that will be

impacted by this rule, the staff believes that

increasing the number of physical controls to two is

the best option in achieving the goal of reducing the
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current number of stolen gauges and, at the same

time, providing sufficient flexibility for the

licensees in selecting controls that are most suitable

to the licensee. There are approximately 1100 NRC

licensees and 4000 Agreement State licensees that

will be impacted by the final rule.

As discussed in Commission Paper (SECY) 03-0092

(http://www.nrc.gov/reading-rm/doc-collections/

commission/secys/2003/secy2003-0092) for the

proposed rule, the staff evaluated various control

options, including: (a) no action alternative; (b)

prohibiting unattended storage in vehicles at an

annual cost impact of about $70 million; (c)

prohibiting unattended storage at locations other

than licensed facilities (e.g., requiring daily return of

gauges) at an annual cost of about $220 to $625

million; (d) requiring use of a metal enclosure with

a one-time cost of about $10 million and an annual

cost of $400,000; and (e) requiring two physical

controls with a one-time cost of about $5 million

and an annual cost of $200,000. The estimated

benefit gained is about $170,000 per year from

resources saved from reduction of the need to

replace lost or stolen gauges, and the response to

events. To help determine these costs, a 50-percent

reduction in the number of stolen gauges was

assumed in the benefit analysis.

This amended rule was developed on the basis of

public health and safety, not on the basis of common

defense and security. As stated in the International

Atomic Energy Agency (IAEA) “Categorization of

Radioactive Sources” (TECDOC-1344), a portable

gauge is a Category 4 source. Since the IAEA

“Code of Conduct on the Safety and Security of

Radioactive Sources” only covers Categories 1, 2

and 3 sources, the Code of Conduct does not apply

to portable gauges. Also, under the IAEA interim

guidance on the “Security of Radioactive Sources”

(TECDOC-1355), the designated security grouping

for a portable gauge is Group C, which requires

access control at the source location and one

technical measure separating the source from

unauthorized personnel. Currently, the United

States has not adopted IAEA interim guidance

TECDOC-1355.

Rulemaking Background and Comments

On January 25, 2002, the staff provided the

Commission with proposed interim compensatory

measures for various categories of NRC licensees,

including materials licensees, to increase security in

response to the September 11, 2001, terrorist

attacks. A supplement to the interim compensatory

measures was developed proposing that the

Commission issue Orders, under its retained

authority to provide for the common defense and

security for four categories of material licensees.

These categories include: (1) large irradiators: (2)

large unsealed sources: (3) self-shielded irradiators:

and (4) industrial radiography and well logging

sources. The supplement also proposed to

undertake a rulemaking for portable gauges on a

health and safety basis. The Commission approved

the staff’s proposal to initiate discussions with the

Agreement States in a Staff Requirements

Memorandum dated July 2, 2002.

In August 2002, a working group was formed to

explore various options and requirements for the

proposed rulemaking. The working group was

comprised of NRC staff and personnel from the

Agreement States of Florida and Arkansas. During

the rulemaking process, staff also consulted with the

U.S. Department of Transportation (DOT)

hazardous material transportation staff. In addition,

a steering group was formed to address issues and

facilitate concurrences.

During the rulemaking process, the working group

developed the proposed rule (SECY-03-0092, June

5, 2003), which was approved for publication by the

Commission in a SRM dated July 14, 2003. The

proposed rule was published in the Federal Register

(FR) (68 FR 45172) on August 1, 2003. The

comment period on the proposed rule closed on

October 15, 2003, and 11 comment letters were

received. The commenters included a member of

the public, members of an industry advisory group,

three licensees, one radiation service company, two

manufacturers, and three States.

Among the 11 comment letters, six indicated that

they supported the goal to reduce the loss or theft of

portable gauges, but some believed that NRC had

not effectively addressed the root cause; two stated

that current requirements were adequate; one

indicated that the rule was well-intended; one

expressed the view that a double-lock requirement

might be excessive; and one believed that the

current practice of using a chain to secure a gauge in

an open-bed pickup truck was not adequate security.

These comments and further NRC responses are

discussed in detail in the Federal Register notice

(68 FR 45172).

Similarly, three States submitted comments on the

published proposed rule. The State of Washington

indicated that NRC security measures did not go far

enough, noting that its requirements exceeded

NRC’s proposed rule requirements regarding

visibility and daily return of portable gauges to an
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approved storage location. The State of North

Carolina believed that current regulations were

sufficient to ensure the protection of the

occupational worker, members of the public, and the

environment, with regard to the hazards associated

with the safe use of portable gauges. Also, it did not

believe that the NRC rule would effectively address

the root cause of unauthorized removal or theft of

portable gauges. In the State of North Carolina’s

view, the visibility of the transportation cases or the

easy access to the portable gauges are the root

causes. The Commonwealth of Virginia supported

the goal of the rule, but believed the proposed rule

to be impractical to implement.

Working Group Recommendation

After considering public comments, and discussions

with the DOT staff, the working group

recommended that no changes should be made to

the proposed rule for enhancing the security

requirements for portable gauges. Therefore, the

final rule contains exactly the same requirements as

the proposed rule. The final rule requires that each

portable gauge licensee use a minimum of two

independent physical controls that form tangible

barriers to secure portable gauges from unauthorized

removal, whenever portable gauges are not under

the control and constant surveillance of the licensee.

The final rule is expected to reduce the frequency of

unauthorized removal or theft of portable gauges,

consistent with the NRC Security Goal to “Ensure

the secure use and management of radioactive

materials.” Fewer incidents of unauthorized

removal or theft of portable gauges should result in

a lower potential for public exposure, and a lower

probability of events such as inadvertent steel

smelting of gauges. This result would be consistent

with the NRC Safety Goal to “Ensure protection of

public health and safety and the environment.” The

final rule is consistent with the NRC Effectiveness

Goal to “Ensure that NRC actions are effective,

efficient, realistic, and timely,” because the new

requirement increases control of licensed material,

without undue burden on the regulated community.

Finally, consistent with the NRC Openness Goal to

“Ensure openness in our regulatory process,” the

staff developed the rule through a rulemaking

process involving a working group with non-NRC

members (i.e., Agreement States), consulted with

another cognizant Federal agency, and received

stakeholder and public input in the development of

the rule through posting on the NRC rulemaking

forum website and publication in the Federal

Register of the proposed rule. In addition, the

Federal Register notice of the final rule addressed

public and State comments on the proposed rule and

NRC’s responses. The staff plans to incorporate

implementing guidelines through future routine

updates of the consolidated guidance document,

NUREG-1556, Vol. 1, “Program-Specific Guidance

About Portable Gauge Licenses.”

Agreement State Issues

In accordance with the procedures established in

Part III of Handbook 5.9 to NRC Management

Directive 5.9, “Categorization Process for NRC

Program Elements,” the staff has determined that

the amendment, 10 CFR 30.34(i), should be

classified as Compatibility Category “C.” An

Agreement State should adopt the essential

objectives of the Compatibility Category “C”

program elements to avoid conflict, duplication,

gaps, or conditions that would jeopardize an orderly

pattern in the regulation of Agreement material on a

nationwide basis. The staff has determined that the

essential objective of the amendment, 10 CFR

30.34(i), is to reduce the frequency of unauthorized

removal or theft of portable gauges by requiring

licensees to provide a minimum of two independent

physical controls that form tangible barriers to

secure portable gauges from unauthorized removal

whenever portable gauges are not under the control

and constant surveillance of the licensee.

(Contact: Michael K. Williamson,

Office of Nuclear Material Safety and Safeguards,

301-415-6234; e-mail: mkw1@nrc.gov or Lydia

Chang, Office of Nuclear Material Safety and

Safeguards, 301-415-6319; e-mail: lwc1@nrc.gov )

NRC’s ANNUAL REPORT on the STATUS

of the DECOMMISSIONING PROGRAM

The staff of the Division of Waste Management and

Environmental Protection (DWMEP) has completed

work on NUREG-1814, “Status of

Decommissioning Program - 2004 Annual Report.”

This NUREG report provides a comprehensive

status of the U.S. Nuclear Regulatory Commission’s

decommissioning program. Its purpose is to provide

a stand-alone reference document that describes the

decommissioning process and summarizes the status

of all decommissioning activities since the last

report, through August 1, 2004, including the

decommissioning of complex decommissioning

sites, commercial reactors, research and test

reactors, uranium mill tailings facilities, and fuel

cycle facilities. In addition, this report discusses

accomplishments in the decommissioning program

since last year’s report (SECY-03-0161), and it
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informs the Commission of decommissioning issues

that the staff will address in the coming year.

Because the annual report contains information that

is not expected to change from year to year (i.e.,

discussion of the materials decommissioning

process), the staff will publish the report in the form

of a NUREG document every 2 years, beginning

with this report. In the odd-number years, the staff

will publish the report as a shortened paper to the

Commission, referencing the decommissioning

Website.

The NUREG is one part of the overall

communication strategy for the decommissioning

program. To support the Commission Paper issued

in the odd years, the staff is updating its web page to

reflect the entire decommissioning program,

including site summaries. In addition, the staff

plans to develop a general brochure, summarizing

the decommissioning program, that can be handed

out to members of the public.

(Contact: John Buckley, Division of Waste

Management and Environmental Protection,

301-415-6607; e-mail: jtb@nrc.gov)

NMSS PARTICIPATED in ISO

WORKING GROUP SESSION on TWO

INTERNATIONAL STANDARDS for

SEALED RADIOACTIVE SOURCES

On February 23-24, 2005, staff from the Division of

Industrial and Medical Nuclear Safety/Nuclear

Material Safety and Safeguards, participated in a

meeting of the International Organization for

Standards (ISO) Working Group on Sealed

Radioactive Sources. The meeting was held at the

French national standardization institute, AFNOR,

in St. Denis, France. In preparation for the meeting,

ISO requested participation from the national

standards organizations in 30 countries; in response,

six countries and the International Atomic Energy

Agency (IAEA) sent a total of 11 delegates to the

meeting. Two international standards were the

subject of the meeting.

1. The Working Group revised/updated

International Standard ISO-2919, “Radiation

Protection - Sealed Radioactive Sources -

General Requirements and Classification.”

The objective was to update the Standard,

revised last in 1999, to current industry

practices, as well as to bring the Standard

into agreement with the various national

standards.

The major changes, developed by the

Working Group, included the addition of

• two sets of tests for brachytherapy

sources,

• tests for tritium-imbedded titanium foils

for neutron generators,

• specification of the working life in the

source certificates, and

• references to other source safety and

security guidance documents, such as

IAEA TECDOC-1344, “Categorization

of Radioactive Sources.”

With these changes, the ISO standard will be

in close agreement with the corresponding

U.S. standard, ANSI 43.6, “Sealed

Radioactive Sources - Classification,” which

was updated in 2004, and will be issued in

2005. The only major differences are in the

additional performance tests that the ISO

standard contains for brachytherapy sources,

medical surface applicators, and tritiumimbedded titanium foils. The two standards

are sufficiently close that, in the next

revision cycle, due in 5 years, they can be

made identical to the current joint standard

on quality assurance, ANSI/ISO/ASQ 9001,

issued in 2001. U.S. manufacturers prefer

joint standards because, in such cases, their

products need to meet only one set of

requirements for both the domestic and the

international markets.

2. The Working Group drafted a new

international standard, ISO-21482, “Warning

Symbol for High-Level Radioactive

Sources.” The new standard is based on

IAEA’s initiative for a sign that would

supplement the current trefoil, to convey

worldwide to untrained persons the danger

when encountering orphan or stolen sources.

IAEA is currently testing five final sign

candidates in 11 countries. IAEA intends to

issue guidelines for the member countries on

the use of the warning sign, develop a “tool

kit” for users such as scrap yard operators or

customs agents, and submit a request to ISO

for a standard in 2005. The draft standard is

scheduled to be sent to the national

standardization bodies for vote in early 2006,

and the new international standard is to be

issued in June 2006.

(Contact: John Jankovich, NMSS, 301-415-7904;

e-mail: jpj2@nrc.gov)
5

SPENT FUEL PROJECT OFFICE

LICENSING PROCESS CONFERENCE

A conference sponsored by the Spent Fuel Project

Office (SFPO) was held on February 8, 2005, in

Rockville, Maryland. SFPO held the conference as

part of the staff’s initiative to continuously improve

the licensing process for 10 CFR Part 71 and 10

CFR Part 72 licensing actions. Approximately 150

people were in attendance.

Conference topics included SFPO’s “Rules of

Engagement” with licensees, lessons learned

regarding the existing licensing processes, and an

open discussion on ideas for improving the

effectiveness and efficiency of the licensing process.

The conference key note speaker was Margaret

Federline, Deputy Director of the Office of Nuclear

Material Safety and Safeguards. She discussed the

need for SFPO processes and procedures to provide

a sense of stability and predictability for licensees,

applicants, and stakeholders. She emphasized that

while the principle focus of a regulator must always

be health and safety, that does not mean the

regulator should be disengaged from the state of the

industry. She also invited the audience to discuss

their experiences, both positive and negative, such

that SFPO could acknowledge it and factor it into

the agency’s continuous improvement initiatives.

Bill Brach, SFPO Director, emphasized that SFPO

wanted feedback from its stakeholders regarding the

efficiencies and effectiveness of its licensing and

certification process for conducting transportation

and storage reviews. He stated that SFPO wanted to

hear and understand stakeholder comments,

suggestions and recommendations on ways to

improve the effectiveness and efficiency of SFPO

programs.

The conference included three sessions. Session 1,

included SFPO staff presentations, and was meant to

provide the audience with the context and backdrop

for the SFPO conference. Information was provided

on a continually growing program for transportation

of radioactive material and storage of spent fuel.

Staff also presented SFPO’s “Rules of

Engagement.” The rules were disseminated to

industry on December 16, 2004, in Regulatory Issue

Summary (RIS) 2004-20, “Lessons Learned from

Review of 10 CFR Parts 71 and 72 Applications.”

These rules were developed 6 years ago and have

evolved based on lessons learned. They provide a

clearly defined review process.

Session 2, was a series of individual industry/

stakeholder presentations, and was meant to inform

the audience of concerns and issues relative to

things that worked well and things that did not work

as well. The six-person panel: three representatives

from transportation and storage certificate holders,

two representatives from independent spent fuel

storage installations, and one media press

representative. This panel shared their historical

perspectives on lessons learned and experiences that

they had gained in their interactions with SFPO.

Each panel member gave a short 10-15 minute

presentation.

Session 3 consisted of a facilitated open dialogue

with stakeholders. The primary goal of the session

was for SFPO to obtain feedback and ideas on how

to make the licensing process more effective and

efficient while maintaining the high level of safety.

This session was facilitated by Chip Cameron, of

the NRC’s Office of the General Counsel. Mr.

Cameron engaged the audience through a list of

questions and issues, which were developed prior to

the conference and identified through discussions

during Session 2. The questions focused on broad

licensing process topics, such as communications,

schedules and timeliness, quality of requests for

additional information (RAIs), safety evaluation

reports (SERs), Certificates of Compliance (CoCs),

Technical Specifications, etc.

The “next steps” that SFPO will take in evaluating

the information discussed during the conference

were also discussed. The conference planning

committee and SFPO’s management team will review

the information, feedback, and recommendations

provided by the stakeholders. A status of SFPO

actions taken to implement these recommendations

will be presented to industry at a later date.

(Contact: Julia Barto, Spent Fuel Project Office,

301-415-8512; e-mail: jam4@nrc.gov)

GENERIC COMMUNICATIONS ISSUED

(December 17, 2004 - March 1, 2005)

The following are summaries of U.S. Nuclear

Regulatory Commission (NRC) generic

communications. If one of these documents appears

relevant to your needs and you have not received it,

please call one of the technical contacts listed

below. The Internet address for the NRC library of

generic communications is : http://www.nrc.gov/

reading-rm/doc-collections/gen-comm/index.html.

Please note that this address is case-sensitive and

must be entered exactly as shown. If you have any
6

questions or comments about generic

communications in general, please contact

Angela R. McIntosh at (301) 415-5030,

or e-mail: arm@nrc.gov.

Bulletins (Bls)

No bulletins have been issued from

December 17, 2004 – March 1, 2005.

Information Notices (INs)

No information notices have been issued from

December 17, 2004 – March 1, 2005

Regulatory Issue Summaries (RIS)

RIS 2005-02, “Clarifying the Process for Making

Emergency Plan Changes,” was issued on

February 14, 2005. This RIS was issued to all

holders of operating licenses for nuclear power

reactors including research and test reactors and to

fuel facility licensees, to: (1) clarify the meaning of

“decrease in effectiveness (DIE),” as stated in 10

CFR 50.54(q); (2) clarify the process for making

changes to emergency plans; and (3) provide some

examples of changes that are not DIEs and some

examples of DIE emergency plans.

(General Contact: Angela R. McIntosh, NMSS,

301-415-5030; e-mail: arm@nrc.gov)

SIGNIFICANT EVENTS

Event 1: Dose to Fetus

Date and Place: November 16, 2004, Riverside

Methodist Hospital, Cleveland, Ohio

Nature and Probable Causes: The licensee reported

that a pregnant patient was administered radioactive

iodine. The patient was administered 7.59

Megabecquerel (205 microcuries) of Iodine-123 (I123) on November 2, 2004, during an uptake study

pursuant to a diagnosis of hyperthyroidism. On

November 16, 2004, the patient was administered

469.9 Megabecquerel (12.7 millicuries) of Iodine131 (I-131) as treatment. Before this

administration, the patient was counseled regarding

pregnancy and acknowledged in writing that she

was not and could not be pregnant at that time. A

pregnancy test was not performed to confirm this

declaration. Later, the patient saw her physician

because of abdominal pain. A radiograph of the

abdomen revealed the pregnancy. A prenatal

specialist determined that the fetus was 17 weeks

old at the time of the I-131 administration. The

dose estimate for the fetus was 2.0432 centigray

(rad) to the whole body and 22,400 centigray (rad)

to the fetal thyroid from both the I-123 and I-131

administrations. The Ohio Department of Health

investigated the licensee on January 28, 2005, and

determined that the licensee followed all required

procedures. The patient will carry the fetus to term.

The perinatal specialist has performed a blood test

on the fetus and has confirmed that the fetus has

hypothyroidism. An ultrasound test on the fetus

showed no abnormalities in fetal development. The

perinatal specialist will perform treatments in-utero

to mitigate the effects of hypothyroidism.

Actions Taken to Prevent Recurrence

Licensee: The licensee has implemented a policy of

performing a serum pregnancy test and receiving the

results within 80 hours of administration of

therapeutic amounts of I-131. This test will be

performed on all women 13 to 50 years of age,

unless the women have been surgically sterilized.

(Contact: Angela R. McIntosh, NMSS,

301-415-5030; e-mail: arm@nrc.gov)

SIGNIFICANT ENFORCEMENT

ACTIONS

The U.S. Nuclear Regulatory Commission’s

(NRC’s) enforcement program can be accessed via

the NRC’s homepage, “[http://www.nrc.gov/]”

under “What We Do.” Documents related to cases

can be accessed at “[http://www.nrc.gov/],”

“Electronic Reading Room,” “Documents in

ADAMS.” ADAMS is the Agency-wide Document

Access and Management System. Help in using

ADAMS is available from the NRC Public

Document Room, telephone: 301-415-4737 or

1-800-397-4209.

Gauges

Triad Engineering, Inc. (EA-04-235)

On February 24, 2005, a Notice of Violation and

Exercise of Enforcement Discretion was issued for a

Severity Level III violation involving the failure to

verify that the receiver of a transferred portable

gauge was authorized to receive it before shipping it

to the receiver. Although a civil penalty would

normally have been issued for this type of violation,

a decision was made not to issue a civil penalty in

accordance with the exercise of enforcement

discretion process in Section VII.B.6 of the

Enforcement Policy, based on the fact that: (1) the

violation was not willful; (2) it was unrelated to the
7

willful violations that were the subject of an April

2004 civil penalty; (3) the violation occurred in

November 2003, which was the same time frame as

the violations that were the subject of the April 2004

civil penalty; and (4) corrective actions

implemented in response to these violations have

demonstrated program improvement.

Materials Testing Incorporated (EA-05-003)

On January 24, 2005, a Notice of Violation was

issued for a Severity Level III violation involving

the failure to secure, control, or maintain constant

surveillance of licensed material in a nuclear gauge.

Specifically, during an inspection at a temporary job

site in Bridgeport, Connecticut, NRC concluded that

over a period of approximately two months before

this inspection, a Humbolt nuclear gauge was

routinely not secured or controlled while being

stored in an unlocked employee’s vehicle, and not

under the direct surveillance of the authorized user.

Engineering Consulting Services, Ltd.

(EA-05-005)

On February 1, 2005, a Notice of Violation was

issued for a Severity Level III violation involving

three instances where the licensee failed to secure,

control or maintain constant surveillance of portable

nuclear gauges containing NRC licensed material in

unrestricted areas. Specifically, on those three

occasions, the portable gauges were left unattended

in unrestricted areas at temporary job sites, and

during those times, the gauges were damaged by

construction vehicles.

U.S. Department of Agriculture (EA-05-004)

On January 28, 2005, a Notice of Violation was

issued for a Severity Level III violation involving

the failure, on three separate occasions, to secure,

control, or maintain constant surveillance of

portable nuclear gauges containing NRC licensed

material in unrestricted areas.

Irradiator

Baxter Healthcare Corporation (EA-04-118)

On January 26, 2005, NRC issued an immediately

effective Confirmatory Order to confirm recent

commitments made as part of a settlement

agreement concerning a Notice of Violation and

Proposed Imposition of a Civil Penalty in the

amount of $44,400 issued on October 25, 2004, to

Baxter Healthcare Corporation (Baxter). The action

was issued for two willful Severity Level II

violations (assessed $28,800 for three occurrences

of failure to adhere to emergency procedures and

$9600 for failure to perform an adequate survey)

and a willful Severity Level III violation ($6000 for

failure to provide an individual radiation monitoring

device) related to an event involving personnel

entering an irradiator when the source was stuck in

an unshielded position. In response to that Notice,

Baxter requested the use of Alternative Dispute

Resolution to resolve differences it had with NRC

concerning the Notice. As part of the settlement

agreement, Baxter agreed to characterize the three

violations as a one Severity Level II problem, pay a

civil penalty in the amount of $31,200, and take

additional corrective action. Baxter and the NRC

also agreed to disagree on the willful

characterization of the third violation.

Medical

Washington Hospital Center (EA-04-157)

On February 15, 2005, a Notice of Violation was

issued to Washington Hospital Center for a willful

Severity Level III violation involving the use of

licensed radioactive material in humans by an

individual who was not an authorized user and who

was not under the supervision of an authorized user.

The violation occurred when a Nuclear Medicine

Technologist was injected with a diagnostic dosage

of technetium-99m without the knowledge nor

approval of a physician or authorized user.

Radiography

KTL Roudebush Testing (EA-04-178)

On December 30, 2004, an Order Revoking License

was issued to KTL Roudebush based on the

licensee’s deliberate acts and omissions involving

radiography activities (previously identified and

addressed in an immediately effective Order

Suspending License and Demand for Information

issued by NRC on March 11, 2004) and the

Commission’s lack of requisite reasonable

assurance that the public health and safety are

adequately protected by continuing activities under

the existing license.

Other

United States Enrichment Corporation

(EA-04-123)

On January 27, 2005, an immediately effective

Confirmatory Order was issued the United States

Enrichment Corporation to confirm certain
8

commitments involving training related to employee

protection. The Order was discussed during an

Alternative Dispute Resolution session and, subject

to satisfactory completion of the commitments,

NRC will not pursue further enforcement action on

this issue.

Soil Consultants, Inc. (EA-04-103)

On January 27, 2005, NRC issued an Order

Imposing Civil Monetary Penalty in the amount of

$9,600 to Soil Consultants Inc. (SCI). The action

was based on an October 6, 2004, Notice of

Violation and Proposed Imposition of Civil Penalty

in the amount of $9,600 for a Severity Level II

violation for discrimination against an employee for

engaging in certain protected activities (reporting

safety concerns to his employer or the NRC). In its

November 5, 2005, response, SCI denied that a

violation occurred. After considering SCI’s

response, NRC concluded that a violation occurred

as stated and that SCI did not provide an adequate

basis for withdrawing the violation, reducing the

severity level, or mitigating or rescinding the civil

penalty.

University of Sciences (EA-04-219)

On December 21, 2004, Notice of Violation was

issued for a Severity Level III violation involving

the failure to control and maintain constant

surveillance of licensed material in three

laboratories that were in unrestricted areas, and

where the material was not in storage. The Notice

of Violation was issued to the University of

Sciences.

Individual Actions

Lawrence Dioh (IA-04-023)

On February 15, 2005, a Notice of Violation was

issued to Lawrence Dioh for a Severity Level III

violation based on his deliberate activities while

employed at the Washington Hospital Center. As a

Nuclear Medicine Technologist, he knowingly used

licensed radioactive material without the knowledge

and approval of a physician or authorized user.

Christopher V. Roudebush (IA-04-019)

On December 30, 2004, an immediately effective

Order Prohibiting Involvement in NRC-Licensed

Activities (for five years) was issued to Christopher

V. Roudebush, based on his deliberate misconduct

while working at KTL Roudebush Testing. As the

president, owner, and Radiation Safety Officer, he

deliberately failed to: have sufficient number of

qualified personnel present at temporary job sites;

provide safety and dosimetry training to employees;

conduct inspections and maintenance of industrial

radiography equipment at specified intervals;

maintain records of NRC required inspection and

maintenance records; and provide complete and

accurate information to the NRC.

(General Contact: Sally Merchant,

Office of Enforcement, 301-415-2747;

e-mail: slm2@nrc.gov)

SELECTED FEDERAL REGISTER NOTICES

(December 15, 2004 - February 28, 2005)

10 CFR Parts 25 and 95, “Broadening Scope of

Access Authorization and Facility Security

Clearance Regulations,” 69 FR 74949,

December 15, 2004.

(Contact: Dr. Anthony N. Tse, Office of Nuclear

Material Safety and Safeguards, 301-415-6233;

e-mail: ant@nrc.gov)

10 CFR Parts 19, 34, 40, 55, and 60,

“Minor Correction Amendments for FY2004,”

69 FR 76599, December 22, 2004.

(Contact: Alzonia Shepard, Office of

Administration, 301-415-6864; e-mail:

aws1@nrc.gov)

10 CFR Part 71, “ Packaging and Transportation of

Radioactive Material; Withdrawal of Subpart I,”

70 FR 312, January 4, 2005.

(Contact: Neelam Bhalla, Office of Nuclear

Material Safety and Safeguards, 301-415-6843;

e-mail: nxb@nrc.gov)

10 CFR Part 30, “ Security Requirements for

Portable Gauges Containing Byproduct Material,”

70 FR 2001, January 12, 2005.

(Contact: Lydia Chang, Office of Nuclear

Material Safety and Safeguards, 301-415-6319;

e-mail: lwc1@nrc.gov)

10 CFR Part 20, “Sander C. Perle, ICN Worldwide

Dosimetry; Denial of Petition for Rulemaking,”

70 FR 2577, January 14, 2005.

(Contact: Torre Taylor, Office of Nuclear

Material Safety and Safeguards, 301-415-7900;

e-mail: tmt@nrc.gov)
9

NUREG-1600, “ NRC Enforcement Policy;

Extension of Enforcement Discretion of Interim

Policy,” 70 FR 2662, January 14, 2005.

(Contact: Sunil Weerakkody, Office of Nuclear

Reactor Regulation, 301-415-2870; e-mail:

sdw1@nrc.gov or Rene Pedersen, Office of

Enforcement, 301-415-2742; e-mail: rmp@nrc.gov)

10 CFR Part 20, “Northeast Ohio Regional Sewer

District; Denial of Petition for Rulemaking,”

70 FR 3898, January 27, 2005.

(Contact: Lydia Chang, Office of Nuclear

Material Safety and Safeguards, 301-415-6319;

e-mail: lwc1@nrc.gov)

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

73, 76 and 150, “Protection of Safeguards

Information,” 70 FR 7196, February 11, 2005.

(Contact: Marjorie Rothschild, Office of the

General Counsel, 301-415-1633; e-mail:

mur@nrc.gov or Bernard Stapleton, Office of

Nuclear Security and Incident Response,

301-415-2432; e- mail: BWS2@nrc.gov)

10 CFR Parts 170 and 171 “Revision of Fee

Schedules; Fee Recovery for FY 2005,”

70 FR 8678 February 22, 2005.

(Contact: Tammy Croote, Office of the

Chief Financial Officer, 301-415-6041;

e-mail: txc1@nrc.gov)

10 CFR Parts 25 and 95 “Broadening Scope of

Access Authorization and Facility Security

Clearance Regulations: Withdrawal of Direct Final

Rule,” 70 FR 8921, February 24, 2005.

(Contact: Dr. Anthony N. Tse, Office of Nuclear

Material Safety and Safeguards, 301-415-6233;

e-mail: ant@nrc.gov)

10 CFR Part 72 “List of Approved Spent Fuel

Storage Casks: NUHOMS-24PT4 Revision,”

70 FR 9548, February 28, 2005.

(Contact: Jayne M. McCausland, Office of

Nuclear Material Safety and Safeguards,

301-415-6219; e-mail: jmm2@nrc.gov)

10 CFR Part 72 “List of Approved Spent Fuel

Storage Casks: HI-STORM 100 Revision,”

70 FR 9550, February 28, 2005.

(Contact: Jayne M. McCausland, Office of

Nuclear Material Safety and Safeguards,

301-415-6219; e-mail: jmm2@nrc.gov)

(General Contact: Michael K. Williamson,

Office of Nuclear Material Safety and Safeguards,

301-415-6234; e-mail: mkw1@nrc.gov )

ISSUANCE of MULTI-AGENCY

RADIOLOGICAL LABORATORY

ANALYTICAL PROTOCOLS MANUAL

Staff from the NRC Offices of Nuclear Material

Safety and Safeguards and Nuclear Regulatory

Research participated with representatives from

other Federal agencies in development of the

Multi-Agency Radiological Laboratory Analytical

Protocols (MARLAP) manual. In addition to NRC,

the other participating Federal agencies included:

(1) Department of Defense; (2) Department of

Energy; (3) Department of Homeland Security;

(4) Environmental Protection Agency;

(5) Department of Commerce (National Institute

of Standards and Technology); (6) Department

of Interior (U.S. Geological Survey); and

(7) the Department of Health and Human Services

(Food and Drug Administration). On December 27,

2004, the participating agencies announced the

availability of the MARLAP manual (69 Federal

Register 77228 - 77230). The MARLAP manual

provides guidance for planning, implementation,

and assessment phases of projects that require

laboratory analysis of radionuclides. The manual

offers a framework for a performance-based

approach to achieving data requirements and needs.

This framework should promote national

consistency in the generation of radioanalytical data

of known quality appropriate for the intended use.

The MARLAP manual supports activities such as:

(1) site characterization; (2) decommissioning;

(3) cleanup and compliance demonstration;

(4) emergency response; (5) effluent and

environmental monitoring; and (6) radioactive

waste management. The MARLAP manual (NRC

document number NUREG-1576) is issued in three

volumes, and is available through the Internet at:

http://www.nrc.gov/reading-rm/doc-collections/

nuregs/staff/sr1576/.

(Contact: Rateb (Boby) Abu-Eid, Office of Nuclear

Material Safety and Safeguards, 301-415-5811;

e-mail: bae@nrc.gov, or Michael K. Williamson,

Office of Nuclear Material Safety and Safeguards,

301-415-6234; e-mail: mkw1@nrc.gov or

Valerie A. Young, Office of the Chief Information

Officer, Department of Energy, 202-586-8853;

e-mail: Valerie.Young@hq.doe.gov)
10

NOTE TO READERS: In an attempt to keep the

NMSS Quarterly Newsletter relevant, useful and

informative, feedback regarding the content of the

newsletter is welcomed. Readers desiring to

contribute articles, self-explanatory diagrams,

suggestions for future articles, bulletins, web-site

postings, and other items of interest to the NMSS

Newsletter readership, should contact Michael

Williamson, from the Office of Nuclear Materials

Safety and Safeguards, Rulemaking and Guidance

Branch. Mr. Williamson may be contacted at

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

In addition, to ensure proper delivery of the NMSS

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: T8F-3

Washington, D.C. 20555-0001