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

Regulatory Material Safety No. 05-04

Commission and Safeguards December 2005

NMSS Quarterly Newsletter

Contents	 Page

1.	 Energy Policy Act of 2005 Requirements

Treatment of Accelerator-Produced and

Other Radioactive Material as Byproduct

Material; Waiver................................................1

2. 	 Disposal of Radioactive Material by Release

Into Sanitary Sewer Systems; Withdrawal of

Advance Notice of

Proposed Rulemaking........................................2

3. 	 Guidance On Minimum

Subcritical Margin.............................................3

4. NUREG 1556, Volume 9, “Program-Specific 

Guidance About Medical Use Licenses,”

Revision 1 Erratum............................................4

5. 	 Status of Integrated Safety Analysis (ISA)

Summaries and Interim Staff Guidance ............4

6. 	 Options For Dealing With Unwanted

Sealed Sources...................................................5

7.	 Generic Communications Issued.......................6

(September 1, 2005 – November 30, 2005)

8 Significant Medical Events................................7

(September 1, 2005 – November 30, 2005)

9.	 Selected Federal Register Notices ...................7

10. Significant Enforcement Actions ......................8

ENERGY POLICY ACT of 2005 

REQUIREMENTS – TREATMENT of 

ACCELERATOR-PRODUCED and OTHER 

RADIOACTIVE MATERIAL as BYPRODUCT 

MATERIAL; WAIVER

The President of the United States signed the

Energy Policy Act of 2005 on August 8, 2005. The

provisions of the Act became effective immediately,

unless another effective date was expressly provided. 

Since no effective date was stated for the provisions

of section 651(e) of the Act, section 651(e) became

effective immediately, and brought byproduct

material, as defined in paragraphs (3) and (4) of 

section 11e. of the Atomic Energy Act of 1954 (42

U.S.C. 2201 et seq.), as added by section 651(e)(1),

under the immediate regulatory authority of the

Nuclear Regulatory Commission (NRC). Section 11

e.(3) of the Atomic Energy Act of 1954 now includes

as byproduct material: (1) any discrete source of

radium-226 that is produced, extracted, or converted

after extraction (before, on, or after August 8, 2005),

for use for a commercial, medical, or research

activity; and (2) any material that has been made

radioactive by use of a particle accelerator and is

produced, extracted, or converted after extraction

(before, on, or after August 8, 2005), for use for

a commercial, medical, or research activity. In

addition, section 11 e.(4) expands the definition to 

include any discrete source of naturally occurring

radioactive material, other than source material, if

certain conditions are met.

Before enactment of the Energy Policy Act of 2005,

the NRC did not have authority over the newly

covered byproduct material, and it fell under the

authority of the States. Therefore, the NRC does

not currently have regulations in place that would

specifically apply to the material. With the enactment 

of the Energy Policy Act of 2005, the States may

no longer assert the authority to regulate the newly

covered byproduct material, except as authorized

to do so by the Act. The Energy Policy Act of 2005

gave the Commission 18 months after the date of

enactment to issue final regulations for the newly 

covered byproduct material. To facilitate an orderly

transition of regulatory authority with respect to

the newly defined byproduct material, the Act 

also provides for preparation and publication of a

transition plan for States that have not previously

entered into an Agreement with the Commission

under section 274 b of the Atomic Energy Act

and for those States that have entered into such an

Agreement. However, neither the regulations issue,
2

nor the transition plan have yet been developed.

Until such time as the regulations and transition plan

have been completed and are in place, persons that

engage in activities involving the material will want

to continue with their activities.

To ease the transition period from individualized

State programs to a more uniform regulatory

program developed under the Atomic Energy Act

and its section 274b Agreement State Program,

section 651(e) of the Energy Policy Act of 2005

authorizes the Commission to issue waivers of its

authority. Waivers of the Commission’s jurisdiction

will permit existing State authorities to continue. 

Ultimate transition from NRC to State authority

for those States with an existing Agreement State

program is expected to proceed easily. For States

without such programs, that want to enter into an

agreement with the NRC, this waiver period will

permit them to go through the processes necessary to

establish and carry out an Agreement State program

to regulate this material after the waiver period

expires.

The authorization to grant waivers is subject to the

Commission’s determination that the waiver is in

accordance with the protection of the public health

and safety and the promotion of the common defense

and security. The Commission has determined that

there is no basis on which to conclude that these

materials will not continue to be used in a manner

that ensures that the public health and safety will be

protected while this waiver is in effect. 

The Energy Policy Act of 2005 also specifically 

requires the Commission to consider, in

promulgating regulations, the impact on the

availability of radiopharmaceuticals to physicians

and to patients relying on radiopharmaceuticals for

treatment. The Commission believes that it is in

the best interests of the country to allow continued

use of the newly defined byproduct material in 

radiopharmaceuticals for medical purposes, and to

allow the States to continue to regulate the newly

defined byproduct material until the Commission can 

codify new regulations for these materials.

In sum, the Commission currently does not have

in place a specific set of regulations to oversee the 

use of byproduct material, as defined in paragraphs 

(3) and (4) of section 11e. of the Atomic Energy

Act of 1954, as added by section 651(e) of the

Energy Policy Act of 2005. Granting of the waiver

will allow States to continue with their programs,

persons engaged in activities involving the newly

defined Atomic Energy Act byproduct material 

to continue their operations in a safe manner, and

continued access to medical radiopharmaceuticals. 

Furthermore, this will also permit the Commission

and States that currently do not have Sec. 274i

Agreement State regulatory programs, but wish

to enter into an agreement with the NRC, to

appropriately address the newly defined byproduct 

material. 

(Contact: Merri L. Horn,

Office of Nuclear Material Safety and Safeguards, 

301-415-8126, e-mail: mlh1@nrc.gov)

DISPOSAL of RADIOACTIVE MATERIAL 

by RELEASE INTO SANITARY SEWER 

SYSTEMS; WITHDRAWAL of ADVANCE 

NOTICE of PROPOSED RULEMAKING

The Nuclear Regulatory Commission (NRC)

is withdrawing an advance notice of proposed

rulemaking (ANPR) that presented possible

changes to the regulations governing the release of

radionuclides from licensed nuclear facilities into

sanitary sewer systems. Changes were proposed

to account for the potential for radionuclide

concentration during some types of wastewater

treatment processes. NRC is withdrawing this

advance notice of proposed rulemaking because it

has determined that there are no widespread public

health and safety concerns caused by potential

radiation exposures associated with the handling,

beneficial use, and disposal of sewage sludge 

containing radioactive materials.

In the 1994 ANPR, the Commission requested

advice and recommendations on several proposals

and asked related questions regarding whether and

in what way the regulations governing the release

of radionuclides from licensed nuclear facilities into

sanitary sewer systems should be changed. Because

there were concerns raised about the broader issue

of long-term effects of releases of radioactive

materials into sanitary sewer systems, action on the

ANPR was deferred until studies were conducted

regarding potential radioactive contamination

in sewage sludge. Since that time, NRC has

participated in the Interagency Steering Committee

of Radiation Standards (ISCORS) and co-chaired,

with the Environmental Protection Agency (EPA),

the Sewage Sludge Subcommittee, to facilitate

a systematic and thorough study of the potential

concerns related to radionuclides in sewage sludge

and to obtain data to support a technical basis for a

regulatory decision.

Between 1998 and 2000, the EPA and NRC (through

the ISCORS) jointly conducted a voluntary survey

of publicly owned treatment works (POTW )sewage
3

sludge and ash to help assess the potential need

for NRC and/or EPA regulatory decisions. Sludge

and ash samples were analyzed from 313 POTWs,

some of which had greater potential to receive

releases of radionuclides from NRC and Agreement

State licensees, and some of which were located in

areas of the country with higher concentrations of

naturally occurring radioactive material (NORM). 

In November 2003, the results of the survey were

published in a final report, NUREG-1775, “ISCORS 

Assessment of Radioactivity in Sewage Sludge: 

Radiological Survey Results and Analysis.” No

widespread or nationwide public health concern

was identified by the survey and no excessive 

concentrations of radioactivity were observed in

sludge or ash. The results indicated that the majority

of samples with elevated radioactivity had elevated

concentrations of NORM, such as radium, and did

not have elevated concentrations of radionuclides

from manmade sources.

In February, 2005, the Sewage Sludge Subcommittee

published a report, NUREG-1783, ”ISCORS

Assessment of Radioactivity in Sewage Sludge:

Modeling to Assess Radiation Doses.” This report

contains dose modeling results for seven different

sewage sludge management scenarios for POTW

workers and members of the public. Results of the

dose models and survey results indicated that there

is no widespread concern to public health and safety

from potential radiation exposures associated with

the handling, beneficial use, and disposal of sewage 

sludge containing radioactive materials, including

NORM.

Reasons for Withdrawing the ANPR 

The results of the survey and dose modeling

work conducted by the ISCORS Sewage Sludge

Subcommittee regarding radioactive materials in

sewage sludge and ash provide a technical basis for

withdrawing the ANPR. The survey demonstrated

that the most significant levels of radioactive 

materials in POTWs are attributable to NORM. 

The dose modeling work indicated that, in general,

the doses from licensed materials in sewage sludge

present a sufficiently low health and safety risk to 

POTW workers and to the public under the current

regulatory structure. Therefore, it is not necessary

to modify the current restrictions regarding the

release of radioactive materials into sanitary sewers

(10 CFR 20.2003) as discussed in the ANPR. In

addition, public comments indicated that several of

the options discussed in the ANPR would be costly

to implement and may not be consistent with efforts

to maintain doses ALARA. For these reasons, NRC

has withdrawn the ANPR.

(Contact: A. Christianne Ridge,

Office of Nuclear Material Safety and Safeguards, 

301-415-5673, e-mail: acr1@nrc.gov)

GUIDANCE ON MINIMUM 

SUBCRITICAL MARGIN

Computer codes used to calculate the neutron

multiplication factor (k-effective) of a fissionable 

system must be validated by performing calculations

for known critical configurations. These critical 

“benchmark experiments” have k-effective equal to

1. (Systems with k-effective less than 1 are said to

be “subcritical.”) Because infinite precision is not 

possible, Upper Subcritical Limits are established

to account for any systematic deviation between the

calculated and known experimental k-effective (i.e.,

bias). A minimum margin of subcriticality (MMS) is

also applied to account for any unknown sources of

uncertainty.

Historically, fuel cycle facilities have been licensed

with many different values of the MMS, ranging

from 0.02, for certain low-enriched facilities, to 0.1,

for some high-enriched facilities.

The MMS value can have a direct bearing on the

economic profitability and safety of fuel cycle 

operations. A number of recent licensing actions

involving proposed MMS at new facilities or

reduced MMS for existing facilities, an increased

reliance on computer calculations, and reduced

conservatism in computer models, indicated the need

for detailed guidance on this topic.

In a July 2004 Integrated Safety Analysis workshop,

NRC and the industry agreed on the need for

guidance as to what constitutes an acceptable MMS. 

The Division of Fuel Cycle Safety and Safeguards

(FCSS) issued a draft Interim Staff Guide, FCSSISG-10, in November 2004. Numerous public

comments were received, and a workshop focusing

on FCSS-ISG-10 was held in May 2005. FCSSISG-10, Revision 1, addressing these comments, was

issued for public comment on October 18, 2005.

FCSS-ISG-10 takes a risk-informed approach to

justifying the MMS and takes facility- and processspecific factors into account; these include: (1) the 

conservatism in criticality computer models; (2)

the number, quality, and applicability of benchmark

experiments; (3) the sensitivity of k-effective to

changes in system parameters; (4) independent

knowledge of the neutron physics of the system;

and (5) the likelihood of achieving the evaluated

conditions. The ISG contains acceptance criteria

for all five factors, but it is not anticipated that all 

the criteria will apply in every situation. Licensees
4

may use one or more of these arguments, as

appropriate to their specific processes and facility, 

to demonstrate an acceptable MMS. Other suitable

justifications may also be employed.

The risk-informed philosophy is that more

justification is needed for smaller subcritical 

margins. MMS values of 0.05 for typical lowenriched fuel processes will generally be acceptable. 

However, MMS values smaller than 0.02 will not

be approved. This is justified based on the inherent 

uncertainty in the nuclear data, and also recently

discovered errors in some of the computer codes.

Changes in Revision 1 of FCSS-ISG-10 include: (1)

standardizing divergent licensee terms to be more

consistent with ANSI/ANS-8.1, “Nuclear Criticality

Safety in Operations with Fissionable Materials

Outside Reactors”; (2) narrowing the discussion

on validation to those aspects that have a direct

bearing on the MMS; (3) emphasizing the primary

role played by modeling conservatism; and (4)

adding consideration of uncertainty to the section

on sensitivity. Modeling conservatism is of primary

importance because, together with the MMS, it

represents the total margin of subcriticality of the

system; margin may be provided either by making

conservative assumptions in calculations or by using

explicit margin in k-effective. Uncertainty and

sensitivity must both be considered in estimating the

potential magnitude of any undiscovered errors.

Public comments were accepted until the cutoff date

of November 17, 2005. Several sets of comments

were received and are currently being evaluated. 

Most of those who have provided written or oral

feedback considered Revision 1 to be a significant 

improvement over the original draft. The staff

expects the ISG to be finalized on review and 

appropriate incorporation of the comments.

(Contact: Christopher S. Tripp,

Division of Fuel Cycle Safety and Safeguards, 301-

415-7733; e-mail: cst@nrc.gov)

NUREG 1556, VOLUME 9, “PROGRAMSPECIFIC GUIDANCE ABOUT MEDICAL 

USE LICENSES,” REVISION 1 ERRATUM

On November 3, 2005, an erratum to NUREG 1556,

Volume 9, “Program-Specific Guidance About 

Medical Use Licenses,” Revision 1 (Rev.1) was

published by the Division of Industrial and Medical

Nuclear Safety, Office of Nuclear Material Safety 

and Safeguards.

Rev.1 was published in May 2005, to provide

conforming guidance to the final training and 

experience (T&E) rule in 10 CFR Part 35. However,

at the time it was published, it was printed without

a sample medical broad scope license. The

erratum correction replaces page F1 of Appendix F

(Appendix F contains sample medical licenses) and

includes a discussion about the broad scope licenses. 

Additionally, it includes a sample medical broad

scope license, by adding pages F24 through F28 to

Appendix F. The erratum correction was mailed

to the medical use licensees and has been posted on

the Commission’s public web site at http://www.nrc.

gov/reading-rm/doc-collections/nuregs/staff/sr1556/

v9/r1/errata.pdf.

(Contact: Neelam Bhalla,

Office of Nuclear Material Safety and Safeguards, 

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

STATUS of INTEGRATED 

SAFETY ANALYSIS (ISA) SUMMARIES and 

INTERIM STAFF GUIDANCE

The new Subpart H of 10 CFR Part 70 identifies 

risk-informed performance requirements and

requires applicants and existing licensees to conduct

an integrated safety analysis (ISA) and submit

an ISA summary, as well as other information. In

general terms, the requirements in 10 CFR Part

70 specify the information that an applicant must

supply in its safety program description. To date,

all licensees required to submit an ISA summary

have done so. The staff reviews of these ISA

summaries has shown that each licensee has used

varying approaches to satisfy the requirements

of 10 CFR 70.61. The submittals were accepted

based on the acceptance criteria identified in the 

Standard Review Plan (NUREG-1520); however, all

the ISA submittals have required formal Requests

for Additional Information, as well as site visits

and verbal communication with the licensees to

clarify the ISA methodologies used and means of

implementation. 

The Commission has developed Standard Review

Plans and Interim Staff Guidance (ISG) documents

to offer a consistent approach to reviewing the

methods, assumptions, and data used in the ISAs. 

The primary document, NUREG-1520, provides

guidance on acceptable methods of demonstrating

compliance with the regulations. However, use of

the methods in NUREG-1520 is optional and other

methods may be used to demonstrate compliance. 

As issues have been raised and addressed, the

Nuclear Regulatory Commission (NRC) has
5

developed draft ISGs to further guide and document its approach to these issues. NRC staff provided nine draft

Fuel Cycle Safety and Safeguards (FCSS) ISGs to stakeholders between July 29, 2004, and May 20, 2005. The

current status of, and Agency-wide Document Access and Management System (ADAMS) Accession numbers

for, Interim Staff Guidance on Part 70 for ISAs are listed in the table below.

OPTIONS FOR DEALING 

WITH UNWANTED SEALED SOURCES

The U.S. Department of Energy (DOE) sponsors a

program to recover excess and unwanted radioactive

sealed sources presenting disposal difficulties. It 

conducts this program with little or no cost to the

licensees. Traditionally, the program has dealt

mainly with americium-241 and plutonium sources. 

Owing to heightened concerns about terrorist

threats to steal radioactive material for use in a dirty

bomb, DOE is moving aggressively to include other

radioactive material of concern. DOE is currently

increasing focus on recovery of larger excess sources

containing cobalt-60 and cesium-137 (e.g., medical

and other self-shielded irradiators), and medical and

academic licensees are encouraged to register sealed

sources for potential inclusion in this program. 

DOE is also considering a campaign to manage

large numbers of small obsolete sources (e.g.,

cesium-137 brachytherapy sources, and various

Title Status ADAMS

Accession 

Numbe

FCSS-ISG 01, “Qualitative

Criteria for Evaluation of Likelihood”

Issued final June 2005 ML051520236

FCSS-ISG 02, “Accident Sequences Resulting in

Consequences below, 10 CFR 70.61 Performance

Requirements”

Issued for comment, September

2004; under revision by staff

ML042610008

FCSS-ISG 03, “Nuclear Criticality Safety Performance

Requirements and Double Contingency Principle”

Issued final February 2005 ML042460011

FCSS-ISG 04, “Clarification of Baseline Design Criteria” Issued final June 2005 ML051520313

FCSS-ISG 05, “Additional Reporting Requirements of

10 CFR 70.74”

Issued for comment September

2004; under revision by staff

ML042460012

FCSS-ISG 06, “Correcting Performance Deficiencies and

Implementing Corrective Measures”

Issued for comment

September 2004; cancelled

ML042460014

FCSS-ISG 07, “Rules of Engagement” Issued for comment

September 2004; cancelled

ML042460015

FCSS-ISG 08, “Natural Phenomena Hazards” Issued final November 2005 ML052650305

FCSS-ISG 09, “Initiating Event Frequencies” Issued final June 2005 ML051520323

(Contact: James A Smith, Division of Fuel Cycle Safety and Safeguards, 301-415-6459; e-mail jas4@nrc.gov)

radium-226, americium-241, and other sources). To

be considered for DOE recovery, institutions can

register their material with Los Alamos National

Laboratory.

Also, DOE continues to encourage holders of

sources that would constitute greater-than-class-C

(GTCC) waste to register all sources, even those that

are currently in use. Source registration is voluntary,

but has the advantage of allowing DOE to plan and

prioritize recovery efforts. The source registry is a

key component in planning to ensure that adequate

funding, facility, and personnel resources are

available to recover, store, and eventually dispose of

GTCC waste.

The link for more information on the DOE program,

and for registering sources is: http://osrp.lanl.gov/.
6

Additional information on the DOE program, as well

as other options for dealing with unwanted sources,

can be found in NMSS Quarterly Newsletter

Nos. 01-02, 03-01, and 04-02. The link to the

NMSS Quarterly Newsletters is: http://www.nrc.

gov/reading-rm/doc-collections/nuregs/brochures/

br0117/.

(Contact: Michele Burgess,

Office of Nuclear Material Safety and Safeguards, 

301-415-5868, e-mail: mlb5@nrc.gov)

GENERIC COMMUNICATIONS ISSUED

(September 1, 2005 – November 30, 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 questions or comments about generic

communications in general.

(Contact Angela R. McIntosh,

(301) 415-5030, or by e-mail: arm@nrc.gov.)

Bulletins (BLs)

None.

Information Notices (INs)

IN 2005-27, “Low Dose-Rate Manual 

Brachytheraphy Equipment Related Medical 

Events,” was issued on October 7, 2005. This IN

was issued to all medical licensees.

(Technical contact: Ronald Zelac,

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

IN 2005-28, “Inadequate Test Procedure Fails 

to Detect Inoperable Criticality Accident Alarm 

Horns,” was issued on October 31, 2005. This IN

was issued to all licensees authorized to possess a

critical mass of special nuclear material.

(Technical contact: Dennis Morey, NMSS, 301-415-

6107; e-mail: dcm@nrc.gov)

IN 2005-31, “Potential Non-conservative Error in 

Preparing Problem-dependent Cross Sections for 

use with the KENO V.a or KENO-VI Criticality 

Code,” was issued November 17, 2005. This IN

was issued to all licensees using the KENO V.a or

KENO-VI criticality code module in Version 5 of

the Standardized Computer Analyses for Licensing

Evaluation (SCALE) software developed by Oak

Ridge National Laboratory (ORNL).

(Technical contact: Lawrence Berg,

NMSS, 301-415-6215; e-mail: ljb2@nrc.gov)

Regulatory Issue Summaries (RIS)

RIS 2004-17, Rev. 1, “Revised Decay-in-Storage 

Provisions for the Storage of Radioactive Waste 

Containing Byproduct Material,” was issued

September 27, 2005. This RIS was issued to all

licensees regulated under 10 CFR Parts 30, 32, 33,

35, 39, and 50.

(Technical contact: Angela McIntosh,

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

RIS 2005-21, “Clarification of the Reporting 

Requirements in 10 CFR 20.2201,” was issued

November 14, 2005. This RIS was issued to all U.S.

Nuclear Regulatory Commission licensees and Part

76 certificate holders authorized to possess licensed 

material.

(Technical contact: Joe DeCicco,

NMSS, 301-415-7833; e-mail: jxd1@nrc.gov)

RIS 2005-22, “Requirements for the Physical 

Protection During Transportation of Special 

Nuclear Material of Moderate and Low Strategic 

Significance: 10 CFR Part 72 vs. Regulatory 

Guide 5.59 (1983),” was issued October 28, 2005. 

This RIS was issued to all holders of licenses for the

possession of special nuclear material (SNM) that

ship Category II and III quantities of this material.

(Technical contacts: Phillip Brockman,

NSIR, 301-415-6557, e-mail: pgb@nrc.gov;

Mary Adams,

NMSS, 301-415-7249; e-mail: mta@nrc.gov)

RIS 2005-23, “Clarification of the Physical 

Presence Requirement During Gamma 

Stereotactic Radiosurgery Treatments,” was

issued October 7, 2005. This RIS was issued to all

gamma stereotactic radiosurgery (GSR) licensees.

(Technical contacts: Donna-Beth Howe, NMSS,

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

Ragland, R1, 601-337-5083; e-mail: rcr1@nrc.gov)

RIS 2005-27, “NRC Timeliness Goals, 

Prioritization of Incoming License Applications 
7

and Voluntary Submittal of Schedule for Future

Actions for NRC Review,” was issued November 8,

2005. This RIS was issued to all 10 CFR Parts 71

and 72 licensees and certificate holders.

(Technical contact: Jill Caverly,

NMSS, 301-415-6699; e-mail jsc1@nrc.gov)

(General Contact: Angela R. McIntosh,

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

SIGNIFICANT MEDICAL EVENTS

(September 1, 2005 – November 30, 2005)

Event: Potential radiographer overexposure at a

temporary job site.

Date and Place: November 18, 2005, Sand Springs,

Oklahoma

Nature and Probable Causes: The license,

located in Tulsa, Oklahoma, reported a potential

overexposure to a radiographer at a temporary

job site. The crew was using a SPEC exposure

device (Model 150) with a 2.44 terabequerel (66

curie) Iridium -192 source. The radiographer went

to change the radiographic film, thinking that the 

assistant had fully retracted the source. While en

route to change the film, the radiographer set down 

his radiation detection instrument to answer his

cell phone. At the same time, the assistant was

sending a text message on his cell phone. The

radiographer was in front of the exposure device

for approximately three minutes and his alarming

rate meter was turned off. The calculated dose

the radiographer received was 23 centisieverts

(rem). The radiographers were taken to the

hospital for blood tests as a precautionary measure

and their dosimeters were sent for analysis. The

Oklahoma Department of Environmental Quality

(ODEQ) investigated the event on November

21, 2005, and determined that the radiographer’s

thermoluminescent dosimeter (TLD) result was 4.4

centisieverts (rem). The radiographer’s total year-todate whole body exposure is 6.9 centisieverts (rem). 

The assistant radiographer’s TLD result was 1.21

millisieverts (121 millirem). Both radiographers

were suspended pending further investigation.

(Contact: Angela McIntosh, 

Office of Nuclear Material Safety and Safeguards, 

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

Selected Federal Register Notices

(September 1, 2005 – November 30, 2005)

10 CFR Part 63 [RIN 3150-AH68], “Implementation

of a Dose Standard After 10,000 Years,”

70 FR 53313, September 8, 2005.

(Contact: Timothy McCartin, Office of Nuclear 

Material Safety and Safeguards, 301-415-7285,

e-mail: tjm3@nrc.gov; Janet Kotra, Office of Nuclear 

Material Safety and Safeguards, 301- 415-6674,

e-mail: jpk@nrc.gov; or Lydia Chang, Office of 

Nuclear Material Safety and Safeguards, 301-415-

6319, e-mail: lwc1@nrc.gov)

Notice of Availability, “Documents Regarding

Spent Fuel Transportation Package Response to

the Baltimore Tunnel Fire Scenario,” 70 FR 54780,

September 16, 2005.

(Contact: Allen Hansen, Spent Fuel Project Office, 

Office of Nuclear Material Safety and Safeguards, 

301-415-1390, e-mail: agh@nrc.gov)

10 CFR Part 72 [RIN 3150-AH77], “List of

Approved Spent Fuel Storage Casks: Standardized

NUHOMS 32PT, -24PHB, and -24PTH, Revision

8,” 70 FR 55023, September 20, 2005.

(Contact: Jayne M. McCausland, Office of Nuclear 

Material Safety and Safeguards, 301-415-6219, email: jmm2@nrc.gov)

10 CFR Part 73 [RIN 3150-AH60], “ Design Basis

Threat,” 70 FR 67380, November 7, 2005.

(Contact: Timothy Reed, Office of Nuclear Reactor 

Regulation, 301-415-1462; e-mail: tar@nrc.gov or

Richard Rasmussen, Office of Nuclear Security and 

Incident Response, 301- 415-8380; e-mail: rar@nrc.gov)

10 CFR Part 1 [RIN 3150-AH79], “ Statement of

Organization and General Information,” 70 FR

69421, November 16, 2005.

(Contact: Alzonia Shepard, Office of Administration, 

301-415-6864, e-mail: aws1@nrc.gov)

10 CFR Part 72 [RIN 3150-AH77], “List of

Approved Fuel Storage Casks: Standardized

NUHOMS -32PT, -24PHB, and -24PTH Revision

8, Confirmation of Effective Date, “ 70 FR 71381, 

November 29, 2005.

(Contact: Jayne M. McCausland,

Office of Nuclear Material Safety and Safeguards, 

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

“State of Minnesota: NRC Draft Staff Assessment

of a Proposed Agreement Between the Nuclear

Regulatory Commission and the State of

Minnesota,” 70 FR 71863, November 30, 2005.
8

(Contact: Cardelia Maupin, Office of State and Tribal 

Programs, 301-415-3340, e-mail: chm1@nrc.gov)

(General Contact: Michael K. Williamson, Office of 

Nuclear Material Safety and Safeguards, 301-415-

6234, e-mail: mkw1@nrc.gov)

SIGNIFICANT ENFORCEMENT ACTIONS

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

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 Agencywide 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.

Radiography

American Engineering Testing, Inc. (EA-05-161)

On October 20, 2005, a Notice of Violation was

issued for a Severity Level III problem involving: 

(1) the failure to maintain continuous direct visual

surveillance to protect against unauthorized entry into

a high radiation area during a radiographic exposure

at a field location; and (2) the failure to conduct a 

survey of the radiographic exposure device and guide

tube after an exposure, and before approaching the

device and guide tube, to ensure that the sealed source

had returned to its shielded position.

Medical

Saint Joseph Regional Medical Center (EA-05-128)

On September 23, 2005, a Notice of Violation

and Proposed Imposition of Civil Penalties in the

cumulative amount of $19,200, was issued for three

Severity Level II problems, one Severity Level II

violation, and two Severity Level IV violations,

associated with brachytherapy treatments that

resulted in unintended radiation doses to five patients. 

Because these violations directly contributed to

significant health consequences for patients 3, 4, 

and 5, each of those three events is categorized as

a separate Severity Level II problem in accordance

with NRC Enforcement Policy. In addition, the

licensee became aware that three medical events had

occurred and did not notify the NRC of these events

until more than one day after the medical events were

discovered, contrary to 10 CFR 35.3045(c) which

requires licensees to notify the NRC Operations

Center, by telephone, no later than the next calendar

day after discovery of such events. The events

associated with patients 1 and 2 are categorized as

separate examples of a Severity Level IV problem

in accordance with the NRC Enforcement Policy

because of the more limited health consequences

associated with these medical events.

Mountainside Hospital (EA-05-158)

On September 21, 2005, a Notice of Violation was

issued for a Severity Level III violation involving the

failure to maintain constant surveillance and control

of a nuclear imaging camera containing NRC licensed

material while in transit. Specifically, the licensee 

shipped a Siemens Model ECAM without removing

the sealed sources from their protective housings

inside the camera before shipment. The licensee

identified the violation while the camera was in transit 

and had the camera returned. A Severity Level IV

violation was also cited based on the licensee’s failure

to provide the required packaging for transport of the

camera.

Boone Hospital Center (EA-05-127)

On September 2, 2005, a Notice of Violation and

Proposed Imposition of Civil Penalty in the amount

of $3250 was issued for a Severity Level III violation

involving the failure to control and maintain constant

surveillance of iodine-125 in a controlled area. 

Specifically, a cartridge containing iodine-125 seeds 

was transferred to an unauthorized and untrained

licensee employee who subsequently transferred the

cartridge to a second unauthorized and untrained

licensee employee, who in turn, opened the cartridge

and inadvertently lost control of some of the seeds.

Mallinckrodt, Inc. (EA-05-105)

On August 25, 2005, a Notice of Violation was

issued for a Severity Level III violation involving

the licensee’s deliberate failure to perform radiation

contamination and ambient exposure surveys of a

molybdenum-99/ technetium-99m generator before

servicing the generator, contrary to the requirements

in 10 CFR 20.1501 (which require, in part, that the

licensee control the annual occupational dose to

individual adults), resulting in the contamination of

two individuals.

St. John’s Mercy Medical Center (EA-05-107)

On August 25, 2005, a Notice of Violation(NOV)

was issued for a Severity Level III problem involving

a violation of NRC regulations and the licensee’s

license conditions. Specifically, the NOV cited: (1) 

the licensee’s administration of a dosage in excess

of 1.12 Megabecquerels (30 microcuries) and more

than 20 percent different from the prescribed dose,

to an infant; and (2) the licensee’s failure to check

the patient’s name and identification number and the 

prescribed radionuclide, chemical form, and dosage

before administering the dosage to the patient.
9

Gauges

Geo-Engineering & Testing, Inc. (EA-05-108)

On September 12, 2005, a Notice of Violation was

issued for a Severity Level III violation involving a

failure to maintain security of NRC-licensed material. 

Specifically, the licensee failed to control and 

maintain constant surveillance of two portable nuclear

gauges containing licensed material that were stored

in a shed that was unsecured on property controlled

by the licensee.

ECS Mid-Atlantic, LLC (EA-05-078) and (EA-05-079)

On September 8, 2005, a Notice of Violation (NOV)

and Proposed Imposition of a Civil Penalty in the

amount of $3250 was issued. The NOV cited two

Severity Level III violations, both of which involved

the transfer of licensed material in portable gauging

devices to an individual not authorized to receive

nor possess byproduct material. The first violation, 

EA-05-078, involved the improper sale and transfer

of a portable gauging device containing licensed

material from the licensee’s Richmond facility. The

second violation, EA-05-079, which resulted in the

imposition of a civil penalty, involved the willful

transfer of several portable gauges containing licensed

material from the licensee’s Chantilly facility to the

same individual.

Foundation Engineering Science, Inc. (EA-05-146)

On November 22, 2005, a Notice of Violation and

Proposed Imposition of Civil Penalty in the amount

of $3250 was issued for a Severity Level III problem

involving the failure to secure from unauthorized

removal, or limit access to, a nuclear gauge located

in a company vehicle parked in a public parking lot. 

As a result, a nuclear gauge was stolen, and remained

uncontrolled in the public domain. In addition, the

licensee did not immediately report the theft of the

licensed material as required.

(General Contact: Sally Merchant, Office of 

Enforcement, 301-415-2747; e-mail: slm2@nrc.gov)

NOTE TO READERS: In an effort to keep the NMSS

Quarterly Newsletter relevant, useful and informative,

feedback regarding the content of the newsletter is

welcomed. Readers desiring to contribute articles, selfexplanatory diagrams, suggestions for future articles,

bulletins, web-site postings, and other items of interest

to the NMSS Quarterly Newsletter readership, should

contact Michael K. Williamson, from the Office of 

Nuclear Material 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 and non-interruption

of subscription service, please report any address

changes, additions, or deletions to Mr. Williamson.

Please send written correspondenceand requests to:

Michael K. Williamson, Editor

NMSS Licence 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

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