U.S. Nuclear 

Regulatory 

Commission

Office of Nuclear 

Material Safety

and Safeguards

NUREG/BR-0117

No. 02-1

March-April 2002

NRC STAFF ISSUES DRAFT VOLUME 1 

OF CONSOLIDATED NMSS 

DECOMMISSIONING GUIDANCE

On January 31, 2002 (67 Federal Register

4764), the U.S. Nuclear Regulatory Commission’s 

(NRC’s) Office of Nuclear Material Safety and 

Safeguards (NMSS) announced the availability of 

a draft document entitled, “Consolidated NMSS 

Decommissioning Guidance: Decommissioning 

Process” (NUREG-1757, Vol. 1), for a 90-day public 

comment. This document provides guidance for the 

planning and implementation of the termination of 

licenses issued through NMSS licensing programs. 

The guidance is intended for NRC staff, licensees, 

and the public, and is being developed in response 

to the NMSS performance goals, in NRC’s 

Strategic Plan, of: (1) making NRC activities and 

decisions more effective, efficient, and realistic; 

and (2) reducing unnecessary regulatory burden on 

stakeholders. NRC is seeking public comment, to 

receive feedback from the widest range of interested 

parties and to ensure that all information relevant 

to developing the document is available to the 

NRC staff. This draft document is being issued 

for comment only and is not intended for interim 

use. NRC will review public comments received 

on the draft document. Suggested changes will be 

incorporated, where appropriate, in response to those 

comments, and a final document is planned to be 

issued for use in September 2002.

NUREG-1757 is available at the Commission’s 

Public Document Room, U.S. NRC’s Headquarters 

Building, 11555 Rockville Pike (First Floor), 

Rockville, Maryland, and electronically from the 

ADAMS Electronic Reading Room on the NRC web 

site at: http://www.nrc.gov/reading-rm/adams.html. 

NUREG-1757 is also available on the NRC 

web site at: http://www.nrc.gov/reading-rm/doccollections/nuregs/staff.

A free single copy of NUREG-1757 will be available 

to interested parties until the supply is depleted. 

Such copies may be requested by writing to the 

U.S. Nuclear Regulatory Commission, Distribution 

Services, Washington, DC 20555-0001 or submitting 

e-mail to distribution@nrc.gov.

(Contact: Jack Parrott, 301-415-6700; e-mail: 

jdp1@nrc.gov)

NMSS Licensee Newsletter

(March - April 2002)

Contents Page

1. NRC Staff Issues Draft Volume 1 of 

Consolidated NMSS Decommissioning Guidance .............................................. 1

2. Status of Revision to 10 CFR Part 35, 

“Medical Use of Byproduct Material” ....... 2

3. The Advisory Committee on the Medical Uses of Isotopes Spring 2002 Commission Briefing and Public Meeting ......... 2

4. Significant Events ...................................... 3

5. Significant Enforcement Actions ................ 4

6. Generic Communications Issued................. 5

(December 1, 2001-January 31, 2002)

7. Selected Federal Register Notices .............. 6

(November 30, 2001-February 28, 2002)

NMSS Licensee Newsletter
2

STATUS OF REVISION TO 10 CFR PART 

35, “MEDICAL USE OF BYPRODUCT 

MATERIAL”

The revision to 10 CFR Part 35, “Medical Use 

of Byproduct Material,” is progressing. On 

Febuary 11, 2002, the U.S. Nuclear Regulatory 

Commission (NRC) issued its report to Congress 

explaining why the regulatory burden could not be 

further reduced without adversely affecting public 

health and safety. The revised Part 35, when 

implemented, should generally achieve a significant 

reduction in burden. For the low-risk activities of 

diagnostic nuclear medicine, NRC believes that the 

regulatory burden is commensurate with the low 

risk of adverse impact on health and safety from 

these procedures.

NRC currently intends to publish the revised 

Part 35 as a final rule in the early spring of 2002. 

The rule will allow for a 6-month implementation 

period before the requirements go into effect. During 

that implementation period, NRC plans to publish 

NUREG-1556, Volume 9, for public comment, and 

conduct a public workshop on the draft document. 

NRC also plans a public workshop to obtain 

input from stakeholders to develop guidance for 

diagnostic-only, nuclear medicine licensing. Finally, 

NRC will post on its web site the draft inspection 

guidance and hold a public workshop to obtain 

stakeholder input. In addition, the NRC staff will 

be trained on the revised licensing and inspection 

guidance to familiarize it with requirements of 

Part 35. These efforts will effect a smooth transition 

and implementation of NRC’s risk-informed and 

performance-based approach to the regulation of 

medical uses of byproduct material. 

(Contact: Roger Broseus, NMSS, 301-415-7608; 

e-mail: rwb@nrc.gov)

THE ADVISORY COMMITTEE ON THE 

MEDICAL USES OF ISOTOPES SPRING 

2002 COMMISSION BRIEFING AND 

PUBLIC MEETING

The Advisory Committee on the Medical Uses 

of Isotopes (ACMUI) held its Spring meeting on 

February 19-20, 2002. During the February 19 

session, ACMUI briefed the Commission on three 

areas: (1) ACMUI support of the implementation 

of the revised 10 CFR Part 35, “Medical Use of 

Byproduct Material”; (2) efforts to coordinate the 

implementation of the revised Part 35 between State 

and Federal governments; and (3) staffing issues 

for certain medical professionals, as a result of the 

new training and experience requirements in revised 

Part 35. 

During the first briefing topic, ACMUI gave strong 

support to the revised Part 35. It provided a 

point-by-point outline of the steps the U.S. Nuclear 

Regulatory Commission (NRC) and ACMUI took to 

ensure that the revision process was fair, balanced, 

and involved significant stakeholder input.

During the second briefing topic, ACMUI informed 

the Commission of specific actions that the Agency 

should consider to help bring State and Federal 

regulations into alignment, in light of the revised 

Part 35. ACMUI also gave recommendations to 

ensure uniformity in the implementation of the 

new rule.

While briefing the Commission on staffing issues, 

ACMUI expressed concern regarding licensees’ 

ability to retain and recruit medical physicists, 

radiation safety officers, and nuclear pharmacists. 

ACMUI ended this discussion with recommended 

specific short- and long-term initiatives that the 

Agency can undertake to mitigate what it perceived 

as unintended negative staffing consequences 

brought about by revised Part 35’s training and 

experience requirements.

During the February 20 session, ACMUI held a 

public meeting on a wide range of topics. Most 

were discussions of routine activities of interest 

in the regulated medical community (e.g., NRC 

position on dose assessment of “mixed” doses; status 

of the implementation of NUREG-1556, Vol. 9), 

although a few topics arose out of the September 11, 

2001, events (e.g., security restrictions on the NRC 

website; and what NRC is doing to heighten security 

of radioactive material in the public domain). 

During the meeting, NRC staff informed the ACMUI 

that an effort to address ACMUI concerns on training 

and experience requirements had been initiated.

(Contact: Angela Williamson, NMSS, 

301-415-5030; e-mail: arw@nrc.gov)
3

SIGNIFICANT EVENTS

The U.S. Nuclear Regulatory Commission (NRC) 

is providing summaries of these events to inform 

licensees of conditions they may encounter and of 

actions that may be taken to deal with them.

Event 1: Radioactive Contamination of a Steel Mill

Date and Place: July 13, 2001; Ameristeel 

Incorporated; Baldwin, Florida.

Nature and Probable Consequences: Ameristeel, 

Inc. (a non-licensee) reported that a radioactive 

device/source was melted at its facility in Florida. 

The Florida Bureau of Radiation Control (BRC) 

responded to the facility, along with the Mobile 

Emergency Response Laboratory. The team 

determined that the isotope was cesium-137 

(Cs-137), but the source of the contamination 

was unknown. Investigators suspected that the 

contamination was from a sealed source belonging 

to a fixed gauge. Preliminary estimates placed the 

source activity at no more than 3.7 gigabecquerels 

(100 millicuries). The contamination was first 

identified when a radiation detector in the mill’s 

baghouse alarmed. The source apparently eluded 

detection by multiple detectors designed to scan 

scrap metal loads before they are loaded into the 

furnace. The contamination was confined to two 

bag houses that collect dust from the furnace and 

the ductwork going from the furnace to the bag 

houses. There was no release of radioactive material 

outside of the facility and the steel product was 

not contaminated. The slag materials were surveyed 

and no Cs-137 was detected. Twenty-two individuals 

were working in the area at the time of the 

event and initial surveys indicated that nobody 

received any external exposure or contamination. 

These individuals were sent for whole-body surveys 

as a precautionary measure. The tests confirmed 

that there was no internal contamination of facility 

personnel. The facility was shut down for cleanup. 

Cleanup of the facility was determined to be a major 

operation, because of high heat conditions that posed 

a significant hazard even for workers in protective 

clothing and respirators. The BRC conducted a 

confirmatory survey, granted preliminary clearance, 

and determined that the facility met the radiological 

criteria for unrestricted use. The facility stated 

that it was shut down for more than 24 days 

for decontamination. The total cost of cleanup is 

estimated at 10 to 12 million dollars.

Event 2: Distribution and Administration of Multiple 

Mislabeled Therapeutic Dosages Over a Period of 

Several Years

Date and Place: December 14, 2001; Spectrum 

Pharmacy Inc.; Mishawaka, Indiana.

Nature and Probable Consequences: The U.S. 

Nuclear Regulatory Commission (NRC) licensee 

identified multiple instances, over the past 3 

years, where it dispensed dosages of samarium-153 

(Sm-153) that were 21 to 28 percent less than the 

quantity indicated on the dosage label. Sm-153 is a 

therapeutic radiopharmaceutical used to relieve bone 

pain associated with metastatic cancer. The licensee 

notified the nine affected client medical facilities. 

NRC Region III received written reports from each 

of the nine medical facilities, which reported a 

total of 61 individual medical events involving an 

underdose of Sm-153. The licensee’s calibration 

procedures for Sm-153 did not properly account for 

the different shielding properties of plastic syringes 

and glass vials. Sm-153 is predominantly a betaemitter; therefore, the material’s container provides 

a shielding effect. The licensee received the bulk 

material in glass vials and drew the dosages into 

plastic barreled syringes for dispensing purposes. 

When the licensee began dispensing Sm-153 in April 

1998, the staff determined a dose calibrator response 

factor (shielding factor) for the glass vial, but did not 

determine a similar factor for the plastic syringes 

(a lower shielding factor). As a result, the activity 

of the Sm-153 in syringes was measured as if it 

were still shielded by glass. Because the dose 

calibrator indicated activities 20 to 30 percent higher 

than expected, the pharmacy staff removed enough 

Sm-153 from the syringes to achieve the desired 

dose calibrator response, resulting in dispensed 

doses that were actually 20 to 30 percent too low. 

Actions Taken to Prevent Recurrence

NRC: NRC Region III conducted a special 

inspection of the licensee and selected customer 

facilities during January 2002. Region III is still 

evaluating this event.
4

(Contact: Roberto Torres, NMSS, 301-415-8112; 

e-mail: rjt@nrc.gov)

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.” Soon, cases will be listed under “document 

collections related to enforcement,” which can be 

accessed from that page. Additionally, 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.

Medical

V.A. Medical Center (EA 01-312)

On December 28, 2001, a Notice of Violation was 

issued for a Severity Level III violation involving 

the failure to secure from unauthorized access, 

or maintain constant surveillance over, licensed 

material in an unrestricted area. A package 

containing iodine-131 was left unattended at 

the nuclear medicine reception desk, when the 

receptionist became involved with scheduling tasks.

Advanced Medical Imaging and Nuclear Services 

(EA 01-313)

On December 14, 2001, an immediately effective 

Order Suspending License was issued. The order 

was based on the licensee’s possession and 

use of radioactive materials (including diagnostic 

administration to patients) without a required 

authorized user or Radiation Safety Officer.

Radiopharmacy

Geodax Technology, Inc. (EA 01-257)

On January 4, 2002, a Notice of Violation was 

issued for a Severity Level III violation involving 

the licensee allowing an individual to work as 

an authorized nuclear pharmacist (ANP) without 

notifying the U.S. Nuclear Regulatory Commission 

(NRC) within 30 days after the date that the licensee 

allowed the individual to work as an ANP. Although 

a civil penalty would normally have been proposed, 

in this case NRC exercised discretion in accordance 

with Section VII.B.6 of the Enforcement Policy and 

refrained from issuing a penalty. Discretion was 

warranted because NRC concluded that: the potential 

safety consequences were low; the pharmacist was 

forthcoming during NRC’s inspection; the Radiation 

Safety Officer promptly initiated supervision of the 

pharmacist, on being informed of the inspection 

finding; and all individuals involved accepted 

responsibility for the violation, and cooperated 

during the investigation.

Central Pharmacy Services, Inc. (EA 01-283)

On December 18, 2001, a Notice of Violation was 

issued for a Severity Level III problem involving 

the willful failure of an employee to: (1) wear 

a thermoluminescent finger badge when preparing, 

assaying, or dispensing millicurie quantities of 

radioactive material; and (2) use vial shields for 

preparing and dispensing radiopharmaceuticals.

Spectrum Pharmacy, Inc. (EA-02-018)

On February 23, 2002, a Notice of Violation 

was issued for a Severity Level III violation 

involving the failure to adequately measure the 

radioactivity of samarium-153 (Sm-153), before 

commercial distribution, which resulted in 61 

misadministrations. The error occurred because 

the licensee failed to follow the pharmaceutical 

manufacturer’s recommended procedures for 

determination of the dose calibrator calibration 

factor (potentiometer setting) for this radiopharmaceutical. Although the manufacturer’s procedure was 

based on the use of a 10-cubic-centimeter (.338-oz) 

glass vial for the calibration, the licensee measured 

unit dosages of Sm-153 in plastic syringes. The 

error resulted in dosages that were 21 to 28 percent 

less than the amount listed by the dose calibrator.

Radiography

Longview Inspection, Inc. (EA-01-267 and 

EA-01-281)

On January 18, 2002, a Notice of Violation was 
5

issued for a: (1) Severity Level III problem 

involving the failure to secure from unauthorized 

removal, or limit access to, licensed material [4.9 

terabecquerels (133 curies) of iridium-192 in a 

radiography camera] in an unrestricted area; failure 

to control and maintain constant surveillance of 

licensed material; and failure to lock the camera or 

its container when at a temporary jobsite; and (2) 

a Severity Level III violation involving the failure 

to have an additional qualified individual observe 

radiography operations. 

Other

University of Wisconsin-Madison (EA 01-282)

On December 21, 2001, a Notice of Violation 

and Imposition of Civil Penalty in the amount of 

$3000 was issued for a Severity Level III violation 

involving the failure to secure from unauthorized 

removal, or limit access to, byproduct material 

(americium-241) contained in six sealed sources; 

and the failure to control and maintain constant 

surveillance of this licensed material. Although the 

civil penalty would have been fully mitigated based 

on the normal civil penalty assessment process, 

a base civil penalty was assessed in accordance 

with Section VII.A.1.g of the Enforcement Policy, 

to reflect the importance of maintaining control of 

licensed material.

(Contact: Sally Merchant, OE, 301-415-2747; 

e-mail: slm2@nrc.gov)

GENERIC COMMUNICATIONS ISSUED

(December 1, 2001 - January 31, 2002)

Note that these are only 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 -- www.nrc.gov/NRC/GENACT/

GC/index.html. Please note that this address is casesensitive and must be entered exactly as shown.

Information Notices (INs)

IN 2001-19, “Improper Maintenance and 

Reassembly of Automatic Oil Bubblers,” was issued 

on December 17, 2001. This notice was issued 

to all holders of operating licenses for nuclear 

power reactors, except those who have permanently 

ceased operations and have certified that fuel has 

been permanently removed from the reactor vessel, 

to alert them to recent problems resulting from 

improper maintenance and reassembly of automatic 

oil bubblers. 

Contacts: Omid Tabatabai, NRR, 301-415-3738, 

e-mail: oty@nrc.gov; 

Javier Brand, Region I, 301-474-3589, e-mail: 

jmb3@nrc.gov.

IN 2002-03, “Highly Radioactive Particle Control 

Problems During Spent Fuel Pool Cleanout,” was 

issued January 10, 2002. This notice was sent 

to all holders of operating licenses for nuclear 

power reactors, holders of licenses for permanently 

shutdown facilities with fuel onsite, and holders 

of licenses for non-power reactors, to alert them 

to recent issues involving evaluation and control 

of radioactive particles generated during removal of 

material from a spent fuel pool before shipping the 

material offsite for disposal. The issue emphasized in 

this notice is that highly radioactive (hot) particles 

represent a radiological hazard, not just in terms of 

shallow dose to the skin or an extremity, but also as a 

deep or whole-body dose.

Contacts: James E. Wigginton, NRR, 301-415-1059, 

e-mail: jew2@nrc.gov;

James D. Noggle, Region I, 610-337-5063, e-mail: 

jdn@nrc.gov.

Regulatory Issue Summaries (RIS’)

RIS 2001-24, “Status of Receipt of NRC Mail 

Following the Closing of the Brentwood Postal 

Facility,” was issued on December 6, 2001. This 

summary was issued to all U.S. Nuclear Regulatory 

Commission (NRC) licensees, to provide them with 

information that will assist them in determining 

which method they should use to submit documents 

to NRC. The Agency is experiencing delays in 

the delivery of incoming mail because of the 
6

FINAL RULES 

“List of Approved Spent Fuel Storage Casks: NACUMS Revision; Confirmation of Effective Date,” 66 

FR 67073, December 28, 2001.

Contact: Jayne M. McCausland, NMSS; 

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

“List of Approved Spent Fuel Storage Casks: 

FuelSolutions\TM\Cask System Revision; 

Confirmation of Effective Date,” 67 FR 3431, 

January 24, 2002.

Contact: Merri Horn, NMSS; 301-415-8126; 

e-mail: mlh1@nrc.gov.

“Revised Filing Requirements,” 67 FR 3584, 

January 25, 2002.

Contact: Carrie Brown, NMSS, 301-415-8092; 

e-mail: cxb@nrc.gov.

“List of Approved Spent Fuel Storage Casks: 

Standardized NUHOMS-24P, -52B, and -61BT 

Revision; Confirmation of Effective Date,” 67 FR 

5934, February 8, 2002.

Contact: Merri Horn, 301-415-8126; e-mail: 

mlh1@nrc.gov.

PROPOSED RULES

“Specification of a Probability for Unlikely 

Features, Events, and Processes,” 67 FR 3628, 

January 25, 2002.

Contacts: Timothy McCartin, 301-415-7285; 

e-mail: tjm3@nrc.gov; Clark Prichard, 

301-415-6203; email: cwp@nrc.gov.

“List of Approved Spent Fuel Storage Casks: 

Standardized Advanced NUHOMS-24PT1 

Addition,” 67 FR 6203, February 11, 2002.

Contact: Jayne McCausland, 301-415-6219; 

e-mail: jmm2@nrc.gov.

inspection and investigation processes associated 

with the potential presence of anthrax in mailhandling facilities.

Contact: Michael L. Springer, ADM, 301-415-6222, 

e-mail: mls@nrc.gov.

RIS 2002-01, “Changes to NRC Participation in 

the International Nuclear Event Scale” (INES) was 

issued on January 14, 2002. This summary was 

issued to all U.S. Nuclear Regulatory Commission 

(NRC) licensees and certificate holders to inform 

them of NRC’s increased level of participation 

in the INES. Licensees were informed that the 

requirements for reporting events and incidents to 

NRC will remain unchanged.

Contact: Robert J. Stransky, Jr., IRO, 301-415-6411, 

e-mail: rjs3@nrc.gov.

RIS 2002-02, “Lessons Learned Related to Recently 

Submitted Decommissioning Plans and License 

Termination Plans,” was issued on January 16, 

2002. This summary was issued to all U.S. 

Nuclear Regulatory Commission (NRC) licensees 

to inform them of lessons learned from reviews 

of recently submitted decommissioning plans (DPs) 

and license termination plans (LTPs). The RIS 

provides licensees with information that may help 

them develop more complete DPs and LTPs, which 

should result in more effective and efficient use of 

both licensees’ and NRC’s resources.

Contact: Stewart W. Brown, NMSS, 301-415-6605, 

e-mail: swb1@nrc.gov.

(General Contact: Kevin M. Ramsey, NMSS, 

301-415-7887, e-mail: kmr@nrc.gov)

SELECTED FEDERAL REGISTER

NOTICES

(November 30, 2001 - February 28, 2002)

NOTE: U.S. Nuclear Regulatory Commission 

(NRC) contacts may be reached by mail at the U.S. 

Nuclear Regulatory Commission, Washington, DC 

20555-0001.
7

OTHER NOTICES

“Portsmouth Gaseous Diffusion Plant, United States 

Enrichment Corporation; Notice of Consideration of 

Request for Temporary Exemption,” 66 FR 63077, 

December 4, 2001.

Contact: Dan E. Martin, NMSS, 301- 415-7254; 

e-mail: dem1@nrc.gov.

“Enforcement Program and Alternative Dispute 

Resolution; Request for Comments,” 66 FR 64890, 

December 14, 2001. 

Contacts: Terrence Reis, OE, 301-415-3281; 

e-mail: txr@nrc.gov;

Francis X. Cameron, OGC, 301-415-1642; 

e-mail: fxc@nrc.gov.

“Denial of Petition for Rulemaking by Jeffery C. 

Angel,” 67 FR 274, January 3, 2002.

Contact: Gary Comfort, NMSS, 301-415-8106; 

e-mail: gcc1@nrc.gov.

“Updated and Consolidated Decommissioning 

Policy and Guidance of the Nuclear Regulatory 

Commission’s Office of Nuclear Material Safety and 

Safeguards,” 67 FR 4764, January 31, 2002.

Contact: Jack D. Parrott, 301-415-6700; 

e-mail: jdp1@nrc.gov.

“Decommissioning Criteria for the West Valley 

Demonstration Project (M-32) at the West Valley 

Site; Final Policy Statement,” 67 FR 5003, 

February 1, 2002.

Contact: Chad Glenn, 301-415-6722; 

e-mail: cjg1@nrc.gov.

“Solicitation of Comments on a Draft Standard 

Review Plan (NUREG-1569) for Staff Reviews 

for In-Situ Leach Uranium Extraction License 

Applications,” 67 FR 5347, February 5, 2002.

Contact: John Lusher, 301-415-7694; 

e-mail: jhl@nrc.gov.

“Solicitation of Comments on a Draft Standard 

Review Plan (NUREG-1620) for Staff Reviews of 

Reclamation Plans for Mill Tailings Sites Under Title 

II of the Uranium Mill Tailings Radiation Control 

Act,” 67 FR 5348, February 5, 2002.

Contact: John Lusher, 301-415-7694; 

e-mail: jhl@nrc.gov.

“Fitness-for-Duty Programs, Availability of 

Draft Outline and Rule Wording,” 67 FR 7093, 

February 15, 2002.

Contact: Garmon West, 301-415-1044; e-mail: 

fitnessforduty@nrc.gov.

“Department of Energy, Office of Civilian and 

Radioactive Waste Management; Nuclear Waste 

Repository Program: Yucca Mountain Site 

Recommendation to the President and Availability 

of Supporting Documents,” 67 FR 9048, 

February 27, 2002.

Contact: Yucca Mountain Site Characterization 

Office, Office of Civilian Radioactive Waste 

Management, U.S. Department of Energy, M/S 025, 

P.O. Box 364629, North Las Vegas, NV 89036-8629, 

telephone, 1-800-225-6972.

(General Contact: Paul Goldberg, NMSS, 

301-415-7842; e-mail: pfg@nrc.gov)

Comments, and suggestions you may have for 

information not currently included, that might 

be helpful to licensees, should be sent to:

E. Kraus

NMSS Licensee Newsletter Editor

Two White Flint North, Mail Stop T-8A23

U.S. Nuclear Regulatory Commission

Washington, D.C. 20555-0001
8