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

Regulatory Material Safety No. 05-02

Commission and Safeguards July 2005

NMSS Quarterly Newsletter

Contents Page

1. Medical Use of Byproduct Material -

Recognition of Specialty Boards; Final Rule ...... 1

2. National Source Tracking System...................... 3

3. Radiation Safety Program Oversight:

Tasks May Be Delegated, But

Responsibilities May Not .................................. 4

4. Decommissioning Workshop ............................ 4

5. Licensing Impact of New Uranium

Maximum Contaminant Levels ......................... 5

6. Calibration of Dose Calibrators for P-32

and Other Beta Emitters or Low-Energy

Photon Emitters................................................. 6

7. What’s New In the Medical Toolkit................... 6

8. Understanding 10 CFR 35.3045(a)(3) Wrong

Treatment Site Reportable Medical Event.......... 7

9. Significant Medical Events................................ 7

10. Generic Communications Issued

(December 17, 2004 - May 20, 2005) ................ 8

11. Significant Enforcement Actions ..................... 10

12. Selected Federal Register Notices

(March 1, 2005 - May 31, 2005) ...................... 10

MEDICAL USE OF BYPRODUCT

MATERIAL - RECOGNITION OF

SPECIALITY BOARDS; FINAL RULE

The U.S. Nuclear Regulatory Commission (NRC)

published a final rule to amend its requirements for

training and experience (T&E) for “Medical Use

of Byproduct Material,” 10 CFR Part 35, in the

Federal Register (FR) on March 30, 2005 (70 FR

16335). The rule amends the regulations to change

requirements for recognition of certain specialty

boards’ certification processes. These boards’

certifications may be used for demonstrating the

adequacy of the training and experience of

individuals to serve as authorized users (AUs);

authorized medical physicists (AMPs); authorized

nuclear pharmacists (ANPs); or radiation safety

officers (RSOs). The final rule also revises the

requirements for demonstrating the adequacy of

T&E for the educational pathway, other than the

certification pathway, for achieving authorized

status. The rule provides a more flexible and

performance-based approach to specifying

requirements for training and experience, using a

graded approach to ensure that training in radiation

protection is consistent with the need for adequate

understanding and skills.

Background

The current regulations in Part 35 offer three

pathways for individuals to satisfy T&E

requirements to be approved as an RSO, AMP,

ANP, or AU. These pathways are: (1) approval of

an individual who is certified by a specialty board,

whose certification process has been recognized by

the NRC or an Agreement State as meeting NRC’s

requirements for training and experience;

(2) approval based on an evaluation of an

individual’s training and experience; or

(3) identification of an individual’s approval on an

existing NRC or Agreement State license. For this

discussion, pathway 1 will be referred to as the

“certification pathway” and pathway 2 as the

“alternate pathway.”

During development of proposed and final rules for

the prior-to-recent-amendment medical use

regulations in Part 35, August 13, 1998 (63 FR

43516) and April 24, 2002 (67 FR 20249),

respectively, it was generally believed that the

specialty boards, whose certification processes were

recognized by the NRC, would meet, or could make

adjustments to meet, the new requirements,

established by that rulemaking, governing NRC

recognition of specialty boards, and that they would

continue to be recognized by NRC. However, when

applications for recognition were received, NRC

staff determined that, except for one board (the
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Certification Board of Nuclear Cardiology), the

boards did not meet all the requirements in the final

rule. To address the potential that individuals would

no longer satisfy requirements for T&E under the

certification pathway, NRC modified the final rule

by reinserting Subpart J of Part 35 for a 2-year

transition period, during which NRC could work to

ensure that appropriate requirements for T&E apply

to recognition of specialty board certification

processes. Subpart J provided for continuing

recognition of the specialty boards, listed therein,

during the transition period, which ended on

October 24, 2004, as provided for in the revised rule

published on April 24, 2002. NRC’s Advisory

Committee on the Medical Uses of Isotopes

(ACMUI) provided recommendations for an

approach to revising requirements for T&E during

the development of the current rule. In order to

ensure an effective transition, the effective date of

Subpart J was extended to October 24, 2005, under

a separate rulemaking action (69 FR 55736,

September 16, 2004).

In a SRM dated October 9, 2003, the Commission

approved publication of a proposed rule to amend

the requirements for T&E (SECY-03-0145, August

21, 2003). The proposed rule was published in the

Federal Register (FR) on December 9, 2003

(68 FR 68549). The comment period on the

proposed rule closed on February 23, 2004.

Twenty-seven comments were received. The

comments came from the Agreement States, the

public, and the ACMUI, and are discussed in detail

in the FR (70 FR 16335, March 30, 2005). In

addition, the Organization of the Agreement States

(OAS) filed a petition (PRM-35-17) requesting that

10 CFR 35.55, 35.190, 35.290, and 35.390 be

amended to define and specify the minimum number

of “didactic” training hours for AUs and ANPs

identified in these sections.

Summary of Changes to Part 35

The principal changes in regulations in the final rule

relate to revising the criteria that a certification

board must meet for its certification process to be

recognized by the NRC or an Agreement State.

Changes have also been made to requirements for

T&E in the alternate pathway. The NRC staff

implemented the direction from the Commission, in

an SRM dated October 9, 2003, related to SECY03-0145, to make various changes to the proposed

rule. In particular, the requirement for a preceptor

statement was “decoupled” from the requirements

for recognition of specialty board certification

processes (placing the requirement on the individual

to obtain the preceptor statement) in the proposed

rule, published in the FR (68 FR 68549, December

9, 2003). This approach was followed in the final

rule, as was the requirement for preceptor

statements to be provided to NRC by licensees, for

approval of applications for individuals to serve as

RSOs, AMPs, ANPs, or AUs.

Significant amendments in the final rule are:

• The requirement, in 10 CFR 35.390(b)(1)(ii)(F),

for experience with the elution of generators,

testing, processing, and preparation of labeled

radioactive drugs, is removed from 10 CFR

35.390.

• The requirements for experience with oral and

parenteral administrations of byproduct material

for which a written directive (WD) is required,

currently in 10 CFR 35.390(b)(1)(ii)(G), are

removed from the requirements for recognition

of specialty board certification processes.

However, the regulations continue to require

this experience for individuals to qualify as AUs

for uses of byproduct material for which a

written directive is required under 10 CFR

35.300, for both the certification pathway and

the alternate pathway.

• A new 10 CFR 35.396, entitled “Training for

the parenteral administration of unsealed

byproduct material requiring a written

directive,” is included in the final rule. This

allows individuals who do not meet other

requirements in 10 CFR 35.390(b)(1), to serve

as AUs for parenteral administration of

byproduct material for which a WD is required,

if they meet the requirements in 10 CFR 35.396.

• Requirements for individuals to serve as RSOs

were amended (10 CFR 35.50) to include

medical physicists who meet the requirements

specified therein.

• A requirement is added for AUs in 10 CFR

35.190, 35.290, and 35.390, and for ANPs in

10 CFR 35.55, that training in basic radionuclide handling techniques must include a

minimum number of hours of classroom and

laboratory training, for individuals to be

approved as AUs and ANPs under the alternate

pathway. Specifically, the final rule requires 8,

80, and 200 hours of classroom and laboratory

training for 10 CFR 35.190, 35.290, 35.55 and

35.390, respectively, under the alternate

pathway.
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• “Attest” and “attestation” are used in place of

“certify” and “certification,” in requirements for

the preceptor statements.

• The final rule grants, in part, OAS petition

PRM-35-17, by incorporating requirements for

certain minimum hours of classroom and

laboratory training in basic radionuclide

handling techniques, for ANPs and AUs, under

the alternate pathway in 10 CFR 35.55, 35.190,

35.290, and 35.390.

• Agreement States are allowed up to 3 years to

adopt the final rule.

• 10 CFR 35.10 provides for implementation of

the requirements in 10 CFR 35.14(a) to provide

the Commission with a copy of written

attestation, signed by a preceptor, on or before

October 25, 2005. Also, before October 25,

2005, a licensee shall satisfy the training

requirements for an AU, AMP, ANP, or an

RSO, by complying with either: (a) the training

requirements in subpart J, or (b) the appropriate

training requirements in subpart B or subparts

D through H.

These and other changes to the rule are discussed in

more detail in the FR (70 FR 16335, March 30, 2005).

NRC staff believes that the final rule provides

requirements that are less prescriptive than

those in the prior-to-recent-amendment medical use

regulations and allows for more flexible approaches

by specialty boards in setting up their certification

processes and requirements. The changes will also

permit more flexibility in training programs that

lead to certification -- steps that will continue to

ensure radiation safety while resulting in a reduction

of regulatory burden.

Licensing guidance for medical uses of byproduct

material, NUREG 1556, Volume 9, has been revised

to conform to the revisions in the final rule.

(Contact: Neelam Bhalla, Office of Nuclear

Material Safety and Safeguards, 301-415-6843;

e-mail: nxb@nrc.gov or Cindy Flannery, Office

of Nuclear Material Safety and Safeguards,

301-415-0223; e-mail: cmf@nrc.gov)

NATIONAL SOURCE TRACKING SYSTEM

The U.S. Nuclear Regulatory Commission (NRC) is

developing a new National Source Tracking System

(NSTS) for radioactive sources of concern. These

sources will be called nationally tracked sources.

A nationally tracked source is a sealed source

containing a quantity of radioactive material equal

to or greater than the Category 2 levels listed in a

new Appendix F to 10 CFR Part 20. A nationally

tracked source may be either a Category 1 source

(100 times the Category 2 threshold) or a Category

2 source. Nationally tracked sources do not include

material encapsulated solely for disposal, or nuclear

material contained in any fuel assembly,

subassembly, fuel rod, or fuel pellet. The radioactive material and threshold values are from the

International Atomic Energy Agency (IAEA) Code

of Conduct. The NRC has adopted the Category 2

values, to allow alignment between domestic and

international efforts to increase the safety and

security of radioactive sources.

NSTS will eventually provide a life history of each

nationally tracked source. The system will contain

information on sources possessed by NRC and

Agreement State licensees, as well as U.S. Department of Energy facilities. In order to implement the

NSTS, NRC is conducting a rulemaking to require

reporting of source transactions to the NSTS.

These transactions include the manufacture of new

sources, transfer of sources, receipt of sources,

and disposal of sources. Licensees will be given

the option of reporting by several mechanisms:

(1) on-line to the NSTS; (2) batch load using

electronic file submission; (3) mail; (4) facsimile;

or (5) by telephone, with follow-up by facsimile or

mail. Licensees will be required to make the report

by the close of the next business day after the

transaction.

The information to be reported for each source

includes the manufacturer, model, serial number,

radioactive material, source strength, and associated

date. Also to be included in each report is the

company name and license number. Transfer

information would include the recipient, the

shipping date, and the estimated arrival date.

Receipt information would include the receipt date,

the company name, and license number of the

facility providing the source. Information for

disposal would include the method and date of

disposal, the waste manifest number, and the

container identification of the container with the

source.

Each licensee would be required to report its initial

inventory of Category 1 sources by December 31,

2006, and its inventory of Category 2 sources by

March 31, 2007. To ease the burden on licensees,

NRC will use the information in the interim

inventory database for the initial loading into the

NSTS. Licensees will be asked to verify and/or
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update the information by the same dates.

Licensees would be required to begin reporting

transactions for Category 1 sources by December

31, 2006. For Category 2 sources, the date to begin

reporting would be March 31, 2007.

To maintain the accuracy and reliability of the

information in the NSTS, the rule would also

require licensees to reconcile their onsite inventory

of nationally tracked sources with the information

previously reported to the NSTS . The licensee

would be required to verify that the inventory in the

NSTS is correct. This reconciliation and verification process would occur in June of each year.

The proposed rule should be published for public

comment in summer 2005. NRC plans to hold

public meetings during the public comment period.

The locations, dates, and times will be published in

the Federal Register. The proposed rule, regulatory

analysis, Office of Management and Budget

supporting statements, and information on the

public meetings will be available on the NRC

rulemaking web site at http://ruleforum.llnl.gov.

Before actual implementation of the system in

December 2006, NRC will hold several workshops

around the country to demonstrate the NSTS. These

workshops will provide an opportunity for licensees

to have hands-on access to the system. The format

for the electronic submission should be available at

the workshops.

(Contact: Merri Horn, Division of Industrial and

Medical Nuclear Safety, NMSS, 301-415-8126;

e-mail: mlh1@nrc.gov)

RADIATION SAFETY PROGRAM

OVERSIGHT: TASKS MAY BE

DELEGATED, BUT RESPONSIBILITIES

MAY NOT

During a recent inspection at a facility that

performs brachytherapy procedures, it was observed

that the licensee exercised poor oversight of the

brachytherapy radiation safety program. The

licensee’s poor oversight of the program was a

contributing factor to a series of medical events.

The licensee delegated the responsibility for the

day-to-day implementation of the brachytherapy

radiation safety program to contract medical

physicists. Additionally, the licensee also relied on

them to monitor activities regarding the licensee’s

brachytherapy radiation safety program. Although

the licensee relied on the contract medical physicists

to audit the brachytherapy radiation safety program,

the licensee did not take any steps to validate their

audit findings. Also, the licensee relied on the

contract medical physicists to interpret NRC

regulations concerning identification and

notification of medical events. The licensee

accepted the contract medical physicists’ misinterpretation of 10 CFR 35.3045. Furthermore, the

licensee provided poor supervision of the contract

medical physicists by expecting them to be familiar

with the technical limitations of the applicator and

to provide the authorized user with the aforementioned technical limitations. The authorized user

was not familiar with the applicator instructions or

the technical limitations regarding the use of the

applicator and he did not provide these instructions

and technical limitations to the contract medical

physicist before the first use of the applicator. The

licensee’s poor management oversight of the

brachytherapy radiation safety program resulted in

missed opportunities to identify precursors

associated with five medical events and failure to

promptly identify and report those medical events.

In this instance, NRC is particularly concerned

with the licensee’s lack of management oversight

of its radiation safety programs and the lack of

supervisory and Radiation Safety Officer (RSO)

oversight of its contract medical physicists. Certain

duties may be assigned to others when adequate

supervision is provided; however, the RSO is still

responsible for implementing the radiation safety

program, and the licensee is still responsible for

regulatory compliance. NRC expects licensees to

maintain adequate oversight of their radiation safety

programs to ensure safe use of radioactive materials

and the protection of public health and safety.

Licensees are encouraged to refer to 10 CFR 35.24,

“Authority and responsibilities for the radiation

protection program”, 10 CFR 35.27, “Supervision”,

and 10 CFR 35.2024, “Records of authority and

responsibilities for the radiation protection program”.

(Contact: Cindy Flannery, Office of Nuclear

Material Safety and Safeguards, 301-415-0223;

e-mail: cmf@nrc.gov)

DECOMMISSIONING WORKSHOP

The Decommissioning Directorate of the Division

of Waste Management and Environmental

Protection (DWMEP) held a workshop on April 20

and 21, 2005, at the Shady Grove Center in

Rockville, Maryland. DWMEP held the workshop

as part of the staff’s initiatives to continually

improve the process for decommissioning, and to

solicit feedback on specific technical issues
5

concerning decommissioning. Approximately 180

people attended the workshop.

The first day of the workshop began with

introductory talks by DWMEP Division Director,

Larry Camper, and DWMEP Director of the

Decommissioning Directorate, Dan Gillen. Staff

then summarized the Integrated Decommissioning

Improvement Plan (IDIP). The IDIP describes staff

initiatives to improve the decommissioning process

over the next 2 years.

The first day of the workshop was also devoted to

obtaining feedback on issues that the staff evaluated

as part of the License Termination Rule (LTR)

Analysis. The LTR Analysis was conducted over a

period of 2 years, resulting in staff obtaining

direction from the Commission in two Staff

Requirements Memoranda (SRM) (SRM-SECY-03-

0069 and SRM-SECY-04-0035). Nine specific

issues were evaluated in the LTR Analysis and staff

recommended options for addressing the issues and

providing paths forward regarding informing

licensees and other stakeholders of the issues and

resolutions. The staff identified several issues

requiring further guidance for licensees and

stakeholders, and the workshop was used as an

initial opportunity for stakeholders to provide input

into the guidance on these issues. To achieve this,

individual breakout sessions were conducted with

smaller groups of attendees, that addressed each of

the LTR Analysis issues, and there were focused

discussions on specific items and topics that staff

intends to address in guidance.

Commissioner Jeffrey Merrifield presented the keynote speech on the morning of the second day of the

workshop. His presentation on “Decommissioning

Lessons Learned,” provided the backdrop for the

purpose of the second day of the workshop, which

was dedicated to detailed discussions of lessons

learned by the industry and NRC in decommissioning, and how best to use these lessons learned in

future decommissioning projects. A panel

comprised of NRC staff, an Agreement State

representative, and industry representatives gave

informative presentations on their perspectives of

lessons learned in decommissioning.

After the panel presentations, the remainder of the

second day of the workshop consisted of a facilitated

discussion on lessons learned in decommissioning that

focused on both the industry and NRC. A discussion

was held to solicit feedback on the best ways for NRC

to collect the lessons learned on decommissioning, to

preserve those that should be used in future decommissioning projects, and to incorporate those lessons

learned in documents or other communication

methods, so they would be available to use for future

decommissioning efforts.

Staff will post a draft summary report of the

workshop on the Decommissioning Workshop

Webpage (http://www.nrc.gov/public-involve/

conference-symposia/decommissioning.html) for

attendees to review and provide corrections and

additions to the summary report before it is

finalized. After the Summary Report is finalized,

staff will begin evaluating and implementing some

of the processes suggested at the workshop for

identifying, preserving, and communicating

decommissioning lessons learned.

(Contact: Derek A. Widmayer, Division of

Waste Management and Environmental Protection,

301-415-6677; e-mail: daw@nrc.gov)

LICENSING IMPACT OF NEW URANIUM

MAXIMUM CONTAMINANT LEVELS

In December 2000, The U.S. Environmental

Protection Agency (EPA) published its final rule for

radionuclides in drinking water using its authority

under the Safe Drinking Water Act. The final rule

included maximum contaminant levels (MCLs) for

multiple classes of radionuclides, including

uranium. For uranium, EPA adopted an MCL of 30

micrograms per liter ( μg/l) in community water

systems (CWS’). A CWS is a water system that

serves at least 15 service connections or 25 residents

regularly, year-round. The rule requires that CWS’

comply with the new requirements by December 31,

2007. EPA has estimated that approximately 500

CWS’ would be affected. Industry sources that

have contacted NRC have estimated this number to

be 1000 or higher.

The technologies that would be used to remove

uranium from drinking water could have two

results: (1) the CWS could be in possession of

source material (uranium) exceeding 0.05 weight

percent; and (2) the CWS could possess greater than

15 pounds of uranium in a very short period of time.

Under these circumstances, these CWS’ would

require a specific license from NRC, or the

corresponding Agreement State, to possess the

source material.

Staff is preparing a Commission paper that will

provide options and recommendations for the

Commission’s consideration. Until such time as any

regulatory changes are made effective, the existing

licensing requirements in 10 CFR Part 40 would

apply.
6

Additional EPA information on this topic can be

found at: http://www.epa.gov/safewater/rads/

technicalfacts.html or http://www.epa.gov/

safewater/radionuc.html

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

e-mail: gcc1@nrc.gov or Bob Nelson, Chief,

Uranium Processing Section, NMSS, 301-415-7298,

e-mail: ran@nrc.gov)

CALIBRATION of DOSE CALIBRATORS

FOR P-32 and OTHER BETA EMITTERS

OR LOW- ENERGY PHOTON EMITTERS

During a recent inspection, a licensee was

measuring and adjusting Phosphorous-32 (P-32)

radiopharmaceutical dosages using a dose calibrator

that had only been calibrated using high-energy

gamma-emitting sources and had not been calibrated

for P-32 use. 10 CFR 35.60, “Possession, use, and

calibration of instruments used to measure the

activity of unsealed byproduct material,” requires

the licensee to calibrate instruments used for direct

measurement of dosages before medical use. In

spite of this requirement, the licensee erroneously

believed it was not required to calibrate the dose

calibrator but to “only perform periodic test

following a nationally recognized standard.” The

standard cited was American National Standards

Institute (ANSI) N42.13, “American National

Standard Calibration and Usage of ‘Dose Calibrator’

Ionization Chambers for the Assay of

Radionuclides.” This standard describes required

calibration procedures (i.e., initial calibration with

standard sources for each radionuclide of interest,

dependence of the assay on geometric configuration

and composition of the source container, and energy

range) and advisory calibration recommendations to

be applied when practical (i.e., cover complete

activity ranges used) to achieve acceptable accuracy

and reproducibility limits.

The licensee did not perform the procedures

required in ANSI N42.13. Instead, the licensee used

the dose calibrator manufacturer’s radionuclide

calibration setting for P-32 without performing the

geometric dependency test. To properly calibrate

the dose calibrator and accurately measure the

activity of its P-32 dosages, the licensee needed,

among other things, to perform the geometric

dependency test for the actual containers and

volumes routinely used at the licensee’s facility and

use the resulting data to obtain a site specific

correction factor for P-32. This was important

because the manufacturer’s table of radionuclides

and calibration settings included the disclaimer “no

warranty of any kind can be made as to their

(calibration numbers) accuracy, since there were

many uncontrollable factors (as well as the accuracy

of the published data) involved in the overall

accuracy of an assay” and further warned that the

P-32 data was for “estimation use only.”

The U.S. Nuclear Regulatory Commission (NRC)

recognizes the difficulties associated with

measuring and calibrating dose calibrators for pure

beta-emitting radionuclides and discussed some of

these difficulties in Information Notice 2002-19,

“Medical Misadministrations Caused by Failure to

Properly Perform Test on Dose Calibrators for Betaand-Low-Energy Photon-Emitting Radionuclides.”

An additional difficulty with beta calibrations is that

lack of standard sources for certain radionuclides

and, even if the standard sources were available,

most medical use licensees do not have access to the

National Institute of Standards and Technology

prepared or traceable standard sources needed to

perform the calibrations for beta-emitting

radionuclides. All these difficulties contributed to

NRC giving medical use licensees the option (in 10

CFR 35.63, “Determination of dosages of unsealed

byproduct material for medical use”) of determining

the proper dosages by using a combination of

volumetric measurements and mathematical

calculations, based on the activity per unit volume

determination made by the manufacturer or preparer

licensed under 10 CFR 32.72, “Manufacture,

preparation, or transfer for commercial distribution

of radioactive drugs containing byproduct material

for medical use under Part 35.” This option gives

licensees a better method of determining activities

without depending on dose calibrator reading from

instruments that are not calibrated for the

radionuclides being administered to humans.

(Contact: Donna-Beth Howe, Ph.D., Office of

Nuclear Material Safety and Safeguards,

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

WHAT’S NEW IN THE MEDICAL

TOOLKIT

With the March 30 publication in the Federal

Register (FR) of the 10 CFR Part 35 “Medical Use

of Byproduct Material—Recognition of Specialty

Boards; Final Rule,” the U.S. Nuclear Regulatory

Commission (NRC) updated its medical uses

licensee toolkit (http://www.nrc.gov/materials/miau/

med-use-toolkit.html) to: (1) include a link to the

FR copy of the April 2002 revision of 10 CFR Part

35; (2) include a link to the FR copy of the new

March 2005 rule; (3) add a red-line strike-out copy

of sections of 10 CFR Part 35 changed by the final
7

rule; (4) include a link to NUREG-1556, Vol 9, Rev.

1, “Program-Specific Guidance About Medical Use

Licenses;” (5) clarify that the “Guide for Diagnostic

Nuclear Medicine,” published in 2002 by the

American College of Nuclear Physicians and the

Society of Nuclear Medicine, has not been updated

to conform to the changes to the training and

experience requirements issued in the final rule; and

(6) revise the link to the April 2005 NRC Form

313A, “Medical Use Training and Experience and

Preceptor Attestation.”

(Contact: Donna-Beth Howe, Ph.D.,

Office of Nuclear Material Safety and Safeguards,

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

UNDERSTANDING 10 CFR 35.3045(a)(3)

WRONG TREATMENT-SITE

REPORTABLE MEDICAL EVENT

A few medical use licensees have incorrectly

interpreted the criteria in 10 CFR 35.3045(a)(3) for

determining when a medical event involving the

“wrong site” must be reported to the U.S. Nuclear

Regulatory Commission (NRC). 10 CFR

35.3045(a)(3) requires a licensee to report any

events, except for an event that results from patient

intervention, if there is a dose to the skin or an organ

or tissue other than the treatment site that exceeds

by 0.5 sievert (Sv) (50 rem) to an organ or tissue

and 50 percent or more of the dose expected from

the administration defined in the written directive

(excluding, for permanent implants, seeds that were

implanted in the correct site but migrated outside the

treatment site).”

Some licensees erroneously believed that if the

“wrong site” received 0.5 Sv (50 rem) then it needed

to receive at least 50 percent of the dose intended

for the correct treatment site before the event met

the criteria in 10 CFR 35.3045(a)(3). The correct

interpretation is that once the “wrong site” receives

0.5 Sv (50 rem), the event is reportable if this site

also receives a dose that is 50 percent more than

anticipated at the “wrong site” if the administration

had been delivered correctly (i.e., the right dose was

delivered in accordance with the written directive to

the correct treatment site).

When the written directive specifies the dose to the

treatment site, it is understood that, even when the

administration is delivered correctly, doses may be

delivered to areas beyond the treatment site. For

radiopharmaceuticals, tables may be used to identify

the expected doses to other organs or tissues. When

using sealed sources or the radiation from sealed

sources, treatment planning systems are used to

estimate and map expected dose curves at or near

the correctly placed sources or correctly delivered

radiation beam. When the dose or dosage is not

given in accordance with the written directive, the

licensee needs to determine the total dose delivered

to the “wrong site” and compare it to the dose that

would have been delivered to this “wrong site” if

the administration had been given correctly.

If the “wrong site” were not expected to receive any

dose during the correct administration, and it

received .05 Sv (50 rem), the medical event needs to

be reported. If the “wrong site” was suppose to

receive .01 Sv (10 rem) during the correct

administration but received .06 Sv (60 rem), the

medical event would be reportable. In this case,

the dose received by the “wrong site” exceeded by

.05 Sv (50 rem) the dose it should have received, as

well as more than 50 percent of what it should have

received. If the “wrong site” was suppose to receive

.01 Sv (10 rem) and it received .04 Sv (40 rem), the

medical event would not be reportable because the

dose to the “wrong site” was under .05 Sv (50 rem)

even though the “wrong site” received more than 50

percent of what it should have. For permanent

implants, NRC recognizes that the sources may

migrate after being implanted in the correct site.

This migration would not result in a reportable event

under 35.3045(a)(3).

(Contact: Donna-Beth Howe, Ph.D.,

Office of Nuclear Material Safety and Safeguards,

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

SIGNIFICANT MEDICAL EVENTS

Event 1: Medical Event at St. Joseph Regional

Medical Center

Date and Place: February 23, 2004, South Bend,

Indiana

Nature and Probable Causes: The licensee reported

that five patients who received brachytherapy

treatments for endometrial cancer, received

radiation doses to the wrong location. The first

patient was treated in January 2004; the second and

third patients in February 2004; and the fourth and

fifth patients in March 2004.

A new Wang vaginal applicator was used during the

procedures. The tandem device was loaded with

Cesium-137 sources, and the sources were

manufactured by Amersham. The tandem device

was designed to use 3M brachytherapy sources;

however, Amersham sources were used. The
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Amersham sources were too small for use in the

tandem device, causing the sources to slide out of

position and irradiate the inner thigh, whenever the

patients moved into a more up-right position.

Approximately 2 weeks after treatment, the third,

fourth and fifth patients developed ulcerations on

the skin of the inner thigh. The licensee’s initial

calculations estimated the skin doses to be below 50

centisieverts (cSv) (rem). However, the third

patient exhibited recurring skin ulcerations,

prompting the licensee to reevaluate the calculated

doses. The licensee’s revised calculations

determined that the third patient received an

unintended dose to a small area of the skin on the

upper thigh of approximately 2000 centigray (cGy)

(rad). The fourth patient received an unintended

dose to a similar area of the thigh of approximately

1500 to 2000 cGy (rad). Despite the unintended

doses to the inner thigh, the licensee believed that

the patients received the respective prescribed doses

to the treatment areas, based on clinical

observations. All patients were notified of the error.

A NRC Region III inspection will review the

circumstances surrounding the event and an NRC

medical consultant will provide an independent

medical evaluation of the probable deterministic

effects of the radiation exposures.

Actions Taken to Prevent Recurrence

Licensee: The licensee retrained personnel and

replaced the applicator with one that will accept

both source sizes.

Event 2: Medical Event at Saddleback Memorial

Hospital

Date and Place: January 24, 2005, Laguna Hills,

California

Nature and Probable Causes: The licensee reported

a medical event involving a breast cancer patient

treated with a Varian Medical Systems remote high

dose rate (HDR) afterloading unit (model VS2000)

and Iridium -192 (Ir-192) source with an activity of

277.5 gigabecquerels (7.5 curies). Ten fractional

treatments were administered from January 24 to

January 28, 2005. The prescribed dose was

350 centigray (cGy) (350 rad) per fraction at

1 centimeter (cm) from the surface of the balloon, at

two fractions per day, for a total of 3500 cGy (rad).

The patient returned on March 18, 2005,

complaining of pain on her breast. A moist

desquamation was noted on the breast surface at

the point the catheter had entered the breast. Reevaluation of the treatment plan revealed that the

wrong catheter length parameter (source travel

distance) was used during the treatment. The Ir-192

source was implanted 8 cm short of its planned

location, near the catheter breast entry point.

Dosimetry reconstruction indicated that the maximum dose delivered to a tissue area of 2.5 by 2.1

by 0.5 cm, at the entrance port was 7000 cGy (rad).

Actions Taken to Prevent Recurrence

Licensee: Corrective actions included instituting

a quality assurance checklist requiring two persons

to verify and document treatment parameter

determinations and correct treatment computer

inputs, to include the catheter length parameter.

Also, normal catheter length parameters for standard

treatments will be documented and checked before

treatments. Staff will be trained in these new

procedures before using the HDR unit.

Event 3: Medical Event at St. Johns Mercy

Hospital Center

Date and Place: March 9, 2005, St. Louis, Missouri

Nature and Probable Causes: The licensee

reported that a 5 month-old infant was prescribed

18.5 megabecquerel (MBq) [0.5 millicuries (mCi)]

of Technetium-99m (Tc-99m) myoview sulfur

colloid, but instead received 429.2 MBq (11.6 mCi)

of Tc-99m myoview sulfur colloid. Personnel did

not look at the label when measuring the dose to be

administered. The whole body dose to the infant

was calculated to be between 5.2 and 10

centisieverts (rem). The physician has informed the

infant’s parents.

Actions Taken to Prevent Recurrence

Licensee: The licensee is determining corrective

actions to prevent recurrence.

(Contact: Angela McIntosh, Division of Industrial

and Medical Nuclear Safety, 301-415-5030;

e-mail: arm@nrc.gov)

GENERIC COMMUNICATIONS ISSUED

(December 17, 2004 - May 20, 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
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must be entered exactly as shown. If you have any

questions or comments about generic

communications in general, please contact Angela

R. McIntosh, 301-415-5030; e-mail: arm@nrc.gov.

Bulletins (BL)

BL 2005-01, “Material Control and Accounting

at Reactors and Wet Spent Fuel Storage

Facilities,” was issued on February 11, 2005. This

BL was sent to all holders of operating licenses for

nuclear power reactors, decommissioning nuclear

power reactor sites storing spent fuel in a pool, and

wet spent fuel storage sites. Note that this bulletin

relates to material control and accounting programs

and is, therefore, being withheld from public

disclosure in accordance with 10 CFR 2.390. The

bulletin is being provided only to those licensees

needing to respond and addressees are requested to

treat the information accordingly (i.e., similar to

trade secrets and commercial or financial

information).

(Technical Contacts: Martha Williams, NSIR, 301-

415-7878; e-mail: msw2@nrc.gov; Dori Votolato,

NSIR, 301-415-7633; e-mail: dxv1@nrc.gov;

Glenn Tuttle, NSIR, 301-415-7644; e-mail:

gwt@nrc.gov; Lead Project Manager: David Jaffe,

NRR, 301-415-1439; e-mail: dhj@nrc.gov)

Information Notices (IN)

IN 2005-05, “Improving Material Control and

Accountability Interface with Criticality Safety

Activities at Fuel Cycle Facilities,” was issued on

March 10. 2005. This IN was sent to all licensees

authorized to possess a critical mass of special

nuclear material to inform them of a safety concern

related to criticality safety at fuel fabrication and

other facilities processing, storing, or handling

critical masses of fissile material. The safety

concern arises when licensees fail to establish

and maintain a communication process between

criticality safety staff and material control and

accountability staff, so as to support timely

identification of fissile material-related process

upsets that challenge the criticality safety basis

for the facility.

(Technical Contact: Dennis Morey, NMSS,

301-415-6107; e-mail: dcm@nrc.gov)

IN 2005-07, “Results of HEMYC Electrical

Raceway Fire Barrier System Full Scale Fire

Testing,” was issued on April 1, 2005. This IN was

sent 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,

and fuel facilities licensees. This IN was issued to

inform addressees of the results of HEMYC

electrical raceway fire barrier system (ERFBS) fullscale fire tests. The HEMYC ERFBS did not

perform for one hour as designed because shrinkage

of the HEMYC ERFBS occurred during the testing.

(Technical Contact: Daniel Frumkin, NRR,

301-415-2280, e-mail: dxf1@nrc.gov)

IN 2005-10, “Changes to 10 CFR Part 71

Packages,” was issued on April 7, 2005. This IN

was sent to all 10 CFR Part 71 licensees and

certificate holders to remind them of the requirement to obtain NRC approval of all changes to

NRC-approved Part 71 packages before use of the

changed packages.

(Technical Contact: Frank Jacobs, NMSS,

301-415-3961; e-mail: fxj2@nrc.gov.)

Regulatory Issue Summaries (RIS)

RIS 2005-02, “Clarifying The Process for

Making Emergency Plan Changes,” was issued on

February 14, 2005. This RIS was sent to all holders

of operating licenses for nuclear power reactors,

including research and test reactors and fuel facility

licensees. This RIS was issued 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 a

DIE and some examples of a DIE emergency plan.

(Technical Contact: Kevin Williams, NSIR,

301-415-1104; e-mail: kxw@nrc.gov)

RIS 2005-03, “10 CFR Part 40 Exemptions for

Uranium Contained in Aircraft Counterweights -

Storage and Repair,” was issued on February 28,

2005. This RIS was sent to all persons possessing

aircraft counterweights containing uranium, under

the exemption in

10 CFR 40.13(c)(5), to emphasize the scope and

restrictions of the exemption from licensing

requirements in 10 CFR 40.13(c)(5), as applied to

counterweights containing uranium.

(Technical Contact: Gary Comfort, NMSS, 301-

415-8106; e-mail: gcc1@nrc.gov.)

RIS 2005-04, “Guidance on the Protection of

Unattended Openings That Intersect a Security

Boundary or Area,” was issued on April 14, 2005.
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This RIS was sent to all holders of operating

licenses or construction permits for nuclear power

reactors, research and test reactors, decommissioning reactors with fuel on site, Category 1 fuel cycle

facilities, critical mass facilities, uranium

conversion facility, independent spent fuel storage

installations, gaseous diffusion plants, and certain

other material licensees. Note that the RIS contains

physical security information and is, therefore,

being withheld from public disclosure in accordance

with 10 CFR 2.390.

(Technical Contact: Albert Tardiff, Office of

Nuclear Security and Incident Response,

301-415-7015; e-mail: axt1@nrc.gov)

RIS 2005-06, “Reporting Requirements for

Gauges Damaged at Temporary Job Sites,” was

issued on April 18, 2005. This RIS was sent to all

material licensees possessing portable gauges,

regulated under 10 CFR Part 30 to inform them of

the reporting requirement associated with gauges

damaged at temporary job sites.

(Technical Contact: Angela R. McIntosh, NMSS,

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

(General Contact: Angela R. McIntosh, NMSS,

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

SIGNIFICANT ENFORCEMENT ACTIONS

The NRC’s enforcement program can be accessed

via the U. S. Nuclear Regulatory Commission’s

(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

R&M Engineering Consultants (EA-05-023)

On May 9, 2005, a Confirmatory Order Modifying

License was issued to confirm recent commitments

by R&M Engineering Consultants, to take in lieu of

NRC pursuing escalated enforcement action. The

commitments included leak testing and transferring

two NRC-licensed gauges to an authorized

recipient, providing copies of documents

demonstrating that the transfer has taken place, and

a request to terminate its NRC license.

Medical

Good Samaritan Regional Medical Center

(EA-04-234)

On March 31, 2005, a Notice of Violation was

issued for a Severity Level III problem involving

twelve violations indicating a lack of appropriate

oversight and control of the brachytherapy program,

including a programmatic weakness in the

implementation of written directives.

Other

Soil Consultants (EA-04-103)

On April 27, 2005, an immediately effective

Confirmatory Order was issued to confirm

commitments made as part of a settlement

agreement concerning an Order Imposing Civil

Monetary Penalty in the amount of $9000 issued on

February 1, 2005. The action was based on a

Severity Level II violation for discrimination against

an employee for engaging in certain protected

activities (reporting safety concerns to his employer

or to the NRC). In response to the Order, the

licensee requested the use of NRC’s alternative

dispute resolution (ADR) process to resolve

differences it had with NRC concerning the

violation. As part of the settlement agreement that

was reached through the ADR process, the licensee

agreed to pay a civil penalty in the amount of

$1200, and to take additional corrective actions to

emphasize the importance of a Safety Conscious

Work Environment at their facility.

Safety Light Corporation (EA-04-148)

On February 25, 2005, the NRC withdrew the

December 10, 2004 Order. This decision was made

after the Commission exercised its supervisory

authority over licensing and enforcement

proceedings, and by Order dated February 22, 2005,

lifted the immediate effectiveness of the December

10, 2004 Order.

(General Contact: Sally Merchant, Office of

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

SELECTED FEDERAL REGISTER NOTICES

(March 1, 2005 - May 31, 2005)

NUREG - 1814, “Status of Decommissioning

Program – 2004 Annual Report,” 70 FR 12248,

March 11, 2005

(Contact: John T. Buckley, Decommissioning

Directorate, Division of Waste Management and

Environmental Protection, Office of Nuclear

Material Safety and Safeguards, 301-415-6607;

e-mail: jtb@nrc.gov)
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Revision 2 of Regulatory Guide 7.9, “Standard

Format and Content of Part 71 Applications for

Approval of Packages for Radioactive Material,”

70 FR 12755, March 15, 2005

(Contact: Nancy L. Osgood, Spent Fuel Project

Office, 301-415-8513; e-mail: nlo@nrc.gov)

Revision 2 of Regulatory Guide 7.10, “Establishing

Quality Assurance Programs for Packaging Used in

Transport of Radioactive Material,” 70 FR 12756,

March 15, 2005

(Contact: James J. Pearson, Spent Fuel Project

Office, NMSS, 301-415-1985; e-mail:

jjp@nrc.gov)

10 CFR Part 35 “Medical Use of Byproduct

Material--Recognition of Specialty Boards,”

70 FR 16336, March 30, 2005

(Contact: Neelam Bhalla, Office of Nuclear

Material Safety and Safeguards, 301-415-6843;

e-mail: nxb@nrc.gov or Cindy Flannery, Office

of Nuclear Material Safety and Safeguards,

301-415-0223; e-mail: cmf@nrc.gov)

10 CFR Part 2 [RIN 3150-AH71], “Model

Milestones for NRC Adjudicatory Proceedings,”

70 FR 20457, April 20, 2005

(Contact: Geary Mizuno, Office of the General

Counsel, 301-415-1639; e-mail: gsm@nrc.gov)

10 CFR Part 71, “Regulations for the Safe

Transport of Radioactive Material; Solicitation of

Comments on Proposed Changes,” 70 FR 21684,

April 27, 2005

(Contact: John Cook, Office of Nuclear

Material Safety and Safeguards, 301-415-8521;

e-mail: jrc1@nrc.gov)

10 CFR Part 72 [RIN 3150-AH64], “List of

Approved Spent Fuel Storage Casks: HI-STORM

100 Revision; Withdrawal of Direct Final Rule”

70 FR 24936, May 12, 2005

(Contact: Jayne M. McCausland, Office of

Nuclear Material Safety and Safeguards,

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

10 CFR Part 72 [RIN 3150-AH72], “List of

Approved Spent Fuel Storage Casks: Standardized

NUHOMS 24P, 52B, 61BT, 32PT, 24PHB, and

24PTH. Revision 8” 70 FR 29931, May 16, 2005

(Contact: Jayne M. McCausland, Office of

Nuclear Material Safety and Safeguards,

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

10 CFR Part 110 [RIN 3150-AH67], “Export and

Import of Nuclear Equipment and Material; Exports

to Syria Embargoed,” 70 FR 29934, May 25, 2005

(Contact: Kirk Foggie, Office of International

Programs, 301-415-2238; e-mail: kxf@nrc.gov, or

Suzanne Schuyler-Hayes, Office of International

Programs, 301-415-2333; e-mail: ssh@nrc.gov)

(General Contact: Michael K. Williamson,

Office of Nuclear Material Safety and Safeguards,

301-415-6234; e-mail: mkw1@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, self-explanatory diagrams,

suggestions for future articles, bulletins, web-site

postings, and other items of interest to the NMSS

Licensee Newsletter readership, should contact

Michael 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 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
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