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

Regulatory Material Safety No. 06-01

Commission and Safeguards March 2006

NMSS Quarterly Newsletter

Contents	 Page

1.	 Regulatory Issue Summary 2005-31 – Control

of Security-Related Sensitive Unclassified 

Non-Safeguards Information.............................1

2.	 Proposed Rule: Requirements for Expanded

Definition of Byproduct Material......................3

3.	 Performing the Surgical Procedures Associated

With Sentinel Lymph Node Biopsy...................4

4.	 Issuance of Order for Increased Controls for

Certain Radioactive Materials Licensees..........4

5. Significant Events 

(November 1, 2005 – January 31, 2006)...........7

6.	 Generic Communications Issued

(December 3, 2005 – February 28, 2006) ........7

7. Significant Enforcement Actions.......................8

8.	 Selected Federal Register Notices...................10

REGULATORY ISSUE SUMMARY 2005-31

 – CONTROL OF SECURITY-RELATED 

SENSITIVE UNCLASSIFIED NONSAFEGUARDS INFORMATION

The U.S. Nuclear Regulatory Commission (NRC)

traditionally has given the public access to a

significant amount of information about the facilities 

and materials the Agency regulates. Openness has

been and remains a cornerstone of NRC’s regulatory

philosophy. The Atomic Energy Act, subsequent

legislation, and various NRC regulations have given

the public the right to participate in the licensing and

oversight process for NRC licensees. To participate

in a meaningful way, the public must have access

to information about the design and operation of

regulated facilities and use of nuclear materials. 

However, NRC and other Government agencies

have always withheld some information from public

disclosure for reasons of security, personal privacy,

or commercial or trade secret protection.		

In the post-September 11, 2001 environment, NRC,

like many other agencies, has found it necessary to

be more judicious in determining what information

to voluntarily release, so as not to inadvertently

provide assistance to those who might use certain

information for malevolent acts. NRC has issued

orders and advisories and taken specific actions 

regarding the security of its licensed facilities and has

also assessed and revised its policies and practices

for making information available to the public. For

example, one of the actions NRC took was to suspend

public access to documents in its electronic Agencywide Documents Access and Management System 

(ADAMS) on October 25, 2004. Subsequently, NRC 

screened those documents to determine whether they

contained security-related sensitive information. Based 

on this screening, numerous documents were returned

to public access in ADAMS. This screening process 

continues as requests for specific documents are 

received and as new documents are created by NRC

and received from licensees and others.

To facilitate this screening process, NRC has

developed screening criteria for conducting its

reviews. In November 2005, NRC issued guidance

[NRC Regulatory Issue Summary (RIS) 2005-26]

for assessing whether documents associated with

reactor licensees should be made publicly available. 

As part of the continuing efforts in this area, NRC

has now developed the criteria for screening from

public disclosure security-related sensitive information

associated with various NRC-regulated activities

of persons handling source, byproduct, and special

nuclear material.

This RIS sets forth procedures that licensees and others

are encouraged to follow when handling documents,

and/or when submitting documents to the NRC that

contain security-related sensitive information, other

than classified or safeguards information, that could be 

useful, or could reasonably be expected to be useful, to

a terrorist in a potential attack.
2

This RIS and its attachments do not apply to

classified information or Safeguards Information. 

Classified information (Confidential, Secret, Top 

Secret) is withheld from the public by law. Safeguards Information is withheld because it provides

details of security measures at nuclear facilities. 

Handling requirements for classified information and 

Safeguards Information are set forth in various NRC

orders, regulations, and generic communications

(e.g., requirements for the handling and protection

of Safeguards Information are discussed in RIS2003-08, “Protection of Safeguards Information

from Unauthorized Disclosure,” dated April 30,

2003). Sensitive (but unclassified, non-safeguards) 

information covers a range of information for which

the loss, misuse, modification, or unauthorized 

access can reasonably be foreseen to harm the

public interest, commercial or financial interests of 

an entity, the conduct of NRC and Federal Programs,

or the personal privacy of individuals. As noted

above, this RIS covers security related information

that, if released, could cause harm to the public

interest as it could be useful, or could reasonably

be expected to be useful, to a terrorist in a potential

attack.

SUMMARY OF ISSUE

This RIS: 1) informs licensees and others of the

screening criteria that NRC uses to identify and

protect Security-Related Sensitive Information

in documents generated by the Agency and in

documents received from licensees and others; 2)

encourages licensees and others to identify securityrelated sensitive information contained in documents

submitted to NRC, by using the screening criteria in

Attachment 2 of this RIS and marking procedures;

and 3) encourages licensees and others that may

possess security-related sensitive information to

control the information, to limit the risk that the

information might fall into the hands of those who

would use it for malevolent acts.

Specifically, protection of the information should be 

implemented in the following manner:

1. Screening of future documents submitted to

NRC to assure that future submittals containing

security-related sensitive information are not made

publicly available in ADAMS, while still making 

other appropriate information available to the

public. NRC is encouraging licensees and others to

screen submittals. If practical, documents submitted

to NRC should avoid including security-related

sensitive information, so as to permit releasing the

document to the public in its entirety.

2. Marking and submitting documents containing 

security-related sensitive information if it is

necessary to include security-related sensitive

information in a submitted document, the submittal

should be marked to indicate the presence of such

information as follows:

a) The cover letter should clearly state that the

attached documents contain security-related

sensitive information. When separated from the

attached documents, if the cover letter itself does not

contain security-related sensitive information, the

cover letter itself is uncontrolled.

b) As shown in Attachment 1 of the RIS (Section A),

the top of every page of a letter or document that

contains security-related sensitive information

should include the marking “Security-Related

Information — Withhold Under 10 CFR 2.390”

(note that NRC’s procedure for these documents is to

mark them as “Official Use Only - Security-Related 

Information). For the pages having security-related

sensitive information, an additional marking (e.g., an

editorial notebox) should be included adjacent to the

material meeting the screening criteria in Attachment

2 of the RIS. Information on suggested handling and

methods of submittal of security-related sensitive

information is also contained in Attachment 1

(Section B). Licensees and others can submit both a 

public and a non-public version of a document, when

security-related documents need to be submitted. 

The public version could have the security-related

sensitive information “marked out” or removed with

a notation that the information was withheld on

the basis that it is “Security-Related Information.” 

This is similar to what is sometimes done to protect

proprietary information under 10 CFR 2.390,

except that an affidavit is not needed. Alternatively, 

security-related sensitive information could be

segregated from the main body of the document and

included only in attachments to the submittal. Only

the attachments containing security-related sensitive

information would be marked for withholding from

public disclosure. Using this approach, the public

version need not be marked as containing securityrelated sensitive information.

3. Protection of Security-Related Sensitive

Information Documents that contain security-related

sensitive information should be protected from

public disclosure, using methods similar to that for

protecting proprietary information. To the extent

practicable, any existing documents containing

security-related sensitive information that licensees

or others have previously made available to the

public should be withdrawn from public access. As

with proprietary information, licensees and others
3

should have sufficient internal controls to prevent 

release of information. Possible methods to prevent

the inadvertent release of security-related sensitive

information include marking documents “SecurityRelated Information - Withhold Under 10 CFR

2.390,” restricting access to electronic recordkeeping

systems that contain such information, and controlling the reproduction, distribution, and destruction

of potentially sensitive records. Licensees and others

should ensure that similar controls are in place when

security-related sensitive information is provided

to outside parties such as contractors or other

Government agencies, and that the information is

made available only to such parties who have a need

to know the information to perform their jobs and

who are made aware of the security-related nature of

the information.

This RIS, the attached screening criteria, and

additional explanatory material, as appropriate,

are also posted on the NRC Website at http://www.

nrc.gov/reading-rm/sensitive-info.html (note that

the criteria for fuel cycle facilities in this website

and in this RIS supersede information at http://

www.nrc.gov/materials/fuel-cycle-fac/reviewcriteria-fuel-cycle.html). NRC staff will interact

with licensees and others on a case-by-case basis

to resolve questions about the application of the

procedures and screening criteria set forth in this

RIS and its attachments. NRC will continue to

make as much information as possible available to

the public. Much of NRC’s information is readily 

available to the public via the NRC Website (www.

nrc.gov) and NRC’s ADAMS system (www.

nrc.gov/reading-rm/adams.html). In addition,

other information may be released to the public

in response to formal and/or informal requests. 

Although the security-related sensitive information

screening criteria were developed with the principles

of the Freedom of Information Act (FOIA) in mind,

a review for security-related sensitive information

does not substitute for a FOIA review. FOIA

requests will continue to be reviewed and processed

independently from the security-related sensitive

information review process.

(Contact: Frank Cardile, Division of Industrial and

Medical Nuclear Safety, 301-415-6185, e-mail: 

fpc@nrc.gov)

PROPOSED RULE: REQUIREMENTS FOR 

EXPANDED DEFINITION OF BYPRODUCT 

MATERIAL

The Energy Policy Act of 2005 (EPAct) was

promulgated on August 8, 2005. Section 651(e)

of the EPAct expanded the definition of byproduct 

material, as defined in Section 11e. of the Atomic 

Energy Act of 1954, to include certain discrete

sources of radium, certain accelerator-produced

radioactive material, and certain discrete sources

of naturally occurring radioactive material,

thereby placing these materials under U.S. Nuclear

Regulatory Commission (NRC) jurisdiction. NRC

is required under Section 651(e) of the EPAct, to

develop a regulatory framework for licensing and

regulating this newly defined byproduct material.

As part of this regulatory framework, NRC took

several initiatives in an effort to enhance stakeholder

involvement and to improve efficiency during the 

rulemaking process. As part of this effort, NRC held

a public roundtable meeting on November 9, 2005,

and has established a Web page on the “Expanded

Definition of Byproduct Material (NARM) 

Rulemaking.”

The November 9, 2005, public meeting was

in a “roundtable” format to allow stakeholders

an opportunity to discuss concerns, and to

enhance interaction among all interested parties

on the subject of the NRC regulating NARM. 

Representatives from other Federal agencies, States,

and a broad spectrum of interest groups were invited

to participate in the “roundtable” discussion.

During the public meeting, NRC provided an

overview of the EPAct, and discussed the rulemaking

process and the role of the Nuclear Material 

Safety and Safeguards (NMSS) EPAct Task Force 

established to help implement the requirements of

the EPAct. Other topics discussed included: (a) the

role of State regulations; (b) potential implications

regarding production of radiopharmaceuticals; (c)

availability of radiopharmaceuticals to patients;

(d) definition of discrete source; (e) the NRC 

jurisdiction over accelerator-produced radioactive

material; and (f) waste and transportation issues.

The web page, “Expanded Definition of Byproduct 

Material (NARM) Rulemaking,” may be viewed 

via the rulemaking website at http://ruleforum.llnl.

gov by going to the option “Other rulemakingrelated comment requests.” Once the proposed rule

is published, the web page will be moved to the

“Proposed rules” option on the rulemaking website. 

The web page currently includes: (a) background

information; (b) the EPAct as it relates to this

rulemaking; (c) transcript, meeting summary, and

comments related to the November 9, 2005, public

meeting; (d) and other related documents. The

proposed rule will also be posted on the web page

for public comment.
4

(Contact: Lydia Chang, Division of Industrial and

Medical Nuclear Safety, 301-415-6319, e-mail: 

lwc1@nrc.gov)

PERFORMING THE SURGICAL 

PROCEDURES ASSOCIATED WITH 

SENTINEL LYMPH NODE BIOPSY

A U.S. Nuclear Regulatory Commission (NRC)

licensee requested approval to perform a surgical

biopsy of tissue containing Technetium 99m (Tc99m) at one of its facilities without an NRC license. 

The procedure is called Sentinel Lymph Node

Biopsy (SLNB). 

The licensee stated that the first portion of the 

SLNB procedure - the injection of less than 37 

megabecquerel (1 millicurie) of Tc-99m sulfur

colloid - would be performed at a licensed facility 

under the supervision of an authorised user and,

subsequently, the patient would be released. The

next portion of the SLNB procedure, the surgical 

removal and biopsy of the tissue containing the

technetium, would be performed at one of its

facilities not licensed for radioactive material use.

The surgical removal of the radioactive tissue and

its biopsy constitute the medical use of byproduct

material in imaging and localization studies and

must be performed at a licensed facility under the

supervision of an authorised user. The licensed

facility may have its own byproduct material license

or, in this licensee’s case, become an additional

location of use listed on its existing medical use

license after approval of a license amendment

request to add the site where the surgical procedure

is performed. The amendment must provide

a description of the licensee’s radiation safety

oversight and day-to-day operating radiation

safety program. NRC reviews this information

in accordance with a risk-informed, performancebased approach.

The third portion of the SLNB procedure is the 

transfer of the surgically removed tissue to a

pathology laboratory that may or may not be

required to have an NRC license to receive the

material. The licensee may transfer the tissue

to a pathology laboratory exempt from licensing

under the “exempt-quantity” provisions of 10 CFR

30.18, if the tissue contains an exempt quantity of

radioactive material (in this case, 3.7 megabecquerel

(100 microcuries) or less of Tc-99m). However, if

the tissue contains greater than an exempt quantity,

it must be transferred to a pathology laboratory with

an NRC license. If the licensee does not have or use

its own pathology laboratory, and the tissue exceeds

the exempt quantity criteria, then the licensee must

verify that the recipient is authorized to receive the

tissue containing the radioactive material. When

shipping radioactive material, the licensee shipping

the material and the shipper must meet Department

of Transportation requirements.

In summary:

• The first portion of the procedure - the injection 

	 of the Tc-99m - must be performed under an NRC

	 medical use license by, or under the supervision

	 of, an authorized user who meets the imaging and

localization training and experience qualifi-

	 cations, as stated in 10 CFR 35.290, “Training

	 for imaging and localization.”

•	 The second portion of the procedure - the surgical

	 removal of the radioactive tissue - must also be

	 performed under an NRC medical use license,

	 and under the supervision of an authorized user

	 meeting the requirements in CFR 35.290,

	 “Training for imaging and localization.”

•	 The third portion of the procedure - the pathology

	 study of the radioactive tissue - may or may

	 not have to be performed under an NRC license. 

	 Whether the radioactivity in the tissue contains

	 an exempt quantity of radioactive material (in

	 this case, 3.7 megabecquerel (100 microcuries)

	 or less of Tc-99m) will determine if the pathology

	 laboratory is exempt from licensing under the

	 “exempt - quantity” provisions of 10 CFR 30.18.

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

Material Safeguards and Safety, 301-415-7848, email: dbh@nrc.gov)

ISSUANCE OF ORDER FOR INCREASED 

CONTROLS FOR CERTAIN RADIOACTIVE 

MATERIALS LICENSES

On December 1, 2005, the U.S. Nuclear Regulatory

Commission (NRC) published, in the Federal

Register (70 FR 72128), a notice regarding all

licensees authorized to possess certain radioactive

material, in quantities of concern (see attached

table). This notice describes an Order (EA-05-

090) imposing increased controls on licensees in

possession of these radionuclides of concern, as well

as on those who may possess them in the future. 

Copies of this notice can also be found on the NRC

website in the Agencywide Documents Accession

and Management System (ADAMS) at accession 

number ML053130405. In addition, the Order can 

be found at http://www.nrc.gov/reading-rm/doccollections/enforcement/security/#8.
5

Before the terrorist attacks of September 11, 2001, 

several national and international efforts were

underway to address the potentially significant health 

and safety hazards posed by uncontrolled sources. 

These efforts recognized the need for increased

control of risk-significant radioactive materials to 

prevent inadvertent and intentional unauthorized

access, primarily because of the potential health and

safety hazards posed by the uncontrolled material.

After September 11, 2001, efforts shifted to include

heightened oversight and awareness of the need to

prevent intentional unauthorized access because of

the possibility of potentially malicious acts. At the

international level, the International Atomic Energy

Agency (IAEA) published, in 2004, its “Code of

Conduct on the Safety and Security of Radioactive

Sources” (Code of Conduct), which focused on

radionuclides that may pose a significant risk to 

individuals, society and the environment, and also

focused on developing laws and regulations to

achieve and maintain a high level of safety and

security of these radioactive sources. The U.S.

Government supports the IAEA’s Code of Conduct

and is taking actions to implement its recommended

standards. The attached “Table of Radionuclides of

Concern” is based on the IAEA Code of Conduct.

The loss of control of these risk-significant 

radionuclides has a potential to result in significant 

doses and adverse health effects to the public. 

Consequently, the Commission determined that

licensees possessing such radionuclides must

implement certain additional controls, to supplement

the regulatory requirements. These supplemental

controls are to ensure adequate protection of the

public health and safety, and minimize the danger

from malicious acts.

In November and December 2005, the NRC issued

Order EA-05-090, which requires compliance

with increased controls regarding the possession

of the radioactive material quantities of concern

listed in the attached table. The Order was sent to

licensees authorized to possess these radioactive

materials. The radionuclides of concern, and

their corresponding quantities, are contained in

the aforementioned table. To effect nationwide

implementation, each Agreement State issued

legally binding requirements to put essentially

identical measures in place for licensees under their

regulatory jurisdiction.

The Order was effective immediately and will

remain in effect until the Commission incorporates

similar measures into its regulations. Licensees have

180 days to come into compliance with the increased

controls or on the first day that radionuclides of 

concern are possessed which equal or exceed the

quantity identified in the table, whatever is later. 

Licensees are to report to the Commission when they

have achieved compliance with the requirements of

the Order.

The purpose of the Order is to reduce the risk of

unauthorized use of radioactive material, through

access controls to aid prevention, as well as

prompt detection, assessment, and response to

mitigate potentially high consequences that would

be detrimental to public health and safety. The

increased controls provide enhanced security against

unauthorized removal or access and list actions for

the licensees to take in the following areas:

1. Controlling the access to radioactive material,

and limiting access to only approved individuals

who require access to perform their duties;

2. Developing and documenting a program to

monitor and immediately detect, assess, and respond

to unauthorized access to radioactive material

quantities of concern, with enhanced monitoring

during periods of source delivery or shipment;

3. Using specifically qualified carriers for 

transportation over highways and railways when

the carrier is not the licensee. Additional security

measures (ASMs) are required when shipping 

radioactive materials that equal or exceed 100 times

the quantities in the table below (These ASMs were 

the subject of another NRC security Order issued on

July 19, 2005);

4. Providing additional physical controls on portable

or mobile devices; and,

5. Protecting detailed security information from

unauthorized disclosure.

Licensees were also provided guidance for

implementing the increased controls required by the

Order. The guidance expands on the idea of: (a)

access control; (b) detection and assessment; (c)

coordination of radioactive material shipments; (d)

physical barriers; (e) information protection; and

(f) definitions of terminology used in the Order and 

guidance. The guidance also contains 201 questions

and answers regarding issues of how licensees

can implement these increased controls on these

radioactive materials of concern. This guidance can

also be found on the NRC website and in ADAMS, 

with accession number ML053130233.

It should be noted that the Order to implement the

increased controls is applicable to licensees that
6

currently possess the radionuclides of concern in quantities of concern as listed in the aforementioned table. The

Order is also applicable to licensees that do not currently possess these radionuclides but have near-term plans to

posses the radionuclides at, or above the quantities of concern. In this case, licensees will need to implement the

increased controls before they take possession of radioactive materials that exceed the threshold quantities listed

in the table below.

To facilitate resolution of any issues or questionsrelated to the Order or compliance with the requirementsin the Order,

contact Doug Broaddus at (301) 415-7197, or Frederick Sturz at (301) 415-6678. Questions about the Order and the 

increased controls can also be sent to ICSupport@nrc.gov. Additional guidance in response to licensee questions

will be posted on the NRC website as supplemental questions and answers, and will be accessible through the web

link referenced above. An NRC/Agreement State working group has also been established to ensure consistent

implementation of the increased controls nationwide.

	 	 	

Table of Radionuclides of Concern

1The aggregate activity of multiple, collocated sources of the same radionuclide should be included when the total activity

equals or exceeds the quantity of concern.

2

 The primary values used for compliance with this Order are TBq. The curie (Ci) values are rounded to two significant 

figures for informational purposes only.

3 Radioactive materials are to be considered aggregated or collocated if breaching a common physical security barrier (e.g.,

a locked door at the entrance to a storage room) would allow access to the radioactive material or devices containing the

radioactive material.

4 If several radionuclides are aggregated, the sum of the ratios of the activity of each source, i of radionuclide, n, A(i,n), to the

quantity of concern for radionuclide n, Q(n), listed for that radionuclide equals or exceeds 1. [(aggregated source activity for

radionuclide A) ÷ (quantity of concern for radionuclide A)] + [(aggregated source activity for radionuclide B) ÷ (quantity of 

concern for radionuclide B)] + etc........ >1.

(Contact: Joe DeCicco, Office of Nuclear Material Safety and Safeguards, 301-415-7833, e-mail: jxd1@nrc.gov)

Radionuclide Quantity of 

Concern1 (TBq)

Quantity of 

Concern2 (Ci )

Am-241 0.6 16

Am-241/Be 0.6 16

Cf-252 0.2 5.4

Cm-244 0.5 14

Co-60 0.3 8.1

Cs-137 1 27

Gd-153 10 270

Ir-192 0.8 22

Pm-147 400 11,000

Pu-238 0.6 16

Pu-239/Be 0.6 16

Se-75 2 54

Sr-90 (Y-90) 10 270

Tm-170 200 5,400

Yb-169 3 81

Combinations of radioactive

materials listed above3

See Footnote

Below4
7

SIGNIFICANT EVENTS

(November 1, 2005 – January 31, 2006)

Event #1: Potential radiographer overexposure at

a temporary job site

Date and Place: November 18, 2005,

Sand Springs, Oklahoma

Nature and Probable Causes: The licensee, 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 terabecquerel (66 curie) Iridium192 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 3 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 analyses. 

The Oklahoma Department of Environmental

Quality investigated the event on November 21, 

2005, and determined that the radiographer’s

thermoluminescent dosimeter (TLD) result was 4.4

centisieverts (rem), and the radiographer’s total

year-to-date whole-body exposure was 6.9

centisieverts (rem). The assistant radiographer’s

TLD result was 1.21 millisieverts (121 millirem). 

Both radiographers were suspended pending further 

investigation.

Update: The licensee contracted with the National

Radiological Protection Board, in England, to 

perform cytogenetic testing on the radiographer. 

On December 20, 2005, the results of the test were

received. The National Radiological Protection

Board reported the whole-body exposure to be 4 

centisieverts (rem). This result is in agreement with

the results of the TLD.

Event #2: Extremity overexposure at

radiopharmacy

Date and Place: December 31, 2005,

Houston, Texas

Nature and Probable Causes: The licensee reported

that a nuclear pharmacy technician exceeded the

annual extremity exposure limit with monitor

readings reaching 53.44 centisieverts (rem) for

calendar year 2005. The technician was preparing

Technetium-99m doses when he exceeded the

extremity limit. The dose was being monitored, but

management did not anticipate that the technician

would exceed the limit. The technician experienced

a heavy workload during the week of December 26,

2005 through, January 6, 2006, and his right hand

received 3.12 centisieverts (rem). Corrective actions

taken by the licensee included additional training,

possible modification of technique, hiring new 

technicians, and having corporate health physics

investigate the incident.

Event #3: Underdose at hospital

Date and Place: January 10, 2006,

Houston, Texas

Nature and Probable Causes: The licensee reported

that a patient received an under treatment of

Yittrium -90 microspheres during treatment for liver

cancer. The nuclear medicine physician delivered

the microspheres to the patient; however, after the

treatment was presumed finished, he noted that some 

of the fluid remained in the vial. The retention fluid 

for the microspheres had become backed up from the

site of injection (hepatic artery), and some spillage

at the surface occurred, which was absorbed with

gauze. The patient was prescribed to receive 0.41

gigabecquerel (11 millicuries), but there was 0.17

gigabecquerel (4.5 millicuries) left in the vial. The

licensed medical physicist is evaluating the incident

and making an effort to assess the dose delivered to

the patient. Corrective actions taken by the licensee

included modifying procedures.

(Contact: Angela R. McIntosh, NMSS, 301-415-

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

GENERIC COMMUNICATIONS ISSUED

(December 3, 2005 - February 28, 2006)

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/ readingrm/ 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, please contact Angela R. McIntosh, (301) 

415-5030, or by e-mail: arm@nrc.gov.
8

Bulletins (BL)

None.

Information Notices (IN)

IN 2005-32, “Product Alert for Fire Hydrants,”

was issued on December 23, 2005. This IN was

issued to all holders of operating licenses for nuclear

power reactors and fuel cycle facilities, except those

who have permanently ceased operations and have

certified that fuel has been permanently removed from 

the reactor vessel.

(Technical contacts: Phil Qualls, 301-415-1849, 

e-mail: pmq@nrc.gov; and Rex Wescott, 301- 415-

6727, e-mail: rgw@nrc.gov)

IN 2006-02, “Use of Galvanized Supports and 

Cable Trays with Meggitt Si 2400 Stainless-SteelJacketed Electrical Cable” was issued January 19,

2006. This IN was issued to all holders of operating

licenses for nuclear reactors except those who have

permanently ceased operations and have certified that 

fuel has been permanently removed from the reactor

vessel; and fuel cycle licensees and certificate holders.

(Technical contacts: Robert Wolfgang, 301-415-1624,

e-mail: rjw1@nrc.gov; and Rex Wescott, 301-415-

6727, e-mail: rgw@nrc.gov)

Regulatory Issue Summaries (RIS)

RIS 2005-31, “Control of Security-related Sensitive 

Unclassified Non-safeguards Information Handled 

by Individuals, Firms, and Entities Subject to NRC 

Regulation of the Use of Source, Byproduct, and 

Special Nuclear Material,” was issued December

22, 2005. This RIS was issued to all licensees,

certificate holders, applicants, and other entities 

subject to regulation by the U.S. Nuclear Regulatory

Commission of the use of source, byproduct, and

special nuclear material, except for those as covered

by provisions of RIS 2005-26 for nuclear power

reactors.

(Technical contacts: Materials Licensees may contact 

Paul Goldberg, 301-415-7842, e-mail: pfg@nrc.gov;

Spent Fuel Storage and Transportation Licensees may

contact Joe Sebrosky, 301-415-1131, e-mail: jms3@

nrc.gov; Fuel Cycle Licensees may contact Patricia

Silva, 301- 415-8029, e-mail: pas6@nrc.gov; Waste

Decommissioning Licensees may contact Ted Carter,

301-415-6668, e-mail: thc1@nrc.gov; High-Level

Waste Licensees may contact Alexander Sapountzis,

301-415-7822, e-mail: aps@nrc.gov; Import/Export

Licensees may contact Stephen Dembek, 301-415-

2342, e-mail: sxd@nrc.gov)

RIS 2005-27, Rev.1, “NRC Regulatory Issue 

Summary 2005-27, Rev. 1, NRC Timeliness Goals, 

Prioritization of Incoming License Applications 

and Voluntary Submittal of Schedule for Future 

Actions for NRC Review,” was issued January 31,

2006. This RIS was issued to all 10 CFR Part 71 and

Part 72 licensees and certificate holders.

(Technical contact: Jill Caverly, 301-415-6699, email: jsc1@nrc.gov)

RIS 2006-01, “Expiration Date for NRCApproved Spent Fuel Transportation Routes,”

was issued January 24, 2006. This RIS was issued

to U.S. Nuclear Regulatory Commission licensees

that transport, or deliver to a carrier for transport,

irradiated reactor fuel (spent nuclear fuel).

(Technical contacts: Susan H. Bagley, 301-415-5378, 

e-mail: shb@nrc.gov; and Kelly Riner 301-415-6623,

e-mail: pkr@nrc.gov)

RIS 2002-15, Rev. 1, “NRC Approval of 

Commercial Data Encryption Products for 

the Electronic Transmission of Safeguards 

Information,” was issued January 26, 2006. 

This RIS was issued to all authorized recipients

and holders of sensitive unclassified safeguards 

information.

(Technical contact: Eric Lee, 301-415-8099, e-mail: 

exl@nrc.gov)

(General Contact: Angela R. McIntosh, NMSS, 301-

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

SIGNIFICANT ENFORCEMENT ACTIONS

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

enforcement program can be accessed via the NRC’s

homepage [http://www.nrc.gov/] under “What We

Do.” Documents related to cases can be accessed at

[http://www.nrc.gov/], “Electronic Reading Room,”

“Documents in ADAMS.” ADAMS is the 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.

Medical

Digirad Imaging Solutions, Inc. (EA-05-136)

On January 27, 2006, a Notice of Violation (NOV)

for a Severity Level III violation with no civil penalty

and an immediately effective Confirmatory Order 

was issued to confirm commitments made as part of 

a settlement agreement concerning submission of
9

inaccurate information to the NRC. The settlement

agreement was reached as a result of an Alternative

Dispute Resolution session, held at the request of

the licensee. In addition to the NOV, the licensee has

changed its procedures to ensure that any information

it submits to NRC will be complete and accurate,

and the Radiation Safety Officer will submit articles 

to various medical and health physics journals

describing the incident to provide an opportunity

for other licensees in the industry to learn from the

incident.

Alfred C. Burris, Senior, M.D. (EA-05-110)

On January 27, 2006, a Notice of Violation (NOV) for

a Severity Level III violation, with no civil penalty,

and an immediately effective Confirmatory Order 

was issued to confirm commitments made as part of 

a settlement agreement concerning submission of

false and/or inaccurate information. The settlement

agreement was reached as a result of an Alternative

Dispute Resolution session, held at the request of the

applicant. In addition to the NOV, the applicant has

agreed to correct the inaccurate information, and to

submit an article to a cardiology journal and speak

at training sessions for similar cardiology groups

describing his experience and emphasizing the need

to provide complete and accurate information to the

NRC.

South Jersey Healthcare (EA-05-214)

On January 17, 2006, a Notice of Violation was issued

for a Severity Level III violation involving the failure

to secure from unauthorized removal, or limit access

to, a package containing licensed material which was

stored in a mail room (awaiting inter-office transfer). 

The mail room was an unrestricted area, and the

licensee failed to control and maintain constant

surveillance of this licensed material.

Danville Regional Medical Center (EA-05-201)

On December 13, 2005, a Notice of Violation was

issued for a Severity Level III violation involving the

failure to secure from unauthorized removal or access,

and/or maintain constant surveillance of licensed

material stored in a controlled or unrestricted area. 

Specifically, a High-Dose-Rate Remote Afterloader 

(HDR) unit was left unsecured and unattended in the

HDR treatment room.

Lancaster General Hospital (EA-05-124)

On October 28, 2005, a Notice of Violation was

issued for a Severity Level III problem composed

of three violations. The violations involved: (1) a

programmatic weakness in the licensee’s gamma knife

stereotactic radiosurgery program, which resulted

in an overexposure to a patient; (2) the licensee’s

failure to notify the NRC that the frame of the gamma

knife unit, a basic component designed to prevent

movement of the head during treatment, did not

prevent the change of the treatment site coordinates;

and (3) the licensee’s failure to report the medical

event within the required period.

Crozer-Chester Medical Center (EA-05-164)

On October 28, 2005, a Notice of Violation was

issued for a Severity Level III violation involving the

failure to secure from unauthorized removal or access,

and/or maintain constant surveillance of licensed

material stored in a controlled or unrestricted area.

Specifically, an High-Dose-Rate Remote Afterloader 

(HDR) unit was left unsecured and unattended in the

HDR treatment room.

Hershey Medical Center (EA-04-215)

On October 14, 2005, an immediately effective

Confirmatory Order was issued to confirm 

commitments made as part of a settlement

agreement concerning three separate occasions

where the licensee’s staff were injected with

radiopharmaceuticals without the authorization

of an Authorized User. The settlement agreement

was reached as a result of an Alternative Dispute

Resolution session, held at the request of the licensee. 

As part of the agreement reached, a Notice of

Violation at a Severity Level III, with no civil penalty,

was issued on October 14, 2005. In addition, the

licensee has expanded its training program addressing

NRC regulatory requirements, and the Chief of

Nuclear Medicine, the Radiation Safety Officer, 

and the Chief Technologist will prepare articles, for

various medical and health physics journals, that

address, among other topics, the need to establish

an environment and culture that promote regulatory

compliance through the implementation of controls

and procedures.

Gauges

Dickinson County Road Commission (EA-05-266)

On January 24, 2006, a Notice of Violation was issued

for a Severity Level III violation involving the failure

to secure, or maintain constant surveillance of, NRClicensed material contained in a portable moisture/

density gauge. Specifically, during a routine safety 

inspection, an NRC inspector entered the licensee’s

offices in an unlocked public building and found the 

gauge unsecured.

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
10

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.

U.S. Engineering Laboratories, Inc. (EA-05-152)

On December 2, 2005, a Notice of Violation was

issued for a Severity Level III violation involving the

failure to maintain direct and constant surveillance

of a portable gauge containing licensed material at a

temporary job site, and to properly store a portable

nuclear gauge at a different temporary job site.

Miscellaneous

Sabia, Inc. (EA-05-204)

On November 22, 2005, as part of an Alternative

Dispute Resolution settlement agreement, as

documented in a Confirmatory Order, Sabia, Inc., 

acknowledged two violations of NRC requirements

involving its failure to comply with 10 CFR 150.20

compliance and transfer of licensed material to

individuals not authorized to receive it. As part

of the settlement agreement, Sabia also agreed to

provide additional training to its employees and to

conduct additional audits. NRC has agreed not to

draw any conclusions on whether willfulness was

involved or to pursue further enforcement actions

related to these specific issues.

Safety Light Corporation (EA-03-219)

On November 18, 2005, a Notice of Violation

(NOV) was issued as part of the terms of a

settlement agreement reached between the Safety

Light Corporation (SLC), the Pennsylvania

Department of Environmental Protection, and the

Nuclear Regulatory Commission. The NOV was

issued for a Severity Level III problem involving: 

(1) the willful failure to make payments to the

decommissioning trust fund in accordance with the

schedules defined in SLC’s license conditions; and 

(2) the failure to dispose of pre-2000 tritium wastes,

in accordance with SLC’s license conditions.

Ledoux Company (EA-05-135)

On November 01, 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 failures to adequately

survey, secure and dispose of licensed material, in

accordance with NRC requirements. Specifically, 

the licensee received a package containing seven

analytical samples of Uranium-235, identified six 

of the seven samples shipped, and performed an

unsuccessful cursory search for the seventh sample. 

After initiating a more thorough search, the licensee

concluded that the seventh sample had been disposed

of with the packaging as normal trash.

Pacific Gas and Electric Company, Humboldt 

Bay Power Plant, Unit 3 (EA-05-166)

On December 20, 2005, a Severity Level II Notice

of Violation, with a proposed $96,000 Civil Penalty,

was issued to the Pacific Gas and Electric Company 

(PG&E) as a result of the licensee’s failure to: (1)

keep adequate records of special nuclear material

(SNM) inventory, transfer or disposal; (2) establish 

adequate procedures for control and accounting of

SNM; and (3) conduct adequate physical inventories 

of SNM at the Humboldt Bay Power Plant. PG&E’s 

records failed to account for the whereabouts of

three 45.72 centimeter (18-inch) fuel rod segments

after they were cut from a single fuel rod in 1968.

Likewise, PG&E’s records failed to account for incore detectors, after some were cut in 1973.

(General Contact: Sally Merchant. Office of 

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

SELECTED FEDERAL REGISTER NOTICES

(December 1, 2005 – February 28, 2006)

10 CFR Part 31 [PRM-31-5], “Organization of 

Agreement States; Petition for Rulemaking,” 70 FR

75423, December 20, 2005.

(Contact: Michael T. Lesar, Office of 

Administration, 301-415-7163 or Toll-free: 1-800-

368-5642, e-mail: mtl@nrc.gov)

10 CFR Part 35 [PRM-35-18], “Peter G. Crane; 

Receipt of Petition for Rulemaking,” 70 FR 75752,

December 21, 2005.

(Contact: Michael T. Lesar, Office of Administration, 

301-415-7163 or Toll-Free: 1-800-368-5642, e-mail:

mtl@nrc.gov)

10 CFR Parts 20, 30, 31, 32, 33, and 35, “Expanded

Definition of Byproduct Material (NARM 

Rulemaking), Availability of Web Page,” 71 FR 29,

January 3, 2006.

(Contact: Jayne M. McCausland, Office of Nuclear 

Material Safety and Safeguards, 301-415-6219, email: jmm2@nrc.gov. For questions related to the

NARM rulemaking, contact Lydia Chang, Office of 

Nuclear Material Safety and Safeguards, 301-415-

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

10 CFR Parts 30, 31, 32, and 150 [RIN 3150-AH41],
“Exemptions from Licensing, General Licenses, and

Distribution of Byproduct Material: Licensing and 

Reporting Requirements,” 71 FR 275, January 4,

2006.

(Contact: Catherine R. Mattsen, Office of Nuclear 

Material Safety and Safeguards, 301-415-6264, email: crm@nrc.gov)

	 	 	 	 	 	 	

	 	 	 	

10 CFR Part 35 [RIN 3150-AH19], “Medical Use 

of Byproduct Material--Recognition of Specialty 

Boards; Correction,” 71 FR 1926, January 12, 2006.

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

Material Safety and Safeguards, 301-415-6233, email: ant@nrc.gov)

10 CFR Parts 30, 40, 50, 60, 61, 63, 70, 71,

72, and 76 [RIN 3150-AH59], “Clarification of 

NRC Civil Penalty Authority Over Contractors

and Subcontractors Who Discriminate Against

Employees for Engaging in Protected Activities,” 71

FR 5015, January 31, 2006.

(Contact: Doug Starkey, Office of Enforcement, 

301-415-3456, e-mail: drs@nrc.gov)

10 CFR Parts 170 and 171 [RIN 3150-AH83], “

Revision of Fee Schedules; Fee Recovery for FY

2006,” 71 FR 7349, February 10, 2006.

(Contact: Tammy Croote, Office of the Chief Financial 

Officer, 301-415-6041; e-mail: txc1@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 on the contents of

the newsletter is welcome. Readers desiring to

contribute articles, self-explanatory diagrams,

suggestions for future articles, bulletins, website

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 him.

Please send written correspondence and requests to:

Michael K. Williamson, Editor

NMSS Quarterly 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