January 30, 2002
 

MEMORANDUM TO: Martin J. Virgilio, Director 

Office of Nuclear Materials Safety and Safeguards 

FROM: Carl J. Paperiello, Deputy Executive Director /RA/

 for Materials, Research and State Programs 

William Sinclair, Director /RA/

Division of Radiation Control 

Utah Department of Environmental Quality 

SUBJECT: FINAL REPORT FOR THE INTEGRATED MATERIALS 

PERFORMANCE EVALUATION PROGRAM (IMPEP) 

REVIEW OF THE NRC SEALED SOURCE AND DEVICE 

EVALUATION PROGRAM 

On January 8, 2002, the Management Review Board (MRB) met to consider the proposed final 

Integrated Materials Performance Evaluation Program (IMPEP) report of the NRC Sealed 

Source and Device (SS&D) Evaluation Program. The MRB found the NRC program to be 

adequate to protect public health and safety. 

Section 3.0, page 7, of the attached final report presents the two good practices presented by 

the team and accepted by the MRB. There were no recommendations made by the review 

team. Based on your letter of December 3, 2001 which described your actions taken in 

response to the findings in the draft report, no additional information is required. The MRB 

accepted the team‘s recommendation to conduct the next IMPEP review in four years. 

If you have any questions, please contact David Wesley, C.H.P., Chief, Radioactive Materials 

Licensing, California Department of Health Services at (916) 323-2759. 

We appreciate your staff‘s efforts during the IMPEP review period, especially during the time of 

the team‘s visit. 

Attachments: 

As stated 

cc:	 Donald A. Cool, Director 

Division of Industrial and Medical Nuclear Safety 

Office of Nuclear Materials Safety

 and Safeguards, NRC 

John Hickey, Chief 

Materials Safety Branch 

Office of Nuclear Materials Safety

 and Safeguards, NRC 
 

 

MEMORANDUM TO:	 Martin J. Virgilio, Director January 30, 2002 

Office of Nuclear Materials Safety and Safeguards 

FROM: Carl J. Paperiello, Deputy Executive Director /RA/

 for Materials, Research and State Programs
 

William Sinclair, Director /RA/

Division of Radiation Control 

Utah Department of Environmental Quality 

SUBJECT:	 FINAL REPORT FOR THE INTEGRATED MATERIALS 

PERFORMANCE EVALUATION PROGRAM (IMPEP) 

REVIEW OF THE NRC SEALED SOURCE AND DEVICE 

EVALUATION PROGRAM 

On January 8, 2002, the Management Review Board (MRB) met to consider the proposed final 

Integrated Materials Performance Evaluation Program (IMPEP) report of the NRC Sealed 

Source and Device (SS&D) Evaluation Program. The MRB found the NRC program to be 

adequate to protect public health and safety. 

Section 3.0, page 7, of the attached final report presents the two good practices presented by 

the team and accepted by the MRB. There were no recommendations made by the review 

team. Based on your letter of December 3, 2001 which described your actions taken in 

response to the findings in the draft report, no additional information is required. The MRB 

accepted the team‘s recommendation to conduct the next IMPEP review in four years. 

If you have any questions, please contact David Wesley, C.H.P., Chief, Radioactive Materials 

Licensing, California Department of Health Services at (916) 323-2759. 

We appreciate your staff‘s efforts during the IMPEP review period, especially during the time of 

the team‘s visit. 

Attachments: 

As stated
 

cc: See next page 

Distribution: See next page 

*via e-mail sent to L. Rakovan, STP, attached. 

DOCUMENT NAME: C:\Program Files\Adobe\Acrobat 4.0\PDF Output\2001 NRC-SS&D Final Report ~.wpd

To receive a copy of this document, indicate in the box: "C" = Copy without attachment/enclosure "E" = Copy with attachment/enclosure "N" = No copy 

OFFICE RML/CA-DHS STP:D DRC-UDEQ:D DEDMRS 

NAME DWesley:gd PLohaus WSinclair CPaperiello 

DATE 1/08/02* 01/11/02 01/16/02 01/30/02 

STP-I-2 

Martin J. Virgilio -2-
cc:	 Donald A. Cool, Director 

Division of Industrial and Medical Nuclear Safety 

Office of Nuclear Materials Safety

 and Safeguards, NRC 

John Hickey, Chief 

Materials Safety Branch 

Office of Nuclear Materials Safety

 and Safeguards, NRC 

bcc:	 Chairman Meserve 

Commissioner Dicus 

Commissioner Diaz 

Commissioner McGaffigan 

Commissioner Merrifield 

Distribution: 

DIR RF DCD (SP01) 

SDroggitis PDR (YES�) 

KSchneider 

LRakovan 

OSiurano 

GDeegan 

STreby 

JLieberman 

DWhite, RI 

RBores, RI 

RBlanton, STP 

DFogel, Texas 

JJankovich 

TCombs, OCA (2) 

IMPEP File 
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM
 

REVIEW OF NRC HEADQUARTERS 

SEALED SOURCE AND DEVICE EVALUATION PROGRAM
 

SEPTEMBER 10-14, 2001
 

FINAL REPORT
 

ORGANIZATION OF AGREEMENT STATES 
NRC SS&D Final Report Page 1
 

1.0 INTRODUCTION 

This report presents the results of the review of the Nuclear Regulatory Commission‘s (NRC) 

Sealed Source and Device (SS&D) Evaluation Program. The review was conducted during the 

period of September 10 - 14, 2001 by a review team comprised of technical staff from the 

Agreement States of California and Texas, and NRC‘s Office of State and Tribal Programs. 

Members of the review team are listed in Appendix A. The review was conducted in 

accordance with the November 5, 1999, NRC Management Directive (MD) 5.6, "Integrated 

Materials Performance Evaluation Program (IMPEP)." Preliminary results of the review, which 

covered the period of March 1, 1999 to September 14, 2001 were discussed with the NRC 

management on September 14, 2001. 

A draft of this report was issued to the NRC for factual comment on November 6, 2001. Martin 

J. Virgilio, Director, Office of Nuclear Materials Safety and Safeguards (NMSS) sent factual 

comments by letters dated December 3, 2001. The Management Review Board (MRB) met on 

January 8, 2002 to consider the proposed final report. The MRB found NRC‘s SS&D Evaluation 

Program was adequate to protect public health and safety. 

The NMSS Division of Industrial and Medical Nuclear Safety (IMNS) administers the SS&D 

evaluation program through the Materials Safety and Inspection Branch (MSIB). Section A (the 

Section), within the MSIB is responsible for conducting safety evaluations of sealed sources 

and devices that contain radioactive material regulated by NRC. An organizational chart is 

shown in Appendix B. The Section also conducts generic safety reviews of incidents and 

accidents where the failure of a source or device is suspected of being a contributing factor. 

The Section maintains a catalog of SS&D registration certificates for those sources and devices 

that have been determined to meet acceptable design criteria for licensing and use by 

individuals. The Section controls and allocates the vendor designation numbers for the 

registration certificates issued by the NRC and the Agreement States. The Section also 

distributes copies of completed registration certificates to the 32 Agreement State programs 

that license the use of the same devices. 

In preparation for the review, a questionnaire addressing non-common performance 

indicator, Sealed Source and Device Evaluation Program, was sent to NRC on July 27, 2001. 

NRC provided a response to the questionnaire on August 21, 2001. A copy of the 

questionnaire response can be found on the NRC‘s Agencywide Document Access and 

Management System (ADAMS) using the accession number ML012330463. 

The review team‘s general approach for conducting the review consisted of: (1) an examination 

of NRC‘s response to the questionnaire; (2) a review of selected safety evaluation casework, 

(3) a review of staffing and training, (4) a review of incident and allegation files, and (5) 

interviews with the staff and management to answer questions or to clarify issues. The review 

team evaluated the information it gathered against the IMPEP performance criteria for this noncommon performance indicator and made a preliminary assessment of the NRC SS&D safety 

evaluation program. 

The NRC‘s response to recommendations made following the previous IMPEP review for the 

non-common performance indicator, Sealed Source and Device Evaluation Program, are 

discussed in Section 2.0 below. The results of the current review are presented in Section 3.0 
NRC SS&D Final Report	 Page 2
 

below. Finally, Section 4.0 summarizes the review team‘s findings and recommendations. 

Recommendations made by the review team are comments that relate directly to performance 

by the Section. A response is requested from the Section to all recommendations in the final 

report. 

2.0	 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS 

During the previous IMPEP review, which concluded on April 30, 1999, five recommendations 

were made and transmitted to Dr. Carl J. Paperiello, Director, NMSS, on August 11, 1999. The 

team‘s review of the current status of these recommendations are as follows: 

1.	 The review team recommends that checklists be used and retained in the SS&D file as 

recommended in Item 10, NUREG-1556, Vol. 3. (Section 2.1.1) 

Current Status: During this review, all SS&D evaluations examined by the team 

included a checklist if it was reviewed after the effective date of their policy. This 

recommendation is closed. 

2.	 The review team recommends that NRC conduct a review when registry certificates are 

updated to current standards and, in consultation with the Agreement States, and 

develop guidance, e.g., when they are reviewed. (Section 2.1.1) 

Current Status: The existing guidance (NUREG-1556, Vol 3, Section 13) already 

requires a certificate to be amended in its entirety when safety issues are involved. 

Partial changes are accomplished when administrative issues are involved. When 

NUREG-1556, Vol. 3 is reviewed as a part of its normal revision cycle, the NRC will 

coordinate with Agreement States for input. This recommendation is closed. 

3.	 The review team recommends that the working life of each product be routinely added 

to the Conditions of Normal Use on each registry certificate per Item 12.6 of NUREG 

1556, Vol. 3. (Section 2.1.1) 

Current Status: All SS&D evaluations reviewed by the team followed the NUREG 1556, 

Vol. 3 guidance concerning working life. This recommendation is closed. 

4.	 The review team recommends that NRC, in consultation with the Agreement States, 

develop a process to identify and resolve areas of mutual concern in the SS&D review 

process. (Section 2.1.1) 

Current Status: The NRC convened a working group on SS&Ds, including Agreement 

State representatives, and that group has issued its report. The NRC will also 

coordinate with the Agreement States when NUREG-1556, Vol. 3, is revised. This 

recommendation is closed. 

5.	 The review team recommends that NRC should discontinue the practice of permitting 

individuals with restricted signature authority to sign as a second reviewer, and reevaluate the remaining 7 certificates cosigned by staff members with limited signature 

authority. (Section 2.1.2) 
NRC SS&D Final Report	 Page 3
 

Current Status: The Branch Chief, MSIB, reviewed the seven cases, and no safety 

issues were identified. The practice of issuing restricted signature authority has been 

discontinued. This recommendation is closed. 

3.0	 NON-COMMON PERFORMANCE INDICATOR - SEALED SOURCE AND DEVICE 

EVALUATION PROGRAM 

The IMPEP process identifies five common and four non-common performance indicators to be 

used when reviewing Regional and Agreement State programs. This review was limited to 

evaluating the non-common performance indicator, Sealed Source and Device Evaluation 

Program. 

In conducting this review, three sub-indicators were used to evaluate the NRC‘s performance 

regarding their SS&D Evaluation Program. These sub-indicators include: (1) Technical Quality 

of the Product Evaluation; (2) Technical Staffing and Training; and (3) Evaluation of Defects 

and Incidents Regarding SS&Ds. 

3.1	 Technical Quality of the Product Evaluation Program 

The team evaluated the SS&D technical quality in accordance with the guidance provided in 

MD Handbook 5.6. Ten case files were selected for review that included work performed by all 

reviewers. The cross-section sampling included the more complex evaluations completed by 

Section staff over the review period. The reviewed SS&D actions included new certificates, 

amendments, transfers, and inactivations. The SS&D certificates issued by the NRC that were 

evaluated by the review team are listed with case-specific comments in Appendix C. 

The selected SS&D registration certificates and case files were reviewed for accuracy, 

appropriateness for authorization, tie-down statements, and overall technical quality. The 

casework was evaluated for timeliness, adherence to good radiation safety practice, acceptable 

engineering practices, reference to appropriate regulations, evaluation of safety evaluation 

reports, manufacturing Quality Assurance/Quality Control, supporting documents, peer and 

supervisory review as indicated, and proper signature authority. The files were checked for 

retention of necessary documents and other supporting data. 

Analysis of the casework and interviews with staff and engineering technical support 

professionals confirmed that the NRC generally follows the recommended guidance from the 

NRC SS&D training workshops and NUREG-1556, Volume 3, issued in July 1998. All 

applicable and pertinent American National Standards Institute standards, NUREG-1556 

Series, NRC Regulatory Guides, and applicable references were confirmed to be available and 

were used appropriately in performing the SS&D reviews. Appropriate review checklists were 

used to assure that all relevant materials were submitted and reviewed. The checklists are 

retained in the case files. Registrations clearly summarized the product evaluation and 

provided license reviewers with adequate information on areas requiring additional attention to 

license the possession, use, and distribution of the products. The team determined that 

product evaluations were thorough, complete, consistent, of acceptable technical quality, and 

adequately addressed the integrity of the products during use and in the event of likely 

accidents. 
 

NRC SS&D Final Report Page 4
 

Although it was clear that a second review had been performed in each case, it was not always 

clear what that second review had consisted of. In order to have a more complete record of the 

evaluation, the review team discussed with Section staff the benefits of detailing the second 

review with an additional checklist, or using a second set of initial blocks on the primary 

reviewers checklist. 

The Section has recently developed a database entitled —National Sealed Source and Device 

Registry System“ (NSSDR), to aid staff in effectively and efficiently finding specific information 

on SS&Ds. Section staff demonstrated the use of this database for the review team and the 

team found that the database allows the Section to retrieve information expeditiously. The 

newly developed SS&D database, NSSDR, which permits flexible searches based on 

manufacturer, model, nuclide, use, and other characteristics, is identified as a good practice. 

Section staff also discussed with the review team their use of a spreadsheet to aid in SS&D file 

organization. The spreadsheet contains information on enclosed documents and like the 

database, aids Section staff in finding information expeditiously. The addition of a spreadsheet, listing the enclosed documents, at the front of the package of documents for a given 

action makes it much easier to review each package and find appropriate information, and is 

identified as a good practice. 

Based on the IMPEP evaluation criteria, the review team recommends that NRC‘s performance 

with respect to the sub-indicator, Technical Quality of the Product Evaluation Program, be found 

satisfactory. 

3.2 Technical Staffing and Training 

The team evaluated the NRC SS&D program staffing and training in accordance with the 

guidance provided in MD 5.6. The Handbook indicates that SS&D staffing and training should 

be reviewed in the same manner as the common performance indicator, Technical Staffing and 

Training, except with a focus on training commensurate with the conduct of the SS&D reviews. 

At the time of the review, the SS&D program staff consisted of nine individuals. Six were 

engineers, one was a health physicist, one an engineering co-op, and the other was an 

administrative assistant. Four of the engineers had full signature authority. These four, along 

with the administrative assistant, were on staff during the 1999 IMPEP review. The other three 

staff members were in training for SS&D evaluations and had no SS&D signature authority. 

Qualifications, including qualification journals, were reviewed for the three. One of the three 

was a qualified regional license reviewer who specialized in licensing the manufacture of 

exempt sources and devices. He had signature authority for licensing, but not for SS&D 

evaluation. The second was previously a journal qualified transportation packaging and dry 

storage system inspector. The third was a new hire in July with no previous experience. 

During the review period, the SS&D program experienced turnover of engineering co-ops and 

summer hires only. At the time of the review, there were no vacant positions in the program. 

The SS&D program was developing a qualifications journal addressing activities to be 

completed prior to obtaining SS&D signature authority. The training plan associated with the 

journal specified general and specialized training courses. It also required on-the-job 
 

 

 

 

 

NRC SS&D Final Report Page 5
 

experience, including the performance of casework under the supervision of an experienced 

SS&D reviewer. NMSS is working to incorporate the training plan and qualification journal into 

Inspection Manual Chapter 1246. 

Established qualifications for the technical positions include a baccalaureate degree or 

equivalent training in engineering, physical science, or other closely related discipline as 

evidenced by a bachelor‘s degree or equivalent combination of education, training, and 

experience. Individuals granted signature authority must be able to satisfactorily perform the 

competency elements established in MD Handbook 5.6, Part II, Section C.2.b. ii. The review 

team found the training program to be very thorough and sufficient to ensure that the SS&D 

evaluation program maintains a qualified staff. 

Based on these findings, the team concludes that the staff training is adequate. Based on the 

observation that the staff is meeting its performance goals for product evaluations with respect 

to both timeliness and quality, the team concludes that the current staffing is adequate. 

Based on the IMPEP evaluation criteria, the team recommends that NRC‘s performance with 

respect to the sub-indicator, Technical Staffing and Training, be found satisfactory. 

3.3 Evaluation of Incidents and Allegations Regarding the SS&Ds 

The review team used the guidance provided in MD Handbook 5.6 to evaluate the NRC SS&D 

program‘s handling of reported defects and incidents involving SS&Ds. The Handbook 

specifies that the review should be conducted in the same manner as the common performance 

indicator, Response to Incidents and Allegations. The IMPEP review should be conducted so 

as to determine if the evaluation of reported defects and incidents was sufficient to detect 

manufacturing problems or other root causes. The evaluation should also determine if other 

products may be affected by similar problems. Appropriate action and notifications should take 

place. 

The review team discussed the 17 incidents identified in the questionnaire with the staff and 

management. The team reviewed the SS&D incident files, NMED reports, and the Generic 

Assessment Panel‘s records for seven specific events as discussed in Appendix D. The team 

was able to determine that NRC has a very strong incident and event reporting process, which 

the SS&D program fully participates in. Procedures are well and clearly understood by both 

management and staff and were followed in every case. 

The team found that the SS&D program takes coordinated and timely action to track and 

resolve issues identified from incidents. The level of effort expended on resolving these issues 

is commensurate with the potential health and safety significance of the incident. Investigations 

appear appropriately thorough for the risks associated with the incident. Enforcement, or other 

corrective actions, appear to be promptly and accurately identified to NRC management, the 

Agreement States, and to NRC licensees and vendors. 

The SS&D program staff may conduct site visits and accompany inspections of licensed 

activities and vendors as a tool to investigate SS&D incidents. The staff generally depends on 

regional inspectors unless circumstances or issues require special SS&D competency. The 

team notes that NRC usually depends on the source or device manufacturer to perform root 
 

NRC SS&D Final Report	 Page 6 

cause analyses. However, NRC can employ the services of a contractor to independently 

perform engineering analysis and testing to determine the principal cause of failure. 

Records of the actions in response to an incident are typically distributed among several 

groups, (i.e., SS&D program, Generic Assessment Panel, Regional licensing programs, and 

possibly the Office of Enforcement and the Office of Investigations). Thus, a full audit of the 

records for completeness of actions and conformity to NRC procedures was beyond the scope 

of this review. For example, the team was unable to determine from the SS&D program 

records if corrective action was taken against licensees when the root cause of an incident was 

determined to be a performance failure by the licensee. Attempts in three cases to find 

documentation in ADAMS were only marginally successful. 

Consistent with NRC practice, the SS&D program forwards allegations against SS&D vendors 

and suppliers to NMSS‘s allegation program. Some allegations are forwarded to the 

appropriate region for action. The response of the regional programs to allegations is reviewed 

during regional IMPEP reviews. 

The review team discussed the findings of the NRC Allegations Program audit relative to 

allegations involving the SS&D program and discussed the SS&D allegations received with the 

NMSS allegations coordinator. Seven allegations were received during the review period, three 

of which were referred to the appropriate Region or Agreement State. Of the four handled by 

NMSS, two are closed. The open cases are of unusual complexity or recently received. The 

results of NMSS‘s investigation of the closed allegations were provided to the appropriate 

alleger. 

Based on the IMPEP evaluation criteria, the team recommends that NRC‘s performance with 

respect to the sub-indicator, Evaluation of Defects and Incidents Regarding the SS&Ds, be 

found satisfactory. 

4.0	 SUMMARY 

As noted above, the review team recommends that the NRC‘s performance in the subindicators, Technical Quality of the Product Evaluation Program, Technical Staffing and 

Training and Incidents and Allegations Regarding the SS&Ds be found satisfactory. 

Accordingly, the review team recommended and the MRB concurred in finding the NRC‘s 

overall performance for the SS&D Program to be adequate to protect health and safety. Based 

on the results of the current IMPEP review, the review team recommended and the MRB 

concurred that the next review should be in approximately four years. 

GOOD PRACTICES: 

1.	 The newly developed SS&D database, NSSDR, which permits flexible searches based 

on manufacturer, model, nuclide, use, and other characteristics, is identified as a good 

practice. (Section 3.1). 

2.	 The addition of a spreadsheet, listing the enclosed documents, at the front of the 

package of documents for a given action makes it much easier to review each package 

and find appropriate information, and is identified as a good practice. (Section 3.1). 

LIST OF APPENDICES AND ATTACHMENTS
 

Appendix A IMPEP Review Team Members 

Appendix B NRC/NMSS/Materials Safety & Inspection Branch Organization Chart 

(ML013610693) 

Appendix C Sealed Source and Device Casework Reviews 

Appendix D Incident Casework Reviews 

Attachment December 3, 2001 Letter from Martin J. Virgilio 

NRC‘s Response to Draft IMPEP Report 

(ML013340261) 
APPENDIX A 

SS&D REVIEW TEAM MEMBERS 

Name Area of Responsibility 

David Wesley, California Team Leader 

Technical Quality of Product Evaluations 

David Fogle, Texas Technical Quality of Product Evaluations 

Richard Blanton, STP Technical Staffing and Training 

Response to Incidents and Allegations 
APPENDIX B
 

Nuclear Regulatory Commission‘s
 

Office of Nuclear Materials Safety and Safeguards‘
 

Materials Safety and Inspection Branch Organization Chart
 

ML013610693
 

Attachment
 

December 3, 2001 Letter from Martin J. Virgilio
 

NRC‘s Response to Draft IMPEP Report
 

ML013340261