January 29, 2010 

MEMORANDUM TO: Robert J Lewis, Director 

Division of Materials Safety 

 and State Agreements 

FROM: Martin J. Virgilio /RA/ 

 Deputy Executive Director for Materials, Waste, 

 Research, State, Tribal, and Compliance Programs 

 Office of the Executive Director for Operations 

 Shawn Seeley, Chair 

 Organization of Agreement States, Inc. 

SUBJECT: FINAL REPORT FOR THE INTEGRATED MATERIALS 

PERFORMANCE EVALUATION PROGRAM REVIEW OF THE 

U.S. NUCLEAR REGULATORY COMMISSION’S SEALED 

SOURCE AND DEVICE EVALUATION PROGRAM 

On January 5, 2010, the Management Review Board (MRB) met to consider the proposed final 

Integrated Materials Performance Evaluation Program (IMPEP) report of the U.S. Nuclear 

Regulatory Commission’s (NRC) Sealed Source and Device (SS&D) Evaluation Program. The 

MRB found the NRC SS&D Evaluation Program adequate to protect public health and safety. 

Section 4.0, page 6, of the enclosed final report summarizes the results of the review and 

presents the one recommendation made by the review team. Based on the results of the 

current review, the next IMPEP review of the NRC SS&D Evaluation Program will take place in 

approximately 4 years. 

If you have any questions, please contact Joshua Daehler, Radiation Control Officer, 

Massachusetts Radiation Control Program at (617) 242-3035. 

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

the team’s visit. 

Enclosure: 

Final NRC SS&D Evaluation 

 Program IMPEP Report 

cc w/encl: See next page
R.J. Lewis - 2 - 

cc w/encl: Jack W. Foster, Chief 

 Licensing Branch 

 Division of Materials Safety 

 and State Agreements 

 W. Lee Cox, North Carolina 

 Organization of Agreement States 

 Liaison to the MRB 
January 29, 2010 

MEMORANDUM TO: Robert J Lewis, Director 

Division of Materials Safety 

 and State Agreements 

FROM: Martin J. Virgilio /RA/ 

 Deputy Executive Director for Materials, Waste, 

 Research, State, Tribal, and Compliance Programs 

 Office of the Executive Director for Operations 

 Shawn Seeley, Chair /RA/

 Organization of Agreement States, Inc. 

SUBJECT: FINAL REPORT FOR THE INTEGRATED MATERIALS 

PERFORMANCE EVALUATION PROGRAM REVIEW OF THE 

U.S. NUCLEAR REGULATORY COMMISSION’S SEALED 

SOURCE AND DEVICE EVALUATION PROGRAM 

On January 5, 2010, the Management Review Board (MRB) met to consider the proposed final 

Integrated Materials Performance Evaluation Program (IMPEP) report of the U.S. Nuclear 

Regulatory Commission’s (NRC) Sealed Source and Device (SS&D) Evaluation Program. The 

MRB found the NRC SS&D Evaluation Program adequate to protect public health and safety. 

Section 4.0, page 6, of the enclosed final report summarizes the results of the review and 

presents the one recommendation made by the review team. Based on the results of the 

current review, the next IMPEP review of the NRC SS&D Evaluation Program will take place in 

approximately 4 years. 

If you have any questions, please contact Joshua Daehler, Radiation Control Officer, 

Massachusetts Radiation Control Program at (617) 242-3035. 

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

the team’s visit. 

Enclosure: 

Final NRC SS&D Evaluation 

 Program IMPEP Report 

cc w/encl: See next page 

Distribution: See next page.

 ML100110136 EDATS: FSME-2010-0004 

OFFICE FSME/MSSA FSME/MSSA FSME/MSSA Tech Editor 

NAME ATMcCraw:knm1 ADWhite TReis CPoland 

DATE 01/12/10 01/14/10 01/14/10 01/20/10 

OFFICE FSME OAS DEDMRT 

NAME CLMiller (CCarpenter for) SSeeley/via email MJVirgilio 

DATE 01/22/10 01/12/10 01/29/10 

OFFICIAL RECORD COPY
Memorandum to Robert J. Lewis from Martin J. Virgilio dated: January 29, 2010 

DISTRIBUTION: FSME-2010-0004

MSSA RF DCD (SP01) 

EDO RF 

RidsFsmeOd Chairman Jaczko 

RidsSecyCorrespondenceMailCenter Commissioner Klein 

MBeardsley, FSME/MSSA Commissioner Svinicki 

Joshua Daehler, Massachusetts SECY 

Michael Stephens, Florida 

MOrendi, FSME/MSSA 

BJones, OGC 

JKinneman, RI 

MFranovich, OEDO 
Enclosure 

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM 

REVIEW OF THE NRC SEALED SOURCE AND DEVICE EVALUATION PROGRAM 

October 19-23, 2009 

FINAL REPORT
NRC SS&D Final Report Page 1 

1.0 INTRODUCTION 

This report presents the results of the review of the U.S. Nuclear Regulatory Commission’s 

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

during the period of October 19-23, 2009, by a review team comprised of technical staff 

members from the NRC, the State of Florida, and the Commonwealth of Massachusetts. Team 

members are identified in Appendix A. The review was conducted in accordance with the 

“Implementation of the Integrated Materials Performance Evaluation Program and Rescission of 

Final General Statement of Policy,” published in the Federal Register on October 16, 1997, and 

the February 26, 2004 NRC Management Directive 5.6, “Integrated Materials Performance 

Evaluation Program (IMPEP).” Preliminary results of the review, which covered the period of 

September 24, 2005, to October 23, 2009, were discussed with NRC managers on the last day 

of the review. 

A draft of this report was issued to the NRC for factual comment on November 19, 2009. NRC 

responded by letter dated December 15, 2009, from Jack Foster, Chief, Licensing Branch (the 

Branch). A copy of the NRC’s response is included as the Attachment to this report. The 

Management Review Board (MRB) met on January 5, 2010, to consider the proposed final 

report. The MRB found the NRC’s SS&D Evaluation Program adequate to protect public health 

and safety. 

The SS&D Evaluation Program is administered by the Branch in the Division of Materials Safety 

and State Agreements (the Division). The Division is part of the Office of Federal and State 

Material and Environmental Management Programs (the Office). Organization charts for the 

Office and the Division are included in Appendix B. 

At the time of the review, the SS&D Evaluation Program maintained authority for performing 

SS&D evaluations in areas licensed by NRC and also in areas licensed by the Agreement 

States of Arkansas, Iowa, Minnesota, New Jersey, Oklahoma, New Mexico, North Dakota, 

Oregon, Pennsylvania, Rhode Island, Utah, Virginia, and Wisconsin. 

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

indicator SS&D Evaluation Program was sent to the Branch on August 6, 2009. The Branch 

provided its response to the questionnaire on September 30, 2009. A copy of the questionnaire 

response may be found in the NRC’s Agencywide Documents Access and Management System 

(ADAMS) using the Accession Number ML092730651. 

The review team's general approach for conduct of this 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 staff and managers. The review team evaluated the information gathered against the 

established criteria for the non-common performance indicator and made a preliminary 

assessment of the SS&D Evaluation Program’s performance. 

Section 2.0 of this report covers the NRC’s actions in response to recommendations made 

during the previous review. The results of the current review are presented in Section 3.0. 

Section 4.0 summarizes the review team's findings and recommendations. The review team’s 
NRC SS&D Final Report Page 2 

recommendations are comments that relate directly to program performance by the NRC. 

A response is requested from the NRC to all recommendations in the final report. 

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS 

During the previous IMPEP review, which concluded on September 23, 2005, the review team 

made one recommendation in regard to program performance. The status of the 

recommendation is as follows: 

 The review team recommends that the Section adhere more closely to the document 

format and contents in the guidance as identified in the current NUREG-1556, Volume 3. 

(Section 3.2 of the 2005 IMPEP report) 

Current Status: The Branch (formerly the Section) issued a set of Policy and 

Guidance Directives in April 2006 that included direction for staff to follow the 

guidance of NUREG-1556, Volume 3, “Consolidated Guidance About Materials 

Licenses – Applications for Sealed Source and Device Evaluation and 

Registration”. Interviews with staff confirmed that staff follows guidance from the 

current revision of NUREG-1556, Volume 3. As evidenced by fewer format and 

content issues averaged per completed registration discovered during this review 

period of less than one as compared to that discovered during the last review 

period of greater than two, the review team determined that the Branch adheres 

more closely to the document format and contents in the guidance as identified in 

the current NUREG-1556, Volume 3. This recommendation is closed. 

3.0 PERFORMANCE INDICATOR 

IMPEP identifies five common performance indicators and four non-common performance 

indicators to be used in reviewing Agreement State and NRC Programs. This review was 

limited to evaluating the non-common performance indicator, SS&D Evaluation Program. 

In reviewing this performance indicator, the review team used three subelements to evaluate the 

Branch’s performance regarding the SS&D Evaluation Program. These subelements were: (1) 

Technical Staffing and Training, (2) Technical Quality of the Product Evaluation Program, and 

(3) Evaluation of Defects and Incidents Regarding SS&Ds. 

In assessing the Branch’s SS&D evaluation activities, the review team examined information 

contained in the Branch’s response to the IMPEP questionnaire for this indicator and performed 

searches of the National Material Events Database (NMED). The review team evaluated 13 

SS&D evaluations and supporting documents processed during the review period. The review 

team noted the staff's use of guidance documents and procedures, interviewed staff members 

involved in SS&D evaluations, and verified the use of regulations and inspections to enforce 

commitments made in the applications. 

3.1 Technical Staffing and Training

At the time of the review, the SS&D Team Leader and four staff members were conducting 

SS&D reviews. Three individuals were fully qualified to independently review and sign registry 
NRC SS&D Final Report Page 3 

sheets. There is one additional Branch staff member who was fully qualified to independently 

review and sign registry sheets; however, this individual was not conducting reviews at the time 

of the IMPEP. One licensing assistant provides administrative support to the program. Since 

the last review, the program has been through two reorganizations, four individuals (three fully 

qualified and one in training) have left the SS&D group, and two individuals have joined the 

group. Three of the five current staff members conducted reviews throughout the entire review 

period. Staff turnover was the result of individuals taking assignments in other parts of the 

NRC. There were no vacancies in the SS&D group at the time of the review. 

All current staff members spend only a portion of their time conducting SS&D reviews. During 

the last two fiscal years, the highest time expenditure by any individual was 0.30 full-time 

equivalents (FTE). According to the Branch’s questionnaire response, the FTE expenditure on 

the SS&D program during the review period was 1.02 FTE for FY 2006, 1.01 FTE for FY 2007, 

1.01 FTE for FY 2008, and 1.60 FTE for FY 2009. 

The review team evaluated the qualifications of and the respective documentation for the 

individuals who were certified to independently review and sign registry sheets during the review 

period. The review team also evaluated the qualifications of and the respective documentation 

for the two individuals currently in the training process. The qualification procedure used for 

NRC SS&D reviewers is found in the NRC Inspection Manual Chapter (IMC) 1246 Appendix A, 

Section XVI, “Technical Reviewer Qualifications Journal - Byproduct Material Sealed Source 

and Device Reviewers.” 

New staff members are required to complete the training requirements in IMC 1246, Appendix 

A, Section XVI and participate in the review of 20 cases. Depending on the casework available 

during the training period, the required SS&D casework includes sources, irradiators, 

radiography equipment, consumer products, gauges and medical devices. Once the staff 

member has completed the training and casework, the staff member is evaluated by an SS&D 

review board prior to being certified to independently review applications and sign registry 

sheets. 

Based on interviews with staff, a review of casework, and a review of the required training 

courses, the review team concluded that the training program is effective in developing a 

competent and qualified staff. The review team also concluded that staffing levels were 

adequate based on the Branch’s current and projected workload. 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that NRC’s performance with respect to the subelement, Technical Staffing and Training, was 

satisfactory. 

3.2 Technical Quality of the Product Evaluation Program

The review team evaluated 13 SS&D registrations that were completed by the Branch during 

the review period. At the time of the review, the Branch had 236 active SS&D registrations of 

which 46 registrations were for exempt products. The questionnaire response provided by the 

Branch supported that at least 166 SS&D registration cases were completed during the review 

period. Casework selected for review included work performed by four fully qualified staff 

members and consisted of a cross section sampling of new, amended, inactivated, and 
NRC SS&D Final Report Page 4 

corrected registrations. The review team performed their review using the official records in 

ADAMS. A list of SS&D casework examined, with case-specific comments, can be found in 

Appendix C. 

Analysis of the casework and interviews with staff members confirmed that the Branch staff 

follows the recommended guidance from NRC’s SS&D Workshop and NUREG-1556, Volume 3, 

Revision 1. The review team confirmed that all applicable and pertinent American National 

Standards Institute standards, NUREG-1556 Series guides, NRC Regulatory Guides, and 

applicable references were available and used appropriately in performing the SS&D reviews. 

A case file is created for each applicant’s request. This case file will contain all documents 

received and generated by this request and includes the applicant’s request, Branch’s requests 

for additional information, applicant replies, e-mails, the signed registry certificate issued to the 

applicant, etc. Once the case file is closed, the information is made an official agency record in 

ADAMS. The process for document management is described in one of the Branch’s Policy 

and Guidance Directives. The ADAMS documents available for review contained all 

photographs, engineering drawings, and radiation profiles required to evaluate the source or 

device; however, the review team found several instances where the NRC’s official records in 

ADAMS were missing documents that contained commitments made by the licensee that should 

be enforceable via inspection in case of violation. The review team found that 4 of the 13 case 

files evaluated were missing critical information in ADAMS. Of these four files, a total of eight 

documents were missing from ADAMS or incorrect documents were placed in ADAMS in their 

stead. At the time of discovery by the review team, the commitments made under these four 

registrations were not legally enforceable based upon the NRC’s official records. The review 

team noted that the information missing in three of the four files was added to ADAMS during 

the on-site review, because the paper copies of the application and commitments were still 

available. As a general practice, all paper copies of the cases completed during the review 

period are destroyed following the IMPEP review. Subsequent to the on-site portion of the 

review, the NRC discovered the remaining documents for the four files and ensured that they 

were appropriately added to ADAMS and the case files. The review team noted that the 

Branch’s Policy and Guidance Directive for document management requires a final quality 

check of ADAMS documents for each case file to be performed by the SS&D Team Leader; 

however, that final check was not consistently performed. The review team recommends that 

the NRC evaluate the implementation and effectiveness of the Branch’s Policy and Guidance 

Directives and ensure that all of the required documents needed to enforce the provisions of the 

registration certificate are made part of the NRC’s official records in ADAMS, including those 

cases closed during this review period. 

With one exception noted in the next paragraph, the registrations clearly summarized the 

product evaluation to provide license reviewers with adequate information to license the 

possession and use of the product. Requests for additional information clearly stated regulatory 

positions. The review team found that the registry evaluations were of high quality with health 

and safety issues properly addressed. 

The review team found that one SS&D registration had been amended in its entirety twice after 

a health and safety waste disposal issue involving the discovery of long-lived radioactive 

contaminants was identified and documented in NRC Information Notice (IN), IN 2007-10, 

“Yttrium-90 Theraspheres® and Sirspheres® Impurities”. Neither amended registration 
NRC SS&D Final Report Page 5 

incorporated the information to provide license reviewers with adequate information to license 

the possession and use of the product. The registration currently identifies only one 

radionuclide, a short-lived radionuclide, contained in the product and specifies in the Limitations 

and/or Other Considerations of Use Section of the registration, in part, that disposal is to be 

determined by the licensing authority. The review team discussed with Branch management the 

benefit of including information about the long-lived contaminants in the registration to alert 

license reviewers and allow license reviewers to make informed licensing decisions regarding 

disposal of the product. For example, license reviewers may find that a decay-in-storage 

method of disposal is appropriate for a short-lived radionuclide but may find that such disposal 

method is not appropriate for a long-lived radionuclide. The Branch’s management committed 

to issue an amendment to the registration that would add a Reviewer’s Note indicating that 

disposal issues should be handled in accordance with IN 2007-10. 

The staff uses Section 10.7 and Appendix G of NUREG-1556, Volume 3, Revision 1, to review 

details of the applicant’s quality assurance and quality control (QA/QC) program. The review 

team determined that the staff’s evaluation of applicant developed QA/QC programs was 

adequate and consistent with Section 10.7 and Appendix G of NUREG-1556, Volume 3, 

Revision 1. The review team did not evaluate the NRC’s practice of evaluating implementation 

of applicant QA/QC programs as it is handled by the NRC’s Regional offices and, therefore, was 

out of the scope of this review. The review team was provided a copy of NRC Inspection 

Procedure (IP) 87125, “Materials Processor/Manufacturer Programs,” and verified that NRC 

inspectors are provided guidance to evaluate the implementation of QA/QC programs, as 

committed to by the licensee during the application process, during inspections. The NRC 

inspectors’ adherence to the guidance in IP 87125 for evaluating licensees' implementations of 

their respective QA/QC programs is assessed during IMPEP reviews of the NRC’s three 

Regional radioactive materials programs. 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that the NRC’s performance with respect to the subelement, Technical Quality of Product 

Evaluation Program, was satisfactory. 

3.3 Evaluation of Defects and Incidents Regarding SS&Ds

Based upon the Branch’s response to the questionnaire, interviews with Branch staff, review of 

incident files maintained by the SS&D Team Leader and the review team’s searches of NMED, 

the review team determined that one product registered by the NRC exhibited a generic defect 

during the review period. The SS&D registration for the product is identified in Appendix D of 

this report. The generic defect was reported by the distributor of the product to the NRC, and 

the Branch took appropriate action to include evaluation of a design change to mitigate the 

defect and evaluation of corrective actions proposed by the distributor to modify products 

already distributed. The review team noted that the design change is described in the report 

made by the distributor but that the SS&D registration had not been amended to include the 

design change. The SS&D Team Leader explained that the Branch evaluated whether the 

Description section of the registration should be amended and decided that a change in the 

Description section was not warranted. The review team also noted that, unrelated to the 

specific design change made, a picture submitted with the distributor’s report contained different 

information than that contained in diagrams made part of the registration. Specifically, the on 

and off indicators of the product were position reversed. 
NRC SS&D Final Report Page 6 

The review team discussed with Branch management the benefit of adding the distributor’s 

report containing the design change to the registration and also for resolving the on and off 

indicator discrepancy. The Branch’s management committed to add the design change 

information as a reference to the registration, and to resolve the on and off indicator 

discrepancy. Subsequent to the on-site portion of the review, the NRC issued an amendment of 

Registration Certificate NR-1195-D-103-S, dated December 14, 2009, that reflects the design 

change. 

In addition to evaluating incidents and defects of products registered by the NRC, the Branch 

also evaluates defect and incidents of additional sealed source and device products registered 

by Agreement States that are used by NRC licensees. The Branch accomplishes these 

evaluations by performing generic assessments of product incident information that is received 

by the Branch daily through NRC’s Operations Center and also through periodic analysis of 

events reported to NMED. The Branch performs generic assessments in accordance with 

criteria contained in MD 6.4 “Generic Issues Program” dated July 29, 2005. If a generic issue is 

identified, the NRC will issue a generic communication to licensees and Agreement States. 

Examples of generic communications resultant from Branch assessments or participation by 

Branch staff during the review period included IN 2007-35, “Varian Medical Systems Varisource 

HDR Events: Iridium-192 Source Pulled from Shielded Position”; IN 2009-5, “Contamination 

Events Resulting from Damage to Sealed Radioactive Sources During Gauge Dismantlement 

and Non-Routine Operations”; IN 2009-15, “Varian Medical Systems Varisource High DoseRate Remote Afterloader Events: Source Retraction Problems”; and IN 2009-18, “Performance 

of Required Shutter Checks and Reporting of Gauge Shutter Failures”. 

The review team concluded that the Branch is routinely evaluating the root causes of defects 

and incidents involving SS&D evaluations and is taking appropriate actions. 

There were no allegations completed by the NRC during the review period related to defects or 

failures of SS&D products registered by the NRC. 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that the NRC’s performance with respect to the subelement, Evaluation of Defects and Incidents 

Regarding SS&Ds, be found satisfactory. 

4.0 SUMMARY 

As noted in Section 3.0, the NRC’s performance was found satisfactory for all three 

subelements under this performance indicator; therefore, based on the IMPEP evaluation 

criteria, the review team recommended, and the MRB agreed, that the NRC’s performance with 

respect to the indicator, SS&D Evaluation Program, was satisfactory. Overall, the review team 

recommended, and the MRB agreed, that the NRC’s SS&D Evaluation Program is adequate to 

protect public health and safety. Based on the results of the current IMPEP review, the review 

team recommended, and the MRB agreed, that the next full IMPEP review take place in 

approximately 4 years. 
NRC SS&D Final Report Page 7 

Below is the recommendation, as mentioned earlier in the report, for evaluation and 

implementation, as appropriate, by the NRC. 

The review team recommends that the NRC evaluate the implementation and effectiveness 

of the Branch’s Policy and Guidance Directives and ensure that all of the required 

documents needed to enforce the provisions of the registration certificate are made part of 

the NRC’s official records in ADAMS, including those cases closed during this review period. 

(Section 3.2)
LIST OF APPENDIXES AND ATTACHMENT 

Appendix A IMPEP Review Team Members 

Appendix B NRC Organization Charts 

Appendix C Sealed Source & Device Casework Reviews 

Appendix D Incident Casework Reviews 

Attachment December 15, 2009 Letter from Jack Foster 

 NRC’s Response to Draft IMPEP Report 
APPENDIX A 

IMPEP REVIEW TEAM MEMBERS 

Name Area of Responsibility

Joshua Daehler, Massachusetts Team Leader 

Evaluation of Defects and Incidents Regarding 

 SS&Ds 

Monica Orendi, FSME Technical Staffing and Training 

Michael Stephens, Florida Technical Quality of the Product Evaluation 

 Program 
APPENDIX B 

NRC ORGANIZATION CHARTS 

ADAMS Accession No.: ML092730280 
APPENDIX C 

SEALED SOURCE & DEVICE CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Registry No.: NR-0220-D-131-S SS&D Type: (AF) Other Medical 

Applicant Name: MDS Nordion Type of Action: Amendment 

Date Issued: 9/18/09 Reviewers: UB, JJ 

Comment: 

A Reviewer Note (as described in NUREG-1556 Vol. 3, Rev. 1, Section 12.10) was not 

added to the Limitations and/or Other Considerations of Use section to address waste 

disposal issues with this device. 

File No.: 2 

Registry No.: NR-1289-D-101-S SS&D Type: (AA) Manual Brachytherapy 

Applicant Name: MDS Nordion Type of Action: Amendment 

Date Issued: 8/14/08 Reviewers: NA, TH 

Comments: 

a) Leak test frequency on page 1 says “Not Applicable (See Description)” where it is not 

discussed and the Limitations and/or Other Considerations of Use section specifies leak 

tests every 6 months. 

b) Limitation and/or Other Considerations of Use section indicates to avoid storage in 

excessive heat or humidity but does not indicate what is considered excessive. 

c) ADAMS was missing a report dated March 5, 2008, that was referenced in reviewer’s 

letter dated May 6, 2008. Subsequent to the on-site portion of the review, the NRC staff 

located the report in ADAMS and placed it in the case file. 

File No.: 3 

Registry No.: NR-0348-D-806-B SS&D Type: (N) Ion Generators, Chromatography 

Applicant Name: Agilent Technologies Type of Action: Inactivation 

Date Issued: 7/7/08 Reviewers: TH, NA 
NRC SS&D Final Report Page 2 

SS&D Casework Reviews 

File No.: 4 

Registry No.: NR-0220-D-131-S SS&D Type: (AF) Other Medical 

Applicant Name: MDS Nordion Type of Action: Amendment 

Date Issued: 10/3/08 Reviewers: UB, JJ 

Comments: 

a) A Reviewer Note (as described in NUREG-1556 Vol. 3, Rev. 1, Section 12.10) was not 

added to the Limitations and/or Other Considerations of Use section to address waste 

disposal issues with this device. 

b) The SS&D registration dated October 3, 2008, was not available, at the time of the 

review, in ADAMS under the case number folder. Subsequent to the on-site portion of 

the review, the NRC staff determined that the document was in the folder, but it was 

incorrectly profiled with a security classification that made it invisible to the review team. 

The NRC staff re-profiled the document to be consistent with the other content of the 

SS&D folder. 

File No.: 5 

Registry No.: NR-1124-D-101-S SS&D Type: (AF) Other Medical 

Applicant Name: Department of Army Type of Action: Amendment 

Date Issued: 9/5/06 Reviewers: TH, JJ 

File No.: 6 

Registry No.: NR-0163-D-101-G SS&D Type: (N) Ion Generators, Chromatography 

Applicant Name: Smith Detection, Inc. Type of Action: Amendment 

Date Issued: 3/28/08 Reviewers: UB, JJ 

File No.: 7 

Registry No.: NR-0195-D-103-S SS&D Type: (H) General Neutron Source Application 

Applicant Name: SABIA, Inc. Type of Action: Amendment 

Date Issued: 10/20/08 Reviewers: NA, JJ 

File No.: 8 

Registry No.: NR-1302-D-101-B SS&D Type: (D) Gamma Gauge 

Applicant Name: Endress & Hauser Type of Action: New 

Date Issued: 8/24/08 Reviewers: TH, NA 

Comment: 

The References section of the registration listed the following items that were not in the 

official records ADAMS under this case file: application dated November 14, 2007; 

letters dated April 28, 2008, and May 29, 2008; and e-mails dated June 2, 2008, and 

August 15, 2008. Two of the five missing documents were entered into ADAMS as 

official records during the on-site portion of the review. Subsequent to the on-site 

portion of the review, the NRC staff located the missing documents in ADAMS and 

placed them in the case folder. 
NRC SS&D Final Report Page 3 

SS&D Casework Reviews 

File No.: 9 

Registry No.: NR-0122-D-101-B SS&D Type: (E) Beta Gauge and (D) Gamma Gauge 

Applicant Name: Beta Control of America Type of Action: Amendment 

Date Issued: 1/26/06 Reviewers: NA, UB 

File No.: 10 

Registry No.: NR-1235-S-101-S SS&D Type: (J),(K),(L),and(M) 

 Gamma Irradiation Categories 

Applicant Name: International Isotopes Idaho Type of Action: Corrected 

Date Issued: 1/30/07 Reviewers: NA, JJ 

File No.: 11 

Registry No.: NR-1265-D-101-E SS&D Type: (W) Luminous Light Sources 

Applicant Name: Hess Fine Arts Type of Action: New 

Date Issued: 9/26/06 Reviewers: TH, JJ 

File No.: 12 

Registry No.: NR-0348-D-111-B SS&D Type: (N) Ion Generators, Chromatography 

Applicant Name: Agilent Type of Action: Amendment 

Date Issued: 6/30/09 Reviewers: JJ, UB 

File No.: 13 

Registry No.: NR-1307-D-102-S SS&D Type: (J) Gamma Irradiation, Category I 

Applicant Name: Best Theratronics, Ltd. Type of Action: Amendment 

Date Issued: 7/30/08 Reviewers: NA, JJ 

Comment: 

 The official record ADAMS under this case file contained an unsigned registry sheet that 

was also missing the term /RA/. The document was entered into ADAMS as official 

records during the on-site portion of the review to list it as /RA/.
APPENDIX D 

INCIDENT CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Registry No.: NR-1195-D-103-S NMED Item Number: 060169 

Licensee: SABIA, Inc. Type of Incident: 10 CFR 21.21(d)(1)(ii), Generic defect 

NRC License No.: 11-27727-01 Investigation Dates: 1/6-2/07 
ATTACHMENT 

December 15, 2009 Letter from Jack Foster 

NRC’s Response to Draft IMPEP Report 

ADAMS Accession No.: ML093490902 and ML093490918