UNITED STATES

NUCLEAR REGULATORY COMMISSION 

WASHINGTON, D.C. 20555-0001 

March 26, 2015 

MEMORANDUM TO: Catherine Haney, Director 

 Office of Nuclear Material Safety 

 and Safeguards 

FROM: Michael F. Weber /RA/

Deputy Executive Director for Materials, Waste, Research, 

State, Tribal, and Compliance Programs 

 Office of the Executive Director for Operations 

 Michael A. Welling, Chair /RA/ 

 Organization of Agreement States 

SUBJECT: FINAL REPORT FOR THE INTEGRATED MATERIALS 

PERFORMANCE EVALUATION PROGRAM (IMPEP) REVIEW 

OF THE U.S. NUCLEAR REGULATORY COMMISSION’S (NRC) 

SEALED SOURCE AND DEVICE (SS&D) EVALUATION 

PROGRAM 

On March 5, 2015, the Management Review Board (MRB) met to consider the proposed final 

IMPEP report of the NRC SS&D Evaluation Program. The MRB found the NRC SS&D 

Evaluation Program adequate to protect public health and safety. 

Section 4.0, page 5, 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 5 years. 

We appreciate the courtesy and cooperation extended to the IMPEP team during the review, 

and we applaud your staff’s efforts during the IMPEP review period. 

Enclosure: 

Final NRC SS&D Evaluation 

 Program IMPEP Report 

cc: See next page 

CONTACT: Lisa Dimmick, NMSS/MSTR 

 301-415-0694
C. Haney -2- 

 

cc: Raymond Manley, MD 

Organization of Agreement States 

Liaison to the MRB 

Hipolito Gonzales, Branch Chief 

Materials Licensing Branch 

Tomas Herrera, Team Leader 

Sealed Source & Device Team 

Materials Licensing Branch 
 

March 26, 2015 

MEMORANDUM TO: Catherine Haney, Director 

 Office of Nuclear Material Safety 

 and Safeguards 

FROM: Michael F. Weber /RA/

Deputy Executive Director for Materials, Waste, Research, 

State, Tribal, and Compliance Programs 

 Office of the Executive Director for Operations 

 Michael A. Welling, Chair /RA/ 

 Organization of Agreement States 

SUBJECT: FINAL REPORT FOR THE INTEGRATED MATERIALS 

PERFORMANCE EVALUATION PROGRAM (IMPEP) REVIEW 

OF THE U.S. NUCLEAR REGULATORY COMMISSION’S (NRC) 

SEALED SOURCE AND DEVICE (SS&D) EVALUATION 

PROGRAM 

On March 5, 2015, the Management Review Board (MRB) met to consider the proposed final 

IMPEP report of the NRC SS&D Evaluation Program. The MRB found the NRC SS&D 

Evaluation Program adequate to protect public health and safety. 

Section 4.0, page 5, 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 5 years. 

We appreciate the courtesy and cooperation extended to the IMPEP team during the review, 

and we applaud your staff’s efforts during the IMPEP review period. 

Enclosure: 

Final NRC SS&D Evaluation 

 Program IMPEP Report 

cc: See next page 

CONTACT: Lisa Dimmick, NMSS/MSTR 

 301-415-0694 

Distribution: (SP01) see next page

ML15068A034 

OFC TL: Ohio MSTR/ASPB MSTR/ASPB NMSS/MSTR Tech Ed OAS EDO 

NAME KVonAhn 

via email

LDimmick 

w/edits

CEinberg LDudes CPoland MWelling

via e-mail

MWeber 

DATE 3/9/15 3/10/15 03/10/15 03/11/15 3/24/15 3/10/15 3/26/15 

OFFICIAL RECORD COPY
 

Memo to C. Haney from M. Weber and M. Welling dated: March 26, 2015 

SUBJECT: NRC SS&D EVALUATION PROGRAM FY2015 FINAL IMPEP REPORT 

DISTRIBUTION: (SP01) 

RidsEdoMailCenter 

JFoster, OEDO 

RidsOgcMailCenter 

JOlmstead, OGC 

RidsRgn4MailCenter 

RidsSecyCorrespondenceMailCenter Chairman Burns 

RidsNmssOd Commissioner Svinicki 

KMcConnell, NMSS Commissioner Ostendorff 

LDudes, MSTR Commissioner Baran 

PHenderson, MSTR SECY 

RParsons, TN 

MShaffer, RIV 

JOhara, MSTR 

OAS Board 

JWeil, OCA (2 copies) 
Enclosure 

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM 

REVIEW OF THE U.S. NUCLEAR REGULATORY COMMISSION 

SEALED SOURCE AND DEVICE EVALUATION PROGRAM 

DECEMBER 8–11, 2014 

FINAL REPORT
EXECUTIVE SUMMARY 

This report presents the results of the Integrated Materials Performance Evaluation Program 

(IMPEP) review of the U.S. Nuclear Regulatory Commission (NRC) Sealed Source and Device 

(SS&D) Evaluation Program. The review was conducted during the period of 

December 8-11, 2014, by a review team composed of technical staff members from the NRC 

and the States of Tennessee and Ohio.

Based on the results of this review, the review team found the NRC’s performance to be 

satisfactory for all three of the sub-elements of the SS&D performance indicator. 

The review team made one recommendation regarding program performance by the Materials 

Safety Licensing Branch regarding obtaining missing historical documents from SS&D 

registrations transferred from the State of Georgia. The review team determined that the 

recommendation from the 2009 IMPEP review regarding missing information from case files 

should be closed. 

Accordingly, the review team recommended, and the Management Review Board (MRB) 

agreed, that the NRC SS&D Evaluation Program is adequate to protect public health and safety. 

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

approximately five years. 
NRC SS&D Evaluation Program Final Report Page 1 

1.0 INTRODUCTION 

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

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

period of December 8–11, 2014, by a review team composed of technical staff members from 

the NRC and the States of Ohio and Tennessee. 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 October 24, 2009, to December 

11, 2014, were discussed with NRC managers on the last day of the review. 

A draft of this report was issued to the Office of Nuclear Material Safety and Safeguards 

(NMSS) on January 9, 2015, for factual comment. The Materials Safety Licensing Branch 

(MSLB) responded to the findings and conclusions of the review by electronic mail dated 

January 27, 2015. A copy of MSLB’s response is included as an attachment to this report. The 

Management Review Board (MRB) met on March 5, 2015, to consider the proposed final report. 

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

safety. 

The SS&D Evaluation Program (the Program) is administered by the Materials Safety Licensing 

Branch (the Branch) in the Division of Material Safety, State, Tribal, and Rulemaking Programs 

(the Division). The Division is part of the Office of Nuclear Material Safety and Safeguards (the 

Office). Organization charts for the Office and the Division are included in Appendix B. 

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

areas licensed by the NRC and also in areas licensed by the Agreement States of Arkansas, 

Georgia, 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 Program was sent to the Branch 

on August 19, 2014. The Branch provided its response to the questionnaire on 

November 5, 2014. A copy of the questionnaire response may be found in the NRC’s 

Agencywide Documents Access and Management System (ADAMS) using the Accession 

Number ML14297A407. 

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 NRC’s performance. 

Section 2.0 of this report covers the NRC’s actions in response to a recommendation 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. 
NRC SS&D Evaluation Program Final Report Page 2 

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS 

During the previous IMPEP review, which concluded on October 23, 2009, the review team 

made one recommendation in regard to the NRC’s performance as follows: 

“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 2009 IMPEP Report)” 

Current Status: The Branch developed and implemented Policy and Guidance Directives to 

ensure that the required documents were included in ADAMS. The review team found that 

documents from the Branch’s casework were appropriately entered in ADAMS. The review 

team recommended, and the MRB agreed, that this recommendation be closed. 

3.0 PERFORMANCE INDICATORS 

There are five common performance indicators and four non-common performance indicators to 

be used in reviewing Agreement State and NRC Programs under IMPEP. This review was 

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

In reviewing the SS&D indicator, the review team used three sub-elements to evaluate the 

Branch’s performance. These sub-elements are (1) Technical Staffing and Training, 

(2) Technical Quality of the Product Evaluation Program, and (3) Evaluation of Defects and 

Incidents Regarding SS&Ds. 

To assess the Branch’s SS&D evaluation activities, the review team examined the information 

provided in response to the IMPEP questionnaire and evaluated 28 SS&D registration 

certificates and supporting documents processed during the review period. The team also 

evaluated SS&D staff training records, reported incidents involving products authorized by the 

NRC SS&D registration certificates, and the Branch’s use of guidance documents and 

procedures. The team interviewed the staff currently conducting SS&D evaluations. 

3.1. Technical Staffing and Training

At the time of the review, the SS&D Team Leader and two staff in the Branch were fully qualified 

to independently review and sign SS&D registration certificates. Another qualified SS&D 

reviewer is assigned to another branch in the Division and supports the Branch for SS&D 

reviews during peak workloads. One licensing assistant provides administrative assistance to 

the Program. In the interim period between reviews, four qualified reviewers left the Branch due 

to other opportunities in the agency and/or retirement, and two staff joined the Branch. One of 

those staff is currently progressing through the qualification process. There were no vacant 

positions at the time of the onsite IMPEP review. There were no organizational changes during 

the review period until the merger the NMSS and the Office of Federal and State, Materials, and 

Environmental Programs in October 2014. With the merger, the Division and Branch 

responsible for the Program were not significantly impacted. 
NRC SS&D Evaluation Program Final Report Page 3 

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

During the last two fiscal years (FY), the highest time expenditure by an individual was 0.8 

Full-Time Equivalents (FTE). According to the Branch’s response to the IMPEP questionnaire, 

the FTE expenditure on the Program during the review period was 2.5 FTE for FY 2010, 1.3 

FTE for FY 2011, 1.8 FTE for FY 2012, 1.5 FTE for FY 2013, and 2.5 FTE for FY 2014. The 

increase in FTE for FY 2014 is largely attributed to the State of Georgia’s transfer of its SS&D 

evaluation program to the NRC. 

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

individuals who were qualified to independently review and sign SS&D registration certificates 

during the review period. The review team also evaluated the qualifications of the one 

candidate in the qualification process. The qualification procedure used for the NRC SS&D 

reviewer is found in NRC Inspection Manual Chapter (IMC) 1248, Appendix D, “Technical 

Reviewer Qualification Journal, Byproduct Material Sealed Source and Device Reviewer.” All 

other previously qualified staff were qualified to IMC 1246, Section XVI, “Technical Reviewer 

Qualification Journal, Byproduct Material Sealed Source and Device Reviews.” 

Based upon the review team’s 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 competent and qualified staff. The review team concluded that staffing levels were 

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

Based upon the IMPEP evaluation criteria, the review team recommended, and the MRB 

agreed, that the NRC’s performance with respect to the sub-element, Technical Staffing and 

Training, be found satisfactory. 

3.2 Technical Quality of the Product Evaluation Program

The review team evaluated 28 SS&D registration certificates that were completed by the Branch 

during the review period. The questionnaire response provided by the Branch indicated that the 

Branch evaluated 230 SS&D registrations during the review period. The casework selected for 

review by the IMPEP team included work performed by fully qualified staff members and 

consisted of a cross section sampling of new, amended, inactivated, and corrected registrations. 

The review team performed its review using the official records in ADAMS. Appendix C 

contains a listing of SS&D casework examined with case-specific comments. 

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 “Consolidation Guidance About Materials Licenses: Application for Sealed Source 

and Device Evaluation and Registration.” 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. The IMPEP team noted that NUREG-1556, Volume 3, Revision 

2 has been out for public comment since May 2013. The draft Revision 2 incorporates the 

many rule changes that have occurred since Revision 1 was published. The Branch staff is 

cognizant of these discrepancies, and applies the current regulations as applicable. 
NRC SS&D Evaluation Program Final Report Page 4 

To process a SS&D registration certificate, the Branch creates a case file for each applicant’s 

request. This case file contains all documents received and generated by the request and 

includes the application, the 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 ADAMS documents available 

for the casework reviewed contained all photographs, engineering drawings, and radiation 

profiles required to evaluate the source or device. 

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 

comments noted in Appendix C do not reflect deficiencies in the health and safety evaluations of 

the products. 

During the review period, the State of Georgia returned its SS&D program to the NRC. The 

Georgia program transferred 58 active registration certificates. The NRC is in the process of 

converting the certificates to NRC documents. The IMPEP team observed, on four occasions, 

that the State of Georgia registration certificates were amended and converted to NRC 

registration certificates, but the case files in ADAMS did not contain all the historical documents 

listed in the “references” section of the registration certificates. The Branch had identified some 

supporting documents were missing from the Georgia SS&D transfer and added a note to the 

file indicating that they were missing. The review team noted that the commitments made under 

these registrations may not be legally enforceable based upon the incomplete official records. 

The review team recommended, and the MRB agreed, that the Branch develop and implement 

a mechanism to obtain missing historical documents referenced in the SS&D registration 

certificates transferred from the State of Georgia. 

In the 2009 IMPEP review, the team found that a registration certificate had been amended 

without including a reviewer note addressing disposal issues specified in IN 2007-10, 

“Yittrium-90 Theraspheres® and Sirspheres® Impurities.” The Branch committed to adding a 

reviewer note to the SS&D registration certificate. At the time of the current review, the team 

found that the SS&D registration certificate number NR-0220-D-131-S had been amended for a 

name change, however the reviewer note was not included with the revised registration 

certificate. Since the on-site portion of the current review on December 12, 2014, the Branch 

has issued an amended page 8 to the registration certificate to include the reviewer note. 

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. 

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

that the NRC’s performance with respect to the sub-element, Technical Quality of Product 

Evaluation Program, be found satisfactory. 
NRC SS&D Evaluation Program Final Report Page 5 

3.3 Evaluation of Defects and Incidents Regarding SS&Ds

The review team reviewed five allegation cases involving SS&D’s and found the NRC’s 

evaluation and disposition of the allegations was timely, effective, and in accordance with its 

prescribed allegations process. There were no allegations completed by the NRC related to 

defects or failures of SS&D products registered by the NRC. 

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 Nuclear 

Materials Events Database (NMED), the review team determined that one product registered by 

the NRC exhibited a potential defect during the review period. The potential defect investigated 

was regarding a contaminated source in a Gammacell 40 irradiator. The Branch conducted an 

in-depth review of the incident and issued Information Notice 2010-24 “Notice of Possible 

Source Leakage During Non-Routine Maintenance on a Gammacell 40 Irradiator” dated 

November 18, 2010. The results of the review did not require an amendment to the device 

registration certificate. 

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”. If the NRC identifies a generic issue, it 

will issue a generic communication to licensees and Agreement States. 

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. 

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

that the NRC’s performance with respect to the sub-element, 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 

sub-elements 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, be found 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 five years. Below is the review team’s recommendation, as mentioned in the 

report, for evaluation and implementation by the Branch: 

The review team recommends that the Branch develop and implement a mechanism to 

obtain missing historical documents referenced in the SS&D registration certificates 

transferred from the State of Georgia. (Section 3.2) 
LIST OF APPENDICES 

Appendix A IMPEP Review Team Members 

Appendix B NRC Organization Charts 

Appendix C Sealed Source and Device Casework Reviews 
APPENDIX A 

IMPEP REVIEW TEAM MEMBERS 

Name Area of Responsibility

Joe O’Hara, NMSS/MSTR/ASPB Technical Staffing and Training 

Evaluation of Defects and Incidents Regarding 

SS&Ds (Allegations component) 

Ron Parsons, Tennessee Technical Quality of the Product Evaluation Program 

Karl Von Ahn, Ohio Team Leader 

Technical Quality of the Product Evaluation Program 

Evaluation of Defects and Incidents Regarding 

SS&Ds (Incidents component) 
APPENDIX B 

NRC ORGANIZATION CHARTS 

ADAMS ACCESSION NO.: ML14297A409 

 



 

APPENDIX C 

SEALED SOURCE AND DEVICE CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

 File No.: 1 

Registry No.: NR-505-D-101-E SSD Type: (W) Self Luminous light source

Applicant Name: Marathon Watch Co. Type of Action: Amendment

Date Issued: 7/30/12 Reviewers: SP, UB

File No.: 2 

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

Applicant Name: Endress & Hauser Type of Action: Amendment

Date Issued: 9/29/14 Reviewers: LS, TH

File No.: 3 

Registry No.: NR-1302-D-103-S SSD Type: (D) Gamma Gauge

Applicant Name: Endress & Hauser Type of Action: Amendment

Date Issued: 12/10/14 Reviewers: MAC, TH

File No.: 4 

Registry No.: NR-1138-D-101-S SSD Type: (K) Gamma irradiator Category II 

(J) Gamma irradiator Category I

Applicant Name: Hopewell Type of Action: Amendment

Date Issued: 8/21/14 Reviewers: TH, MAC

Comments: 

1) Source model CDC.800 should be CDC.811. 

2) Source model CKC.P6 is not referenced in the registration certificate, but it is still used in 

the device although it is not currently distributed in new devices. 

File No.: 5 

Registry No.: NR-1180-D-101-E SSD Type: (W) Self Luminous light source

Applicant Name: Truglo Type of Action: Amendment

Date Issued: 6/12/14 Reviewers: LS, MAC

File No.: 6 

Registry No.: NR-1235-S-104-S SSD Type: (X) Medical Reference Sources 

Applicant: International Isotopes Inc. Type of Action: Amendment

Date Issued: 2/20/13 Reviewers: MAC, SP

Comments: 

1) Omitted BM09 Series in description and external radiation levels since it was 

discontinued. 

2) Should retain information in the registration certificate and state that the BM09 series is 

no longer distributed but still may be approved for licensing purposes. 

 
NRC SS&D Final IMPEP Report C. 2 

SS&D Casework Reviews 

File No.: 7 

Registry No.: NR-1370-D-101-S SSD Type: (D) Gamma Gauge

Applicant Name: RAM Services Type of Action: Amendment

Date Issued: 7/28/14 Reviewers: LS, TH

File No.: 8 

Registry No.: NR-0497-D-108-S SSD Type: (AC) Photon emitting Remote Afterloaders

Applicant Name: Elekta Inc. Type of Action: Amendment

Date Issued: 5/27/14 Reviewers: LS, JJ

Comment: Missing files in ADAMS dated February 12, 1999 and Aug 4, 2003 were not received 

from GA transfer. 

File No.: 9 

Registry No.: NR-0167-D-101-E SSD Type: (P) Ion generators, smoke detectors

Applicant Name: BRK Brands, Inc. Type of Action: Amendment

Date Issued: 10/17/13 Reviewers: JJ, TH

File No.: 10 

Registry No.: NR-0716-D-801-S SSD Type: (D) Gamma Gauges

Applicant Name: Scan Technologies Type of Action: Amendment

Date Issued: 10/16/14 Reviewers: SP, TH

File No.: 11 

Registry No.: NR-0269-S-103-S SSD Type: (AE) Gamma Stereotactic Radiosurgery Units

Applicant Name: Elekta Type of Action: Amendment

Date Issued: 8/12/14 Reviewers: LS, TH

File No.: 12 

Registry No.: NR-0155-D-126-S SSD Type: (W) Self Luminous Applications 

Applicant Name: Department of the Army Type of Action: Amendment

Date Issued: 3/1/13 Reviewers: UB, JJ

Comment: First page should state “Custom Device” not “Custom Source” since the SS&D 

registration certificate was changed to “Safety Evaluation of a Device”. 

File No.: 13 

Registry No.: NR-8261-D-801-S SSD Type: (D) Gamma Gauges

Applicant Name: Krones Inc. Type of Action: Amendment

Date Issued: 11/6/12 Reviewers: JJ, UB

 
NRC SS&D Final IMPEP Report C. 3 

SS&D Casework Reviews 

File No.: 14 

Registry No.: NR-1286-D-102-E SSD Type Device: (W) Self Luminous Light Sources

Applicant Name: Isolite Type of Action: New Registration

Date Issued: 5/10/12 Reviewers: UB, LS

Comment: The first page should state “Custom Device” not “Custom Source” since the SS&D 

registration certificate is for a device. 

File No.: 15 

Registry No.: NR-1195-S-106-S SSD Type: (H) General Neutron source applications 

Applicant Name: Sabia, Inc. Type of Action: Inactivation 

Date Issued: 11/17/11 Reviewers: JOD, UB 

File No.: 16 

Registry No.: NR-0657-D-101-E SSD Type: (P) Ion generators, smoke detectors

Applicant Name: Universal Security 

Instruments, Inc. 

Type of Action: Amendment

Date Issued: 12/10/10 Reviewers: JJ, UB

File No.: 17 

Registry No.: NR-0571-D-101-G SSD Type: (D) gamma gauge, (E) Beta gauge

Applicant Name: Honeywell Inc. Type of Action: Amendment

Date Issued: 10/8/14 Reviewers: MAC, TH

Comment: Historical documents were missing from ADAMS that are listed in the SS&D 

registration; there was a memo to file that the documents were not received from 

Georgia during the SS&D transfer. 

File No.: 18 

Registry No.: NR-1289-S-101-S SSD Type: (AA) Manual brachytherapy

Applicant Name: Eckert & Ziegler Type of Action: Amendment

Date Issued: 9/4/14 Reviewers: MAC, TH

Comments: 

1) SS&D listed the leak test frequency as “not applicable” however a leak test is required 

for I-125 (one of multiple radionuclides). 

2) Sealed source is strand of individual sources, the individual sealed source models were 

not identified in the SS&D. 

File No.: 19 

Registry No.: NR-1124-D-102-E SSD Type: (T) Other 

Applicant Name: Met One Instruments Type of Action: Amendment

Date Issued: 8/14/14 Reviewers: JH, MAC 

 
NRC SS&D Final IMPEP Report C. 4 

SS&D Casework Reviews 

File No.: 20 

Registry No.: NR-1348-D-101-S SSD Type: (H) General Neutron Source Application 

Applicant Name: PanAnalytical Type of Action: Amendment

Date Issued: 8/26/14 Reviewers: SP, TH

Comment: Missing June 3, 1999 document in ADAMS. 

File No.: 21 

Registry No.: NR-1370-D-102-G SSD Type: (E) Beta gauges 

Applicant Name: RAM Services Type of Action: New

Date Issued: 7/8/14 Reviewers: MAC, SP

Comment: Sealed source model KAC.D4 containing Kr-85 has ANSI N43.6 classification of 

33331 instead of the minimum classification of 33332 as referenced by the ANSI 

standard for use in a beta gauge. The source’s registration stated that the source 

was approved for use in a device. The reviewer should have placed a note to the 

file and in the SS&D identifying the reason why the source was approved for use in 

the device. 

File No.: 22 

Registry No.: NR-571-D-107-B SSD Type: (D) Gamma gauge, (E) Beta gauge 

Applicant Name: Honeywell International Type of Action: Amendment 

Date Issued: 8/4/14 Reviewers: MAC, TH

Comment: Device with device housing attached was not included in diagrams to aid others in 

being able to recognize device. 

File No.: 23 

Registry No.: NR-1375-S-101-S SSD Type: (H) General Neutron, (T) Other 

Applicant Name: Babcock & Wilcox Type of Action: New 

Date Issued: 10/7/13 Reviewers: MAC, SP

Comments: 

1) Distances listed in SS&D table for radiation levels was listed as 5, 10 and 30 cm versus 

standard 5, 30, and 100 cm. The data in the table was for the combined gamma and 

neutron doses at 5, 30, and 100 cm. The table heading was in error. 

2) Cover page listed the maximum activity for Cf-252 as 1.80 Ci instead of 1.08 Ci for the 

Model BWSSI source. 

File No.: 24 

Registry No.: NR-0497-D-114-S SSD Type: (AC) photon-emitting remote afterloader

Applicant Name: Elekta Type of Action: Amendment 

Date Issued: 5/27/14 Reviewers: LS, JJ

 
NRC SS&D Final IMPEP Report C. 5 

SS&D Casework Reviews 

File No.: 25 

Registry No.: NR-1267-D-102-E SSD Type: (P) Ion Generator, Chemical Agent Detector

Applicant Name: RapiScan Type of Action: Amendment

Date Issued: 4/28/14 Reviewers: MAC, JJ

Comments: 

1) Reviewer note added under a newly added section “Limitations and other conditions of 

use”. This section is not applicable to exempt devices. 

2) References section of SS&D included “August 24, 2014” when SS&D was issued April 

28, 2014. Referenced document should have been April 24, 2014. 

File No.: 26 

Registry No.: NR-1302-D-102-G SSD Type: (D) Gamma Gauge 

Applicant Name: Endress & Hauser Type of Action: New

Date Issued: 12/5/12 Reviewers: JJ, UB

File No.: 27 

Registry No.: NR-155-D-126-S SSD Type: (N) Ion generators, chromatography 

Applicant Name: Department of the Army Type of Action: Amendment

Date Issued: 4/30/13 Reviewers: UB, JJ

File No.: 28 

Registry No.: NR-0220-D-131-S SSD Type: (AF) Other medical use 

Applicant Name: Nordion Type of Action: Amendment

Date Issued: 3/17/11 Reviewers: UB, JJ
ATTACHMENT 

January 27, 2015 Email from Tomas Herrera 

NRC SS&D Response to the Draft Report 

ADAMS Accession No.: ML115027A320