January 27, 2012 

Ron Chapman, M.D., Director 

California Department of Public Health 

1615 Capitol Avenue 

Sacramento, CA 95899-7377 

Dear Dr. Chapman: 

On January 5, 2012, the Management Review Board (MRB) met to consider the proposed final 

Integrated Materials Performance Evaluation Program (IMPEP) report on the California 

Agreement State Program. The MRB found the California program adequate to protect public 

health and safety, and not compatible with the U.S. Nuclear Regulatory Commission=s (NRC) 

program. 

Section 5.0, page 17, of the enclosed final report contains a summary of the IMPEP team’s 

findings and recommendations. Based on the results of the current IMPEP review, the next 

IMPEP review will take place in approximately 4 years, with an early Periodic Meeting 

scheduled in 1 year from the date of the MRB meeting and an additional Periodic Meeting in 

approximately 2.5 years from the date of the current review. The period of monitoring currently 

in place for California will continue until significant progress is made in the regulation 

promulgation process. 

The MRB acknowledged your response, dated January 5, 2012, to the proposed final report and 

the review team’s recommendation. Your suggested corrections were incorporated in the final 

report. We noted, however, that your response did not fully respond to the recommendation. 

Specifically, the recommendation asks California to develop and implement a detailed action 

plan that fully documents actions, tasks, and milestones associated with each regulation 

package. We would appreciate additional information from you in that regard. If you wish, 

Randy Erickson, your Regional State Agreement Officer, has offered to assist with the 

development of the action plan. Your action plan will be reviewed during the monitoring calls 

and subsequent reviews. 
R. Chapman -2- 

I appreciate the courtesy and cooperation extended to the IMPEP team during the review. 

I also wish to acknowledge your continued support for the Agreement State program. I look 

forward to our agencies continuing to work cooperatively in the future. 

 Sincerely, 

 /RA/ 

 Michael F. Weber

 Deputy Executive Director for Materials, Waste, 

 Research, State, Tribal and Compliance Programs 

 Office of the Executive Director for Operations 

Enclosure: 

California Final IMPEP Report 

cc w/encls: Rufus Howell, Director 

 Center for Environmental Health 

 Gonzalo Perez, Chief 

 Radiologic Health Branch 

 

 Stephen Woods, Chief 

 Division of Food, Drug, and Radiation Safety 

 James D. Boyd, Commissioner 

 California Energy Commission 

 State Liaison Officer
R. Chapman -2- 

I appreciate the courtesy and cooperation extended to the IMPEP team during the review. 

I also wish to acknowledge your continued support for the Agreement State program. I look 

forward to our agencies continuing to work cooperatively in the future. 

 Sincerely, 

 /RA/ 

 Michael F. Weber

 Deputy Executive Director for Materials, Waste, 

 Research, State, Tribal and Compliance Programs 

 Office of the Executive Director for Operations 

Enclosure: 

California Final IMPEP Report 

cc w/encls: Rufus Howell, Director 

 Center for Environmental Health 

 Gonzalo Perez, Chief 

 Radiologic Health Branch 

 

 Stephen Woods, Chief 

 Division of Food, Drug, and Radiation Safety 

 James D. Boyd, Commissioner 

 California Energy Commission 

 State Liaison Officer 

DISTRIBUTION: EDATS: FSME-2012-0002 

See next page 

ML120120369

OFFICE FSME/MSSA FSME/MSSA FSME/MSSA FSME/MSSA 

NAME LDimmick DWhite / kns JLuehman/ NA BMcDermott 

DATE 01/12/12 01/18/12 01/ /12 01/20/12 

OFFICE Tech Editor FSME DEDMRT 

NAME PTressler for CPoland CCarpenter for MSatorius MWeber 

DATE 01/26/12 01/25/12 01/27/12 

OFFICIAL RECORD COPY 
 

Letter to R. Chapman from Michael F. Weber dated: January 27, 2012 

SUBJECT: California 2012 FINAL IMPEP REPORT 

DISTRIBUTION: EDATS: FSME-2012-0002 

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RidsEdoMailCenter 

RidsFsmeOd 

RidsOgcMailCenter 

RidsSecyCorrespondenceMailCenter Chairman Jaczko 

JLynch, RIII/RSAO Commissioner Svinicki 

RErickson, RIV/RSAO Commissioner Apostolakis 

BParker, RI Commissioner Magwood 

VCox, FSME Commissioner Ostendorff 

DTubberville, AL SECY 

KVonAhn, OH 

RidsRgn1MailCenter 

JThompson, AR 

DMerzke, OEDO 

BJones, OGC 

TRothschild, OGC 

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JWeil, OCA (2 copies) 
Enclosure 1 

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM 

REVIEW OF THE CALIFORNIA AGREEMENT STATE PROGRAM 

OCTOBER 17-21, 2011 

FINAL REPORT
EXECUTIVE SUMMARY 

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

(IMPEP) review of the California Agreement State Program. The review was conducted during 

the period of October 17-21, 2011, by a review team composed of technical staff members from 

the U.S. Nuclear Regulatory Commission (NRC) and the States of Alabama and Ohio. 

Based on the results of this review, California’s performance was found unsatisfactory for the 

indicator, Compatibility Requirements, and satisfactory for the six remaining performance 

indicators reviewed. The finding for the Compatibility Requirements indicator remains 

unchanged from the previous IMPEP review. Progress has been made on the indicator, but 

the State has not yet addressed a large number of outstanding NRC comments regarding 

earlier regulation packages. The review team determined that one recommendation from the 

2008 IMPEP review, regarding inspection frequency, should be closed. The other 

recommendation from the 2008 IMPEP review, regarding regulation adoption, was modified to 

require a specific action plan to resolve the backlog of overdue regulations. 

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

agreed, that the California Agreement State Program is adequate to protect public health and 

safety, and not compatible with NRC’s program. The review team also recommended, and the 

MRB agreed, that the period of Monitoring currently in place for California continue until 

significant progress is made in the regulation promulgation process. 

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

approximately four years, with an early Periodic Meeting scheduled in one year from the date of 

the MRB meeting and an additional Periodic Meeting in approximately 2.5 years.
California Final IMPEP Report Page 1 

1.0 INTRODUCTION 

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

(IMPEP) review of the California Agreement State Program. The review was conducted during 

the period of October 17-21, 2011, by a review team composed of technical staff members from 

the U.S. Nuclear Regulatory Commission (NRC) and the States of Alabama and Ohio. 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 

NRC Management Directive 5.6, “Integrated Materials Performance Evaluation Program 

(IMPEP),” dated February 26, 2004. Preliminary results of the review, which covered the period 

of April 5, 2008, to October 21, 2011, were discussed with California managers on the last day 

of the review. 

A draft of this report was issued to California for factual comment on November 10, 2011. The 

State responded by electronic mail dated January 5, 2012. A copy of the State’s response is 

included as an Attachment to this report. The Management Review Board (MRB) met on 

January 5, 2012, to consider the proposed final report. The MRB found the California 

Agreement State Program adequate to protect public health and safety, and not compatible with 

NRC’s program. 

The California Agreement State Program is administered by the Radiologic Health Branch (the 

Branch), which is located within the Division of Food, Drug, and Radiation Safety (the Division). 

The Division is part of the Department of Public Health (the Department). Organization charts 

for the Department, Division, and the Branch are included as Appendix B. 

At the time of the review, the California Agreement State Program regulated 1,853 specific 

licenses authorizing possession and use of radioactive materials. The review focused on the 

radioactive materials program as it is carried out under the Section 274b. (of the Atomic Energy 

Act of 1954, as amended) Agreement between the NRC and the State of California. 

In preparation for the review, a questionnaire addressing the common and applicable noncommon performance indicators was sent to the Branch on June 23, 2011. The Branch 

provided its response to the questionnaire on October 1, 2011. A copy of the questionnaire 

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

(ADAMS) using the Accession Number ML11279A020. 

The review team’s general approach for conduct of this review consisted of: (1) examination of 

the Branch’s response to the questionnaire, (2) review of applicable California statutes and 

regulations, (3) analysis of quantitative information from the Branch’s database, (4) technical 

review of selected regulatory actions, (5) field accompaniments of nine inspectors, and 

(6) interviews with staff and managers. The review team evaluated the information gathered 

against the established criteria for each common and the applicable non-common performance 

indicator and made a preliminary assessment of the California Agreement State Program’s 

performance. 

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

during previous reviews. Results of the current review of the common performance indicators 
California Final IMPEP Report Page 2 

are presented in Section 3.0. Section 4.0 details the results of the review of the applicable noncommon performance indicators, and Section 5.0 summarizes the review team’s findings. 

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS 

During the previous IMPEP review, which concluded on April 4, 2008, the review team made 

two recommendations regarding the California Agreement State Program’s performance. The 

status of the recommendations is as follows: 

1. The review team recommends that the State reevaluate its justification for inspecting 

high dose rate remote afterloader (HDR) licensees on a 3-year interval and 

demonstrate that the health, safety, and security of HDR devices are not 

compromised. (Section 3.2 of the 2008 IMPEP report) 

Status: California modified the inspection frequency for HDR licensees to a 2-year 

interval, consistent with NRC’s inspection frequency. This recommendation is 

closed. 

2. The review team recommends that the Branch develop and implement an action plan 

to adopt NRC regulations in accordance with the current NRC policy on adequacy 

and compatibility. (Section 4.1.2 of the 2008 IMPEP report) 

Status: The State developed an action plan and has made considerable progress in 

the adoption of regulations; however, a backlog of uncompleted regulation packages 

remains. The review team modified the 2008 recommendation to require a specific 

plan, with actions, tasks and milestones, to resolve the backlog of overdue 

regulations, as described in Section 4.1 below. This recommendation remains open. 

3.0 COMMON PERFORMANCE INDICATORS 

Five common performance indicators are used to review NRC Regional and Agreement State 

radioactive materials programs. These indicators are: (1) Technical Staffing and Training, 

(2) Status of Materials Inspection Program, (3) Technical Quality of Inspections, (4) Technical 

Quality of Licensing Actions, and (5) Technical Quality of Incident and Allegation Activities. 

3.1 Technical Staffing and Training

Issues central to the evaluation of this indicator include the Branch’s staffing level and staff 

turnover, as well as the technical qualifications and training histories of the staff. To evaluate 

these issues, the review team examined the Branch’s questionnaire response relative to this 

indicator, interviewed Branch managers and staff, and reviewed job descriptions, training plans, 

and training records. The review team also considered any possible workload backlogs in 

evaluating this indicator. 

At the time of the previous review, the Branch was comprised of five Sections, all reporting to 

the Branch Chief. During the review period, the Branch added a sixth Section to allow each 

Section to have a more focused approach to the Branch’s business. The Financial Operations 

and Analysis Section support program infrastructure and human resources. The Registration 
California Final IMPEP Report Page 3 

and Certification Section, and the Inspection, Compliance, and Enforcement Section, Radiation 

Machines, deal primarily with machine-made radiation. The Radioactive Materials Licensing 

Section (the Licensing Section) performs all of the Agreement State licensing functions. The 

Inspection, Compliance, and Enforcement (ICE) Section, Radioactive Materials, is the 

inspection arm of the Branch for the materials program; and, the new Strategic Planning & 

Quality Assurance Section handles special projects and strategic planning for the Branch. 

The Licensing Section employs three Senior Health Physicists as Unit Supervisors and has staff 

positions for 15 Associate Health Physicists, one Assistant Health Physicist, and two Junior 

Health Physicist positions. Most licensing functions are performed in the Sacramento office by 

three Units in the Licensing Section. A previous fourth Licensing Unit was moved from the 

Licensing Section to the Strategic Planning & Quality Assurance Section. This Unit, in part, 

performs radiological assessments. 

The ICE Section is operated out of the Sacramento office and two regional offices, one in 

Richmond (Northern California), and one in Brea (Southern California). Both of the regional 

offices have a Senior Health Physicist as a supervisor. The Northern California Office has six 

Associate Health Physicists and two support staff, while the Southern California Office has four 

Associate Health Physicists. In addition, the Branch has contracts with Los Angeles and San 

Diego Counties to perform radioactive material inspections. Three full-time equivalents for 

radioactive materials inspections are currently contracted in the County programs. At the time 

of the review, the total number of health physicist positions dedicated to radioactive materials in 

the ICE Section was 12, not including contractor support. The review team found that the 

balance in staffing between the licensing and inspection programs was effective. 

A separate unit, the Regulations Unit, is staffed by a Senior Health Physicist and an Associate 

Health Physicist that maintain the State’s radioactive materials regulations. These individuals 

previously reported to the Branch Chief but now report to the Strategic Planning & Quality 

Assurance Section Chief. 

The Branch Chief position is vacant due to a retirement and is in the process of being filled, and 

is currently staffed by Section Chiefs rotating through the position. Discussions with Divisional 

managers indicated that the Branch Chief position would be permanently filled in the near 

future. The current Acting Branch Chief is also the Section Chief for the Licensing Section. The 

Section Chief for the ICE Section will act in the Branch Chief position beginning 

December 1, 2011. The review team noted that the Branch had two vacancies in the materials 

program at the time of the review. One position was being permanently held open due to 

personnel issues, and a selection and job offer had been made for the second vacant position. 

The review team determined that actions taken by the Branch in reorganizing and recruiting 

qualified individuals for vacancies have proven effective. Despite being subject to a fragile 

economy, staff departures are promptly filled, helping to keep up with the high volume of work 

produced by the Branch. 

One area the review team noted where staffing was an issue was in the area of regulation 

development. As discussed later in this report, regulation development has continued to be an 

ongoing problem for the Branch. California has a long process for rule adoption which 

commences after regulations are drafted by the Branch. That initial drafting of regulations was 

an area of concern for the review team. For several years, the Branch has had one individual 
California Final IMPEP Report Page 4 

primarily responsible for all rule development (materials, X-ray and other areas). Because this 

individual is primarily responsible for all regulation development, the time allocated to each type 

of regulation development is limited. This splitting of time has resulted in the Branch often being 

several years behind in regulation development and ultimately being placed on different forms of 

increased surveillance by the NRC. Department managers are committed to applying additional 

resources to address this problem. 

The review team also reviewed job descriptions, qualification matrixes, and training records 

maintained by the inspection and licensing sections. The training policy for inspectors is 

contained in the ICE Section manual 17.0, “Qualification of Inspectors.” Inspectors are 

permitted to independently perform inspections for those categories of licenses for which 

training was completed. The Branch documents the training requirements for license reviewers 

in Procedure 07-01, “Training Program for Radioactive Materials Licensing Health Physicists.” 

Qualifications for both license reviewers and inspectors are consistent with those found in 

NRC’s Inspection Manual Chapter (IMC) 1246, “Formal Qualification Programs in the Nuclear 

Materials Safety and Safeguards Program Area.” Currently, all license categories are covered 

by trained inspectors or license reviewers as indicated by the Branch’s qualification records. 

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

that California’s performance with respect to the indicator, Technical Staffing and Training, be 

found satisfactory. 

3.2 Status of Materials Inspection Program

The review team focused on five factors while reviewing this indicator: inspection frequency, 

overdue inspections, initial inspections of new licenses, timely dispatch of inspection findings to 

licensees, and performance of reciprocity inspections. The review team=s evaluation was based 

on the Branch’s questionnaire response relative to this indicator, data gathered from the 

Branch=s database, examination of completed inspection casework, and interviews with 

management and staff. 

The review team verified that California’s inspection frequencies for all types of radioactive 

material licenses are at the same frequency as similar license types listed in IMC 2800, 

“Materials Inspection Program.” 

The review team determined that during the review period, the Branch conducted approximately 

685 Priority 1, 2, and 3 inspections, based on the inspection frequencies established in 

IMC 2800. Fifty-four of these inspections were conducted overdue by more than 

25 percent of the inspection frequency prescribed in IMC 2800. The review team identified nine 

current overdue inspections at the time of the review. 

The Branch performed approximately 153 initial inspections during the review period, of which 

19 were conducted overdue. As required by IMC 2800, initial inspections should be conducted 

within 12 months of license issuance. 

Branch supervisors stated the inspections were sometimes conducted late due to changing 

inspection priority codes, database issues and lack of management monitoring of overdue 

inspections. The Branch self-identified the issues and developed a plan to better monitor 
California Final IMPEP Report Page 5 

inspection due dates. Overall, the review team calculated that the Branch performed 

9.8 percent (82 overdue inspections out of 838 inspections) of the total Priority 1, 2, and 3 and 

initial inspections overdue during the review period. 

The review team evaluated the Branch=s timeliness in providing inspection findings to licensees. 

The review team’s evaluation of 22 inspection reports identified only two inspection findings 

letters were communicated to the licensees beyond the Branch=s goal of 30 days postinspection. The two late inspection letters were issued 45 and 68 days after the inspections. 

During the review period, the Branch granted 204 reciprocity permits, 75 of which were 

candidate licensees, based upon the criteria in IMC 1220, “Processing of NRC Form 241 and 

Inspection of Agreement State Licensees Operating under 10 CFR 150.20.” Twenty-six of the 

candidate licensees were inspected. The review team determined that the Branch met or 

exceeded the NRC=s criteria of inspecting 20 percent of candidate licensees operating under 

reciprocity in each of the four years covered by the review period. 

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

that California=s performance with respect to the indicator, Status of Materials Inspection 

Program, be found satisfactory. 

3.3 Technical Quality of Inspections

The review team evaluated the inspection reports, enforcement documentation, inspection field 

notes, and interviewed inspectors for 29 radioactive materials inspections conducted during the 

review period. The casework reviewed included inspections conducted by 15 Branch inspectors 

and covered inspections of various license types, including: medical broad scope, medical 

institutions, medical private practice, portable gauges, industrial radiography, well logging, 

research and development, veterinary use, gamma knife, nuclear pharmacy, mobile nuclear 

medicine, service providers, reciprocity and Increased Controls. The evaluation also included a 

review of documentation of decommissioning inspections and confirmatory surveys performed 

by the Radiological Assessment Unit. Appendix C lists the inspection casework files reviewed, 

with case-specific comments, as well as the results of the inspector accompaniments. 

Based on the evaluation of casework, the review team noted that inspections covered all 

aspects of licensed radiation programs. The review team found that compliance inspection 

reports were generally complete and consistent, with sufficient documentation to ensure that a 

licensee’s performance with respect to health and safety was acceptable. The documentation 

supported violations, recommendations made to licensees, unresolved safety issues, and 

discussions held with licensees during exit interviews. The reports used for Increased Controls 

inspections were properly marked with "Official Use Only - Security Related Information" and 

correspondence to licensees pertaining to those inspections was also found to be properly 

marked.

The review team determined that inspectors conducted field inspections, as appropriate, to 

evaluate a licensee’s program. The review of the casework did note one instance where an 

unqualified inspector performed an inspection of a nuclear pharmacy. This was brought to the 
California Final IMPEP Report Page 6 

Division management’s attention by the review team and based on the circumstances, a 

decision was made by Branch managers to consider the inspection incomplete. The inspection 

was rescheduled to be performed by a qualified inspector. 

The inspection procedures utilized by the Branch are generally consistent with the inspection 

guidance outlined in IMC 2800. The Branch has a goal of performing 90 percent of its 

inspections as unannounced, but allows one-day announced inspections to increase inspector 

efficiency. The compliance inspection reports used by the inspectors are detailed with 

opportunities for the inspector to add comments as needed to describe items noted during the 

inspection. For the inspections, the inspector has the option to provide inspection results to the 

licensee utilizing the Branch 2514 “short” form, which requires signature by the licensee and 

inspector, and is left with the licensee at the completion of the onsite inspection. This method 

can be used for an inspection where no violations or only minor items of concern are identified. 

The ICE Section supervisors review and sign all inspection reports. Supervisory 

accompaniments were conducted annually for all inspectors. 

The review team determined that the inspection findings were appropriate and prompt 

regulatory actions were taken, as necessary. All inspection findings were clearly stated and 

documented in the reports and communicated to the licensees. The Branch issues to the 

licensee either a letter indicating a clear inspection or a letter with a Notice of Violation which 

details the results of the inspection. These letters are routinely sent within 30 days of the 

inspections with a few exceptions noted. When the Branch issues a Notice of Violation, the 

licensee is required to provide a written corrective action plan within 30 days. The licensee’s 

corrective measures are evaluated by the inspector and an ICE Section supervisor, and if found 

satisfactory, an acknowledgement letter is sent to the licensee. After all actions are completed, 

an inspection packet that includes a compliance inspection code sheet, inspection report and 

enforcement documentation, is sent to the Sacramento office where it is filed and the inspection 

database is updated. 

The review team noted that the Branch has an adequate supply of survey instruments to 

support their inspection program. Inspectors are assigned appropriate, calibrated survey 

instrumentation, such as Geiger-Mueller (GM) meters, scintillation detectors, ion chambers, 

micro-R meters and portable multichannel analyzers. The Branch also has neutron detectors 

and a wide array of survey and analysis equipment to support the inspection program and the 

Radiological Assessment Unit. Instruments are calibrated annually by an approved vendor in 

the Sacramento area. 

A review team member visited the State laboratory facility to evaluate its support to the Branch. 

The State laboratory is located adjacent to the Branch’s Northern California Office and performs 

sample analysis for multiple programs within the Branch. The laboratory has four staff positions 

which are dedicated to radiochemistry analysis, two of which are funded entirely by the Branch. 

The laboratory has a wide array of analytical equipment capable of detailed radiochemistry 

analysis. The equipment includes multiple high purity germanium detectors, several gamma 

counters, and various scintillation counters. 

The review team accompanied nine of the Branch’s inspectors in September 2011. The 

inspectors conducted inspections at industrial radiography facilities, a nuclear pharmacy, a 

gamma knife, medical facilities, a pool irradiator, and a research facility. Three of the 
California Final IMPEP Report Page 7 

inspections included a review of the licensees’ implementation of the Increased Controls. 

Appendix C lists the inspector accompaniments. The inspectors demonstrated performancebased inspection techniques and knowledge of the regulations. The inspectors were well 

trained, prepared for the inspections, and thorough in their audits of the licensees’ radiation 

safety programs. The inspectors conducted interviews with appropriate personnel, observed 

licensed operations, conducted confirmatory measurements, and utilized good health physics 

practices. The inspectors held entrance and exit meetings with the appropriate level of licensee 

management. The review team determined that the inspections were adequate to assess 

radiological health, safety, and security at the licensed facilities. 

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

that California’s performance with respect to the indicator, Technical Quality of Inspections, be 

found satisfactory. 

3.4 Technical Quality of Licensing Actions

The review team examined completed licensing casework and interviewed license reviewers for 

34 specific licensing actions. Licensing actions were reviewed for completeness, consistency, 

proper radioisotopes and quantities, qualifications of authorized users, adequacy of facilities and 

equipment, adherence to good health physics practices, financial assurance, operating and 

emergency procedures, appropriateness of license conditions, and overall technical quality. 

The casework was also reviewed for timeliness, use of appropriate deficiency letters and cover 

letters, reference to appropriate regulations, supporting documentation, consideration of 

enforcement history, pre-licensing visits, peer/supervisory review, and proper signatures. 

The licensing casework was selected to provide a representative sample of licensing actions 

completed during the review period. Licensing actions selected for evaluation included 3 new 

licenses, 4 renewals, 3 decommissioning or termination actions, 2 bankruptcy actions, and 

22 amendments. Files reviewed included a cross-section of license types, including: broad 

scope, medical diagnostic and therapy, brachytherapy, industrial radiography, research and 

development, nuclear pharmacy, gauges, manufacturers, panoramic and self-shielded 

irradiators. The casework sample represented work from 23 license reviewers. A listing of the 

licensing casework evaluated is provided in Appendix D. 

Overall, the review team found that the licensing actions were thorough, complete, consistent, 

and of high quality with health, safety, and security issues properly addressed. License tiedown conditions were stated clearly and were supported by information contained in the file. 

Deficiency letters clearly stated regulatory positions, were used at the proper time, and identified 

substantive deficiencies in the licensees’ documents. Terminated licensing actions were well 

documented, showing appropriate transfer and survey records. All licensing actions are 

maintained in the Branch’s electronic database and files. License reviewers use the Branch’s 

licensing guides, policies, checklists, and standard license conditions, specific to the type of 

licensing actions, to ensure consistency in licenses.

Incoming actions are processed by the Special Projects Unit, which logs them in and delivers to 

the appropriate unit. Unit chiefs assign actions to the reviewers, who then take the actions for 

review. If other areas apply, such as financial assurance, increased controls or need for a prelicensing visit, the action is forwarded to the appropriate person or group for additional review or 
California Final IMPEP Report Page 8 

attention. Once completed, each licensing action undergoes a peer review before going to the 

Unit chief for final review and signature. 

Licenses are issued for a ten-year period under a timely renewal system. The review team 

noted that the Branch’s backlog for license renewals (pending greater than one year) had 

significantly increased over the review period. This has resulted in approximately 20 percent of 

licensees operating under timely renewal. The increase in the backlog for license renewals is 

largely attributed to the adoption of 10 CFR Part 35 and the corresponding medical licensing 

actions necessary to support the rule. In addition, license amendments issued for health and 

safety to address overdue regulations took priority over backlogged renewals. The review team, 

based on its assessment of the licensing program, believed safety was maintained through the 

amendment process and inspection program, in spite of the backlog. Branch management 

indicated that they intend to focus on the backlog and have a plan in place. 

Based on the casework evaluated, the review team concluded that the licensing actions were of 

high quality and consistent with the NUREG-1556 guidance documents, the State’s regulations, 

and good health physics practices. The review team attributed the consistent use of templates 

and quality assurance reviews to the overall quality noted in the casework reviews. 

The Branch’s pre-licensing review methods incorporate the essential elements of NRC’s revised 

pre-licensing guidance to verify that the applicant will use requested radioactive materials as 

intended. All new licensees receive a pre-licensing site visit which includes an evaluation of the 

applicant’s radiation safety and security programs prior to receipt of the initial license. In fact, 

the Branch performs pre-licensing checks of all significant licensing actions. This approach is 

more restrictive than NRC policy and requires significant resources to accomplish. Branch 

management indicated during the review that they were revising the pre-licensing procedures to 

align more closely to current NRC policy. 

The review team examined the Branch’s licensing practices regarding the Increased Controls 

and Fingerprinting Orders. The review team noted that the Branch uses legally binding license 

conditions that meet the criteria for implementing the Increased Controls Orders, including 

fingerprinting, as appropriate. The review team analyzed the Branch’s methodology for 

identifying those licenses and found the rationale was thorough and accurate. The review team 

confirmed that license reviewers evaluated new license applications and license amendments 

using the same criteria. The Branch requires full implementation of the Increased Controls prior 

to issuance of a new license or license amendment that meets the established criteria. 

The review team noted that sensitive, unclassified, non-safeguards information (SUNSI) related 

to security and Increased Controls, was properly controlled and protected to prevent 

unauthorized access in accordance with “Additional Guidance and Clarification Regarding the 

Review of the Control of Sensitive Information During Integrated Materials Performance 

Evaluation Program (RCPD-11-005).” The Branch does not mark documents as suggested by 

NRC Regulatory Issue Summary (RIS) 2005-31, “Control of Security-Related SUNSI Handled 

by Individuals, Firms, and Entities Subject to NRC Regulation of the Use of Source, Byproduct, 

and Special Nuclear Material,” dated December 22, 2005. However, discussions with Branch 

management indicated that since all documents are withheld from public disclosure, the Branch 

felt this eliminated the need to further mark documents. The review team found this sufficient. 
California Final IMPEP Report Page 9 

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

that California’s performance with respect to the indicator, Technical Quality of Licensing 

Actions, be found satisfactory. 

3.5 Technical Quality of Incident and Allegation Activities

In evaluating the effectiveness of the Branch=s actions in responding to incidents and 

allegations, the review team examined the Branch=s response to the questionnaire relative to 

this indicator, evaluated selected incidents reported for California in the Nuclear Material Events 

Database (NMED) against those contained in the Branch=s files, and evaluated the casework for 

20 radioactive materials incidents. A listing of the incident casework examined, with casespecific comments, may be found in Appendix E. The review team also evaluated the Branch=s 

response to 19 allegations involving radioactive materials, including 17 allegations referred to 

the State by the NRC during the review period. 

When the Branch is notified of an incident or allegation, the staff member who receives the 

notification records the information in a Form 5010, “Matter Requiring Investigation/Inspection.” 

A supervisor assigns responsibility for initial response to incidents and allegations involving 

radioactive material, to a technical staff member. The Branch has comprehensive written 

procedures for handling investigations. Once the investigation is completed, a “Materials 

Investigation Closing Memo” is generated, signed off by the appropriate supervisor, and placed 

in the investigation file. 

The incidents selected for review included the following categories: medical events, lost/stolen 

material, leaking sources, damaged equipment, and transportation. The review team 

determined that the Branch=s response to incidents was complete and comprehensive. Initial 

responses were prompt and well-coordinated, and the level of effort was commensurate with the 

health and safety significance. The Branch dispatched inspectors for on-site investigations 

when appropriate and took suitable enforcement and follow-up actions. If the incident met the 

reportability thresholds, as established in the Office of Federal and State Materials and 

Environmental Management Programs (FSME) Procedure SA-300 “Reporting Material Events,” 

the State notified the NRC Headquarters Operations Center and entered the information into 

NMED in a prompt manner. The NRC’s contractor that runs the NMED database stated that 

California did an outstanding job in providing initial and follow-up information for inclusion in the 

database. 

The review team identified 237 radioactive material incidents in NMED for California during the 

review period. The review team evaluated the Branch=s timeliness of reporting incidents and 

found that all incidents are reported in the required time frame, following the Branch=s receipt of 

notification from the licensees. 

In evaluating the effectiveness of California’s actions responding to allegations, the review team 

evaluated the casework for the 17 allegations referred to the State by the NRC, as well as the 

casework for two additional allegations reported directly to the State. The Branch evaluated 

each allegation and determined the proper level of response. The casework review indicated 

that the Branch took prompt and appropriate action in response to all concerns raised. All of the 
California Final IMPEP Report Page 10 

allegations reviewed were appropriately closed, and appropriate parties were notified of the 

actions taken. The review team identified no performance issues from the review of the 

allegation casework. 

The State has a Freedom of Information Act- equivalent law, the Public Records Act. The 

review team discussed the Branch’s process for release of records under the Public Records 

Act and determined that the alleger’s identities were adequately protected. 

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

that California=s performance with respect to the indicator, Technical Quality of Incident and 

Allegation Activities, be found satisfactory. 

4.0 NON-COMMON PERFORMANCE INDICATORS 

Four non-common performance indicators are used to review Agreement State programs: 

(1) Compatibility Requirements, (2) Sealed Source and Device Evaluation Program, (3) LowLevel Radioactive Waste Disposal Program, and (4) Uranium Recovery Program. The NRC’s 

Agreement with California does not relinquish regulatory authority for a uranium recovery 

program; therefore, only the first three non-common performance indicators applied to this 

review. 

4.1 Compatibility Requirements

4.1.1 Legislation

California became an Agreement State on September 1, 1962. The statutory authority for the 

State’s Radiation Control Program is found in Section 7.6 of the California Health and Safety 

Code. The Division is designated as the State’s radiation control agency, and the Branch 

implements the radiation control program. The review team found that one piece of legislation 

was passed during the review period that will become effective in 2012. This legislation adds 

one additional step to the rule development process and requires a broader analysis of the 

economic impacts of rules being developed. The Branch is uncertain at this time how this State 

law will specifically affect their rule development process. 

4.1.2 Program Elements Required for Compatibility

The State’s regulations for control of radiation are located in Title 17 of the California Code of 

Regulations and apply to all ionizing radiation, whether emitted from radionuclides or devices. 

California requires a license for possession and use of all radioactive materials. The review 

team also determined that the State is not subject to sunset regulations. 

The review team evaluated the Branch’s response to the questionnaire relative to this indicator, 

reviewed the status of regulations required to be adopted by the State under the Commission’s 

adequacy and compatibility policy, and verified the adoption of regulations with data obtained 

from the State Regulation Status sheet that FSME maintains. 

A review of the State’s rulemaking process revealed that the process can take well over 

600 days from the time a draft rule is placed in the system to the final filing with the Secretary of 
California Final IMPEP Report Page 11 

State. The rules then become effective in 30 days. The public, NRC, other State agencies, and 

all potentially impacted licensees and registrants are offered an opportunity to comment during 

the rulemaking review process. When a proposed rule is sent for public comment, it is also sent 

to NRC for a compatibility review. After resolution of any comments, the final rules are sent to 

the California Register as notification of adoption. Final rules are also sent to licensees and to 

the NRC. 

With so much lead time required, the Branch must initiate its rulemaking process for those rules 

necessary for compatibility, immediately after NRC publishes its final rule, in order to meet the 

three-year compatibility requirement. This initiation of the rulemaking process and the timely 

drafting of regulations have been noted as an issue for the Branch since the 2004 IMPEP 

review, and continues to be an issue for the Branch in this review. The Branch only has one 

staff member assigned to regulation development, including both materials and x-ray 

regulations. When this staff member is working to develop x-ray regulations, rules necessary 

for materials compatibility are not being developed. This staffing issue, as illustrated earlier in 

this report, was discussed with Division managers who agreed to consider additional resources 

to alleviate this problem. Division managers stated at the MRB meeting that an additional 

regulations staff member would be in place by February 1, 2012. 

The State reported they continue to make some progress on the regulation backlog. California 

processes rule packages by “Parts”, such as Part 20 or Part 35, instead of by amendments that 

cross over several Parts as is done during NRC rule promulgation. 

The review team found that the State can also adopt regulations by reference, but noted that 

State regulations need to pass a criterion called clarity, where the regulation needs to be clear, 

difficult to misunderstand, and be stand-alone, requiring no additional guidance. The State has 

difficulty at times incorporating NRC rules by reference because NRC regulations tend to be 

performance-based, with implementing guidance available in another document. The State 

would need to make the requirement specific and incorporate some of the guidance information 

in its regulations for them to pass the clarity criterion. 

At the time of the 2008 IMPEP review there were 14 overdue regulations. During the review 

period, the Branch completed ten amendments; nine of which were overdue at the time of their 

completion. Currently the Branch has 12 overdue regulations with an additional 3 regulations 

coming due for adoption in the near future. The review team noted at the time of the review that 

no new amendments were being prepared by the Branch for processing, and the regulation 

development staff member indicated with the current workload, that amendment packages 

would likely not be processed for some time, likely a year. 

Current NRC policy requires that Agreement States adopt certain equivalent regulations or 

legally binding requirements no later than three years after they become effective. The 

following amendments are overdue, some significantly longer than three years from their 

effective date. 

• “Decommissioning Recordkeeping and License Termination: Documentation Additions 

[Restricted areas and spill sites],” 10 CFR Parts 30, and 40 amendments (58 FR 39628), 

that was due for Agreement State implementation on October 25, 1996. 
California Final IMPEP Report Page 12 

• “Timeliness in Decommissioning of Materials Facilities,” 10 CFR Parts 30, 40, and 70 

amendments (59 FR 36026), that was due for Agreement State implementation on 

August 15, 1997. 

This rule is tied to the amendment “Radiological Criteria for License Termination.” See 

below. 

• "Licenses for Industrial Radiography and Radiation Safety Requirements for Industrial 

Radiography Operations," 10 CFR Parts 30, 34, 71 and 150 amendments (62 FR 28947) 

that was due for Agreement State implementation on June 27, 2000. 

• “Radiological Criteria for License Termination,” 10 CFR Parts 20, 30, 40, and 70 

amendments (62 FR 39057), that was due for Agreement State implementation on 

August 20, 2000. 

The 10 CFR Part 20 portion of the regulation was adopted and then challenged in State 

court by "The Committee to Bridge the Gap, et al." The challenge was successful, and 

the "Radiological Criteria for License Termination" portion of the regulation was repealed 

on August 8, 2002. The Branch is currently terminating licenses on a case-by-case 

basis. This amendment remains open. 

• “Minor Corrections, Clarifying Changes, and a Minor Policy Change,” 10 CFR Parts 20, 

32, 35, 36, and 39 amendments (63 FR 39477 and 63 FR 45393), that was due for 

Agreement State implementation on October 26, 2001. 

• “Requirements for Certain Generally Licensed Industrial Devices Containing Byproduct 

Material,” 10 CFR Parts 30, 31, and 32 amendments (65 FR 79162), that was due for 

Agreement State implementation on February 16, 2004. 

• “Medical Use of Byproduct Material,” 10 CFR Parts 20, 32, and 35 amendments (67 FR 

20249), that was due for Agreement State implementation on October 24, 2005. 

• “Medical Use of Byproduct Material - Recognition of Specialty Boards,” 10 CFR Part 35 

amendment (70 FR 16336 and 71 FR 1926), that was due for Agreement State 

implementation on April 29, 2008. 

• “Minor Amendments,” 10 CFR Parts 20, 30, 32, 35, 40, and 70 amendments (71 FR 

15005), that was due for Agreement State implementation by March 27, 2009. 

• “Medical Use of Byproduct Material – Minor Corrections and Clarifications,” 10 CFR 

Parts 32 and 35 amendments (72 FR 45147, 72 FR 54207), that was due for Agreement 

State implementation by October 29, 2010. 

• “Exemptions from Licensing, General Licenses, and Distribution of Byproduct Material: 

Licensing and Reporting Requirements,” 10 CFR Parts 30, 31, 32, 150 amendments 

(72 FR 58473), that was due for Agreement States implementation by December 17, 

2010. 
California Final IMPEP Report Page 13 

• “Requirements for Expanded Definition of Byproduct Material,” 10 CFR Parts 20, 30, 31, 

32, 33, 35, 61, and 150 amendments (72 FR 55864), that was due for Agreement State 

implementation by November 30, 2010. 

The review team identified the following regulation changes and adoptions that will be needed in 

the future, and the State related that the regulations would be addressed in upcoming 

rulemaking or by adopting alternate legally binding requirements: 

• “Medical Use of Byproduct Material – Authorized User Clarification,” 10 CFR Part 35 

amendment (74 FR 33901), that is due for Agreement State implementation by 

September 28, 2012. 

• “Decommissioning Planning,” 10 CFR Parts 20, 30, 40, and 70 amendments (76 FR 

35512), that is due for Agreement State implementation by December 17, 2015. 

• “Licenses, Certifications, and Approvals for Materials Licensees,” 10 CFR Parts 30, 36, 

39, 40, 70, and 150 amendments (76 FR 56591), that is due for Agreement State 

implementation by November 14, 2014. 

The review team also noted little progress on an issue noted during the 2008 review, and 

discussed with the Branch during subsequent Periodic Meetings and Monitoring calls. This 

involves the incompatibility of legislation found in Section 115261 of California’s “Health and 

Safety Code – Radiation Control Law” to NRC’s 10 CFR Part 61 with regard to low-level 

radioactive waste disposal. This incompatibility was initially noted in an amendment submission 

to NRC on June 25, 2007. At that time, NRC notified the State that their statute was more 

restrictive than 10 CFR 61.41, and therefore did not meet the Compatibility Category “A” 

designation assigned to the rule. To date, this compatibility issue has not been resolved. 

Branch supervisors were uncertain when this issue will be resolved. 

Considering the continued number of overdue regulation changes and the lengthy process to 

complete regulation development, the review team was again not able to find that the California 

Agreement State Program was meeting the compatibility requirements as identified in the 

IMPEP evaluation criteria. As noted during previous reviews, the review team believes that 

additional time and resources will be needed before the State can adopt all overdue regulations 

required for compatibility. 

At the time of the 2008 review, the team made a recommendation that the Branch develop and 

implement an action plan to adopt NRC regulations in accordance with the current NRC policy 

on adequacy and compatibility. The review team concluded that the Branch did develop and 

implement a general action plan for adoption of NRC regulations; however, the team believes 

that the Branch’s plan is not specific enough to transition them through the regulation 

development process in a timely manner. Therefore, the review team is modifying the previous 

recommendation to include greater specificity. The review team recommends that the State 

develop and implement a detailed action plan that fully documents actions, tasks, and 

milestones associated with each regulation package, to better track adoption of required 

regulations in accordance with the current NRC policy on adequacy and compatibility. 
California Final IMPEP Report Page 14 

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

that California’s performance with respect to the indicator, Compatibility Requirements, be found 

unsatisfactory. 

4.2 Sealed Source and Device Evaluation Program

In reviewing this indicator, the review team used three subelements to evaluate the Branch’s 

performance regarding the Sealed Source and Device (SS&D) Evaluation Program. The subelements are: (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 

provided by the Branch in response to the IMPEP questionnaire for this indicator. The review 

team conducted a review of all new, amended, and inactivated SS&D evaluations and 

supporting documents covering the review period. The review team noted the staff’s use of 

guidance documents and procedures, interviewed the staff involved in SS&D evaluations, and 

verified the use of regulations, license conditions, and inspections to enforce commitments 

made in the applications. 

4.2.1 Technical Staffing and Training

The Branch has three individuals that are fully qualified SS&D reviewers with full signature 

authority to perform concurrence reviews. There are 12 other reviewers that are either partially 

qualified reviewers or are reviewers in training, and they have limited initial reviewer signature 

authority, in accordance with the Branch’s documented training program. The supervisor 

assigning the SS&D reviews makes the assignments based on the extent of reviewer’s training 

and experience relative to the complexity of the review required. The Branch uses the 

concurrence reviewer as the final technical quality reviewer. 

The Branch’s comprehensive training program is discussed in detail in Section 3.1 of this report. 

The Branch has a documented qualification program for SS&D reviewers as a subsection of its 

qualification procedure. The Branch maintains a qualification journal for all reviewers, which 

lists the completed course work relevant to SS&D evaluations. 

The Branch had a list of 62 cases pending review. The breakdown of the cases is six 

amendments, 20 inactivations, and 36 transfer amendments from one manufacturer to another. 

The review team determined that the nature and number of open cases does not present a 

health and safety concern. The Branch has committed to assigning appropriate staff to clear 

out the backlog of cases. 

The review team determined that the staffing level dedicated to performing SS&D evaluations is 

adequate. 

4.2.2 Technical Quality of the Product Evaluation Program

During the review period, the Branch completed 92 SS&D actions, which included one new 

source and device evaluation, with the balance evenly split between amendments of previously 

issued registrations, and inactivations of registration certificates. The casework reviewed 
California Final IMPEP Report Page 15 

included 21 of these actions. The cases selected for review were chosen to be representative 

of the work performed by the Branch during the review period, taking the following factors into 

account: the types of actions performed; the pool of licensees; the types of products evaluated; 

and the different reviewers who performed SS&D evaluations. A listing of the SS&D certificates 

evaluated, with case-specific comments, can be found in Appendix F. 

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

recommended guidance from the NRC SS&D training workshops and NUREG-1556, Volume 3, 

Revision 1, “Consolidation Guidance About Materials Licenses: Application for Sealed Source 

and Device Evaluation and Registration.” The Branch used appropriate review checklists to 

ensure all relevant materials were submitted and reviewed. The review team verified that 

pertinent American National Standards Institute standards, Regulatory Guides, and applicable 

references were available and were used when Branch staff performed SS&D reviews. 

The review team noted some administrative issues and practices that differ from those used in 

the SS&D community in general. These issues and practices were shared with Branch staff 

members. The review team noted that safety issues were not affected by any of these 

administrative issues and practices. 

The review team noted that typed names were used in lieu of handwritten signatures on the 

SS&D registrations. A Branch supervisor had an informal email from their legal representative 

indicating that the typed signature was acceptable for electronic documents. 

The review team noted in registration number CA-406-S-238-S for a line source that the 

registration did not indicate how the singly vs. doubly or triply encapsulated sealed sources 

could be distinguished from one another. The issue being that the singly encapsulated sealed 

source is not robust enough to be used in the gamma gauge applications, as is with the double 

and triple encapsulated sources. Once this was brought to the Branch’s attention, they 

committed to contacting the vendor to clarify the issue. 

The review team determined that the registration files contained all correspondence, 

photographs, engineering drawings, radiation profiles, and details of the applicant’s quality 

assurance and quality control program. The registrations clearly summarized the product 

evaluation to provide license reviewers with adequate information to license the possession and 

use of the product. Deficiency letters clearly stated regulatory positions and all health and 

safety issues were properly addressed. The review team found that the evaluations were of 

high quality with health and safety issues properly addressed. 

4.2.3 Evaluation of Defects and Incidents Regarding SS&Ds

The review team examined a selected sample of incidents or failures regarding SS&D 

registered products that occurred during the review period. The review team examined 

incidents that occurred within the State of California, as well as incidents nationwide that 

occurred within the review period involving equipment or sources registered by the Branch. The 

review team determined that the Branch followed their procedures, analyzed the events and 

evaluated the issues, followed up on the incidents that were relevant to SS&D issues, and 

documented the issues. 
California Final IMPEP Report Page 16 

The review team evaluated the Branch’s response to three separate event or allegation issues 

regarding a high dose rate remote afterloader. These included sources sticking in the unit 

during servicing, transfer guide tube length changes, and failure of an extension adapter during 

prostate treatment. The review team determined the incident investigations were complete, 

thorough, and fully addressed the issues. 

The review team also analyzed the Branch’s response to multiple incidents involving a 

radiography camera in which the locking mechanism prematurely tripped and locked the source 

outside of the secured (safe) position. Based on the Branch’s root cause analysis, the 

manufacturer revised the device instruction manual and the Branch issued an information notice 

regarding user maintenance issues. The review team identified design issues that the Branch’s 

initial investigation did not address, such as a potential device modification to alleviate 

malfunction causative factors. During the review, the Branch reopened the investigation and 

contacted the manufacturer to schedule a meeting to address the additional design issues at the 

manufacturer’s facility. 

The Branch’s evaluation of defects and incidents regarding sealed source and device 

registrations were resolved in accordance with the regulatory requirements and the relevant 

guidance documents and procedures. In cases affecting other Agreement States or the NRC, 

the Branch took the appropriate action to contact the States or the NRC and requested followup action. 

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

that California’s performance with respect to the indicator, Sealed Source and Device 

Evaluation Program, be found satisfactory. 

4.3 Low-level Radioactive Waste Disposal Program

In 1981, the NRC amended its Policy Statement, "Criteria for Guidance of States and NRC in 

Discontinuance of NRC Regulatory Authority and Assumption Thereof by States Through 

Agreement," to allow a State to seek an amendment for the regulation of LLRW as a separate 

category. Although the California Agreement State Program has LLRW disposal authority, the 

NRC has not required States to have a program for licensing a LLRW disposal facility until such 

time as the State has been designated as a host State for a LLRW disposal facility. When an 

Agreement State has been notified or becomes aware of the need to regulate a LLRW disposal 

facility, they are expected to put in place a regulatory program which will meet the criteria for an 

adequate and compatible LLRW disposal program. There are no plans for a LLRW disposal 

facility in California. Accordingly, the review team did not review this indicator. 

 
California Final IMPEP Report Page 17 

5.0 SUMMARY 

As noted in Sections 3.0 and 4.0 above, California’s performance was found unsatisfactory for 

the indicator, Compatibility Requirements, and satisfactory for the remaining performance 

indicators reviewed. The review team modified a recommendation from the 2008 IMPEP review 

regarding the timely promulgation of regulations. 

Accordingly, the review team recommended, and the MRB agreed, that the California 

Agreement State Program is adequate to protect public health and safety, and not compatible 

with NRC’s program. The review team also recommended, and the MRB agreed, that the 

period of Monitoring currently in place for California, be continued until significant progress is 

made in the regulation promulgation process. 

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

approximately four years, with a Periodic Meeting scheduled in one year from the date of the 

MRB meeting and an additional Periodic Meeting in approximately 2.5 years.

The current review team recommendation, modified from the 2008 IMPEP review, is as follows: 

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

detailed action plan that fully documents actions, tasks, and milestones associated with each 

regulation package, to better track adoption of required regulations in accordance with the 

current NRC policy on adequacy and compatibility. 
LIST OF APPENDICES 

Appendix A IMPEP Review Team Members 

Appendix B California Organization Charts 

Appendix C Inspection Casework Reviews 

Appendix D License Casework Reviews 

Appendix E Incident Casework Reviews 

Appendix F Sealed Source and Device Casework Reviews 
APPENDIX A 

IMPEP REVIEW TEAM MEMBERS 

Name Area of Responsibility

Jim Lynch, Region III Team Leader 

 Technical Quality of Incident & Allegation Activities 

 Inspector Accompaniments 

Randy Erickson, Region IV Technical Staffing and Training 

 Compatibility Requirements 

 Inspector Accompaniments 

Vanessa Cox, FSME Status of Materials Inspection Program 

Bryan Parker, Region I Technical Quality of Licensing Actions 

David Turberville, Alabama Technical Quality of Inspections 

Karl Von Ahn, Ohio Sealed Source and Device Evaluation Program 
APPENDIX B 

CALIFORNIA ORGANIZATION CHARTS 

ADAMS ACCESSION NO.: ML112790126 
 APPENDIX C 

INSPECTION CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

Licensee: Cardinal Health License No.: 6925-19 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 8/26/10 Inspectors: DK, JD 

File No.: 2 

Licensee: Cardinal Health License No.: 3822-19 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 8/26/10 Inspector: DK 

File No.: 3 

Licensee: Kaiser Permanente Medical Center License No.: 3653-21 

Inspection Type: Routine, Announced Priority: 3 

Inspection Date: 9/15/11 Inspector: KAH 

File No.: 4 

Licensee: Geo Environ License No.: 6636-30 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 3/3/11 Inspector: AR 

File No.: 5 

Licensee: Industrial Nuclear Co., Inc. License No.: 2229-01 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 5/10/11 Inspector: KAH 

File No.: 6 

Licensee: Seton Medical Center License No.: 1391-41 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Dates: 4/28-5/3/11 Inspector: GF 

File No.: 7 

Licensee: Triad Isotopes, Inc. License No.: 3219-19 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 6/2/11 Inspector: JD 

Comment: Inspector determined to be not qualified to perform inspection. 

File No.: 8 

Licensee: Qal-Tek Associates License No.: NRC 11-27610-01 

Inspection Type: Routine, Announced - Reciprocity Priority: 3 

Inspection Date: 3/28/11 Inspector: RO 
California Final IMPEP Report Page C.2

Inspection Casework Reviews 

File No.: 9 

Licensee: TechCorr Inspection & Engineering License No.: NRC 42-29261-01 

Inspection Type: Routine, Unannounced - Reciprocity Priority: 1 

Inspection Date: 7/14/10 Inspector: AT 

File No.: 10 

Licensee: University of the Pacific License No.: 0840-39 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 1/7/11 Inspector: KF 

File No.: 11 

Licensee: Southern California Edison License No.: 5244-30 

Inspection Type: Routine, Announced Priority: 1 

Inspection Dates: 6/9-15/11 Inspector: KH 

File No.: 12 

Licensee: Corona Regional Medical Center License No.: 1550-33 

Inspection Type: Routine, Announced Priority: 3 

Inspection Date: 4/20/11 Inspector: KH 

File No.: 13 

Licensee: TC Inspection, LLC License No.: 5299-07 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Dates: 6/15-7/11/11 Inspector: RO 

File No.: 14 

Licensee: San Diego Gamma Knife Center License No.: 6072-37 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Dates: 3/9-13/11 Inspector: RY 

File No.: 15 

Licensee: Mercy Imaging Center License No.: 7809-34 

Inspection Type: Initial, Unannounced Priority: 3 

Inspection Date: 1/4/11 Inspector: KF 

File No.: 16 

Licensee: Medi-Physics, Inc. License No.: 5796-37 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 3/11/11 Inspector: RY 

File No.: 17 

Licensee: Newport Imaging Center License No.: 7144-30 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 4/28/11 Inspector: AT 

 
California Final IMPEP Report Page C.3

Inspection Casework Reviews 

File No.: 18 

Licensee: CY Geotech, Inc. License No.: 6617-19 

Inspection Type: Routine, Announced Priority: 5 

Inspection Date: 5/12/11 Inspector: AR 

File No.: 19 

Licensee: City of Alameda Health Care District License No.: 1948-01 

Inspection Type: Routine, Announced Priority: 3 

Inspection Dates: 10/29-11/4/10 Inspector: EM 

File No.: 20 

Licensee: CA Foundation for Health License No.: 4000-15 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 11/29/10 Inspector: AT 

File No.: 21 

Licensee: Pengo Wireline of California License No.: 3943-15 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 11/18/10 Inspector: KF 

File No.: 22 

Licensee: Rapiscan Laboratories License No.: 2484-43 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 1/3/11 Inspector: GF 

File No.: 23 

Licensee: Prime Health Care Management License No.: 0940-19 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Dates: 2/1-3/11 Inspector: JO 

File No.: 24 

Licensee: Golden Empire Cardiology License No.: 7456-15 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 11/17/10 Inspector: AT 

File No.: 25 

Licensee: Radiocat, Inc. License No.: 7255-41 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 6/15/10 Inspector: PL 

File No.: 26 

Licensee: North Oaks Radiation Center License No.: 3693-56 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 3/22/10 Inspector: DA 

 
California Final IMPEP Report Page C.4

Inspection Casework Reviews 

File No.: 27 

Licensee: Halliburton Energy Services, Inc. License No.: 6481-57 

Inspection Type: Routine, Announced Priority: 3 

Inspection Date: 12/10/10 Inspector: EM 

File No.: 28 

Licensee: Beverly Oncology and Imaging Centers Medical Group, Inc. License No.: 3666-19 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 12/13/10 Inspectors: JO, JD 

File No.: 29 

Licensee: North American Scientific License No.: 5537-19 

Inspection Type: Special, Announced - Decommissioning Priority: 2 

Inspection Dates: 12/15/09 - 1/27/10 Inspector: RL 

INSPECTOR ACCOMPANIMENTS 

The following inspector accompaniments were performed prior to the on-site IMPEP review: 

Accompaniment No.: 1 

Licensee: IsoRx License No.: 6264-38 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 9/12/11 Inspector: EF 

Accompaniment No.: 2 

Licensee: Mistras Group, Inc. License No.: 4886-48 

Inspection Type: Special, Unannounced Priority: 1 

Inspection Date: 9/13/11 Inspector: EM 

Accompaniment No.: 3 

Licensee: Washington Hospital License No.: 1585-01 

Inspection Type: Special, Unannounced Priority: 2 

Inspection Date: 9/14/11 Inspector: RO 

Accompaniment No.: 4 

Licensee: Kaiser Permanente License No.: 3653-21 

Inspection Type: Routine, Announced Priority: 3 

Inspection Date: 9/15/11 Inspector: NH 

Accompaniment No.: 5 

Licensee: St. Helena Hospital License No.: 3653-21 

Inspection Type: Routine, Announced Priority: 3 

Inspection Date: 9/16/11 Inspector: KF 

 
California Final IMPEP Report Page C.5

Inspection Casework Reviews 

Accompaniment No.: 6 

Licensee: Vertex Pharmaceuticals License No.: 6336-37 

Inspection Type: Routine, Announced Priority: 5 

Inspection Date: 9/26/11 Inspector: RY 

Accompaniment No.: 7 

Licensee: Sterigenics US, LLC License No.: 5956-33 

Inspection Type: Routine, Announced Priority: 2 

Inspection Date: 9/27/11 Inspector: DK 

Accompaniment No.: 8 

Licensee: Davis Laboratories, Inc. License No.: 3951-30 

Inspection Type: Special, Announced Priority: 1 

Inspection Date: 9/28/11 Inspector: AT 

Accompaniment No.: 9 

Licensee: West Hills Hospital & Medical Center License No.: 1388-19 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 9/29/11 Inspector: JO 
APPENDIX D 

LICENSE CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

Licensee: St. Francis Memorial Hospital License No.: 0115-38 

Type of Action: Amendment Amendment No.: 68 

Date Issued: 11/25/09 License Reviewer: JH 

File No.: 2 

Licensee: El Camino Hospital License No: 0312-43 

Type of Action: Amendment Amendment No.: 86 

Date Issued: 9/2/08 License Reviewer: IS 

File No.: 3 

Licensee: Chevron USA Product Co. License No.: 0490-07 

Type of Action: Amendment Amendment No.: 57 

Date Issued: 11/13/08 License Reviewer: BB 

File No.: 4 

Licensee: L-3 Communications License No.: 0553-01 

Type of Action: Amendment Amendment No.: 63 

Date Issued: 5/4/11 License Reviewer: TE 

File No.: 5 

Licensee: University of Redlands License No.: 0824-36 

Type of Action: Amendment (Decommissioning) Amendment No.: 17 

Date Issued: 10/22/09 License Reviewer: JG 

File No.: 6 

Licensee: El Camino Hospital – Los Gatos License No.: 1670-43 

Type of Action: Amendment Amendment No.: 50 

Date Issued: 7/22/09 License Reviewer: PL 

File No.: 7 

Licensee: Cemex, Inc. License No.: 1947-44 

Type of Action: Amendment Amendment No.: 22 

Date Issued: 9/9/11 License Reviewer: KD 

File No.: 8 

Licensee: University of California – San Diego License No.: 1339-37 

Type of Action: Renewal Amendment No.: 112 

Date Issued: 7/7/11 License Reviewers: IS, JG 
California Final IMPEP Report Page D.2 

License Casework Reviews 

File No.: 9 

Licensee: Parkview Community Hospital License No.: 2082-33 

Type of Action: Amendment Amendment No.: 49 

Date Issued: 2/23/11 License Reviewer: BG 

File No.: 10 

Licensee: Victor Valley Community Hospital License No.: 2236-36 

Type of Action: Amendment Amendment No.: 43 

Date Issued: 7/20/11 License Reviewer: JC 

File No.: 11 

Licensee: MHM, Inc. License No.: 2336-58 

Type of Action: Amendment Amendment No.: 13 

Date Issued: 8/2/11 License Reviewer: RB 

File No.: 12 

Licensee: Palmdale Regional Medical Center License No.: 2649-19 

Type of Action: Amendment Amendment No.: 32 

Date Issued: 6/3/11 License Reviewer: CR 

File No.: 13 

Licensee: Philips Medical Systems, Inc. License No.: 2760-43 

Type of Action: Amendment Amendment No.: 48 

Date Issued: 3/24/11 License Reviewer: ZG 

File No.: 14 

Licensee: Philips Medical Systems, Inc. License No.: 2760-43 

Type of Action: Amendment Amendment No.: 47 

Date Issued: 1/6/09 License Reviewer: LL 

File No.: 15 

Licensee: Radiation Oncology Medical Group of So. Cal. License No.: 2833-30 

Type of Action: Amendment Amendment No.: 28 

Date Issued: 6/1/11 License Reviewer: RC 

File No.: 16 

Licensee: Consolidated Testing Labs License No.: 3277-54 

Type of Action: Amendment Amendment No.: 20 

Date Issued: 2/18/10 License Reviewer: BH 

File No.: 17 

Licensee: Sterigenics US, LLC License No.: 3390-30 

Type of Action: Amendment Amendment No.: 45 

Date Issued: 12/19/08 License Reviewer: RR 

 
California Final IMPEP Report Page D.3 

License Casework Reviews 

File No.: 18 

Licensee: Geocon, Inc. License No.: 3924-37 

Type of Action: Amendment Amendment No.: 25 

Date Issued: 3/12/09 License Reviewer: BH 

File No.: 19 

Licensee: Western University of Health Sciences License No.: 4288-31 

Type of Action: Amendment Amendment No.: 31 

Date Issued: 10/20/10 License Reviewer: PG 

File No.: 20 

Licensee: Western University of Health Sciences License No.: 4288-31 

Type of Action: Renewal Amendment No.: 30 

Date Issued: 6/18/08 License Reviewer: FT 

File No.: 21 

Licensee: Western Industrial X-Ray, Inc. License No.: 4424-48 

Type of Action: Amendment Amendment No.: 42 

Date Issued: 4/23/09 License Reviewer: LL 

File No.: 22 

Licensee: Kaiser Foundation Hospital License No.: 4484-34 

Type of Action: Amendment Amendment No.: 23 

Date Issued: 11/2/09 License Reviewer: HA 

File No.: 23 

Licensee: Cardinal Health License No.: 4999-30 

Type of Action: Amendment Amendment No.: 61 

Date Issued: 3/30/09 License Reviewer: DV 

File No.: 24 

Licensee: California Steel Industries, Inc. License No.: 4485-36 

Type of Action: Amendment Amendment No.: 15 

Date Issued: 4/6/11 License Reviewer: HA 

File No.: 25 

Licensee: AMEC Geomatrix, Inc. License No.: 4768-01 

Type of Action: Amendment Amendment No.: 20 

Date Issued: 11/1/10 License Reviewer: RB 

File No.: 26 

Licensee: Moore Twining Associates License No.: 7765-33 

Type of Action: New Amendment No.: 0 

Date Issued: 4/16/09 License Reviewer: DC 

 
California Final IMPEP Report Page D.4 

License Casework Reviews 

File No.: 27 

Licensee: Orange Co. Comprehensive Radiation Oncology Ctr. License No.: 7791-30 

Type of Action: New Amendment No.: 0 

Date Issued: 2/8/10 License Reviewer: HA 

File No.: 28 

Licensee: AHMC International Cancer Center License No.: 7886-19 

Type of Action: New Amendment No.: 0 

Date Issued: 8/8/11 License Reviewer: BG 

File No.: 29 

Licensee: Libertytown USA 2, Inc. License No.: 4182-15 

Type of Action: Renewal Amendment No.: 92 

Date Issued: 7/29/10 License Reviewer: JR 

File No.: 30 

Licensee: Northern California Veterinary Specialists License No.: 6417-34 

Type of Action: Termination (Bankruptcy) Amendment No.: 7 

Date Issued: 4/5/11 License Reviewer: JR 

File No.: 31 

Licensee: Spansion, LLC License No.: 7631-43 

Type of Action: Amendment (Bankruptcy) Amendment No.: 1 

Date Issued: 3/30/10 License Reviewer: RJ 

File No.: 32 

Licensee: Acadia Pharmaceuticals, Inc. License No.: 6451-37 

Type of Action: Renewal Amendment No.: 14 

Date Issued: 6/26/09 License Reviewer: PG 

File No.: 33 

Licensee: Hitachi Chemical Research License No.: 5524-30 

Type of Action: Termination Amendment No.: 16 

Date Issued: 8/4/10 License Reviewer: PG 

File No.: 34 

Licensee: Cardinal Health License No.: 5910-50 

Type of Action: Termination Amendment No.: 23 

Date Issued: 3/7/11 License Reviewer: JG 
APPENDIX E 

INCIDENT CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

Licensee: STERIS, Inc. License No.: 6666-36 

Date of Incident: 9/16/08 NMED Log No.: 080567 

Investigation Date: 9/16/08 Type of Incident: Damaged Equipment 

 Type of Investigation: Telephone. 

File No.: 2 

Licensee: Schlumberger Technology Corporation License No.: 0144-15 

Date of Incident: 4/11/08 NMED Log No.: 080295 

Investigation Date: 4/29/08 Type of Incident: Abandoned Source 

 Type of Investigation: Letter 

File No.: 3 

Licensee: Mission Hospital Regional Medical Center License No.: 2278-30 

Date of Incident: 6/10/11 NMED Log No.: 110302 

Investigation Date: 6/14/11 Type of Incident: Medical Event 

 Type of Investigation: Telephone 

File No.: 4 

Licensee: General Atomics License No.: 0145-37 

Date of Incident: 8/19/10 NMED Log No.: 100446 

Investigation Date: 8/19/10 Type of Incident: Damaged Sources 

 Type of Investigation: Site 

File No.: 5 

Licensee: ProTechnics License No.: 6387-15 

Date of Incident: 10/10/10 NMED Log No.: 110115 

Investigation Date: 11/15/10 Type of Incident: Abandoned Sources 

 Type of Investigation: Telephone 

File No.: 6 

Licensee: Sutter General Hospital License No.: 2964-34 

Date of Incident: 6/17/10 NMED Log No.: 100320 

Investigation Date: 6/18/10 Type of Incident: Medical Event 

 Type of Investigation: Telephone 

File No.: 7 

Licensee: General Nucleonics, Inc. License No.: 1288-19 

Date of Incident: 10/6/08 NMED Log No.: 080861 

Investigation Date: 10/23/08 Type of Incident: Leaking Source 

 Type of Investigation: Telephone 

 
California Final IMPEP Report Page E.2 

Incident Casework Reviews 

File No.: 8 

Licensee: Siemens Medical Solutions License No.: 0218-19 

Date of Incident: 1/27/09 NMED Log No.: 090379 

Investigation Date: 4/20/09 Type of Incident: Lost Sources 

 Type of Investigation: Site 

File No.: 9 

Licensee: Regents of the University of California, Los Angeles License No.: 1335-19 

Date of Incident: 5/8/09 NMED Log No.: 090486 

Investigation Date: 5/8/09 Type of Incident: Lost Sources 

 Type of Investigation: Telephone 

File No.: 10 

Licensee: J. L. Shepherd & Associates License No.: 1777-19 

Date of Incident: 1/18/10 NMED Log No.: 100058 

Investigation Date: 1/19/10 Type of Incident: Leaking Source 

 Type of Investigation: Telephone 

File No.: 11 

Licensee: J. L. Shepherd & Associates License No.: 1777-19 

Date of Incident: 9/22/09 NMED Log No.: 090737 

Investigation Date: 9/23/09 Type of Incident: Leaking Source 

 Type of Investigation: Telephone 

File No.: 12 

Licensee: CPN Instrotek License No.: 1100-07 

Date of Incident: 12/7/09 NMED Log No.: 090871 

Investigation Date: 12/7/09 Type of Incident: Stolen Gauge 

 Type of Investigation: Telephone 

File No.: 13 

Licensee: University of California, San Diego License No.: 1339-37 

Date of Incident: 9/25/08 NMED Log No.: 080617 

Investigation Date: Type of Incident: Leaking Source 

 Type of Investigation: Telephone 

File No.: 14 

Licensee: Isotope Products Laboratories License No.: 1509-19 

Date of Incident: 7/24/09 NMED Log No.: 090765 

Investigation Date: 7/24/09 Type of Incident: Lost Sources 

 Type of Investigation: Site 

File No.: 15 

Licensee: Furgo West, Inc. License No.: 4377-01 

Date of Incident: 1/5/11 NMED Log No.: 110041 

Investigation Date: 1/5/11 Type of Incident: Damaged Equipment 

 Type of Investigation: Telephone 
California Final IMPEP Report Page E.3 

Incident Casework Reviews 

File No.: 16 

Licensee: University of California at Berkeley License No.: 1333-01 

Date of Incident: 11/19/08 NMED Log No.: 080821 

Investigation Date: 11/21/08 Type of Incident: Leaking Source 

 Type of Investigation: Telephone 

File No.: 17 

Licensee: University of California at Berkeley License No.: 1333-01 

Date of Incident: 11/1/10 NMED Log No.: 100555 

Investigation Date: 11/3/10 Type of Incident: Leaking Source 

 Type of Investigation: Telephone 

File No.: 18 

Licensee: Hoag Memorial Hospital Presbyterian License No.: 0272-30 

Date of Incident: 3/20/09 NMED Log No.: 090565 

Investigation Date: 6/22/09 Type of Incident: Medical Event 

 Type of Investigation: Site 

File No.: 19 

Licensee: Cypress Surgery Center License No.: 7342-54 

Date of Incident: 6/3/08 NMED Log No.: 080319 

Investigation Date: 6/3/08 Type of Incident: Transportation 

 Type of Investigation: Site 

File No.: 20 

Licensee: California Department of Public Health License No.: 0377-01 

Date of Incident: 4/19/08 NMED Log No.: 080265 

Investigation Date: 4/28/08 Type of Incident: Lost Sources 

 Type of Investigation: Telephone
APPENDIX F 

SEALED SOURCE AND DEVICE CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

Registration No.: CA-626-D-101-G SS&D Type: (N) Ion Chromatography 

Applicant Name: Lagus Applied Technology Type of Action: Amendment 

Date Issued: 6/13/11 SS&D Reviewers: ZG, RR 

File No.: 2 

Registration No.: CA-406-S-239-S SS&D Type: (F) Well Logging Source 

Applicant Name: Eckert & Zeigler Isotope Products Type of Action: New 

Date Issued: 2/5/09 SS&D Reviewers: ZG, RR 

File No.: 3 

Registration No.: CA-0406-S-828-U SS&D Type: (U) X-Ray Fluorescence 

Applicant Name: Eckert & Zeigler Isotope Products Type of Action: Inactivation 

Date Issued: 2/16/11 SS&D Reviewers: CR, HA 

File No.: 4 

Registration No.: CA-0406-S-827-S SS&D Type: (X) Medical Reference Source 

Applicant Name: Eckert & Zeigler Isotope Products Type of Action: Inactivation 

Date Issued: 2/13/11 SS&D Reviewers: DCT, HA 

File No.: 5 

Registration No.: CA-0406-S-238-S SS&D Type: (AB) Medical Diagnosis Sources , 

 (D) Gamma Gauge, (X) Medical Reference 

Applicant Name: Eckert & Zeigler Isotope Products Type of Action: Amendment 

Date Issued: 5/29/09 SS&D Reviewers: DCT, BH, JF 

Comment: 

The sealed sources can be singly, doubly, or triply encapsulated sources but there is no 

indication how they can be identified – have same model numbers 

File No.: 6 

Registration No.: CA-0406-S-196-S SS&D Type: (A) Ind.Rad., (D) Gamma Gauge, 

 (F) Well Logging 

Applicant Name: Eckert & Zeigler Isotope Products Type of Action: Amendment 

Date Issued: 3/3/11 SS&D Reviewers: HA, JF 

Comment: 

Description on Page 2 states “capsule is robust enough to retain buildup of Helium gas 

during working life of the device”, but the only radionuclides used are Cs-137 and Co-60, 

neither of which generate Helium gas. 

 
California Final IMPEP Report Page F.2 

Sealed Source and Device Casework Reviews 

File No.: 7 

Registration No.: CA-8231-D-801-S SS&D Type: (H) General Neutron Source 

Applicant Name: Thermo Gamma Metrics Type of Action: Inactivation 

Date Issued: 3/28/11 SS&D Reviewers: VK, RR 

File No.: 8 

Registration No.: CA-8204-D-801-S SS&D Type: (H) General Neutron Source 

Applicant Name: NOVA R&D Type of Action: Inactivation 

Date Issued: 5/15/08 SS&D Reviewers: MG, JF 

File No.: 9 

Registration No.: CA-0406-S-180-S SS&D Type: (X) Medical Reference Source 

Applicant Name: Eckert & Zeigler Isotope Products Type of Action: Amendment 

Date Issued: 4/24/09 SS&D Reviewers: MG, JF 

File No.: 10 

Registration No.: CA-0638-D-801-S SS&D Type: (D) Gamma Gauge 

Applicant Name: Level Link, Inc. Type of Action: Inactivation 

Date Issued: 8/27/08 SS&D Reviewers: MG, JF 

File No.: 11 

Registration No.: CA-0406-S-240-S SS&D Type: (F) Well Logging 

Applicant Name: Eckert & Zeigler Isotope Products Type of Action: New 

Date Issued: 6/6/09 SS&D Reviewers: ZG, RR 

Comment: 

Maximum activity listed was 24 Ci ± 20%, maximum activity requested was 20 Ci ± 20%; 

maximum activity for radiation profile was 24 Ci. 

File No.: 12 

Registration No.: CA-1080-S-104-S SS&D Type: (AC) Photon Emitting Remote Afterloader 

Applicant Name: Varian Medical Systems Type of Action: Amendment 

Date Issued: 3/10/09 SS&D Reviewers: RR, JF 

File No.: 13 

Registration No.: CA-1259-D-101-S SS&D Type: (H) General Neutron Source 

Applicant Name: Clear Path Technology Type of Action: Amendment 

Date Issued: 3/2/10 SS&D Reviewers: VK, RR 

File No.: 14 

Registration No.: CA-0406-S-243-S SS&D Type: (D) Gamma Gauges, (I) Calib. Sources 

Applicant Name: Eckert & Zeigler Isotope Products Type of Action: Amendment 

Date Issued: 10/5/10 SS&D Reviewers: BG, HA 

Comments: 

a) Under “Isotope and Maximum Activity,” isotope listed as “Atomic Numbers 3-83” 

b) External radiation levels only listed for three isotopes, not for Atomic Numbers 3-83 

 
California Final IMPEP Report Page F.3 

Sealed Source and Device Casework Reviews 

c) External radiation levels in units of “R/hr”, should have been mR/hr based on maximum 

activity 

File No.: 15 

Registration No.: CA-0406-S-106-S SS&D Type: (AB) Med. Diag., (D) Gamma Gauge, 

(I) Calibration Source 

Applicant Name: Eckert & Zeigler Isotope Products Type of Action: Amendment 

Date Issued: 4/14/11 SS&D Reviewers: ZG, RR 

File No.: 16 

Registration No.: CA-0406-S-244-S SS&D Type: (D) Gamma Gauge, (I) Calibration Source 

Applicant Name: Eckert & Zeigler Isotope Products Type of Action: Amendment 

Date Issued: 2/10/11 SS&D Reviewers: JR, JF 

File No.: 17 

Registration No.: CA-181-D-101-G SS&D Type: (T) Other 

Applicant Name: Beckman Coulter Type of Action: Amendment 

Date Issued: 2/17/10 SS&D Reviewers: MG, JF 

Comments: 

a) Licensee stated that device is no longer manufactured, amendment to add new sealed 

source model for servicing existing devices, should have queried on using inactive 

product registration code 

b) Cannot verify that the general license label meets the labeling requirements of 10 CFR 

32.51 (SS&D and application only reference a GL label) 

File No.: 18 

Registration No.: CA-1218-D-101-S SS&D Type: (D) Gamma Gauge 

Applicant Name: RapidScan Systems Neutronics Type of Action: Amendment 

Date Issued: 6/17/09 SS&D Reviewers: RR, JF 

Comments: 

a) Under “Limitations,” text states that the owners must possess an NRC license or foreign 

permit, but omit agreement state license 

b) Source holder design referenced by name and SS&D registration number, no diagram of 

source holder 

File No.: 19 

Registration No.: CA-1046-D-101-B SS&D Type: (H) General Neutron Source Application 

Applicant Name: Thermo Gamma Metrics Type of Action: Amendment 

Date Issued: 3/4/11 SS&D Reviewers: VK, RR 

File No.: 20 

Registration No.: CA-0406-S-818-S SS&D Type: “General Medical Use” 

Applicant Name: Eckert & Zeigler Isotope Products Type of Action: Inactivation 

Date Issued: 3/26/09 SS&D Reviewers: ZG, JF 
California Final IMPEP Report Page F.4 

Sealed Source and Device Casework Reviews 

File No.: 21 

Registration No.: CA-661-D-103-S SS&D Type: (AC) Photon Emitting Afterloader 

Applicant Name: Varian Medical Systems Type of Action: Amendment 

Date Issued: 1/30/08 SS&D Reviewers: RR, JF 

File No.: 22 

Registration No.: CA-0384-D-109-S SS&D Type: (A) Industrial Radiography 

Applicant Name: Industrial Nuclear Type of Action: Amendment 

Date Issued: 9/28/11 SS&D Reviewers: RR, JF 

Comment: 

Areas of product design review did not include location of drive cable attachment and 

locking mechanism, combined with open accessibility of locking mechanism to permit 

debris intrusion 

File No.: 23 

Registration No.: CA-0406-S-813-U SS&D Type: X-Ray Fluorescence 

Applicant Name: Eckert & Zeigler Isotope Products Type of Action: Inactivation 

Date Issued: 3/23/09 SS&D Reviewers: ZG,JF 
ATTACHMENT(S) 

January 5, 2012 Letter from Ron Chapman 

California’s Response to the Draft Report 

ADAMS Accession No.: ML1200580280