August 12, 2004

Richard J. Jackson, MD, MPH

State Public Health Officer

Department of Health Services

P.O. Box 997413

MS-0000

Sacramento, CA 95899-7413

Dear Dr. Jackson:

On July 28, 2004, 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 IMPEP review was conducted April 26-30, 2004. The MRB

found the California program adequate, but needs improvement, and not compatible with U.S.

Nuclear Regulatory Commission’s (NRC’s) program. Because of the significance of the

findings, the MRB determined the California program should undergo a period of heightened

oversight. Heightened oversight is an increased monitoring process used by NRC to follow the

progress of improvement needed in an Agreement State program. It involves preparation of a

program improvement plan, bimonthly conference calls, and submission of status reports prior

to each call with the appropriate California and NRC staffs. 

The MRB agreed with the team finding that the underlying root causes of the identified

weaknesses are lack of adequate funding and staffing for the program. We appreciate your

commitment to the program expressed during the MRB meeting and your efforts to obtain

funding and to free up frozen staff positions necessary to operate an adequate and compatible

program.

We request that you prepare and submit a program improvement plan as part of your response

to the recommendations in Section 5 of the enclosed final report, “Integrated Materials

Performance Evaluation Program, Review of California Agreement State Program - Final

Report.” I ask that you have your staff dialogue with Paul Lohaus on the required elements of

this plan to ensure that the “get-well” path and measures of success are clearly identified. The

plan should be submitted within 30 days of this letter. Upon review of the program improvement

plan, the staff will schedule the first conference call. The initial conference call should be

scheduled and conducted no later than October 4, 2004. Based on the results of the current

IMPEP review, a follow-up review will be scheduled during the period April 2005 - June 2005. 

The follow-up review will cover the State’s action on the recommendations from the April 2004

review. 
Richard J. Jackson -2-

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

your continuing support of the Radiologic Health Branch. I look forward to our agencies

continuing to work cooperatively in the future. 

Sincerely,

/RA/

Martin J. Virgilio

Deputy Executive Director 

 for Materials, Research and State Programs

Enclosure: 

As stated

cc: Kevin Reilly, DVM, Prevention Services

Larry Barrett, DVM, Division of Food, Drug & Radiation Safety

Edgar Bailey, Chief, Radiologic Health Branch

Clayton Bradt, NY, OAS Liaison to the MRB
Richard J. Jackson -2-

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

your continuing support of the Radiologic Health Branch. I look forward to our agencies

continuing to work cooperatively in the future. 

Sincerely,

/RA/

Martin J. Virgilio

Deputy Executive Director

 for Materials, Research and State Programs

Enclosure: 

As stated

cc: Kevin Reilly, DVM, Prevention Services

Larry Barrett, DVM, Division of Food, Drug & Radiation Safety

Edgar Bailey, Chief, Radiologic Health Branch

Clayton Bradt, NY, OAS Liaison to the MRB

bcc: Chairman Diaz

Commissioner McGaffigan

Commissioner Merrifield

Distribution:

DIR RF DCD (SP01) PDR (YES/)

KSchneider, STP JStrosnider, NMSS

ISchoenfeld, OEDO KCry, OGC

CMiller, NMSS/IMNS JGray, OGC

RStuckmeyer, NMSS/IMNS FCameron, OGC

JLynch, RIII TCombs, OCA (2 copies)

LMcLean, RIV

AMauer, STP

HBermudez, RII

DFogle, Texas

KWiebeck, Arkansas

STreby, OGC

California File

DOCUMENT NAME: C:\NRC\Others\CA Final IMPEP Report 8-12-04.wpd

*See previous Concurrence

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

OFFICE RIII:RSAO STP:DD STP:D DEDMRS

NAME Jlynch:kk*

(KNSchneider for)

JMPiccone*

(PHLohaus)

PHLohaus* MJVirgilio

DATE 8/3/04 8/4/04 8/4/04 8/12/04

 ML042170329 Pkg. OFFICIAL RECORD COPY
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM

REVIEW OF CALIFORNIA AGREEMENT STATE PROGRAM

April 26-30, 2004

 FINAL REPORT

U.S. Nuclear Regulatory Commission
California Final Report Page 1

1.0 INTRODUCTION

This report presents the results of the review of the California radiation control program. The

review was conducted during the period of April 26-30, 2004, by a review team comprised of

technical staff members from the Nuclear Regulatory Commission (NRC) and the Agreement

States of Texas and Arkansas. 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 a 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 October 9, 1999 to April 30, 2004 were discussed with

California management on April 30, 2004.

A draft of this report was issued to California for factual comment on May 28, 2004. The State

responded in a letter dated July 1, 2004. At the time of the review, the team found California’s

performance satisfactory for four performance indicators, and satisfactory, but needs

improvement, for the performance indicators, Technical Staffing and Training and Technical

Quality of Incident and Allegation Activities. The review team found California’s performance to

be unsatisfactory for the performance indicator, Compatibility Requirements. Because of the

significance of the concerns, the team recommended that a period of heightened oversight be

implemented to assess the progress of the State in implementing corrective actions. 

On July 28, 2004, the Management Review Board (MRB) met to consider the proposed final

report with California staff. The MRB agreed with the team finding that the underlying root

causes of the identified weaknesses are the lack of adequate funding and staffing for the

program. As discussed with California staff during the MRB, California management is

committed to the program and are continuing efforts to obtain funding and to free up frozen staff

positions necessary to operate an adequate and compatible program. The MRB concurred in

the individual findings by the review team for each indicator and concurred in the review team’s

recommendation for a period of heightened oversight to assess the progress of the State in

implementing corrective actions. The MRB found the California radiation control program was

adequate, but needs improvement, and not compatible with NRC’s program.

The MRB directed that: (1) a program improvement plan should be prepared and submitted as

part of the responses to the recommendations found in Section 5; (2) that a follow-up review be

conducted during the period April-June 2005; and (3) that bimonthly conference calls take place

with California staff, with a written progress report submitted two weeks prior to each call.

The California Agreement State program is located in the Department of Health Services (the

Department). Within the Department, the Radiologic Health Branch (the Branch) located in the

Division of Food, Drug, and Radiation Safety (the Division) administers the radioactive materials

program. Organization charts for the Governor’s office, the Department, Division and Branch

are included as Appendix B. The California program regulates approximately 2,182 specific

licenses authorizing radioactive materials. The review focused on the material 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 non-common

performance indicators was sent to the State on January 6, 2004. The Department provided a
California Final Report Page 2

response to the questionnaire on April 12, 2004. A copy of the questionnaire response may be

found on NRC’s Agencywide Document Access and Management System using the Accession

Number ML041060605.

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

California's responses to the questionnaire; (2) review of applicable California statutes and

regulations; (3) analysis of quantitative information from the Department’s licensing and

inspection data base; (4) technical evaluation of selected licensing and inspection actions; 

(5) field accompaniments of nine California inspectors; and (6) interviews with staff and

management to answer questions or clarify issues. The team evaluated the information that it

gathered against the IMPEP performance criteria for each common and applicable non-common

performance indicator and made a preliminary assessment of the radiation control program’s

performance.

Section 2 below discusses the State’s actions in response to recommendations made following

the previous IMPEP review and the team’s conclusions regarding close-out of the

recommendations. Results of the current review for the IMPEP common performance indicators

are presented in Section 3. Section 4 discusses results of the applicable non-common

performance indicators, and Section 5 summarizes the review team's findings and

recommendations. Recommendations made by the review team are comments that relate

directly to program performance by the Department. A response is requested from the

Department to all recommendations in the final report.

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS

During the previous IMPEP review, which concluded on October 8, 1999, four recommendations

were made and the results transmitted to James W. Stratton, M.D., Deputy Director,

Department of Health Services on January 4, 2000. The review team’s evaluation of the current

status of the recommendations is as follows:

1. The team recommends that the Branch submit reportable events to Nuclear Materials

Events Database (NMED) within one month of their occurrence in accordance with the

“Handbook on Nuclear Event Reporting in the Agreement States.” (Section 3.5 of the

1999 report)

Current Status: The Branch improved their reporting frequency since the last IMPEP

review, and no longer report events to NMED on a quarterly basis. However, a number

of reportable events for the current review period were not submitted within one month of

their occurrence. Of the 76 events which the Branch has tracked as being reportable

within 30 days, 35 events were reported late. Of these 35 events, 20 were reported

more than 60 days after the event. This recommendation remains open and is further

discussed in Section 3.5.

2. The team recommends that the Sealed Source and Device (SS&D) Unit formalize

procedures for the review of applications, particularly the proper use of checklists,

handling of proprietary information, full control of records, incorporating regulations and

policies as legally binding requirements, and the requirement for signatures by two

qualified reviewers. (Section 4.2 of the 1999 report)

Current Status: The Branch established and implemented several new procedures,

RML-04-1, RML-04-02 and RML-04-03, effective March 26, 2004, that address the
California Final Report Page 3

above noted areas. The Senior Health Physicist supervising the SS&D evaluation

program indicated that Office of State and Tribal Programs (STP) Procedure SA-201

“Review of State Regulatory Requirements” would be followed when incorporating

regulations and policies as legally binding requirements. This recommendation is

closed.

3. The team recommends that the Branch establish formal training and qualification

requirements for SS&D reviewers. (Section 4.2 of the 1999 report)

Current Status: The Branch has established and implemented the Licensing Projects

Unit Training Journal system, effective date October 21, 2002, for documenting training

and qualification requirements for SS&D reviewers. The review team’s evaluation of this

document identified an effective training tool, as detailed in Section 4.2. This

recommendation is closed.

4. The team recommends that source certificate CA-406-S-177-S be amended to reflect

the change in fabrication process. (Section 4.2 of the 1999 report)

Current Status: On February 20, 2001, the Branch issued an ‘amendment in entirety’ to

the above-cited SS&D sheet appropriately addressing the change in the fabrication

process. This recommendation is closed.

In addition to the above recommendations, a recommendation from the 1996 California review

was re-evaluated. The issue was closed during the 1999 IMPEP review, but the review team

observed that all corrective actions had not been completed. The recommendation was:

The review team recommends that the State re-evaluate the Nova R&D, Inc., Model

Cindi neutron device with special attention to the potential exposure received by the

general licensed user. If it is determined that the exposure rate exceeds that which is

allowed for persons covered under the general license, the device should be reclassified

for distribution to persons covered under a specific license and the SS&D evaluation

certificate should be amended to reflect any required changes. (Section 4.2 of the 1996

report)

Current Status: The team determined that the Branch has been addressing this issue

with the licensee to revise the SS&D sheet for QA/QC issues and reissue under current

SS&D format as a distribution to specific licensees only. A deficiency letter was issued

to the licensee in 2002. The manufacturer’s response was that the licensee had not

produced this model in several years and wanted to inactivate the SS&D sheet. The

Branch is still working with the licensee to gather the information necessary, per

NUREG-1556, Volume 3, “Applications for Sealed Source & Device Evaluation and

Registration,” to inactivate the SS&D sheet. In the State’s July 1, 2004 response to the

draft IMPEP report, the Branch indicated that they contacted the licensee on June 14,

2004. The licensee stated that they still plan to deactivate the SS&D for the device in

question and would submit the appropriate information. In the interim, the Branch will

evaluate and administratively amend the SS&D to support distribution to specific

licensees only. This recommendation remains open.
California Final Report Page 4

3.0 COMMON PERFORMANCE INDICATORS

IMPEP identifies five common performance indicators to be used in reviewing both NRC

Regional and Agreement State 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 responses relative to this

indicator, interviewed Branch management and staff, reviewed job descriptions and training

records, and considered any possible workload backlogs.

The Branch has four Sections, all reporting to the Branch Chief. The Financial Operations and

Analysis Section serves the program infrastructure. The Registration, Certification,

Mammography and Standards Section deals primarily with machine-made radiation. The

Radioactive Materials Licensing Section performs all of the Agreement State licensing functions. 

The Inspection, Compliance, and Enforcement (ICE) Section is the inspection arm of the

Branch.

The ICE Section is operated out of the Sacramento office and four regional offices, in Berkeley,

Granada Hills, Brea and San Jose. Each of the offices has a Senior Health Physicist with seven

Associate Health Physicists spread amongst the offices. In addition, the Branch has contracts

with Los Angeles and San Diego Counties to perform radioactive material inspections. Five

radioactive materials positions are currently employed by the County programs. The total

number of health physicist positions in the ICE Section is currently 17, two less than in 1999.

The Radioactive Materials Licensing Section employs four Senior Health Physicists, 20

Associate Health Physicists and four support staff. All of the Branch licensing functions are

performed in the Sacramento office. The Regulations Unit reports directly to the Branch Chief

and is staffed by a Senior Health Physicist, an Associate Health Physicist and two Analysts.

Approximately 50 positions in the Branch are predominantly dedicated to the radioactive

materials program. As the Branch also regulates the use of machine-made radiation, some

positions are shared between program areas. The Branch is staffed with a Branch Chief, an

Assistant Branch Chief, four Section Chiefs, a technical assistant to the Branch Chief, health

physics staff and administrative support staff. Three of the four Section Chief positions are

currently vacant, with senior staff filling the positions in an acting capacity. The Assistant

Branch Chief is also acting in that position. 

The non-permanence of Branch supervisors is due to a current State-mandated hiring freeze

and promotion prohibition policy. The Branch Chief noted that, with rare exceptions, the Branch

is not authorized to hire or promote individuals because of the severe financial condition of the

State. An additional burden for the Branch is a longtime State practice in which a position, if

vacant for a period of six months, is abolished. Thus, a “Catch-22" is created when the Branch

loses an employee to retirement or outside employment and the position is abolished, as

another individual cannot be promoted into that position, nor can an individual be hired to fill the
California Final Report Page 5

position or an acting employee’s position. These limitations have resulted in most of the Branch

management in acting positions as Section Chiefs along with their own Senior Health Physicist

responsibilities. In addition, several other technical positions were lost due to the “Catch-22"

situation that has resulted in a program staffing shortage. The staffing shortage has impacted

the Branch performance in most program areas as discussed in this report. 

During the last IMPEP review in 1999, California was commended for a “good practice” for

establishing a Quality Assessment (QA) Unit in the ICE Section. When innovative and effective

practices are identified during IMPEP reviews, the NRC shares these “good practices” with all

Agreement States and NRC Regional Offices. The 1999 IMPEP team commented on the

positive effects of the QA Unit in improving the quality of the Branch’s inspection and incident

response efforts. Health Physicists in the QA Unit developed policies, performed audits of

inspections and incident follow-up actions, and emphasized consistency among the seven

program offices. The positions in the QA Unit were abolished during the review period when

vacant positions were not filled due to the hiring limitations identified above. Some of the QA

duties were assumed by a senior health physicist. However, this staff member was not

assigned these duties on a full-time basis, which has resulted in significant delays in QA

reviews. Issues identified in Section 3.5, “Technical Quality of Incident and Allegation

Response Activities,” clearly show the quality gap created when the QA Unit was disbanded. 

The California radiation control program is in critical financial condition. Branch managers

shared with the review team budget revenue and expenditure data which shows a continuous

negative budget trend. Efforts to increase licensee fees have been pursued for the last five to 

six years, with no success. With revenues not increasing to meet increased program costs,

financial reserves are being exhausted. The review team believes that the overall root cause of

the program deficiencies identified during this review is the critical financial condition of the

program. A significant contributing factor is the inability of the Branch to update their fee system

to reflect the actual costs of the radiation control program. Without an increase in the program’s

fee system, the Branch is projected to face insolvency in late 2004 or early 2005. The review

team recommends that the State ensure that adequate resources, both funding and staffing, be

devoted to the radiation control program.

The Branch’s training policy for inspectors is contained in the ICE Section manual. Inspectors

are permitted to perform inspections for those categories of licenses for which training has been

received. An inspector qualification matrix was shared with the team during the review. The

team did not identify any instances in which an inspection was performed by an unqualified

inspector. Qualifications for license reviewers are not formally documented, with the exception

of the SS&D staff (see Section 4.2.2). Discussions with the Acting Licensing Section Chief and

Senior Health Physicists indicated, however, a good awareness of training history and needs of

Licensing staff. The review team found that the excellent peer review and training techniques

observed during the review constituted an adequate training program.

Due to current budget limitations, outside training for Branch staff has been sharply curtailed. 

This limited training budget, along with out-of-State travel restrictions, will, in the future, severely

limit the ability of the program to maintain a technically trained staff. Even in-State travel faces

impediments. All overnight travel by Branch staff must be approved at a Divisional level. This

added burden makes it difficult to arrange for training at universities or manufacturers, or even

in Sacramento for those staff located in Southern California.
California Final Report Page 6

With the current inability to send staff to out-of-state NRC-sponsored training courses, the

Branch is looking to import courses into the State. In September 2003, an SS&D Workshop

was held in Los Angeles. The review team encouraged the Branch to look for other

opportunities to bring training to California and to work with neighboring States to share training

efforts. Many of the NRC-sponsored training courses are “portable” and can be held in a State

if the State can host the course and guarantee that at least one-half of the student slots are

filled.

The review team discussed the role of the Nuclear Medicine Council with Branch managers. 

The Council serves as an advisory committee to the Branch for advice on nuclear medicine

issues and increases opportunities for communication within the regulated community. The

Council met last in early 2003. No evidence of any conflict of interest issues was identified.

As noted above, the overall root causes of the program weaknesses identified during this review

are the lack of adequate funding and staffing for the program. This has placed the program

under stress and the Branch cannot continue to operate under these conditions without

experiencing additional performance shortfalls. Based on the IMPEP evaluation criteria, the

review team recommends that California's performance with respect to the indicator, Technical

Staffing and Training, be found satisfactory, but needs improvement.

3.2 Status of Materials Inspection Program

The team focused on five factors in reviewing this indicator: inspection frequency, overdue

inspections, initial inspection of new licensees, the timely dispatch of inspection findings to

licensees, and the performance of reciprocity inspections. The evaluation is based on the

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

Branch’s licensing and inspection data tracking system, the examination of completed licensing

and inspection casework, and interviews with managers and staff.

As previously mentioned, the Branch has contracts with Los Angeles and San Diego Counties

to perform radioactive material inspections. County employees can only inspect licensees that

have all of their licensed operations in that County. Therefore, an industrial radiographer could

not be inspected by the County for temporary jobsites since the license would allow use of

radioactive materials at temporary jobsites outside of County jurisdiction.

In April 2004, the Branch adopted the inspection frequencies for various types of material

licenses listed in NRC Manual Chapter (MC) 2800, “Materials Inspection Program,” under

“Emerging Technologies.” This change in frequencies was in reaction to NRC’s inspection

frequency modifications in October 2003. The staff uses a database management system for

tracking inspections. The information is compiled monthly in a special report and sent to the

inspection field offices. All inspectors have access to these monthly reports. The review team

verified that inspection intervals for various types of material licenses are as frequent as, or

more frequent than, similar license types listed in MC 2800.

In their response to the questionnaire, the Branch indicated that no routine inspections were

overdue by more than 25 percent of the NRC frequency at that time. The Branch also indicated

that in the first half of 2001 they discovered a defect in a newly implemented inspection

scheduling system that caused 51% of the inspections completed during that period to be

overdue. Aggressive steps taken by the Branch to address the problem resulted in the
California Final Report Page 7

percentage of overdue inspections to go down to 45% during the second half of 2001, down to

35% during the first half of 2002, and down to 6% by the end of 2002. Since then, the

percentage of overdue inspections has fully met IMPEP performance criteria.

The review team noted that two portable gauge licensees could not be located and have

appeared as overdue inspections in the Branch’s records for approximately two years. The

team also noted that two medical facilities had gone out of business, one a boarded up building

and the other a building undergoing renovations by the new owner. Upon assessment of the

team’s concerns, the Branch determined that one of the medical facilities was authorized to

possess only accelerator-produced radioactive isotopes, and was thus beyond the scope of this

IMPEP review. The team determined that the Branch has not been able to account for the

whereabouts of the materials possessed under three licenses, and that the Branch did not

appear to have a process in place to resolve these types of situations. On May 6, 2004, the

NRC provided the State early written notification of this issue, given its significance. A copy of

the State’s July 8, 2004 response to this notification is attached. The review team recommends

that the Branch enhance its ability to account for the whereabouts and security of licensed

materials known to have existed under a license.

With respect to initial inspections of new licensees, the review team analyzed the Branch

process for ensuring that new licensees are inspected within one year of license issuance. 

Monthly inspection due date reports are distributed to regional offices and are tracked to ensure

timely completion. The review team confirmed that initial inspections were performed as

required through review of inspection records and by verification with Branch staff.

The timeliness of the issuance of inspection findings was evaluated during the inspection

casework review. Of the 39 inspection reports reviewed, nine showed that correspondence

transmitting the inspection findings to the licensees were issued greater than 30 days from the

completion of the inspection. No special circumstances to justify the delays were noted in any

of the nine late reports which ranged from 32 to 99 days post inspection. A list of the inspection

reports reviewed is provided in Appendix C. The Branch reviewed the incidence and

significance of the late reports and determined that there was no impact on health and safety

because of the lateness. The review team recommends that the Branch implement procedures

to ensure inspection findings are issued to licensees within 30 days of the completion of routine

inspections.

During the review, the team determined that the Branch met and exceeded NRC’s current

criteria of inspecting candidate licensees (inspection Priorities 1, 2 and 3) operating under

reciprocity as specified in NRC MC 1220. From 2000 to 2003, the Branch inspected twentynine of seventy-nine reciprocity licensees. The Branch also inspected approximately 20-25% of

portable gauge and device reciprocity licensees entering the State.

Based on the IMPEP evaluation criteria, the review team recommends that California’s

performance with respect to the indicator, Status of Materials Inspection Program, be found

satisfactory.

3.3 Technical Quality of Inspections

The team evaluated the inspection reports, enforcement documentation, and interviewed 

inspectors for 39 radioactive material inspections conducted during the review period. The
California Final Report Page 8

review included casework from all of the materials inspectors and several supervisors, and

covered inspections of various types including medical therapy, industrial radiography, mobile

high dose-rate remote afterloaders (HDRs), and nuclear medicine. Particular attention was

given to industrial radiography inspections as the team was aware of the lack of the two-person

rule requirements in the California regulations and a reliance by the Branch on office

inspections rather than field inspections of radiographers. Appendix C lists the inspection

casework files reviewed for completeness and adequacy, with case-specific comments.

Nine Branch inspectors (including three County employees) were accompanied during

inspections by review team members in late 2003 and early 2004. Inspector accompaniments

were conducted during inspections as follows: a pool irradiator; two industrial radiographers; a

medical institution with brachytherapy; a nuclear pharmacy; two research and development

laboratories; and two nuclear medicine programs. These accompaniments are identified in

Appendix C. During the accompaniments, the Branch inspectors demonstrated appropriate

inspection techniques and knowledge of the regulations. The inspectors were well trained,

prepared, and thorough in their audits of the licensees' radiation safety programs. Overall, the

technical performance of the inspectors was good, and their inspections were adequate to

assess radiological health and safety at the licensed facilities.

Information available in the inspection reports revealed that only six out of 26, or approximately

23%, of radiography inspections included a field inspection. One of the six field inspections

performed was requested by an IMPEP reviewer who was accompanying the inspector as part

of this review. This is significantly lower than the 50% field review required by the Branch’s

procedure, especially when reports document that field work is done by licensees on a routine

basis. The review team and Branch managers discussed the value that field inspections add to

the inspection program. Branch management agreed to the benefits of increasing the

percentage of field radiography inspections conducted by the Branch, given that opportunities to

complete radiography field inspections are available.

Regarding supervisory inspector accompaniments, the team noted that the majority but not all

inspector accompaniments were performed annually. Of the 13 staff members currently

assigned to inspection positions, four had not been accompanied on an annual basis. Review

team members, however, accompanied all of the inspectors that had not been accompanied by

supervisors during the past year. The team and the Branch discussed the value of tracking

supervisory inspector accompaniments to ensure they are performed in a timely manner.

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

support the current inspection program. Appropriate, calibrated survey instrumentation such as

Geiger-Mueller (GM) meters, scintillation detectors, ion chambers, and micro-R meters were

noted to be available. The instruments are calibrated at least annually by a commercial

calibration service. The Department’s Sanitation and Radiation Laboratory provides support to

the program through radiological analyses of samples taken by inspectors during inspections.

Based on the IMPEP evaluation criteria, the review team recommends that California’s

performance with respect to the indicator, Technical Quality of Inspections, be found

satisfactory.
California Final Report Page 9

3.4 Technical Quality of Licensing Actions

The review team interviewed license reviewers, evaluated the licensing process, and examined

licensing casework for 26 specific licenses. Licensing actions were reviewed for completeness,

consistency, proper radioisotopes and quantities, qualifications of authorized users, adequate

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

operating and emergency procedures, appropriateness of the license conditions, and overall

technical quality. The casework files were also reviewed for timeliness, use of appropriate

deficiency letters and cover letters, reference to appropriate regulations, product certifications,

supporting documentation, consideration of enforcement history, pre-licensing visits,

supervisory review as indicated, and proper signatures. The files were checked for retention of

necessary documents and supporting data.

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

which were completed during the review period. The sampling included the following types: 

academic, medical, nuclear pharmacy, veterinary, industrial radiography, irradiator,

decommissioning, gauge, and in-vitro laboratory. Licensing actions reviewed included three

new licenses, including one financial surety document, four renewals, five terminations, and

fourteen amendments. A listing of the casework licenses evaluated with case-specific

comments may be found in Appendix D.

All licensing actions are performed in the Sacramento office by the Radioactive Materials

Licensing Section. The Section includes the Medical Unit, the Industrial & General Licensed

Device Unit, and the Sealed Source & Devices Unit/Financial Surety Unit.

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

and of high quality with health and safety issues properly addressed. License tie-down

conditions were stated clearly, backed by information contained in the file, and inspectable. 

Deficiency letters clearly state regulatory positions, are used at the proper time, and identify

deficiencies in the licensees' documents.

In the Medical Licensing Unit, the Senior Health Physicist assigns licensing actions each

Monday to the license reviewers. The license reviewers in the Industrial & General Licensed

Device Unit select licensing actions daily from an updated printout of pending actions. The

status of all licensing actions is tracked with a database. The Licensing Section generates

licenses and correspondence with standardized conditions and formats. Each action is

reviewed by a peer reviewer as well as the Unit’s Senior Health Physicist, who signs the

licensing actions. The Medical Unit has developed multiple licensing guides based on the

NUREG-1556 series as well as licensing guidelines for emerging technologies. The Licensing

Units issue a complete license for each licensing action.

In late 2000, license terms were extended for three years, changing the seven-year expiration to

a ten-year term. A complete renewal application is required to be submitted every ten years to

maintain current information in the files. The general staffing shortage in the Branch has

affected the ability of the Licensing Section to keep current with incoming licensing casework

and a large backlog of license renewals has occurred. The Licensing Section currently has a

backlog of 75 renewals submitted in 2004 and 54 renewals received prior to this year. The

review team did not identify any health and safety impact caused by the backlog of licensing

actions. 
California Final Report Page 10

The Licensing Units review each inspection file prior to reviewing renewal applications to

determine the inspection and enforcement history of the licensee. However, the review team

noted that the lack of a tracking system and unavailability of incident and allegation files in the

Sacramento office has directly impacted the Licensing Unit’s ability to review a licensee’s

complete history. The review team recommends that the incident and allegation history of a

licensee be reviewed during evaluation of licensing actions.

Decommissioning actions involving licensees removing a building or location of use were

reviewed. The review team found that decommissioning licensing actions were well

documented, showing appropriate transfer records or appropriate disposal methods and

records, confirmatory surveys, and survey records. Terminated licensing actions were well

documented, showing appropriate transfer and survey records. It was noted that due to the

rescinding of decommissioning legislation, there has been a processing delay for

decommissioning/termination actions. The Licensing Units have made progress in this area

since January 2004.

Based on the IMPEP evaluation criteria, the review team recommends 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, the review

team examined the Branch’s response to the questionnaire regarding this indicator, evaluated

selected incidents reported for California in the “Nuclear Materials Events Database” (NMED)

against those contained in the California files, and evaluated the casework and supporting

documentation for 13 material incidents. A list of incident files examined along with casespecific comments is contained in Appendix E. The team also reviewed the ICE Section’s

response to 15 allegations, including 13 allegations referred to the State by NRC, during the

review period. 

The review team interviewed program management and staff to discuss the Branch’s incident

and allegation process, file documentation, the State’s equivalent to the Freedom of Information

Act, NMED, and notification of incidents to the NRC. The 13 incidents selected for review

included the following types: transportation, misadministration, damaged equipment, equipment

failure, lost/stolen material, and leaking source. While the quality of the incident and allegation

activities needs improvement, the team found the program’s overall response to incidents and

allegations to be adequate to protect public health and safety. 

When the Branch is notified of an incident or allegation, a Form 5010, “Matter Requiring

Investigation/Inspection,” is filled out by the staff member who receives the notification. The

responsibility for initial response to incidents and allegations involving radioactive material, both

falling under the category of “investigations,” is then assigned to a technical staff member by a

manager. Once the investigation has been closed out by a manager, a “Materials Investigation

Closing Memo” is completed and placed in the investigation file. The investigation is then

reviewed by a senior health physicist. The ICE Section has written procedures for handling

investigations. The team noted that the QA Health Physicist review of investigations, which was

identified as a good practice in the last review, is still the practice; however, the staff member

performing these reviews is not assigned QA duties on a full-time basis, resulting in delays in
California Final Report Page 11

follow-up actions on issues identified in the review. Completed investigations are reviewed by a

Health Physicist, however, due to workload, may be delayed for long periods of time.

The review team evaluated four misadministrations which occurred during the review period,

two of which were significant events which constituted Abnormal Occurrences. The

investigation file for one of the significant misadministrations could not be located by Branch

staff. Branch managers indicated that a comprehensive investigation was performed of the

event but the investigation file was somehow lost. The event had previously been reported to

the NRC as an Abnormal Occurrence. The other significant misadministration was identified by

Branch staff as satisfying the Abnormal Occurrence criteria, but was not reported to the NRC as

such. STP Procedure SA-300 “Reporting Material Events,” specifies that Agreement States

should routinely screen events against the Abnormal Occurrence criteria, and report any

potential Abnormal Occurrences to the NRC. The Branch agreed to follow up on this incident

and to provide an Abnormal Occurrence report to the NRC. The Branch provided the report to

the NRC on May 7, 2004.

The review team noted that a potential root cause of the four misadministrations that were

examined was the absence of specific requirements for administrations requiring a written

directive. California’s regulations do not require a written directive. See Section 4.1,

Compatibility Requirements, for further information on this issue.

The State has a reporting requirement for misadministrations involving more than 30

microcuries of iodine-131 and iodine-125 which is less restrictive than NRC’s regulations. The

State requires that licensees report such incidents within 15 days. The NRC reporting

requirement for these types of events is 24 hours. The Branch reports such incidents to the

NRC within 24 hours of receipt of the report from the licensee. Compatibility issues associated

with this requirement and other regulations may be found in Section 4.1, Compatibility

Requirements.

The review team queried the incident information reported to the NMED system for the review

period and identified 195 reportable incidents. Of the 195 reportable incidents in NMED, 45

were not complete and additional information needs to be provided to NRC’s contractor, the

Idaho National Engineering and Environmental Laboratory (INEEL). In addition, 172 of the 195

reportable incidents were not closed in NMED. This is an administrative task, and the Branch

agreed to take the appropriate action to close these incidents. The review team recommends

that the Branch, in coordination with INEEL, complete and close all reportable incidents in

NMED.

The team reviewed records maintained by the Branch which note the date that reportable

events are submitted to NMED, and concluded that a significant proportion of events with 30-

day reporting requirements are being reported in more than one month. Of the 76 events which

the Branch has tracked as being reportable within 30 days, 35 events were reported late. Of

these 35 events, 20 were reported more than 60 days after the event. Thus, as discussed in

Section 2.0, the recommendation from the previous IMPEP review remains open.

During the review period, 17 allegations were referred to the Branch by the NRC. The team

reviewed 13 of these, and also reviewed two allegations reported directly to the Branch. For

four allegations referred by the NRC and one allegation reported directly to the Branch, there

were no records of disposition, and investigation files could not be located by Branch staff. 
California Final Report Page 12

Subject matters for the four allegations referred by the NRC included decommissioning, waste

burial, nuclear gauges, and leaking devices. The subject matter for the allegation which was

reported directly to the Branch was not determined. During the review, the team provided

copies of NRC’s allegation transmittal letters to the Branch. The Branch committed to properly

address these allegations, and coordinate with the NRC as appropriate.

The team’s evaluation of the ICE Section’s allegation files indicated that prompt and appropriate

action was taken in response to the concerns in all but two cases. The team also identified two

allegations which should be completed, but remain open. The Branch plans to make

confirmatory calls to the licensees, and complete their investigations. In addition, the team

found one inadequate response to an allegation referred by the NRC. Branch management

agreed with this conclusion, and is taking follow-up action to better address the allegation. The

review team recommends that the Branch establish and implement a system to track incident

and allegation investigations to ensure timeliness, proper documentation, appropriate follow up,

and closure.

Based on the IMPEP evaluation criteria, the review team recommends that California’s

performance with respect to the indicator, Technical Quality of Incident and Allegation Activities,

be found satisfactory, but needs improvement.

4.0 NON-COMMON PERFORMANCE INDICATORS

IMPEP identifies four non-common performance indicators to be used in evaluating Agreement

State programs: (1) Compatibility Requirements; (2) Sealed Source and Device Evaluation

Program; (3) Low-Level Radioactive Waste Disposal Program; and (4) Uranium Recovery

Program. California's Agreement does not cover a uranium recovery program, so only the first

three non-common performance indicators were applicable to this review.

4.1 Compatibility Requirements

4.1.1 Legislation

California became an Agreement State in 1962. Along with their response to the questionnaire,

the State provided the review team with the opportunity to review copies of legislation that affect

the radiation control program. The Branch is designated as the State's radiation control agency. 

Legislative authority to create an agency and enter into an agreement with the NRC is granted

in the Radiation Control Law contained in Division 20, Section 7.6 of the California Health and

Safety Code. The review team noted that during the 2001-2002 legislative session, two lowlevel radioactive waste related bills were signed into law and codified into the Radiation Control

Law (see Section 4.3). No other legislation affecting the radiation control program was passed

since the previous IMPEP review. State legislation is adequate.

4.1.2 Program Elements Required for Compatibility

The Regulations for Control of Radiation, found in Title 17 (Public Health), Division 1, Chapter 5

(Sanitation), Subchapter 4, of the California Code of Regulations apply to all ionizing radiation,

whether emitted from radionuclides or devices. California requires a license for possession,

and use, of all radioactive material including naturally occurring materials, such as radium, and

accelerator-produced radionuclides. California also requires registration of all equipment

designed to produce x-rays and other ionizing radiation.
California Final Report Page 13

The review team evaluated the Branch’s response to the questionnaire, 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 NRC

STP’s Status of State Regulations tracking system.

A review of the State’s administrative rulemaking process found that the process takes at a

minimum one year (and often longer) after preparation of a draft rule to the final filing with the

Secretary of State, after which the rules become effective in 30 days. The public, the NRC,

other agencies, and all potentially impacted licensees and registrants are offered an opportunity

to comment during the process. Comments are considered and incorporated as appropriate

before the regulations are finalized, approved, and filed with the Secretary of State.

Proposed rules are submitted to the Office of Administrative Law for a legal review and to the

Legislative Fiscal Office for consideration and approval to proceed with public comment. Public

notice of proposed rule revisions is made and a 30 to 45-day public comment period takes

place. A public hearing may or may not be conducted. Concurrently, the proposed rules are

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

to the California Register for adoption. Final rules are then sent to licensees and the NRC. 

California law requires that guides, criteria, manuals, and instruction standards of general

application be enforced only as an adopted regulation. The State can adopt other agency

regulations by reference, which has been done with respect to the U.S. Department of

Transportation (DOT) transportation regulations and the NRC 10 CFR Part 20 radiation

protection regulations.

Several NRC amendments pertaining to changes of Title 10 CFR Part 20, “Standards for

Protection Against Radiation” were adopted by reference during the review period and became

effective on November 14, 2001. These amendments included NRC’s “Radiological Criteria for

License Termination” rule. This portion of the regulation was 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

current standard for decommissioning in California is that a “Reasonable effort has been made

to eliminate residual radioactive contamination, if present.” The Branch has been prohibited

from interpreting this to mean that a licensee must reduce contamination to a level that is “As

Low As Reasonably Achievable” (ALARA), and from establishing any numerical

decommissioning standard without first performing a California Environmental Quality Act

review. The Branch has not begun such a review and is currently terminating licenses on a

case-by-case basis.

Since the last IMPEP review, the State has adopted only one amendment. The State’s 10 CFR

Part 20 equivalent was adopted by reference. There are currently 15 regulations that the State

is overdue in adopting and none of these regulations have been started in the State’s

administrative rulemaking process. Because of the State’s inability to adopt regulations in the

time frame required by NRC, the team discussed the use of legally binding requirements or

adopting regulations by reference as other alternatives. Branch management said that adopting

by reference was not easily workable in their process. The team discussed this issue with the

Branch’s legal counsel and determined that to issue a license with legally binding requirements

in lieu of regulations until compatible regulations become effective is defensible, and the Branch

has the authority to do this.
California Final Report Page 14

The Branch has used license conditions in some cases; however, none have been reviewed by

the NRC for compatibility. In fact, absent from the license conditions are sections of rules that

the NRC considers health and safety significant and are listed in STP Procedure SA-200, as B

or H&S compatibility categories. For example, two important sections from 10 CFR Part 34,

“Licenses for Industrial Radiography and Radiation Safety Requirements for Industrial

Radiographic Operations,” are not covered by license conditions. The first is the requirement

for having two qualified individuals present at a location of radiographic operations and the

second is the requirement that a radiographer be certified through a radiographer certification

program by a certifying entity.

The industrial radiography “two-person rule” is an example of a regulation with direct health and

safety implications. It requires the presence of a second trained individual to observe the

operations and be capable of providing immediate assistance to prevent unauthorized entry. 

The Branch is aware of industrial radiography companies, including out-of-state companies,

performing radiography in the State using only one trained individual, to reduce operating costs. 

California is the only jurisdiction in the United States which does not have a two-person rule.

Other excluded parts of the regulations is the required use of written directives and specific

procedures for administrations requiring a written directive, as outlined in 10 CFR Part 35,

“Medical Use of Byproduct Materials.” In Section 3.5 of this report, it was identified that a least

four medical events occurred during the review period. The review team believes that a

contributing factor in all cases may have been that the licensees are not required to have a

written directive and procedures, as required by 10 CFR 35.40, 35.41, or a quality management

program with written directives, as required by Superceded Part 35.

Additionally, the Branch reviewed the license conditions that are currently used to address 10

CFR Part 36, "Licenses and Radiation Safety Requirements for Irradiators," and found that the

conditions do not cover several substantial parts to the regulations. Specifically, the team

reviewed the licenses for commitments comparable to the requirements in 10 CFR 36.57, 36.59,

36.63, and 36.83, and found that California does not consistently ensure that all irradiators

subject to Part 36 have license conditions incorporated in their license that address all of the

requirements.

The review team also noted that the Branch’s inspection manual contains an exception to the

reporting requirement for medical events that involve more than 30 microcuries of iodine-131 or

iodine-125. The exception authorizes a 15-day notification rather than NRC’s 24-hour reporting

criteria.

The Branch has three rule update packages prepared to go through the first step of their

rulemaking process, which is Branch management concurrence. Only one of these packages

has been forwarded to the Branch Chief. The three updates are for radiation safety

requirements for well logging operations, industrial radiographic operations, and miscellaneous 

amendments.

The review team concluded the delay in the promulgation of regulations in a timely fashion was

due in part by staff turnover which requires the Branch staff to divert their time and efforts to

other essential program elements; however, there appears to have been no effort in submitting

the developed rule packages into the rulemaking process for some time. The review team

recommends that the Branch develop and implement an action plan to adopt NRC regulations in

accordance with current NRC policy on adequacy and compatibility.
California Final Report Page 15

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

legally binding requirements no later than three years after they are effective. Several of these

amendments are designated A, B or H&S compatibility categories. The following 15 regulations

are overdue:

• “Quality Management Program and Misadministrations,” 10 CFR Part 35 amendment

(56 FR 34104) that became effective on January 27, 1992.

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

amendments (59 FR 36026) that became effective on August 15, 1994.

• “Performance Requirements for Radiography Equipment,” 10 CFR Part 34 amendment

(60 FR 28323) that became effective June 30, 1995.

• “Medical Administration of Radiation and Radioactive Materials,” 10 CFR Parts 20 and

35 amendments (60 FR 48623) that became effective on October 20, 1995. The 10

CFR Part 20 portion of this rule was adopted by the State on September 10, 1998.

• “10 CFR Part 71: Compatibility with the International Atomic Energy Agency,” 10 CFR

Part 71 amendment (60 FR 50248) that became effective on April 1, 1996.

• “Recognition of Agreement State Licenses in Areas Under Exclusive Federal Jurisdiction

Within an Agreement State,” 10 CFR Part 150 amendment (62 FR 1662) that became

effective February 27, 1997.

• “Criteria for the Release of Individuals Administered Radioactive Material,” 10 CFR Parts

20 and 35 amendments (62 FR 4120) that became effective May 29, 1997. The 10 CFR

Part 20 portion of this rule was adopted by reference in 1998.

• “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 became effective June 27, 1997.

• “Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon-14

Urea,” 10 CFR Part 30 amendment (62 FR 63634) that became effective January 2,

1998.

• “Deliberate Misconduct by Unlicensed Persons,” 10 CFR Parts 30, 40, 61, 70, and 150

amendments (63 FR 1890 and 63 FR 13773) that became effective February 12, 1998.

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

Radiographic Operations,” 10 CFR Part 34 amendment (63 FR 37059) that became

effective July 9, 1998.

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

35, and 36 amendments (63 FR 39777 and 63 FR 45393) that became effective on

November 26, 1998. The 10 CFR Part 20 portion of this rule was adopted by reference

in 1998.
California Final Report Page 16

• “Respiratory Protection and Controls to Restrict Internal Exposure,” 10 CFR Part 20

amendment (64 FR 54543 and 64 FR 55524) that became effective February 2, 1999.

• “Energy Compensation Sources for Well Logging and Other Regulatory Clarifications,”

10 CFR Part 39 amendment (65 FR 20337) that became effective on May 17, 2000.

• “New Dosimetry Technology,” 10 CFR Parts 34, 26, and 39 amendments (65 FR 63750)

that became effective on January 8, 2001.

The 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,” 10 CFR Parts 20, 32, and 35 amendments (67 FR

20250) that became effective on October 24, 2002.

• “Financial Assurance for Materials Licensees,” 10 CFR Parts 30, 40, and 70

amendments (68 FR 57327) that became effective on December 3, 2003.

Based on the IMPEP evaluation criteria, the review team recommends that California’s

performance with respect to the indicator, Compatibility Requirements, be found unsatisfactory.

4.2 Sealed Source and Device (SS&D) Evaluation Program

In assessing the California SS&D evaluation program, the review team examined the

information provided in response to the IMPEP questionnaire. The team evaluated SS&D

registry sheets issued during the review period, and the supporting document files. The team

also evaluated SS&D staff training records, certain reported incidents involving products

authorized in California SS&D sheets, the use of guidance documents and procedures, and

interviewed the staff currently conducting SS&D evaluations. 

Three sub-indicators were used to evaluate the Division’s performance regarding SS&D

evaluation. These sub-indicators were: (1) Technical Staffing and Training; (2) Technical

Quality of the Product Evaluation Program; and (3) Evaluation of Defects and Incidents

Regarding SS&Ds.

4.2.1 Technical Staffing and Training

Presently, the Senior Health Physicist is in charge of the SS&D evaluation program and five

staff members conduct reviews. Two of the five staff members have conducted only one

review. These individuals have been conducting SS&D evaluations for less than a year and are

considered to be in training. Five previously fully qualified and experienced SS&D reviewers left

the SS&D evaluation program during the review period. Most of the SS&D reviews completed

during the review period were performed by staff no longer in the program.

The review team evaluated the qualifications of the new individuals authorized and currently

performing SS&D evaluations. By way of creation of the Licensing Projects Unit Training

Journal, formal requirements for SS&D reviewers have been established. All reviewers were

deemed qualified by either formal education, completion of appropriate training courses or

experience equivalency, except for one reviewer who is lacking the completion of two training
California Final Report Page 17

courses. All have regulatory experience and all have attended the NRC SS&D Workshop. 

Interviews and the casework review indicated that the Senior Health Physicist or the

concurrence reviewer, discusses with staff members the issues and concerns that are identified

in an application.

Due in part to staff turnover, fees not being assessed for SS&D evaluations, and other pressing

licensing functions, such as complex decommissioning and financial assurance, the SS&D

evaluation program maintains a backlog of approximately 45 SS&D actions dating back to

January 1999, representing, according to interviews, approximately two years’ worth of case

work. The team did not identify any immediate health and safety concerns created by the SS&D

backlog.

4.2.2 Technical Quality of the Product Evaluation Program

The review team evaluated 15 of the 160 SS&D evaluation amendments, inactivations and new

registrations the Branch completed during the review period, representing the work of eight

SS&D reviewers. The cases were representative of the Branch’s licensees and SS&D

evaluation personnel completed between October 1999 and February 2004. A list of SS&D files

examined along with case-specific comments may be found in Appendix F. 

The team’s review of the casework and interviews with the staff confirmed that the SS&D

reviewers used guidance found in NRC’s NUREG-1556, Volume 3, and the American National

Standards Institute/ Health Physics Society standards and materials obtained from the most

recent SS&D Workshop held in Los Angeles in September 2003. All pertinent ANSI/HPS

standards, Regulatory Guides, and applicable references were confirmed to be available and

were used when performing SS&D reviews. The appropriate review checklist from NUREG1556, Volume 3, Appendix C was used to assure relevant materials had been submitted and

reviewed. The Branch has augmented the basic Appendix C checklist by creating nine different

checklists that address additional information needs based on the proposed use of the product

(e.g., well logging sources, radiography equipment, etc.). The checklists were retained in all of

the registration files examined and included documentation of second peer or supervisory

reviews.

With few exceptions, the registration files contained all correspondence, engineering drawings,

radiation profiles, and results of tests conducted by the applicant. The Senior Health Physicist

in charge of the SS&D evaluation program related that non-Atomic Energy Act (AEA) material

reviews are performed in the same procedural manner using the same references as used for

AEA sources and devices. The review team noted that the SS&D evaluation program has, onstaff, two persons with a mechanical engineering degree or equivalent background. During staff

interviews it was determined that any product integrity or design parameters not understood by

SS&D reviewers will be referred to these individuals for analysis.

In accordance with procedure number RML-04-1, effective March 26, 2004, the SS&D

evaluation program handles proprietary information by inserting a colored page before any

proprietary or trade secret information. If a request to view SS&D files is received, the Senior

Health Physicist will conduct a review of the entire SS&D file to determine if material received

prior to the effective date of the procedure contains information considered proprietary or trade

secrets.
California Final Report Page 18

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 determined that the product evaluations were thorough, complete, consistent,

of acceptable technical quality, and adequately addressed the integrity of the products during

use and in the event of an accident.

4.2.3 Evaluation of Defects and Incidents Regarding SS&Ds

Through self-reporting directly to the SS&D evaluation program and random interoffice

notifications, the SS&D evaluation program had collected six events related to SS&D

evaluations. The team reviewed four of these cases and identified an adequate response to

each. A list of SS&D incident files examined along with case-specific comments may be found

in Appendix E.

As in the previous IMPEP, it was determined through staff interviews that there exists no

procedure for reporting events associated with SS&Ds to the SS&D evaluation program for

follow up. Additionally, there exists no procedure for handling reports of defects and incidents

by the SS&D evaluation program. Because of these deficiencies, reports of defects and

incidents are not routinely reported to the SS&D evaluation program and appropriate follow-up

investigations are delayed and persist for years in some cases. The review team recommends

that the Branch formally establish and implement (1) a process to notify the SS&D evaluation

program of all defects and incidents involving California administered SS&D sheets; and (2) a

procedure for the SS&D evaluation program to investigate reports of defects and incidents for

root cause and generic implications for possible subsequent reevaluation of SS&D sheets.

Based on the IMPEP evaluation criteria, the review team recommends that California’s

performance with respect to the indicator, Sealed Source and Device Evaluation Program, be

found satisfactory.

4.3 Low-Level Radioactive Waste (LLRW) Disposal Program

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

Discontinuance of NRC 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. Those

States with existing Agreements prior to 1981 were determined to have continued LLRW

disposal authority without the need of an amendment. Although California has such disposal

authority, NRC has not required States to have a program for licensing a disposal facility until

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

When an Agreement State has been notified or becomes aware of the need to regulate an

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.

Funding for the California LLRW program ceased in 2002. Also, in 2002, two LLRW-related

State laws were passed prohibiting the development of an LLRW site at Ward Valley, the only

location in California licensed for the development of an LLRW disposal facility. There are

currently no plans for an LLRW disposal facility in California. Accordingly, the review team did

not evaluate this indicator.
California Final Report Page 19

5.0 SUMMARY

As noted in Sections 3 and 4 above, the review team and the MRB found California’s

performance to be satisfactory for four performance indicators, and satisfactory, but needs

improvement, for the performance indicators, Technical Staffing and Training and Technical

Quality of Incident and Allegation Activities. The review team and the MRB found California’s

performance to be unsatisfactory for the performance indicator, Compatibility Requirements. 

Accordingly, the review team recommended and the MRB concurred in finding the California

Agreement State program adequate, but needs improvement and not compatible with NRC's

program. The review team recommended and the MRB concurred that a period of heightened

oversight be implemented to assess the progress of the State, including preparation of a

program improvement plan, bimonthly conference calls, status reports before each call, and a

follow-up IMPEP review in one year.

Below is a summary list of recommendations, as mentioned in earlier sections of the report, for

evaluation and implementation by the State. Included is one open recommendation from the

1999 IMPEP report and one open recommendation from the 1996 IMPEP report:

RECOMMENDATIONS

1. The review team recommends that the State ensure that adequate resources, both

funding and staffing, be devoted to the radiation control program. (Section 3.1)

2. The review team recommends that the Branch enhance its ability to account for the

whereabouts and security of licensed materials known to have existed under a license. 

(Section 3.2)

3. The review team recommends that the Branch implement procedures to ensure

inspection findings are issued to licensees within 30 days of the completion of routine

inspections. (Section 3.2)

4. The review team recommends that the incident and allegation history of a licensee be

reviewed during evaluation of licensing actions. (Section 3.4)

5. The review team recommends that the Branch, in coordination with INEEL, complete

and close all reportable incidents in NMED. (Section 3.5)

6. The review team recommends that the Branch submit reportable events to NMED within

one month of their occurrence in accordance with the “Handbook on Nuclear Event

Reporting in the Agreement States.” (Section 3.5) (Open recommendation from Section

5.0 of the 1999 report)

7. The review team recommends that the Branch establish and implement a system to

track incident and allegation investigations to ensure timeliness, proper documentation,

appropriate follow up, and closure. (Section 3.5)

8. 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)

9. The review team recommends that the Branch formally establish and implement (1) a

process to notify the SS&D evaluation program of all defects and incidents involving
California Final Report Page 20

California administered SS&D sheets; and (2) a procedure for the SS&D evaluation

program to investigate reports of defects and incidents for root cause and generic

implications for possible subsequent reevaluation of SS&D sheets. (Section 4.2)

10. The review team recommends that the State re-evaluate the Nova R&D, Inc., Model

Cindi neutron device with special attention to the potential exposure received by the

general licensed user. If it is determined that the exposure rate exceeds that which is

allowed for persons covered under the general license, the device should be reclassified

for distribution to persons covered under a specific license and the SS&D evaluation

certificate should be amended to reflect any required changes. (Section 2.0) (Open

recommendation from Section 4.2 of the 1996 report)
LIST OF APPENDICES AND ATTACHMENT

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

Attachments July 1, 2004 Letter from Richard J. Jackson

California’s Response to Draft IMPEP Report

July 8, 2004 Letter from Edgar D. Bailey

California’s Response to NRC’s May 6, 2004 Letter
APPENDIX A

IMPEP REVIEW TEAM MEMBERS

Name Area of Responsibility

James Lynch, Region III Team Leader

Technical Staffing and Training

Inspector Accompaniments

Linda McLean, Region IV Compatibility Requirements

Inspector Accompaniments

Hector Bermudez, Region II Status of Materials Inspection Program

Technical Quality of Inspections

Andrew Mauer, STP Technical Quality of Incident and Allegation

 Activities

Kim Wiebeck, Arkansas Technical Quality of Licensing Actions

David Fogle, Texas Sealed Source and Device Evaluation Program
APPENDIX B

CALIFORNIA ORGANIZATION CHARTS

ADAMS ML041260427







ATTACHMENTS

July 1, 2004 Letter from Richard J. Jackson 

California’s Response to the Draft IMPEP Report

ADAMS ML041960580

July 8, 2004 Response from Edgar D. Bailey

California’s Response to NRC’s May 6, 2004 Letter

ADAMS ML042110327