DATED: JUNE 18, 1997 SIGNED BY: HUGH L. THOMPSON, JR.

Ms. S. Kimberly Belshé, Director

California Department of Health Services

714/744 P Street

P.O. Box 942732

Sacramento, CA 94234-7320

Dear Ms. Belshé:

On June 5, 1997, 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 compatible

with NRC's program. 

Section 5, page 29, of the enclosed final report presents the IMPEP team's

recommendations. We request your evaluation and response to those

recommendations within 30 days from receipt of this letter.

Based on the results of the current IMPEP review, the next review will be

scheduled in three years, unless program concerns develop that require an

earlier evaluation.

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

the review and your support of the Radiation Control Program. I look forward

to our agencies continuing to work cooperatively in the future.

Sincerely,

Hugh L. Thompson, Jr.

Deputy Executive Director

 for Regulatory Programs

Enclosure:

As stated

cc: Dr. James Stratton, State Health Officer

Dr. Larry Barrett, Chief

 California Food, Drugs and Radiation Safety Division

Dr. David Spath, Chief

 Division of Drinking Water & Environmental Management

Mr. Edgar Bailey, Chief, 

 California Radiologic Health Branch
Ms. S. Kimberly Belshé, Director

California Department of Health Services

714/744 P Street

P.O. Box 942732

Sacramento, CA 94234-7320

Dear Ms. Belshé:

On June 5, 1997, 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 compatible

with NRC's program. 

Section 5, page 29, of the enclosed final report presents the IMPEP team's

recommendations. We request your evaluation and response to those

recommendations within 30 days from receipt of this letter.

Based on the results of the current IMPEP review, the next review will be

scheduled in three years, unless program concerns develop that require an

earlier evaluation.

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

the review and your support of the Radiation Control Program. I look forward

to our agencies continuing to work cooperatively in the future.

Sincerely,

Hugh L. Thompson, Jr.

Deputy Executive Director

 for Regulatory Programs

Enclosure:

As stated

cc: Dr. James Stratton, State Health Officer

Dr. Larry Barrett, Chief

 California Food, Drugs and Radiation Safety Division

Dr. David Spath, Chief

 Division of Drinking Water & Environmental Management

Mr. Edgar Bailey, Chief, 

 California Radiologic Health Branch

bcc: Chairman Jackson Distribution:

Commissioner Rogers DIR RF DCD (SP01) KCyr

Commissioner Dicus FXCameron PDR (YES/)

CPaperiello

Commissioner Diaz SBaggett HNewsome FCongel

Commissioner McGaffigan SDroggitis AGrewe, TN GDeegan

KSchneider CHackney, RIV

JHornor, RIV WCFO CGordon, RI

TCombs RFletcher, MD

*See previous concurrence California File LRakovan

DOCUMENT NAME: G:\KXS\96FINLTR.CA G:\KXS\CAIMP96.FIN 

OFFICE OSP E OSP:DD OSP:D EDO

NAME LBolling:gd PHLohaus RLBangart HLThompson 

DATE 06/11/97* 06/11/97* 07/ /97 05/ /97

FILE CODE: SP-AG-4
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM

REVIEW OF CALIFORNIA AGREEMENT STATE PROGRAM

October 21-25, 1996

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

October 21-25, 1996, by a review team comprised of technical staff

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

State of Tennessee. Team members are identified in Appendix A. The

review was conducted in accordance with the "Interim Implementation of

the Integrated Materials Performance Evaluation Program Pending Final

Commission Approval of the Statement of Principles and Policy for the

Agreement State Program and the Policy Statement on Adequacy and

Compatibility of Agreement State Programs," published in the Federal

Register on October 25, 1995 and the September 12, 1995, NRC Management

Directive 5.6, "Integrated Materials Performance Evaluation Program

(IMPEP)." Preliminary results of the review, which covered the period

January 1993 to October 1996, were discussed with California management

on October 25, 1996. 

A draft of this report was issued to California for factual comment on

March 11, 1997. The State of California responded in a letter dated May

5, 1997 (attached). The State had no factual comments on the proposed

final report. The Management Review Board (MRB) met on June 5, 1997, to

consider the proposed final report. Based on the existing NRC

compatibility policy and the IMPEP evaluation criteria, the review team

recommended that California's performance with respect to the indicator,

Legislation and Regulations, be found unsatisfactory. The team

recommended that compatibility findings for the California program be

reevaluated upon final promulgation of California's regulations on

Notification of Incidents and the Definition of Land Disposal and Waste

Site QA program amendment. The amendments on these two regulations are

expected to be adopted by October 1, 1997. Because of the progress to

date in the promulgation of these rules and the expected adoption date

of October 1, 1997, the MRB determined that a sufficient basis did not

exist to support a finding of unsatisfactory for this indicator. The

MRB noted that if significant delays in rule adoption occur or if

California adopts rules that are not compatible with the NRC equivalent

regulations, the MRB could always reconsider the program compatibility

finding at a future date. The MRB final recommendation for Legislation

and Regulations is satisfactory. The MRB found the California radiation

control program was adequate to protect public health and safety and

compatible with NRC's program

The radiation control program is located in the State's Department of

Health Services (DHS). Within DHS, the California radiation control

program is administered by the Radiologic Health Branch (RHB) in the

Food, Drugs & Radiation Safety Division. An organization chart is

included as Appendix B. The California program regulates approximately

2,100 specific licenses. The review focused on the 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

non-common indicators was sent to the State on July 5, 1996. California
California Final Report Page 2

provided its response to the questionnaire on September 16, 1996. A

copy of that response is included as Appendix C to this report. 

The team's general approach for conduct of this review consisted of: 

(1) examination of California's response to the questionnaire; (2)

review of applicable California statutes and regulations; (3) analysis

of quantitative information from the Branch licensing and inspection

data base; (4) technical review of selected files; (5) field

accompaniments of seven 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 non-common indicator and made a preliminary

assessment of DHS's performance. 

Section 2 below discusses the State's actions in response to

recommendations made following the previous review. 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

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

recommendations.

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS

The previous routine review concluded on January 29, 1993, and the

results were transmitted to Dr. Molly Joel Coye, Director of the

California Department of Health Services on April 22, 1993. NRC

conducted a followup review of the program in January 1994 to evaluate

the status of open issues identified in the 1993 review. A second visit

was made in March 1994 to conduct an indepth review of the State's

sealed source and device (SS&D) evaluation program. The results of

these reviews were transmitted to Ms. S. Kim Belshé, Director of the

California Department of Health Services on December 23, 1994. 

2.1 Status of Items Identified During the 1994 Followup Program

Reviews

The January and March 1994 followup reviews evaluated the status of

seventeen recommendations identified as part of the 1993 review. The

IMPEP team looked at each item again to determine whether or not the

current California program had taken additional actions to close open

recommendations. These recommendations are summarized below:

(1) The 1993 review team recommended that the State initiate the

process for revising its regulations with sufficient lead

time to meet the target implementation date (three years

after the NRC effective date) in order to maintain

compatibility. Specifically, the following regulations were

identified as being overdue for adoption:

! "Decommissioning Rule" 10 CFR Parts 30, 40 and 70

amendments (53 FR 24018) needed by July 27, 1991.
California Final Report Page 3

! "Emergency Planning Rule," 10 CFR Parts 30, 40, and 70

amendments (54 FR 14051) needed by April 7, 1993. 

! "Safety Requirements for Radiographic Equipment," 10

CFR Part 34 amendment (55 FR 843) needed by January 10,

1994.

! "Notification of Incidents," 10 CFR Parts 20, 31, 34,

39, 40, and 70 amendments (55 FR 40757) needed by

October 15, 1994.

Current Status: California revised a number of its

regulations during the review period. On March 3, 1994, the

State adopted a revised rule, R-45-93, which is a Part 20

equivalent rule covering "Standards for Protection Against

Radiation." This rule adopts NRC's 10 CFR Part 20 by

reference and was later incorporated, via license condition,

into each of the State's specific licenses. Amendments to

add the Safety Requirements for Radiographic Equipment rule

were promulgated in July 1994. Amendments to the

Decommissioning rule and the Emergency Planning rule were

promulgated via Emergency Rulemaking action in October 1995. 

The amendments on "Notification of Incidents" have not yet

been adopted. The review team examined this recommendation

as part of the Legislation and Regulations non-common

performance indicator (see Section 4.1). This recommendation

is considered closed and will be tracked as a new

recommendation (see Section 5.0).

(2) The 1993 review team identified a significant increase in the

number of overdue inspections in priorities 1 thru 3 and

among initial inspections. Three recommendations were made

regarding the Indicator on Status of Inspection Program. 

These were:

! Every effort should be made to fill three vacant

inspector positions.

! The State should re-evaluate the practice of

contracting inspections and investigations to county

agencies, and if continued, future contracts should

hold counties accountable for work not performed.

! The State should develop inspection schedules which

strictly adhere to the established inspection priority

frequencies. The plan should establish target dates

and milestones for assessing progress.

Current Status: The 1994 review team noted that all

inspector vacancies were filled and that the county contract

agencies were notified that corrective action must be taken

if they fall behind in scheduled inspections. The compliance

supervisor projects the number of inspections required to

meet stated goals and monitors the program's progress
California Final Report Page 4

monthly. The 1996 review team noted that there were only

three inspections overdue, by one week, at the time of the

review and these inspections were scheduled to be conducted

by the end of October 1996. This recommendation is closed. 

(3) The 1993 review team recommended that specific radiopharmacy

inspection forms be developed and used uniformly.

Current Status: The 1996 review team confirmed that a

revised radiopharmacy supplement to the inspection report

form addresses transportation. The review team noted that

this supplement is available to the inspection staff and is

being utilized during inspections. This recommendation is

closed.

(4) The 1993 review team recommended that supervisors should

require all inspectors to use inspection forms in the manner

prescribed in the procedures. This recommendation relates to

inadequate documentation in inspection reports and failure to

detect three minor categories of deficiencies during

supervisory reviews.

Current Status: The 1996 review team noted that the overall

quality of the inspection reports was very good. Only one of

the 26 reports reviewed was in need of improved

documentation. This recommendation is closed. 

(5) The 1994 review team recommended that the State ensure that

the proper testing or engineering analysis be performed on

SS&D by the manufacturer for the intended use. In addition,

the manufacturer should certify that the tests were performed

and that the SS&D passed the test. The American National

Standards Institute (ANSI) guides should be used as the

minimum set of prototype tests for sealed sources and the

ANSI guide for devices should be supplemented with

appropriate prototype tests for the device's intended uses.

Current Status: The 1996 review team identified six cases,

out of the twenty-two SS&D files reviewed, in which comments

were made regarding deficiencies in prototype testing. It

should also be noted that the review team recommends that the

Staff develop a policy on the acceptance of operational

history in lieu of prototype tests when considering the

useful life of a product. The review team examined this

recommendation as part of the Sealed Source and Device

Evaluation Program non-common performance indicator (see

Section 4.2). This recommendation is considered closed and

will be tracked as a new recommendation (see Section 5.0).

(6) The 1994 review team recommended that the State request and

review complete operations manuals and user manuals for

device and source installations, service, maintenance, and

emergency procedures to determine if any proposed activity
California Final Report Page 5

would comprise worker safety, device integrity, or put the

licensee in non-compliance.

Current Status: The 1996 review team noted that the staff is

requesting and reviewing operations and user manuals. The

team did however identify a deficiency in a user manual in

one of the twenty-two SS&D casework files reviewed. The

State staff appears to have adequately addressed this

recommendation. This recommendation is closed.

(7) The 1994 review team recommended that the State request

detailed drawings and lists of materials from

manufacturer/distributors of SS&D for all safety related

components. The information is necessary to check if the

manufacturer's device/sealed source design will withstand the

proposed use. In addition this information is required for

an overall understanding of how the safety features operate

and to determine if components from one manufacturer's design

(i.e., radiography - sealed source and camera combinations)

are compatible with each other.

Current Status: A review of selected SS&D evaluation

casework files and discussions with the staff indicate an

improvement in this area for recently issued evaluations. 

Several files, however, require a re-examination for

completeness. The review team examined this recommendation

as part of the Sealed Source and Device Evaluation Program

non-common performance indicator (see Section 4.2). This

recommendation is considered closed and will be tracked as a

new recommendation (see Section 5.0).

(8) The 1994 review team recommended that the staff re-evaluate

the general licensing of the neutron gauge (Model N-002,

CA380D101G). It appears that the external radiation levels

may exceed the prescribed dose limits for generally licensed

devices (>500 mrem/yr). In addition, the gauge did not

appear to be adequately prototype tested.

Current Status: The review team again examined this casework

file and confirmed the earlier recommendation that this

device should be reevaluated. No complete reevaluation was

performed. It was further noted that a number of these

devices are now in use by several law enforcement agencies. 

The review team examined this recommendation as part of the

Sealed Source and Device Evaluation Program non-common

performance indicator (see Section 4.2). This recommendation

is considered closed and will be tracked as a new

recommendation (see Section 5.0).

(9) The 1994 review team recommended that the State ensure that

the staff receive appropriate training in SS&D reviews. This

training should include, but not be limited to, how to read

blueprints, training on the use of the registry system, and

the necessity of performing independent evaluations of source
California Final Report Page 6

and device designs. The staff should also review all

appropriate ANSI guides.

Current Status: The Senior Health Physicist responsible for

industrial licensing and an Associate Health Physicist

attended the NRC sponsored sealed source and device workshop

in 1995. The review team recommended and the RHB intends to

request further training for its staff in this area. The

review team examined this recommendation as part of the

Sealed Source and Device Evaluation Program non-common

performance indicator (see Section 4.2). This recommendation

is considered closed and will be tracked as a new

recommendation (see Section 5.0).

(10) The 1994 review team recommended that all staff performing

SS&D reviews should be provided copies of all documents,

guides, and information pertaining to SS&D reviews. 

Current Status: The five Health physicists responsible for

performing sealed source and device evaluations have been

provided copies of the sealed source and device workshop

manuals and other reference documents. This recommendation

is closed. 

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 include: (1) Status of Materials Inspection Program; (2)

Technical Staffing and Training; (3) Technical Quality of Licensing

Actions; (4) Technical Quality of Inspections; and (5) Response to

Incidents and Allegations. 

3.1 Status of Materials Inspection Program

The review team focused on five areas in reviewing the status of the

State’s materials inspection program: (1) capability of the State to

maintain and retrieve statistical data on the status of the compliance

program, (2) inspection frequency schedule, (3) initial inspections of

new licenses, (4) overdue inspections, and (5) timely dispatch of

inspection findings to licensees. 

The team found that RHB’s data system is successfully tracking the

compliance actions for the 2,074 specific licenses administered by seven

compliance offices which, in addition to the main office in Sacramento,

include three regional offices and three counties with staff who perform

inspections and investigations under contract with the State. Licensee

compliance histories are available instantaneously to the Sacramento

office through a network of personal computers which are furnished to

all technical staff. The State plans to add the field offices to the

network soon; until then, information is provided to the field offices

through telephone, fax, and overnight mail. Monthly, quarterly, and

annual reports are issued to all supervisors and field offices for

verification and work-load adjustment. The data in several ad hoc
California Final Report Page 7

reports provided to the review team corresponded to the information

found during the inspection file reviews.

The team reviewed the State’s inspection frequency schedule and

confirmed that the State's inspection frequencies for various types of

licenses are identical to similar license types listed in the frequency

schedule in the NRC Inspection Manual Chapter 2800 (IMC 2800). The

State’s adherence to the prescribed frequency schedule was verified

during the inspection file reviews. The team noted that California

schedules inspections of mobile high dose remote (HDR) therapy licensees

at one-year intervals, which is the same inspection frequency used by

NRC. Because the HDR unit is removed after the treatment is completed,

hospitals that use mobile services remain on their normal inspection

frequency in accordance with the IMC 2800 schedule.

Initial inspections for licenses with inspection frequencies of five

years or less become due six months after the license is issued. 

Initial inspections of Priority 6 licenses are due 12 months after the

license is issued. New licenses are entered into the inspection

tracking system at the time that the license is issued. This is done by

administrative staff and verified by management when they review the

monthly computer reports. Comparison of the computer data with the

information gathered during file reviews confirmed that initial

inspections are correctly entered and tracked. In their answers to the

questionnaire, the State explained the procedure for setting up the

first inspection: Three months after the license is issued, the State

calls the licensee to determine whether the radioactive material has

been acquired. If the licensee does not yet possess the material, the

tracking system triggers calls at three-month intervals. After 12

months, the licensee is required to provide written certification to the

State that they have not acquired radioactive material. This cycle

repeats until the licensee obtains the material and an inspection is

scheduled or until the license is terminated. The State justifies this

minor deviation from IMC 2800 because of the geographical size of the

State and the need to make the most efficient use of staff resources. 

In NRC jurisdiction, initial inspections are conducted within one year

of license issuance whether or not radioactive material is on site. 

The review team found no backlog of overdue inspections. During this

review period, the State changed the definition of overdue inspections

from 150% of scheduled frequency to 125% of scheduled frequency. This

is the same criterion used by the NRC. The State effectively used

additional staff and changes in work-load assignments to maintain the

stricter inspection schedule without incurring backlogs of overdue

inspections. This was verified by the review team in examinations of

past quarterly and annual reports, current monthly reports, and review

of the inspection files. The State is currently conducting reciprocity

inspections and meets the criterion in NRC Manual Chapter 1220. The

review team’s calculations agreed with the State’s projections of

approximately 700 inspections that must be performed annually in order

to maintain the prescribed inspection schedule. During FY 95-96, the

State exceeded the goal by performing 718 inspections. In their

response to the questionnaire, the State indicated that at any one time,

a few inspections would be expected to be overdue by a few days, but not
California Final Report Page 8

more than two weeks. At the time of the review, the team found three

such licenses slightly overdue for inspection, and they were scheduled

for inspection by the end of the month. This number is certainly within

the 10 percent criteria for overdue inspections as listed in Management

Directive 5.6. 

The team also evaluated the State's timeliness in issuing inspection

findings to the licensee. Review of the computer reports and inspection

files showed that, during the review period, the State dispatched over

50% of inspection findings within their goal of 15 days, and that with a

few exceptions in complex cases, all were sent within the IMPEP

criterion of 30 days. 

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. 

3.2 Technical Staffing and Training

Issues central to the evaluation of this indicator include: (1) the

radioactive materials program staffing level, (2) the technical

qualifications of the staff, (3) technical staff training, and (4) staff

attrition. To evaluate these issues, the review team examined the

State's questionnaire responses relative to this indicator, interviewed

RHB management and staff, and considered any possible backlogs in

licensing or compliance actions. 

The RHB technical staff includes a Branch Chief and two Supervisory

Health Physicists, one for materials licensing and one for enforcement

and compliance. The RHB has five position classifications for its

technical staff. These are:

! Junior Health Physicist - a trainee position

! Assistant Health Physicist - a first working level position

! Associate Health Physicist - a full journeyperson/lead person

position 

! Senior Health Physicist - a first supervisory level position

! Supervisory Health Physicist - a second supervisory level

position

The Junior Health Physicist classification requires at minimum a

bachelor's degree in physical or life sciences. The other positions

require the same minimum level of education plus increasing professional

work experience at the next lower level. 

The licensing section, with a staff of nineteen, is divided into four

subsections. Each subsection is supervised by a Senior Health

Physicist. Three subsections are directly devoted to materials

licensing and one subsection conducts radiological assessment activities

in support of license terminations, enforcement and compliance and the

Low-Level Waste Site. With respect to the licensing casework,

applications are assigned to the staff in turn and based on their level

of training and experience. Only Supervisory and Senior Health

Physicists have signature authority for licensing documents. The sealed
California Final Report Page 9

source/device certificates are co-signed by the reviewing staff member

and the Senior Health Physicist. There is currently one vacancy in the

materials licensing program. 

With respect to the enforcement and compliance casework, assignments are

made by the Senior Health Physicists based on an inspector's training

and experience. Annual inspector accompaniments are conducted by

supervisors who closely monitor the performance of their staff. Routine

inspection correspondence is signed by the inspectors, however, Notices

of Violation are signed by Senior Health Physicists who have signature

authority for non-routine matters. 

The RHB encourages all licensing and compliance staff to attend

technical courses including: Inspection Procedures Course, Diagnostic

and Therapeutic Nuclear Medicine Course, Safety Aspects of Industrial

Radiography Course, Teletherapy and Brachytherapy Course, Safety Aspects

of Well Logging Course, Health Physics Technology Course and Licensing

Practices and Procedures Course. The RHB selects staff to attend these

courses based on their work assignment, education, work experience and

RHB program needs. Individual staff members may be waived from

attending specific courses on a case-by-case basis upon consideration of

their past experience and education. 

During the review period, seven new employees were hired by the

materials licensing and compliance sections. Two of these employees are

former NRC inspectors and four others were promoted from the X-ray

inspection and certification program. The seventh individual has a

Master's degree in Health Physics and professional work experience in

radiological consulting. Two of the individuals, both inspectors, have

not yet completed all of the requirements to conduct all types of RHB

inspections independently. They are, however, being trained, closely

supervised and are progressing through the various types of compliance

inspections. The new license reviewers are obtaining training

appropriate to their duties including on-the-job training with

experienced reviewers. 

The review team examined the State's response to the questionnaire and

reviewed staff training and experience records and found that the staff

meets the minimum education and work experience requirements for their

duties. The State has established criteria for the qualifications of

personnel in each job category. This is addressed through a combination

of the position descriptions for each job series and the statement of

duties for each employee. Specific courses are not contained in these

documents, however, each supervisor selects candidates for specific

courses based on each employee's education, past experience and work

assignment. With regard to staffing level, attrition is low and the RHB

appears to be more successful, than in the past, in recruiting qualified

applicants when vacancies occur. At the time of this review, the RHB

had only one technical position vacant. 

The review team recommends that the State consider keeping a collective

staff training record to help formalize technical training as an ongoing

requirement for the position and to better allow management to assess

the training level of the staff. Waivers granted to individual staff
California Final Report Page 10

members, from attendance at specific training courses, based on past

education and experience should be documented. 

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.

3.3 Technical Quality of Licensing Actions

The review team examined casework and interviewed the reviewers for

thirty-six specific licenses. Licensing actions were reviewed for

completeness, consistency, proper radionuclides and quantities used,

qualifications of authorized users, adequate facilities and equipment,

and operating and emergency procedures sufficient to establish the basis

for licensing actions. Casework was reviewed for timeliness, adherence

to good health physics practices, reference to appropriate regulations,

documentation of safety evaluation reports, product certifications or

other supporting documents, consideration of enforcement history on

renewals, pre-licensing visits, peer or supervisory review as indicated,

and proper signature authorities. Comments from casework evaluations

performed during the review were discussed with the licensing manager. 

License applications were checked to ensure that all essential elements

met current regulatory guidance for describing the isotopes and

quantities used, qualifications of personnel who used radioactive

material, facilities and equipment, and operating and emergency

procedures sufficient to establish a basis for licensing actions. 

Deficiency letters and other correspondence were checked for accuracy,

completeness, appropriate regulatory language, and promptness. 

Specific licenses were reviewed for accuracy, appropriateness of the

license and of its conditions and tie-down conditions, and overall

technical quality. Casework files were checked for retention of

necessary documents and supporting data. Discussions were held with the

license reviewers and supervisors concerning the casework evaluated

during the review, and to determine their understanding and

implementation of the procedures. The cases were selected to provide a

representative sample of licensing actions which had been completed in

the review period and to include work by most reviewers. The crosssection sampling included twelve of the State's major licenses and

included the following types: isotope and instrument product

manufacturing, isotope product distribution, industrial radiography,

nuclear pharmacy, pool type irradiator, pharmaceutical manufacturer,

fixed, mobile, and transportable high dose rate (HDR) afterloaders,

gamma knife, academic broad scope, portable gauges, research and

development facilities, medical institution, and nuclear medicine

private practice. Licensing actions reviewed included four new

licenses, nineteen renewals, six amendments, and seven terminations. A

list of these licenses with case-specific comments can be found in

Appendix D.

The review team also examined the State's procedure for handling license

terminations. Licensees are required by regulation to notify the RHB 30

days prior to vacating any facility that may have been contaminated with
California Final Report Page 11

radioactive material as a result of licensed activities. The Radiologic

Assessment Unit is responsible for determining that radioactive material

contamination is not present prior to release of a facility for

uncontrolled use. Inspection Policy Memorandum (IMP-88-2) revision

effective August 15, 1995 details the procedures for: determining the

disposition of radioactive material, the need for radiological surveys

and confirmatory measurements, review of licensee submittals, the review

of reports and records, and the receipt of the final inspection report. 

The staff utilizes the NRC provided SDMP action plan cleanup criteria,

the tables in NRC Regulatory Guide 1.86 on Acceptable Surface

Contamination levels and other guidance such as NRC NUREG/CR-5849 on

Conducting Radiological Surveys in Support of License Termination, to

address facility/site decommissioning. Information obtained by the

inspection staff is communicated to the licensing staff, who are

responsible for license terminations, via the License Review Alert Form

(RH 2033). The review team has identified the use of RH 2033 as a good

practice. All seven license termination case files reviewed adequately

addressed the disposition of radioactive materials and the results of

radiological surveys or why no surveys were performed. 

During the review period, one licensee completed a required full

decommissioning effort. Interstate Nuclear Services, Inc. (INS) a

nuclear laundry at 65 Ray Street in Pleasanton, submitted a

decommissioning plan and request for termination of California license

number 0739. The decontamination and decommissioning (D&D) was

performed by INS with split samples provided to the State for their

analysis. The State performed confirmatory surveys during 25 separate

site visits over a period of one year. The State staff conducted areawide surveys and obtained samples from 150 randomly selected locations

in and adjacent to the licensee's building. The surveys were conducted

in accordance with the RHB's internal procedures and their SDMP-like

program, to determine if the licensee met the objectives of their RHB

approved D&D plan and to determine if the site meets the requirements

for release for unrestricted use. The results of the inspector's

confirmatory surveys were documented and communicated to licensing staff

who reviewed other pertinent information and determined that the site

met the requirements for unrestricted use. The review team confirmed

that the RH 2033 Form was on file. In accordance with the State's SDMPlike program, this file has been identified as requiring permanent

retention. 

It should be noted that the State does not agree with the NRC position

that California is responsible for former AEC (pre-Agreement State)

sites. This issue is being addressed separately from the IMPEP review. 

 

The review team found that, overall, the licensing actions were

generally thorough, complete, consistent, and of acceptable quality with

health and safety issues properly addressed. Licenses are issued for a

period of seven years. Tie-down conditions reflecting technical changes

in the license were almost always stated clearly, backed by information

contained in the file, and inspectable. The licensee's compliance

history was taken into account when reviewing renewal applications. The

State's licensing guides and applications were revised to reflect 10 CFR

20 regulations. License policy procedures (licensing manual) were
California Final Report Page 12

established and, although in some cases not revised since 1988, were

complete and followed. Standard license conditions were maintained via

database and routinely used for all licensing actions. It was discussed

with the staff that the standard condition for leak testing of sealed

sources be revised to indicate that sources are to be removed from use

and the device decontaminated if found to be leaking. It was noted that

the license reviewers were implementing the State's licensing

procedures, and that these procedures are consistent with NRC's

procedures. 

The review team found that the current staff is well trained and

experienced in a broad range of licensing activities. License reviewers

showed good research skills in using guide and other licensing

documents. For all files reviewed it was noted that reviewers 

appropriately used the licensing guides and accompanying checklists. 

Checklists were found to be completed (including initials and dates) by

reviewers, then peer reviewed by senior staff and supervisors. 

Licensing actions were signed by the Supervisory Health Physicist or the

Senior Health Physicist of the appropriate section. Pre-license/renewal

visits were performed and documented in the files. No potentially

significant health and safety issues were identified.

Due to the large volume of licensing actions, operations are divided

between medical, industrial, and gauge use sections. Licensing cases

are assigned on the basis of background and experience of reviewers. 

Information provided during the review relative to licensing actions

indicated that overall, a very small backlog existed (primarily for

amendments). Workloads in each section were adequately maintained

including the industrial section which experienced a recent change in

the supervisor position. 

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.

3.4 Technical Quality of Inspections

The team reviewed the inspection reports, enforcement documentation, and

the database information for 26 materials inspections conducted during

the review period. Because the State completed 1,377 inspections

between June 1994 and June 1996, only a very small percentage of the

completed inspection reports could be reviewed. Selection of the

casework, therefore, focused on including all of the State's materials

inspectors and on covering a sampling of a range of license types with

emphasis on core licensees. The review included: one hospital with HDR

therapy, one mobile HDR, two industrial radiographers, one major

manufacturer, one nuclear pharmacy, one Industrial Radiography equipment

manufacturer, one waste broker, one broad type A academic, two sealed

source manufacturers and distributors, five nuclear medicine hospitals

with therapy, one RadioImmunoAssay (RIA) manufacturer and distributor,

one RIA kit distribution only, one broad type A laboratory, one

biological laboratory, two service, one well-logging, one portable

gauge, one fixed gauge, and one RIA storage only. Appendix E provides a
California Final Report Page 13

list of the inspection cases reviewed in depth with case-specific

comments.

The team reviewed the latest version of RHB’s Compliance and Enforcement

Procedures, dated January 10, 1996, various policy memos issued during

the review period, and all current inspection forms. In general, the

policies, procedures, and forms were determined to be consistent with

the inspection guidance provided in IMC 2800 and IP 87100. The State

uses separate supplements to the uniform inspection report form for

various classes of license types, such as group medical, industrial

radiography including field inspections, radiopharmacy, gauges, remote

afterloaders, etc. 

According to the State’s policy, all inspections are to be unannounced

except for initial inspections, inspections of licensees in remote

geographical locations, or as necessary to meet with specific licensee

management or personnel. Examination of the 26 inspection reports

indicated that, for the most part (18 cases), inspectors are not

announcing inspections in advance. 

Inspection reports were reviewed to determine if the reports adequately

documented the areas inspected as contained in the inspection field

notes. The overall quality of the inspection reports was very good, and

the areas inspected were satisfactorily documented. Only one of the 26

reports needed improvement in the documentation of the follow-up of

previous items of non-compliance and of the exit interview. The files

were orderly and contained all documentation including letters and

records of telephone conversations. The inspection findings led to

appropriate and prompt regulatory action. Enforcement letters were

determined to be written in appropriate regulatory language and timely. 

It was verified during review of the files and computer records that the

inspectors and unit supervisors are following the enforcement

procedures. If the inspection results indicate the licensee must take

corrective action, a Notice of Violation (NOV) with a cover letter is

prepared by the inspector. All enforcement correspondence is reviewed

by the unit supervisor, and NOVs require supervisory signature. Items

of non-compliance on the NOV are assigned point values according to the

seriousness of the infraction. If the point total is 64 or more, the

tracking system automatically triggers a follow-up inspection in six

months. Follow-up inspections are usually limited to previous items of

non-compliance. Review of the computer reports showed that the followup inspections are indeed being entered in the data system. During FY

95-96, records show that 11 follow-up inspections were conducted. 

Licensees who fail to adequately respond with their plan for corrective

action within 30 days are contacted by the inspector in an effort to

bring the facility into compliance before escalated enforcement action

is taken. Escalated enforcement actions are initiated if a violation is

serious, if the user does not respond adequately to the NOV, or if the

violations remain uncorrected at the time of the follow-up review. 

Options for escalated enforcement include meetings between the licensee

and RHB management, emergency order, and prosecution under the State’s

criminal code. The records show that eight serious enforcement problems

were escalated to management level during FY 95-96.
California Final Report Page 14

As another means of escalated enforcement action, California inspectors

also have the option to call for an instant end to a serious

noncompliant activity encountered in the field by using the User’s

Declaration Form. This User’s Declaration establishes a legally binding

agreement between the State of California and the licensee. By using

this mechanism, the licensee may voluntarily sign an agreement to take

immediate corrective action, including to cease and desist. This is

similar to NRC's Confirmatory Action Letter, but it can be executed by

the inspector (with management concurrence by telephone) at the time the

infraction is found. Records show that 34 User’s Declaration Forms were

issued in FY 95-96. The review team has identified the use of User's

Declaration Forms as a good practice.

The team found that the State’s enforcement tracking system is working

well. The Chief, Compliance and Enforcement, is able to instantaneously

track all compliance actions, including upcoming, due, and overdue

inspections, correspondence dates, follow-up inspections, and the status

of open and closed enforcement actions. The field offices have similar

systems for tracking enforcement actions within their jurisdiction, and

they are kept abreast of the statewide progress by the periodic reports. 

Inspectors notify the licensing section of any licensing-related issues

through the use of the License Review Alert Form (RH2033). Review of

the files indicated the form is being used when necessary to provide the

appropriate feedback from inspectors to license reviewers.

The State’s radiochemistry laboratory, located in Berkeley, was

evaluated during a performance appraisal by the NRC on May 20-24, 1996,

in conjunction with the State’s Environmental Monitoring Cooperative

Agreement. During that review, it was found that the laboratory

maintained an excellent inventory of state-of-the-art analytical

equipment and instrumentation. It was also noted that the laboratory’s

performance in the Environmental Protection Agency’s cross-check program

was excellent. Review team interviews with RHB staff indicated that the

turn-around time for samples is satisfactory.

Routine samples are analyzed and results are available within one week. 

For emergencies or incidents, overnight or immediate processing can be

authorized.

The team found that the State’s inspection agencies have a variety of

portable instruments for routine confirmatory surveys and use during

incidents and emergency conditions. The instruments are a good mix of

low range GM tubes and pancake probes, micro R meters, high range

instruments, instrumentation with calibration standards for alpha

detection, a neutron rem meter, and portable multichannel analyzers. 

Air monitoring equipment is also available.

RHB instruments from both headquarters and the regional offices are

calibrated under contract by a private company, Medical Physics Center,

located in Sacramento. In addition to performing the calibration, the

company tracks the calibration history of all RHB instruments and

notifies RHB when each instrument is due for calibration. The State
California Final Report Page 15

explained that field offices have enough instruments available to be

able to return those needing calibration to Sacramento. Los Angeles,

Orange, and San Diego Counties are responsible for providing and

calibrating their own instruments. Survey instruments in RHB and county

field offices were examined during visits by a team member during the

review period and found to be in calibration. It was verified through

review of the records that instruments are calibrated at least on an

annual basis, and staggered so as to always have instruments calibrated

within the calendar quarter for use during industrial radiography

inspections. 

The review team noted that the contract with the company that calibrates

RHB instruments had recently expired, and that efforts had not begun to

renew the contract. 

Each inspector is responsible for maintaining the calibration schedule

for their survey instrument. As a backup, however, the contract for

calibration services requires that the contractor prompt each inspection

region regarding the calibration due date for individual instruments. 

The review team recommends that the State take action necessary (renew

the calibration contract) in order to maintain the instrument

calibration schedule. 

Supervisory accompaniments of inspectors are performed annually and

documented with records kept by the Chief, Enforcement and Compliance. 

Review of the records showed that the ten health physicists and seven

unit supervisors who conduct independent inspections were, with one

exception, accompanied by supervisors annually during the review period. 

One accompaniment was missed in 1995 when the Orange County supervisor

retired, but the health physicist involved is an experienced inspector

who has had many previous satisfactory accompaniments.

A member of the review team conducted accompaniments of seven California

inspectors and supervisors during the review period as follows: On

November 9, 1994, a Los Angeles County inspector was accompanied during

an inspection of a medical licensee, Groups I-V. On November 10, 1994,

an RHB inspector was accompanied during an inspection of a radiographer. 

On February 28, 1996, an RHB inspector was accompanied during an

inspection of a radiographer at temporary job sites. On February 29,

1996, an RHB inspector was accompanied during an inspection of a medical

licensee with HDR therapy. On April 2, 1996, the San Diego County

supervisor was accompanied during an inspection of a large nuclear

medicine licensee. On June 4, 1996, the San Jose RHB supervisor was

accompanied during an inspection of a licensee with portable gauges. On

June 20, 1996, the Sacramento RHB unit supervisor was accompanied during

an inspection of the licensed calibration and training facility at the

California Office of Emergency Services. The team found that technical

performance of the inspectors was satisfactory and that the inspections

were adequate to assess radiological health and safety at the licensed

facilities. 

In general the inspectors were thorough, understood the regulations,

observed good health physics practices and performed the inspections in

a professional manner. Exit meetings were held at the appropriate
California Final Report Page 16

management level, and the inspectors clearly described both the positive

findings and items of non-compliance. The portable instruments used

during the accompaniments were operational and calibrated. The results

of the accompaniments were discussed with the inspectors, their

immediate supervisors, and the RHB Chief, Compliance and Enforcement. 

All California inspectors and supervisors conducting independent

inspections have now been accompanied by an IMPEP team member. The team

accompaniments are identified in Appendix E.

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.

3.5 Response to Incidents and Allegations

In evaluating the effectiveness of the State's actions in responding to

incidents and allegations, the review team examined the State's response

to the IMPEP questionnaire relative to this indicator and reviewed the

casework files of incidents, allegations and misadministrations. Events

listed in the Nuclear Material Events Database were also reviewed and

compared to cases obtained from the questionnaire and the State's own

files. Additionally, the review team interviewed the Chief of

Enforcement and Compliance and staff assigned to incident response.

The responsibility for initial response and follow-up to incidents and

allegations involving radioactive materials is assigned to a member of

the technical staff. This assignment comes from the Chief of

Enforcement and Compliance or from the Regional Manager. Written

internal procedures exist for handling incidents, complaints

(allegations) and misadministrations. Initially when an incident,

allegation, or misadministration is received, a Form 5010 (Matter

Requiring Investigation/Inspection) is filled out by the Health

Physicist or Radiation Protection Specialist who first receives the

information. Form 5010 contains three copies of event information and

is distributed as follows: white copy to the manager, yellow to the

investigation file in Sacramento, and the pink copy to the license file. 

Once the Manager receives the white copy it is assigned to a member of

the technical staff for follow-up. The time frame for staff follow-up

after receiving notification of an incident or allegation is set by

written internal RHB policy at 30 days for normal incidents. Most cases

are handled within one or two days of notification. After the incident,

allegation, or misadministration is investigated the person conducting

the investigation then writes a report which is sent to the Chief of

Enforcement and Compliance for review, comment and concurrence. When

the event is closed out a Form 8434 (materials investigation closing

memo) is filled out and placed in the file. The licensee and/or alleger

is notified by letter regarding the results of an investigation. 

The review team examined the State's response to thirty-seven events

that included various incidents reported since the last review, except

for those involving non-Agreement material. The events reviewed

involved lost radioactive material, damaged equipment, equipment

failures, leaking sources, tripped monitors at a landfill, abandoned

material, and overexposures. In addition to the above, twelve
California Final Report Page 17

allegation files were reviewed. These files involved several technical

and administrative issues. The files reviewed were an assortment of the

656 incidents, misadministrations, and allegations on file since the

last review. The team reviewed allegations forwarded to the State by

the NRC and found that they were appropriately handled. The review team

commended the RHB staff for their diligence in providing event data to

the NMED tracking system, even though the event data are reported

quarterly. A list of the casework files, with comments, is attached as 

Appendix F.

Based on the cases reviewed, the review team found that the State's

response satisfied the performance criteria for this indicator. The

level of the response was appropriate to the type of incident and was

handled in a reasonable time frame from the initial notification to the

close-out of the incident. The State notified the NRC in accordance

with NRC guidance though the event data are reported quarterly. 

Allegations were responded to with the appropriate investigation and

follow-up action, and the results were related to the person or the

organization that notified the State of the allegation.

 

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

California's performance with respect to this indicator, Response to

Incidents and Allegations, be found satisfactory. 

4.0 NON-COMMON PERFORMANCE INDICATORS

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

reviewing Agreement State programs: (1) Legislation and Regulations,

(2) Sealed Source and Device Evaluation Program, (3) Low-Level

Radioactive Waste Disposal Program, and (4) Uranium Recovery. 

California has no agreement to regulate uranium recovery operations, so

only the first three non-common performance indicators were applicable

to this review.

4.1 Legislation and Regulations

4.1.1 Legislative and Legal Authority

The legal authority establishing the RHB and its regulations is derived

from the California Health and Safety Code (H&SC). The H&SC contains

the Radiation Control Law (Chapter 7.6) which among other things details

the State's Agreement with the NRC. The State's Code of Regulations

(Title 17) contains specific radiation control requirements including

those addressing the Low-Level Radioactive Disposal Site.

During the review period the Governor signed Senate Bill 1360, which

became effective on January 1, 1996. This legislation reorganized,

renumbered and made non-technical changes to the public health portion

of the H&SC. It should be noted that the scope of the State's

regulatory authority remains unchanged. A copy of these changes was

provided to the team, which reviewed them along with a memorandum to the

staff explaining the changes. These changes appear to be non-technical

as indicated by the State. The State does not have a sunset provision

in its rules.
California Final Report Page 18

4.1.2 Status and Compatibility of Regulations

California's final equivalent to the NRC rule "Standards for Protection

Against Radiation," Part 20, became effective on March 3, 1994. On July

18, 1994 the following rule became effective: "Safety Requirements for

Radiographic Equipment," 10 CFR Part 34. On October 17, 1995 the

following rules became effective: "Decommissioning," 10 CFR Parts 30,

40 and 70; "Emergency Planning," 10 CFR Parts 30, 40 and 70;

"Decommissioning Recordkeeping: Documentation Additions," 10 CFR Parts

30, 40 and 70. NRC staff has reviewed these amended regulations and

found that they are compatible with equivalent NRC regulations. 

According to information provided in the questionnaire, since the State

does not regulate uranium recovery operations it does not have a rule

equivalent to NRC's regulations applicable to uranium recovery contained

in 10 CFR Part 40. 

! "Uranium Mill Tailings Regulations: Conforming NRC

Requirements to EPA Standards," 10 CFR Part 40 amendments (59

FR 28220) that became effective on July 1, 1994.

The State has a low-level radioactive waste disposal licensee and does

have a rule equivalent to NRC's 10 CFR Part 61. However, it has not yet

adopted the revision to the low-level radioactive waste regulations

equivalent to the following NRC rule:

! "Definition of Land Disposal and Waste Site QA Program," 10

CFR Part 61 amendments (58 FR 33886) that became effective on

July 22, 1993. Although the Low-Level Radioactive Waste Site

is not yet operational the State indicated that the expected

date for adoption of this rule is October 1, 1997. 

Current NRC policy on adequacy and compatibility requires that Agreement

States adopt certain equivalent regulations no later than three years

after they become effective. The State has begun the process of

promulgation of the following rules necessary for a compatible program:

! "Timeliness of Decommissioning of Materials Facilities," 10

CFR Parts 30, 40 and 70 amendments (59 FR 36026) that became

effective August 15, 1994.

! "Preparation, Transfer for Commercial Distribution and Use of

Byproduct Material for Medical Use," 10 CFR Parts 30, 32 and

35 amendments (59 FR 61767, 59 FR 65243, 60 FR 322) that

became effective on January 1, 1995.

! "Frequency of Medical Examinations for Use of Respiratory

Protection Equipment," 10 CFR Part 20 amendments (60 FR 7900)

that became effective on March 13, 1995. Note, this rule is

designated as a Division 2 matter of compatibility. Division

2 compatibility allows the Agreement States flexibility to be

more stringent (i.e., the State could choose to continue to

require annual medical examinations). 
California Final Report Page 19

! "Low-Level Waste Shipment Manifest Information and

Reporting," 10 CFR Parts 20 and 61 amendments (60 FR 15649,

60 FR 25983) that will become effective March 1, 1998. 

California and other Agreement States are expected to have an

equivalent rule effective on the same date.

! "Performance Requirements for Radiography Equipment," 10 CFR

Part 34 amendments (60 FR 28323) that became effective June

30, 1995.

! "Radiation Protection Requirements: Amended Definitions and

Criteria," 10 CFR Parts 19 and 20 amendments (60 FR 36038)

that became effective August 14, 1995.

! "Medical Administration of Radiation and Radioactive

Materials," 10 CFR Part 20 and 35 amendments (60 FR 50248)

that became effective October 20, 1995.

The State has placed this regulation on hold pending the

outcome of NRC's determination on the compatibility of the

Quality Management rule and the revision to 10 CFR Part 35.

! "Clarification of Decommissioning Funding Requirements," 10

CFR Parts 30, 40, and 70 amendments (60 FR 38235) that became

effective November 24, 1995.

! "Compatibility with the International Atomic Energy Agency,"

10 CFR Part 71 amendment (60 FR 50248) that became effective

April 1, 1996.

! "Self-Guarantee as an Additional Financial Mechanism," 10 CFR

Parts 30, 40, and 70 amendments (58 FR 68726 and 59 FR 1618)

that became effective on January 28, 1994. Note, this rule

is designated as a Division 2 matter of compatibility. 

Division 2 compatibility allows the Agreement States

flexibility to be more stringent (i.e., the State could

choose not to adopt self-guarantee as a method of financial

assurance). If a State chooses not to adopt this regulation,

the State's regulation, however, must contain provisions for

financial assurance that include at least a subset of those

provided in NRC's regulations, e.g., prepayment, surety

method (letter of credit or line of credit), insurance or

other guarantee method (e.g., a parent company guarantee).

The team reviewed the procedures used in the State's regulation

promulgation process and found that the State's formal regulation

promulgation schedule takes approximately 10 months. Past experience

however indicates that it often takes longer than three years for the

State to promulgate its rules. The root causes of this extended

promulgation schedule are likely attributed to a combination of complex

procedures required for rule promulgation in the State's governmental

system, higher priority work and past staff shortages. Emergency

regulations can be placed on an expedited promulgation schedule,

however, this process reduces the schedule by only 10 days. The public
California Final Report Page 20

and other interested parties are offered an opportunity to comment on

proposed regulations during a 45 day comment period. There is a

provision for holding a public hearing on rulemaking, however, there is

no requirement that a hearing be held for each rulemaking action. 

According to program management, the NRC is provided with drafts for

comment on proposed regulations early in the promulgation process. The

regulations are forwarded to several State administrative, financial and

legal offices in accordance with a schedule which contains specific time

frames for review and approval. The effective date of a final rule is

selected by the Department of Health Services and is at minimum 30 days

after approval by the Secretary of State. A copy of the final

regulation is then provided to the NRC.

The State's regulations were compatible with those of the NRC at the

time of the review, including all regulations necessary for a compatible

program that are due by January 1997, except for the following

regulations which have not yet been promulgated:

! "Notification of Incidents," 10 CFR Parts 20, 30, 31, 34, 39,

40, and 70 amendments (56 FR 40757 and 56 FR 64980) that

became effective on October 10, 1991. 

! "Quality Management Program and Misadministrations," 10 CFR

Part 35 (56 FR 34104) that became effective on January 27,

1993. 

! "Licenses and Radiation Safety Requirements for Irradiators,"

10 CFR Parts 19, 20, 30, 36, 40, 51, 70 and 170 amendments

(58 FR 7715) that became effective on July 1, 1993. 

During discussions with the review team, program management explained

that the staff is in the process of preparing drafts to amendments on

notifications of incidents and the Irradiator rule. The 1994 review

team commented that the Notification of Incidents amendments were due

for adoption by the State on October 10, 1994. The State reports that

compatible regulations in this area are expected to be adopted on

October 1, 1997. The Irradiator rule is currently being addressed

through license conditions pending adoption of a compatible rule, also

in 1997. The case file review of a large pool type irradiator license

renewal confirmed the State's use of license conditions to implement

Part 36 rule requirements. 

Program management reported that the Quality Management Program and

Misadministrations Rule (QM rule) is currently on hold pending NRC's

resolution of National Academy of Sciences Report issues relating to the

regulation of the uses of radiation in medicine. NRC staff is currently

deferring compatibility findings, for Agreement States that have not yet

adopted a compatible QM rule, pending resolution of the issue of

Agreement State compatibility. 

The review team recommends that the State make a concerted effort to

adopt regulations which are required for compatibility and are overdue

for adoption. A special effort should be made to adopt the amendments

on Notification of Incidents, the Irradiator rule and the Definition of
California Final Report Page 21

Land Disposal and Waste Site QA program amendment. Due to the safety

benefits attendant to the QM rule, the State is encouraged to adopt a

compatible QM rule.

Based on the existing NRC compatibility policy and the IMPEP evaluation

criteria, the review team recommended in the proposed final report that

California's performance with respect to the indicator, Legislation and

Regulations, be found unsatisfactory. The team recommended that

compatibility findings for the California program be reevaluated upon

final promulgation of California's regulations on Notification of

Incidents and the Definition of Land Disposal and Waste Site QA program

amendment. Because of the progress to date in the promulgation of these

rules and the expected adoption date of October 1, 1997, the MRB

determined that a sufficient basis did not exist to support a finding of

unsatisfactory for this indicator. The MRB noted that if significant

delays in rule adoption occur or if California adopts rules that are not

compatible with the NRC equivalent regulations, the MRB could always

reconsider the program compatibility finding at a future date. The MRB

final recommendation for Legislation and Regulations is satisfactory. 

4.2 Sealed Source and Device Evaluation Program

In evaluating the State's SS&D program, the review team evaluated the

information provided by the State relative to this indicator in its

response to the questionnaire, reviewed the casework, held reviewer

interviews, and reviewed registration sheets and background files for 22

certificates of registration sheets issued between January 1993 and

October 9, 1996. It is important to note that situations in this

program area associated with past management of the program had resulted

in many verbal approvals and incomplete reviews of certain areas. The

use of verbal approvals resulted in the lack of information for some

files and made this a difficult program to assess. It can be best

stated that the program had some problems, that these problems have been

identified by management and that management is taking corrective

action. The new Section Chief has expressed a strong desire to rebuild

the State's SS&D program and upper management appears to be very

supportive. However, some product safety reviews missed issues that

should have been addressed. Although these product(s) are being

distributed, the deficiencies noted were not significant relative to

health and safety, and no reported failures or equipment problems have

been reported to the State. 

Further when pertinent written supporting information and drawings could

not be located, the review team interviewed State staff and management

to address issues and questions that were identified during the IMPEP

review. Since the previous supervisor responsible for approving SS&D

evaluations is no longer employed by the State, the review team used

professional judgment and information obtained from State staff to make

a determination on technical adequacy of the SS&D casework files

reviewed. Due to a lack of documentation in some specific casework

files, the reasons for some of deficiencies noted in Appendix G could

not be determined. 
California Final Report Page 22

The IMPEP review team reviewed the State's SS&D program in two areas, 1)

the State's implementation of the steps it took to improve their SS&D

Program that resulted from the 1993/1994 Agreement State Review findings

and 2) as a non-common indicator for sealed source and device review.

The State took some steps to address the recommendations that resulted

in findings from the 1993/1994 Agreement State Review. These

recommendations address the following six areas: (1) use of ANSI

standards in reviewing products; (2) review of user or operation manuals

and QA programs for products; (3) review of drawings and list of

materials of construction; (4) reevaluation of a specific neutron gauge

used by general licensees; (5) the need for staff training in this

program area; and (6) providing copies of necessary information to all

the staff members.

California has implemented steps to address recommendations 1, 2, 3, 5,

& 6. However, the review team findings indicate that these steps have

not been fully implemented. The review team recommends that the State

exert greater management oversight over the SS&D evaluation program. 

The team believes that such oversight is needed to assure full

implementation of the recommendations in this area, given that some

recommendations from the 1994 followup program review have not been

fully addressed. The review team feels that this will allow the State

to fully implement past recommendations and to assure that the staff

continues to adhere to the State's own Policy Memoranda in this area. 

These Memoranda cover the maintenance of SS&D registry information and

the procedure for evaluating SS&D's including manufacturing Quality

Assurance/Quality Control. Many of the comments noted in the Appendix G

could have been eliminated if the procedures were fully implemented. 

Some State staff expressed concern that they did not have copies of the

standards and procedures, however, they did know where to get this

information and this was considered to comply with the recommendation to

provide copies of information to the staff members.

State staff has not performed a reevaluation of a neutron gauge in

recommendation 4, at the time of the IMPEP review due to higher priority

work. The Branch Chief verbally committed to performing this task

within a few weeks after the IMPEP review. Discussion with staff

management indicates that such a reevaluation will be done to determine

if the device continues to be in conformance with the general

distribution safety criteria. The reevaluation will be done using the

additional information provided by users of the product, the vendor, and

the specific comments transmitted to the State in letter dated July 12,

1996, from the Office of State Programs. (See recommendation in Section

4.2.1)

Improvements in the nationwide effort to evaluate SS&Ds containing

radioactive material led to NRC adoption of 10 CFR 30.32 (g) on

"Application for Specific Licenses" and 10 CFR 32.210 entitled,

"Registration of Product Information." These regulations were not

initially identified as items of compatibility for Agreement States with

SS&D evaluation programs. All Agreement States letter SP-95-116 dated

July 25, 1995 announced Commission approval of minimum standards for

Agreement States desiring to maintain authority to evaluate SS&Ds. In
California Final Report Page 23

keeping with this guidance, the review team recommends that the State

consider adopting regulations compatible with 10 CFR 30.32 (g) and 10

CFR 32.210. These regulations require manufacturers/distributors to

submit certain key product information in support of an SS&D evaluation

and permits the State to enforce against those commitments. The review

team noted that the State requires manufacturers and distributors of

sealed sources and devices to establish and implement manufacturing

Quality Assurance and Quality Control programs through their internal

Policy Memoranda. More specific guidance in this area is contained in

Regulatory Guide 6.9 dated February 1995 entitled, "Establishing Quality

Assurance Programs for the Manufacture and Distribution of Sealed

Sources Containing Byproduct Material" which is referenced in the

internal Policy Memoranda.

4.2.1 Technical Quality of the Product Evaluation Program

The review team reviewed the files and performed staff interviews for

the 22 new or revised SS&D registry sheets issued since the 1993/1994

review. This included the State's review and approval of a radiography

device for compliance with 10 CFR Part 34.20 for equipment requirements,

sources and devices used in well logging applications and sources and

devices used by specific and general licensees. The SS&D registry

sheets issued by the State and evaluated by the review team are listed

in Appendix G. Based on the review of selected SS&D casework files the

review team recommends that the State: (1) determine and document in

evaluation certificates whether sources approved for use in well logging

applications meet the requirement for insoluble as practicable; (2)

review and possibly modify the Section 1.8 of ADAC Laboratories’ users

manual which appears to condone direct hand contact with the sealed

source, i.e., “Hold the Line source with two hands while positioning the

source;” (3) obtain SS&D training for those staff members that have not

yet had or have limited SS&D training either by using training offered

by NRC or another Agreement State program; (4) develop a policy position

on including information on the useful life of a product and using

operational history data to augment prototype testing when evaluating

SS&D; neither is routinely used by the staff during reviews but both are

useful information in determining whether a product is acceptable for

licensing; (5) determine the actual use conditions for those gauge

sources that do not meet the ANSI standard classification for vibration

and evaluate the need to modify SS&D sheets if the condition of use is

typical for industrial gamma gauging devices as indicated in ANSI N-542;

and (6) 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.

 

State staff are using ANSI standards, Regulatory Guide 10.10 and 10.11

and NRC’s Standard Review Plan to perform the evaluations. They rely

heavily on the Standard Review Plan and the checklist it contains. This

approach should allow the State to identify the majority of the health

and safety issues associated with the product under review. Overall,
California Final Report Page 24

the IMPEP review team identified some concerns with not addressing

health and safety issues and some files were deficient in technical

quality. The review team also identified several files in which the

second signature or audit was not always performed as a technical

quality audit. Rather, only wording was reviewed. The review team

recommends that the State fully implement a program of peer review of

SS&D evaluations as a technical quality assurance measure. 

The review team found that the State had developed and implemented

procedures to improve the SS&D program. The new Section Chief selfidentified some weakness in implementing these procedures and appears

committed to rebuilding the program to a model for other regulatory

programs to emulate. 

It should be noted that several of the findings listed in Appendix G

reflect ineffective past management. For example, management did not

direct staff to obtain necessary bend test information in one case. In

other cases certain information was overlooked as a result of program

direction. These are some of the areas that the new Section Chief is

addressing.

The State staff expressed concern regarding the use of the term useful

life and using operational history data to augment product testing

programs. The State believes that such information is a product

endorsement, therefore this data is not used during a product review. 

It should be noted that operational history data from identical or

similar devices or sources are a valuable tool in assessing the

integrity of the source or device when used with the vendor's estimate

of the useful life of the product. The State should review its position

with regards to these two terms and take action as it deems necessary if

a change in this State position is indeed warranted. 

4.2.2 Technical Staffing and Training

The State reported that the current staff all have at least a bachelors

degree in physical or biological sciences and several have advanced

degrees in nuclear/radiological science. All health physicists have

completed the NRC recommended core training courses for materials

licensing personnel. Senior Health Physicists have completed more

advanced training. During the review period two staff members attended

the SS&D evaluation workshop. Formal course work and on-the-job

training allows the Health Physicists to operate independently in this

area.

All members of the Industrial and Sealed Source and Device Section have

signature authority for product review only. Only the Senior Health

Physicist or management can perform the final technical review and

provide the second signature of the registration certificate. The IMPEP

review team found all section members have signature authority but may

not have had adequate training to review some products. Below is a

listing of the Section members with training and their work experience. 

The loss of the Industrial Licensing Section Chief presented a challenge

to the program. The State is aggressively rebuilding the program as a

result of this loss. The State staff discussed with the IMPEP review
California Final Report Page 25

team a request for State reviewers to work with the Sealed Source Safety

Section at NRC Headquarters, which the Sealed Source Safety Section has

extended. Both the State and NRC management are considering this

request. 

Bob Reyes:

B.S. Radiation Health Physics/Public Health

PhD Education

RSO at Northridge (CSUN) facility for environmental science

and radiological health.

Fred Toyama:

B.S. in Physics

U.S. Army Depot (Calibration Center)

Tom Schell:

B.S. X-ray Technology

RSO at San Louis Obispo

HP for State of Arizona/Wyoming

Radiography Licensee

Pete Patel:

B.S. Chemistry 

Pharmacy Training 

M.M.Sc. - Radiologic Physics 

License Reviewer in Georgia

SS&D Workshop

Dave Wesley:

Senior Health Physicist, Section Chief

B.S. and M.S. in Nuclear Engineering

SS&D Workshop

The new Section Chief has identified some training weaknesses and is

working to correct them. The Section Chief is developing a team

approach to conducting product reviews that will result in two technical

reviews and a senior staff or management approval of registration

certificates. This action should also provide for some cross training

of those persons that need some additional training in this area. The

Section Chief is using the States Policy Memorandum system to provide

direction to the staff in this program area.

4.2.3 Evaluation of defects and incidents regarding SS&Ds

The review team looked at the State's evaluation of defects and

incidents regarding SS&Ds for Industrial Nuclear Inc., (INC) a

radiography equipment and source vendor, Measurex Corporation a gauge

vendor, Nova R&D Inc., a device vendor and Nucleonic Data Systems (NDS)

a gauge vendor that no longer holds a State license. The INC issues

involved a change in a radiography source assembly length, evaluation of

user instructions that were causing equipment problems, and a change to

the lock mechanism of a radiography camera. The Measurex issue involved

its use of nominal source activity for labeling of products and shipping

papers which is a violation of NRC and Department of Transportation
California Final Report Page 26

regulations. It should be further noted that inaccurate labeling may

affect the level of response to incidents or accidents. This issue

involved labeling all products with a maximum nominal activity and then

loading the devices with source activities much less than or equal to

the nominal activity. The Nova R&D Inc., issue involved the State

informing general license users of the device that they must comply with

an annual exposure of 100 millirem instead of the 500 millirem the

regulations require. The NDS issue involved loading the device with

activities greater than that which the State believed they approved. 

The NDS issue will likely involve a reassessment of the general license

safety criteria. 

The State had just received the NDS issue and was planning to address

the issues. The Measurex case was closed by negotiating a tighter

tolerance for defining nominal activity. The IMPEP review team found

an incident in which the State took appropriate actions to evaluate root

cause of radiography equipment failure, determined and implemented

corrective action regarding a source assembly length change and user

manual corrections, but never took the final action by amending the

registration certificate to provide this information to the other users

of the Sealed Source and Device Registry system. The review team

recommends that the State amend the appropriate INC SS&D certificates.

The State has decided that they will continue to use the dose criteria

defined in 10 CFR 32.51 and not 100 millirem as they had informed at

least one general licensed user. This decision was to allow for

nationwide consistency for products used under the general license

provisions. The review team recommends that the State develop a

checklist or internal procedures to follow when approving products for

distribution to persons covered under a general license. 

Based on criteria for this non-common indicator, the review team

recommends a finding of satisfactory with recommendations for

improvement. This finding was chosen because the criteria for

unsatisfactory appear to deal with frequently failing to address health

and safety issues. Because frequently is defined as occurring often or

at close intervals this did not appear to be the case based on the cases

reviewed and on interviews with the State staff.

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 low-level radioactive waste as a separate category. 

Those States with existing agreements prior to 1981 were determined to

have continued low-level radioactive waste disposal authority without

the need of an amendment. California, an Agreement State since 1962,

has low-level radioactive waste disposal authority, and has issued a

license to U.S. Ecology to construct and operate a low-level radioactive

waste disposal facility at Ward Valley near Needles, California. 

California is the host State for the Southwestern LLRW Compact which

includes Arizona, North Dakota and South Dakota. 
California Final Report Page 27

In the process of evaluating this performance indicator, the team

reviewed the State's responses to the questionnaire, the qualifications

and position descriptions of the staff, discussed statutes and

regulations applicable to the site and interviewed the staff assigned to

the LLRW program. The land for the Ward Valley Site has not yet been

transferred from Federal to State control, therefore, site construction

activities have not begun. The team conducted a "forward look" at the

State's planned activities during the construction and operational

phases of the Ward Valley Project.

4.3.1 Introduction

The State's LLRW program resides within DHS, Division of Drinking Water

and Environmental Management. Due to a hold placed on the transfer of

the land, the main focus of the LLRW program staff is providing support

in responding to challenges to the transfer of the land and the issuance

of the license. Some effort is being devoted to developing a disposal

rate formula and drafting accompanying regulations. 

During the project's site construction phase, the LLRW program will

utilize contractor technical support in performing regulatory program

activities related to construction and startup of the LLRW disposal

facility. To assure licensee compliance with previous commitments, made

in their license application, specific tasks under the contract will

include:

! reviewing construction drawings and specifications.

! reviewing operating procedures.

! reviewing environmental monitoring plans.

! reviewing administrative records for commitments made by the

developer during the licensing process.

! providing on-site inspection services during construction.

! reviewing developer's subsurface geological maps; and

! reviewing site closure plans 

4.3.2 Status of Low-Level Radioactive Waste Disposal Inspection

There were no inspection activities conducted during the review period,

therefore, the review team did not evaluate this area.

4.3.3 Technical Staffing and Training

The LLRW Program is in the Division of Drinking Water and Environmental

Management of the State Department of Health Services. The LLRW Program

is currently staffed by three individuals: the program manager; a

research program specialist (Economist); and an office technician. The

program manager is a Registered Professional Engineer with a Bachelors

of Science degree in Civil Engineering and many years of experience in

managing water quality and environmental programs. He is directly

involved in administering the license, managing the LLRW contractors,

developing regulations, developing specific internal licensing and

inspection procedures, and reviewing the licensee's environmental

sampling data. Upon transfer of the land, there are plans to hire six

additional technical staff. These positions are currently authorized,
California Final Report Page 28

funded and can be filled on short notice after transfer of the land

to the State. General position descriptions and specific work

assignments have been developed. These documents were examined by the

review team and appear to be appropriate to the regulation of a LLRW

site. An organizational chart for the LLRW program is attached to this

report as Appendix B.

The program's staffing plan calls for hiring a Senior Engineer, a Senior

Health Physicist and four Associate Health Physicists. These positions

all require at minimum a Bachelors degree in the physical or life

sciences. The Associate Health Physicist positions are journeyperson

positions requiring a minimum of three years of professional health

physics experience or two years with a Master's degree or equivalent

graduate work in radiological science. The Senior Health Physicist

position requires two years of experience at the Associate Health

Physicist level. The additional staff, including a chemist, will be

hired during facility construction. These personnel will be ready to

assume their duties before the facility begins accepting waste. 

The LLRW program plans to have one employee working full-time at the

facility site while construction is ongoing to facilitate the decisionmaking process.

During the operational phase of the facility, the LLRW program plans to

conduct the following inspection related activities:

! On-site inspections at the disposal facility. The LLRW

program will have two full-time inspectors on-site at the

disposal facility. A health physicist will ensure the

operator's compliance with waste acceptance and handling

activities, radiation safety programs, radiation detection

equipment maintenance and calibration, and environmental

monitoring. The health physicist will also conduct an

independent environmental monitoring program to verify the

results of the operator's program. An engineer will be used

to inspect the construction of the trenches and the trench

covers, and will ensure the operator's compliance with

operating procedures for heavy equipment used at the

facility. The personnel in these two positions will be

cross-trained to provide flexibility during employee

absences.

! Point-of-origin inspections. The LLRW program plans to

conduct point-of-origin inspections of individual LLRW

generators' premises in California to ensure compliance with

waste form and packaging requirements. Memoranda of

Agreement will be executed with other States in the

Southwestern LLRW Compact to provide these inspections in a

compatible manner for the LLRW generators within those

States.

Technical support has been obtained through a contract with ERM Program

Management Company of McLean, Virginia for hydrology, geology and

engineering. Health physics support is obtained under a subcontract
California Final Report Page 29

with Rogers and Associates Engineering Corporation of Salt Lake City,

Utah. Both firms are recognized environmental consultants and appear

qualified for the responsibilities assigned to them.

The LLRW program manager plans to send new health physicists to

Industry, NRC and CRCPD sponsored training courses and workshops on LLRW

management (performance assessment), disposal, transportation, and

inspections. This training will occur during the approximately 18-month

construction phase of the project. On-site inspectors will be sent to

existing LLRW disposal facilities to observe operations and learn from

experienced personnel at operating facilities. On-site inspectors will

also work extensively with the LLRW program's construction assistance

contractor to gain familiarity with facility construction and operation

prior to commencement of disposal operations. Point-of-origin

inspectors will be assigned to accompany inspectors from a State with an

operating LLRW disposal site to gain familiarity with their inspection

program procedures.

The review team recommends that the LLRW program consider keeping

official records of each staff member's technical training and

participation in workshops, conferences, etc., in the individual's

training files. The State should also maintain a collective staff

training record to help formalize such training as an ongoing

requirement for the position and to better allow management to assess

the training level of the staff. Waivers granted to individual staff

members, from attendance at specific training courses, based on past

education and experience should be documented. 

4.3.4 Technical Quality of Licensing Action

The LLRW program issued the Ward Valley facility construction and

operating license on September 16, 1993. No license amendments were

issued doing the review period, therefore, this area was not evaluated. 

4.3.5 Technical Quality of Inspections

There were no inspections conducted by the LLRW program during the

review period therefore, this area was not addressed. 

4.3.6 Response to Incidents and Allegations

There were no reported allegations in the LLRW area during the reporting

period. The State reported that allegations referred to the LLRW

program will be handled in the same manner as those reported to the RHB. 

Based on the IMPEP evaluation criteria for the above performance areas,

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

this indicator, Low-Level Radioactive Waste Disposal Program, be found

satisfactory.

5.0 SUMMARY

As noted in Sections 3 and 4 above, the review team found the State's

performance with respect to each of the common and two non-common
California Final Report Page 30

performance indicators to be satisfactory and the non-common indicator,

Sealed Source and Device Evaluation Program to be satisfactory with

recommendations for improvements. Accordingly, after consideration of

the satisfactory finding for the non-common indicator "Legislation and

Regulations," the team recommended, and the MRB concurred, in finding

the California program to be adequate to protect public health and

safety and compatible with NRC's program. 

Below is a summary list of recommendations and suggestions, as mentioned

in earlier sections of the report, for action by the State. 

1. The review team recommends that the State consider keeping a

collective staff training record to help formalize technical

training as an ongoing requirement for the position and to

better allow management to assess the training level of the

staff. Waivers granted to individual staff members, from

attendance at specific training courses, based on past

education and experience should be documented. (Section 3.2)

2. The review team recommends that the State take action

necessary (renew the calibration contract) in order to

maintain the instrument calibration schedule. (Section 3.4) 

3. The review team recommends that the State make a concerted

effort to adopt regulations which are required for

compatibility and are overdue for adoption. A special effort

should be made to adopt the amendments on Notification of

Incidents, the Irradiator rule and the Definition of Land

Disposal and Waste Site QA program amendment. Due to the

safety benefits attendant to the QM rule, the State is

encouraged to adopt a compatible QM rule. (Section 4.1)

4. The review team recommends that the State exert greater

management oversight over the SS&D evaluation program. The

team believes that such oversight is needed to assure full

implementation of the recommendations in this area, given

that some recommendations from the 1994 followup program

review have not been fully addressed. (Section 4.2) 

5. The review team recommends that the State consider adopting

regulations compatible with 10 CFR 30.32 (g) and 10 CFR

32.210. (Section 4.2)

6. The review team recommends that the State determine and

document in evaluation certificates whether sealed sources

approved for use in well logging applications meet the

requirement for insoluble as practicable. (Section 4.2) 

7. The review team recommends that the State review and possibly

modify the Section 1.8 of ADAC Laboratories' users manual

which appears to condone direct hand contact with the sealed

source. (Section 4.2) 
California Final Report Page 31

8. The review team recommends that the State obtain SS&D

training for those staff members that have not yet had or

have limited SS&D training either by using training offered

by NRC or another Agreement State program. (Section 4.2)

9. The review team recommends that the State develop a policy

position on including information on the useful life of a

product and using operational history data to augment

prototype testing when evaluating SS&D. 

(Section 4.2)

10. The review team recommends that the State determine the

actual use conditions for those gauging sources that do not

meet the ANSI standard classification for vibration and

evaluate the need to modify SS&D sheets if the condition of

use is typical for industrial gamma gauging devices as

indicated in ANSI N-542. (Section 4.2)

11. 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) 

12. The review team recommends that the State fully implement a

program of peer review of SS&D evaluations as a technical

quality assurance measure. (Section 4.2)

13. The review team recommends that the State amend the

appropriate Industrial Nuclear Inc., SS&D certificates. 

(Section 4.2)

14. The review team recommends that the State develop a checklist

or internal procedures to follow when approving products for

distribution to persons covered under a general license. 

(Section 4.2)

15. The review team recommends that the LLRW program consider

keeping official records of each staff member's technical

training and participation in workshops, conferences, etc.,

in the individual's training files. (Section 4.3) 

Good Practice. Along with the recommendations for California, the

review team identified the following good practices in California:

1. The use of the License Review Alert Form (RH 2033) used by

the inspection staff to communicate information to the

licensing staff. (Section 3.3)
California Final Report Page 32

2. The use of the User's Declaration Form to establish a legally

binding agreement between California and a licensee that can

be executed by an inspector in the field to put an instant

end to a serious noncompliant activity. (Section 3.4)
LIST OF APPENDICES AND ATTACHMENTS

APPENDIX A: IMPEP Review Team Members

APPENDIX B: California Organization Chart

APPENDIX C: California Questionnaire Response

APPENDIX D: License File Reviews

APPENDIX E: Inspection File Reviews

APPENDIX F: Incident File Reviews

APPENDIX G: Sealed Source and Device Evaluation Reviews

ATTACHMENT 1: California's Response to Review Findings
APPENDIX A - IMPEP REVIEW TEAM MEMBERS

Lloyd Bolling, OSP Team Leader

Technical Staffing and Training

Legislation and Regulations

Low Level Radioactive Waste Disposal Program

Jack Hornor, R-IV Status of Materials Inspection Program

Technical Quality of Materials Inspections

Steven Baggett, NMSS Sealed Source and Device Evaluation Program

Craig Gordon, R-I Technical Quality of Materials Licensing 

Actions

Allen Grewe, Tennessee Response to Incidents and Allegations
APPENDIX B

ORGANIZATIONAL CHARTS