MRB 

UNITED STATES

NUCLEAR REGULATORY COMMISSION 

WASHINGTON, D.C. 20555-0001 

February 12, 2016 

Karen L. Smith, M.D., MPH, Director 

California Department of Public Health 

1615 Capitol Avenue 

Sacramento, CA 95899-7377 

Dear Dr. Smith: 

On January 14, 2016, 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 the U.S. Nuclear Regulatory Commission’s program. 

Section 5.0, page 15, of the enclosed final report contains a summary of the IMPEP team’s 

findings. Based on the results of the current IMPEP review, the next full review of the California 

Agreement State Program will take place in approximately 4 years, with a periodic meeting 

tentatively scheduled for October 2017. Further, the MRB agreed to discontinue the period of 

monitoring. California showed sustained and substantial improvement in its rule development 

program since the 2011 IMPEP review. 

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

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

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

Sincerely, 

 /RA/ 

Glenn M. Tracy 

Deputy Executive Director for Materials, Waste, 

 Research, State, Tribal, Compliance, Administration, 

 and Human Capital Programs 

Office of the Executive Director for Operations 

Enclosure: 

California IMPEP Final Report 

cc: See next page 
K. Smith 2 

cc w/encl: Mark Starr, Director 

Center for Environmental Health 

 

Stephen Woods, Chief 

Division of Food, Drug, and Radiation Safety 

Gonzalo Perez, Chief 

Radiologic Health Branch 

Robert Weisenmiller, Chairman 

California Energy Commission 

State Liaison Officer 

Matthew McKinley, KY 

Organization of Agreement States 

 
K. Smith 2 

Karen L. Smith, M.D., MPH, Director 

California Department of Public Health 

1615 Capitol Avenue 

Sacramento, CA 95899-7377 

Dear Dr. Smith: 

On January 14, 2016, 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 the U.S. Nuclear Regulatory Commission’s program. 

Section 5.0, page 15, of the enclosed final report contains a summary of the IMPEP team’s 

findings. Based on the results of the current IMPEP review, the next full review of the California 

Agreement State Program will take place in approximately 4 years, with a periodic meeting 

tentatively scheduled for October 2017. Further, the MRB agreed to discontinue the period of 

monitoring. California showed sustained and substantial improvement in its rule development 

program since the 2011 IMPEP review. 

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

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

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

Sincerely, 

 /RA/ 

 Glenn M. Tracy 

 Deputy Executive Director for Materials, Waste, 

 State, Tribal, Compliance, Administration, 

 and Human Capital Programs 

 Office of the Executive Director for Operations 

Enclosure: 

California IMPEP Final Report 

cc: See next page 

DISTRIBUTION: (SP01) 

See next page 

ML16019A265 

OFC MSTR/ASPB MSTR/ASPB RI:TL NMSS/MSTR Tech Ed NMSS EDO 

NAME LDimmick PMichalak DJanda 

via e-mail 

PHenderson for 

DCollins 

WMoore SMoore GTracy 

DATE 01/20/16 01/21/16 01/19/16 01/27/16 01/28/16 2/4/16 02/12/16 

OFFICIAL RECORD COPY 
K. Smith 3 

Letter to Karen L. Smith, M.D., MPH from G. Tracy dated: February 12, 2016 

SUBJECT: CALIFORNIA FY2016 FINAL IMPEP REPORT 

DISTRIBUTION: 

RidsEdoMailCenter 

RidsOgcMailCenter 

JFoster, OEDO 

MSpencer, OGC 

RidsRgn4MailCenter 

MShaffer, RIV 

LHowell, RIV 

RidsRgn3MailCenetr 

RidsRgn1MailCenter 

Daniel Dorman, RI 

RidsSecyCorrespondenceMailCenter 

DJanda RI 

RErickson, RIV/RSAO 

LRoldan-Otero, NMSS 

Spackman, NMSS 

MHammond, RIV 

LBakersmith, FL 

JKelly, TX 

OAS Board 

JWeil, OCA 
K. Smith 4 

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM 

REVIEW OF THE CALIFORNIA AGREEMENT STATE PROGRAM 

October 5 – 9, 2015 

FINAL REPORT
EXECUTIVE SUMMARY 

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

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

the period of October 5-9, 2015, by a review team composed of technical staff members from 

the U.S. Nuclear Regulatory Commission (NRC), and the States of Florida and Texas.

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

indicators reviewed. 

The review team made two recommendations (see Section 5.0) regarding the California 

Agreement State Program performance in Sealed Source and Device evaluation, and 

determined that the recommendation from the 2011 IMPEP review, regarding regulation 

adoption, should be closed (see Section 2.0). 

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

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

safety and is compatible with the NRC's program. The review team recommended, and the 

MRB agreed, that the period of monitoring be discontinued and the next IMPEP review take 

place in approximately 4 years. 
California Final IMPEP Report Page 1 

1.0 INTRODUCTION 

This report presents the results of the review of the California Agreement State Program. 

The review was conducted during the period of October 5-9, 2015, by a review team 

composed of technical staff members from the U.S. Nuclear Regulatory Commission 

(NRC), and the States of Florida and Texas. The review team members are identified in 

Appendix A. The review was conducted in accordance with the “Implementation of the 

Integrated Materials Performance Evaluation Program and Rescission of Final General 

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

Management Directive 5.6 (MD 5.6), “Integrated Materials Performance Evaluation 

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

covered the period of October 22, 2011, to October 9, 2015, were discussed with State 

managers on the last day of the review. 

In preparation for the review, a questionnaire addressing the common and applicable 

non-common performance indicators was sent to the State on April 29, 2015. The State 

provided its response to the questionnaire on September 18, 2015. A copy of the 

questionnaire response can be found in the NRC’s Agencywide Documents Access and 

Management System (ADAMS) using the Accession Number ML15267A261. 

A draft of this report was issued to California on November 13, 2015, for factual 

comment. California responded to the findings and conclusions of the review by letter 

dated December 18, 2015. A copy of California’s response can be found in ADAMS 

using the Accession Number ML15365A402, and the review team’s resolution of 

comments using ML15365A400. The Management Review Board (MRB) met on 

January 14, 2016, to consider the proposed final report. The MRB found the California 

Agreement State Program adequate to protect public health and safety, and compatible 

with the NRC’s program. 

The California Agreement State Program (the Program) is administered by the 

Radiologic Health Branch (the Branch) which is located within the Division of Food, 

Drug, and Radiation Safety (the Division). The Division is part of the Center for 

Environmental Health which is located within the Department of Public Health (the 

Department). Organization charts for the State can be found in ADAMS using the 

Accession Number ML15267A069. 

At the time of the review, the Program regulated 1,795 specific licenses authorizing 

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

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

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

The review team evaluated the information gathered against the established criteria for 

each common and the applicable non-common performance indicator and made a 

preliminary assessment of the California Agreement State Program’s performance. 

 
California Final IMPEP Report Page 2 

2.0 PREVIOUS IMPEP REVIEW AND STATUS OF RECOMMENDATIONS 

The previous IMPEP review concluded on October 21, 2011. The final report is 

available in ADAMS (Accession Number ML120120373). The results of the previous 

review and the status of the recommendation are as follows: 

Technical Staffing and Training: Satisfactory 

Recommendation: None 

Status of Materials Inspection Program: Satisfactory 

Recommendation: None 

Technical Quality of Inspections: Satisfactory 

Recommendation: None 

Technical Quality of Licensing Actions: Satisfactory 

Recommendation: None 

Technical Quality of Incident and Allegation Activities: Satisfactory 

Recommendation: None 

Compatibility Requirements: Unsatisfactory 

Recommendation: The review team recommends that the State develop and implement 

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

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

accordance with the current NRC policy on adequacy and compatibility. 

 

Status: To address the recommendation, the Program made several changes to the 

process it uses to develop and track regulations compatible to the NRC’s regulation 

amendments. In early 2012, the Program started developing rulemaking packages that 

address individual NRC amendments instead of developing packages by Parts of Title 

10 of the Code of Federal Regulations (10 CFR), as was the practice previously. The 

Program also developed and implemented a detailed rulemaking process flowchart and 

an NRC amendment adoption tracking chart to closely track and gauge progress toward 

regulation adoption. The success of the Program in adopting regulation amendments 

during the review period demonstrates the effectiveness of the Program’s approach to 

addressing this recommendation. The review team recommended, and the MRB 

agreed, that this recommendation be closed. 

Sealed Source and Device Evaluation Program: Satisfactory 

Recommendation: None 

Overall finding of the previous review: Adequate to Protect Public Health and Safety and 

Not Compatible. The period of monitoring will continue until significant progress is made 

in the regulation promulgation area. 

 
California Final IMPEP Report Page 3 

3.0 COMMON PERFORMANCE INDICATORS 

Five common performance indicators are used to review the NRC regional and 

Agreement State radioactive materials programs. These indicators are (1) Technical 

Staffing and Training, (2) Status of Materials Inspection Program, (3) Technical Quality 

of Inspections, (4) Technical Quality of Licensing Actions, and (5) Technical Quality of 

Incident and Allegation Activities. 

3.1 Technical Staffing and Training 

The ability to conduct effective licensing and inspection programs is largely dependent 

on having a sufficient number of experienced, knowledgeable, well-trained technical 

personnel. Under certain conditions, staff turnover could have an adverse effect on the 

implementation of these programs, and thus could affect public health and safety. 

Apparent trends in staffing must be explored. Review of staffing also requires a 

consideration and evaluation of the levels of training and qualification. The evaluation 

standard measures the overall quality of training available to, and taken by, materials 

program personnel. 

a. Scope 

The review team used the guidance in State Agreements procedure SA-103, “Reviewing 

the Common Performance Indicator: Technical Staffing and Training,” and evaluated 

California’s performance with respect to the following performance indicator objectives: 

• A well-conceived and balanced staffing strategy has been implemented throughout 

the review period. 

• Agreement State training and qualification program is equivalent to NRC’s Inspection 

Manual Chapter (IMC) 1248, “Formal Qualifications Program for Federal and State 

Materials and Environmental Management Programs.” 

• Qualification criteria for new technical staff are established and are being followed or 

that qualification criteria will be established if new staff members are hired. 

• Any vacancies, especially senior-level positions, are filled in a timely manner. 

• There is a balance in staffing of the licensing and inspection programs. 

• Management is committed to training and staff qualification. 

• Individuals performing materials licensing and inspection activities are adequately 

qualified and trained to perform their duties. 

• License reviewers and inspectors are trained and qualified in a reasonable period of 

time. 

b. Discussion 

The California Agreement State Program is budgeted for 40 full-time equivalents (FTE), 

which includes management and staff. An additional two FTE are provided by four 

Regulation Unit staff members who support the Program through regulation 

development. Inspection activities are conducted out of two State regional offices 

(Richmond and Brea), and two county offices (San Diego County and Los Angeles 
California Final IMPEP Report Page 4 

County). Inspection activities in the county offices are conducted under a contract with 

the State. 

Currently the Program has three vacancies, all of which have been vacant since July 

2015. Over the review period a total of eight staff left the Program and 10 were hired. 

Each of the vacancies was open on average for 6 to 9 months before they were filled. 

California has a training and qualification program equivalent to the requirements in 

IMC 1248. 

c. Evaluation 

The team determined that during the review period the California program met the 

performance indicator objectives listed in Section 3.1.a. 

d. Results 

Based on the IMPEP evaluation criteria in MD 5.6, the review team recommended, and 

the MRB agreed, that California’s performance with respect to the indicator, Technical 

Staffing and Training, be found satisfactory. 

3.2 Status of the Materials Inspection Program 

Periodic inspections of licensed operations are essential to ensure that activities are 

being conducted in compliance with regulatory requirements and consistent with good 

safety practices. The frequency of inspections is specified in IMC 2800, “Materials 

Inspection Program,” and is dependent on the amount and kind of material, the type of 

operation licensed, and the results of previous inspections. There must be a capability 

for maintaining and retrieving statistical data on the status of the inspection program. 

a. Scope 

The review team used the guidance in State Agreements procedure SA-101, “Reviewing 

the Common Performance Indicator: Status of the Materials Inspection Program,” and 

evaluated California’s performance with respect to the following performance indicator 

objectives: 

• Initial inspections and inspections of Priority 1, 2, and 3 licensees are performed at 

the frequency prescribed in IMC 2800. 

• Candidate licensees working under reciprocity are inspected in accordance with the 

criteria prescribed in IMC 1220, “Processing of NRC Form 241, Report of Proposed 

Activities in Non-Agreement States, Areas of Exclusive Federal Jurisdiction, and 

Offshore Waters, and Inspection of Agreement State Licensees Operating Under 10 

CFR 150.20.” 

• Deviations from inspection schedules are normally coordinated between technical 

staff and management. 
California Final IMPEP Report Page 5 

• There is a plan to perform any overdue inspections and reschedule any missed or 

deferred inspections; or a basis has been established for not performing any overdue 

inspections or rescheduling any missed or deferred inspections. 

• Inspection findings are communicated to licensees in a timely manner (30 calendar 

days, or 45 days for a team inspection, as specified in IMC 0610, “Nuclear Material 

Safety and Safeguards Inspection Reports”). 

b. Discussion 

California performed 1,003 Priority 1, 2, 3, and initial inspections during the review 

period, of which 38 inspections (3.8 percent) were conducted overdue according to the 

inspection frequencies prescribed in IMC 2800. The threshold for satisfactory 

performance is less than 10 percent of inspections are conduced overdue. A sampling 

of 30 inspection reports indicated that one inspection report was communicated to the 

licensee beyond the Program’s goal of 30 days after the inspection exit. California 

performed greater than 20 percent of candidate reciprocity inspections during each year 

of the review period except 2014. In preparing for the 2015 IMPEP, California identified 

an error in the tracking sheet used to track reciprocity inspections for 2014. The 

corrected tracking sheet indicated the program conducted 9 percent of candidate 

reciprocity inspections. 

c. Evaluation 

The team determined that during the review period California met the performance 

indicator objectives listed in Section 3.2.a. 

d. Results 

Based on the IMPEP evaluation criteria in MD 5.6, the review team recommended, and 

the MRB agreed, that California’s performance with respect to the indicator, Status of the 

Materials Inspection Program, be found satisfactory. 

3.3 Technical Quality of Inspections 

Inspections, both routine and reactive, provide assurance that licensee activities are 

carried out in a safe and secure manner. Accompaniments of inspectors performing 

inspections, and the critical evaluation of inspection records are used to assess the 

technical quality of a program’s inspection capability. 

a. Scope 

The review team used the guidance in State Agreements procedure SA-102, “Reviewing 

the Common Performance Indicator: Technical Quality of Inspections,” and evaluated 

California’s performance with respect to the following performance indicator objectives: 

• Inspections of licensed activities focus on health, safety, and security. 

• Inspection findings are well-founded and properly documented in reports. 
California Final IMPEP Report Page 6 

• Management promptly reviews inspection results. 

• Procedures are in place and used to help identify root causes and poor licensee 

performance. 

• Inspections address previously identified open items and violations. 

• Inspection findings lead to appropriate and prompt regulatory action. 

• Supervisors conduct annual accompaniments of each inspector to assess 

performance and assure consistent application of inspection policies. 

• For programs with separate licensing and inspection staffs, to verify that procedures 

are established and followed to provide feedback information to license reviewers. 

• For Agreement States, to determine if inspection guides are consistent with NRC 

guidance. 

• An adequate supply of calibrated survey instruments is available to support the 

inspection program. 

b. Discussion 

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

interviewed inspectors for 32 materials inspections conducted during the review period. 

The casework reviewed included inspections conducted by 12 of California’s inspectors 

and covered medical, industrial, commercial, academic, research, and service licenses. 

The inspection casework and inspector accompaniments were also assessed for 

implementation of security requirements for risk significant material, as applicable. 

Review team members accompanied eight program inspectors on August 3–5 and 

September 21–25, 2015. The inspectors were found to be well-prepared, thorough, and 

conducted performance-based inspections. The inspections were adequate to assess 

radiological health, safety and security. The inspector accompaniments are identified in 

Appendix B. 

The review team noted the Program performed annual supervisory accompaniments for 

each of the inspectors throughout the review period. 

c. Evaluation 

The team determined that during the review period California met the performance 

indicator objectives listed in Section 3.3.a. 

d. Results 

Based on the IMPEP evaluation criteria in MD 5.6, the review team recommended, and 

the MRB agreed, that California’s performance with respect to the indicator, Technical 

Quality of Inspections, be found satisfactory. 

3.4 Technical Quality of Licensing Actions 

The quality, thoroughness, and timeliness of licensing actions can have a direct bearing 

on public health and safety, and security. An assessment of licensing procedures, 
California Final IMPEP Report Page 7 

actual implementation of these procedures, and documentation of communications and 

associated actions between the California licensing staff and regulated community will 

be a significant indicator of the overall quality of the program. 

a. Scope 

The review team used the guidance in State Agreements procedure SA-104, “Reviewing 

the Common Performance Indicator: Technical Quality of Licensing Actions,” and 

evaluated California’s performance with respect to the following performance indicator 

objectives: 

• Licensing action reviews are thorough, complete, consistent, and of acceptable 

technical quality with health, safety, and security issues properly addressed. 

• Essential elements of license applications have been submitted and elements meet 

current regulatory guidance (e.g., financial assurance, increased controls, 

pre-licensing guidance). 

• License reviewers, if applicable, have the proper signature authority for the cases 

they review independently. 

• License conditions are stated clearly and are inspectable. 

• Deficiency letters clearly state regulatory positions and are used at the proper time. 

• Reviews of renewal applications demonstrate a thorough analysis of a licensee’s 

inspection and enforcement history. 

• Applicable guidance documents are available to reviewers and are followed (e.g., 

NUREG-1556 series, pre-licensing guidance, regulatory guides, etc.). 

• Licensing practices for risk significant radioactive materials are appropriately 

implemented including increased controls and fingerprinting orders (Part 37 

equivalent). 

• Documents containing sensitive security information are properly marked, handled, 

controlled and secured. 

b. Discussion 

During the review period, California performed 7,693 radioactive materials licensing 

actions. The review team evaluated 41 radioactive materials licensing actions. The 

licensing actions selected for review included six new applications, 21 amendments, 

eight renewals, and six terminations. The review team evaluated casework which 

included the following license types and actions: broad scope, medical diagnostic and 

therapy, accelerator, commercial manufacturing and distribution, industrial radiography, 

research and development, academic, nuclear pharmacy, gauges, panoramic and selfshielded irradiators, well-logging, service providers, waste brokers, decommissioning 

actions, financial assurance, and bankruptcies. The casework sample represented work 

from 18 license reviewers. 

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

team noted that the Program’s backlog for license renewals (pending greater than 1 

year) had reduced significantly from 370 during the last IMPEP review period to 209 

licenses during this review period. The team noted that 76 percent of the current license 
California Final IMPEP Report Page 8 

renewal backlog was received in the last 3 years. The Program continues to issue 

amendments to licenses in timely renewal in order to address health, safety, and 

security significant issues. Based on a review of the completed licensing actions, the 

review team determined that health and safety and security were not impacted by the 

backlog in renewal actions. 

c. Evaluation 

The team determined that during the review period California met the performance 

indicator objectives listed in Section 3.4.a. 

d. Results 

Based on the IMPEP evaluation criteria in MD 5.6, the review team recommended, and 

the MRB agreed, that California’s performance with respect to the indicator, Technical 

Quality of Licensing Actions, be found satisfactory. 

3.5 Technical Quality of Incident and Allegation Activities 

The quality, thoroughness, and timeliness of response to incidents and allegations of 

safety concerns can have a direct bearing on public health and safety. An assessment 

of incident response and allegation investigation procedures, actual implementation of 

these procedures, internal and external coordination, and investigative and follow-up 

procedures and actions will be a significant indicator of the overall quality of the 

program. 

a. Scope 

The review team used the guidance in State Agreements procedure SA-105, “Reviewing 

the Common Performance Indicator: Technical Quality of Incident and Allegation 

Activities,” and evaluated California’s performance with respect to the following 

performance indicator objectives: 

• Incident response, investigation, and allegation procedures are in place and 

followed. 

• Response actions are appropriate, well-coordinated, and timely. 

• On-site responses are performed when incidents have potential health, safety or 

security significance. 

• Appropriate follow-up actions are taken to ensure prompt compliance by licensees. 

• Follow-up inspections are scheduled and completed, as necessary. 

• Notifications are made to the NRC Headquarters Operations Center for incidents 

requiring a 24-hour or immediate notification to the Agreement State or the NRC. 

• Incidents are reported to the Nuclear Material Events Database (NMED). 

• Allegations are investigated in a prompt, appropriate manner. 

• Concerned individuals are notified of investigation conclusions. 

• Concerned individuals’ identities are protected, as allowed by law. 
California Final IMPEP Report Page 9 

b. Discussion 

During the review period, 494 incidents were reported to NMED by California of which 

the majority of these were landfill trips involving diagnostic medical waste. The review 

team selected 20 of the remaining events for review. These included radioactive 

materials incidents, lost/stolen radioactive materials, potential overexposures, medical 

events, damaged equipment and leaking sources. The team found that California 

dispatched inspectors for onsite follow-up for each of the cases reviewed by the team. 

During the review period, 73 allegations were received by California. The review team 

evaluated 12 allegations, including six of 10 allegations that the NRC referred to the 

State during the review period. 

c. Evaluation 

The team determined that during the review period California met the performance 

indicator objectives listed in Section 3.5.a. 

d. Results 

Based on the IMPEP evaluation criteria in MD 5.6, the review team recommended, and 

the MRB agreed, that California’s performance with respect to the indicator, Technical 

Quality of Incident and Allegation Activities, be found satisfactory. 

4.0 NON-COMMON PERFORMANCE INDICATORS 

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

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

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

Recovery Program. The NRC’s Agreement with California does not relinquish regulatory 

authority for a uranium recovery program; therefore, only the first three non-common 

performance indicators applied to this review. 

4.1 Compatibility Requirements 

State statutes should authorize the State to establish a program for the regulation of 

agreement material and provide authority for the assumption of regulatory responsibility 

under the agreement. The statutes must authorize the State to promulgate regulatory 

requirements necessary to provide reasonable assurance of protection of public health, 

safety, and security. The State must be authorized through its legal authority to license, 

inspect, and enforce legally binding requirements, such as regulations and licenses. 

The NRC regulations that should be adopted by an Agreement State for purposes of 

compatibility or health and safety should be adopted in a time frame so that the effective 

date of the State requirement is not later than 3 years after the effective date of the 

NRC's final rule. Other program elements, as defined in Appendix A of State 

Agreements procedure SA-200, “Compatibility Categories and Health and Safety 

Identification for NRC Regulations and Other Program Elements,” that have been 

designated as necessary for maintenance of an adequate and compatible program 
California Final IMPEP Report Page 10 

should be adopted and implemented by an Agreement State within 6 months following 

the NRC designation. 

a. Scope 

The review team used the guidance in State Agreements procedure SA-107, “Reviewing 

the Non-Common Performance Indicator: Compatibility Requirements,” and evaluated 

California’s performance with respect to the following performance indicator objectives. 

• The Agreement State program does not create conflicts, duplications, gaps, or other 

conditions that jeopardize an orderly pattern in the regulation of radioactive materials 

under the Atomic Energy Act, as amended. 

• Regulations adopted by the Agreement State for purposes of compatibility or health 

and safety were adopted no later than 3 years after the effective date of the NRC 

regulation. 

• Other program elements, as defined in SA-200 that have been designated as 

necessary for maintenance of an adequate and compatible program have been 

adopted and implemented within 6 months of NRC designation. 

• The State statutes authorize the State to establish a program for the regulation of 

agreement material and provide authority for the assumption of regulatory 

responsibility under the agreement. 

• The State is authorized through its legal authority to license, inspect, and enforce 

legally binding requirements such as regulations and licenses. 

• Impact of sunset requirements, if any, on the State’s regulations. 

b. Discussion 

California became an Agreement State on September 1, 1962. The California 

Agreement State Program‘s current effective statutory authority is contained in the 

Radiation Protection Act of 1999, Containment of Radioactive Materials Law, and 

Radiation Control Law under Division 104 of the California Health and Safety Code. The 

Department is designated as the State’s radiation control agency. There were two 

legislative amendments passed during the review period that minimally affect California’s 

rulemaking process. Senate Bills 617 and 1099 added provisions that adjust the 

economic impact analysis conducted during the pre-notice stage of rulemaking and 

require all regulations filed with the Secretary of State to be posted to the internet. 

Neither of the legislative amendments, enacted in 2013, has impacted the Program’s 

rulemaking process significantly. 

The State’s administrative rulemaking process takes approximately 25 months from 

drafting to finalizing a rule. The public, the NRC, other agencies, and potentially 

impacted licensees and registrants are offered an opportunity to comment during the 

process. Comments are considered and incorporated, as appropriate, before the 

regulations are finalized and approved by the Center. The review team noted that the 

State’s rules and regulations are not subject to “sunset” laws. 
California Final IMPEP Report Page 11 

During the review period, California submitted 16 final regulation amendments to the 

NRC for compatibility review, and all of the submitted regulations were determined to be 

compatible without comment. California addressed 10 of the 12 overdue amendments 

identified in the 2011 IMPEP report and is analyzing whether its current regulations 

appropriately address the remaining two longstanding overdue amendments identified 

below. Additionally, two regulation amendments became overdue in August 2015. 

California has drafted a rulemaking package to address these amendments that is 

currently in the State’s rulemaking process. A complete list of the NRC’s regulation 

amendments can be found on the NRC website at the following address: 

https://scp.nrc.gov/rss_regamendents.html. 

At the time of this review, the following four amendments were overdue: 

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

amendment (59 FR 36026), that was due for Agreement State adoption by 

August 15, 1997. 

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

amendment (62 FR 39057), that was due for Agreement State adoption by 

August 20, 2000. 

• “Advance Notification to Native American Tribes of Transportation of Certain Types 

of Nuclear Waste,” 10 CFR Part 71 amendment (77 FR 34194), that was due for 

Agreement State adoption by August 10, 2015. 

• “Technical Corrections,” 10 CFR Parts 30, 34, 40 and 71 amendment (77 FR 39899), 

that was due for Agreement State adoption by August 6, 2015. 

The two longstanding overdue amendments listed above, “Timeliness in 

Decommissioning Material Facilities” and “Radiological Criteria for License Termination,” 

are related to each other. The "Radiological Criteria for License Termination" portion of 

10 CFR Part 20 was previously adopted by California and subsequently challenged in 

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

and the license termination portion of 10 CFR Part 20 was repealed on August 8, 2002. 

The review team identified that California has not adopted the portions of these 

amendments that are not associated with 10 CFR Part 20. The review team and the 

Program discussed that California may be able to document that the State’s current 

regulations are compatible with these portions of the two amendments. The Program is 

analyzing whether its current regulations appropriately address these longstanding 

overdue amendments and has committed to submit regulations to the NRC to document 

that the portions of these amendments not associated with 10 CFR Part 20 have been 

adopted. 

The review team also reviewed a known compatibility issue regarding low-level 

radioactive waste (LLRW) disposal requirements found in Section 115261 of California’s 

“Health and Safety Code – Radiation Control Law” and the NRC’s 10 CFR Part 61. This 

incompatibility was initially noted in the NRC’s response to California’s amendment 

submitted for review on July 25, 2007. At that time, the NRC notified the State that a 

portion of its statute was more restrictive than 10 CFR 61.41, and therefore did not meet 

the Compatibility Category “A” designation assigned to the rule. To date, this 
California Final IMPEP Report Page 12 

compatibility issue has not been resolved, and California is uncertain when this issue 

can be resolved. The Program is not aware of any prospective applicant for a LLRW 

disposal facility license in California; consequently, California’s requirements that are 

more restrictive than 10 CFR 61.41 are not currently in use by the State. If someone 

were to express interest in applying for a LLRW disposal facility license in California, the 

State appears to have sufficient time to adopt compatible LLRW facility requirements 

before those requirements are needed to license a facility. 

c. Evaluation 

Since the 2011 IMPEP review, the Program has modified its approach to the process 

used to adopt NRC regulations. The Program moved from its long standing practice of 

processing rule packages by “Parts,” such as Part 20 or Part 35 of the CFR, to adopting 

regulations by amendments, which is similar to the manner in which the NRC 

promulgates rules. The Program also added additional staff to the Regulations Unit to 

rule development activities. The success of the Program in adopting 16 regulation 

amendments during the review period demonstrates the effectiveness of the Program’s 

approach to improve upon the unsatisfactory ratings from the previous two IMPEP 

reviews. 

The Program has committed to submit regulations to the NRC to document that the 

applicable portions of the two longstanding overdue amendments are appropriately 

addressed. The two newly overdue amendments are already contained in a rulemaking 

package that is currently in California’s rulemaking process. In addition to the regulation 

packages submitted to the NRC during the review period, the Program has also initiated 

the rulemaking process for amendments coming due in the next several years. In 

summary, the Program has adopted all but a few program elements essential for 

compatibility and meets all the other evaluation criteria for this performance indicator. 

The team determined that during the review period California met the performance 

indicator objectives listed in Section 3.4.1.a. 

d. Results 

Based on the IMPEP evaluation criteria in MD 5.6, the review team recommended, and 

the MRB agreed, that California’s performance with respect to the indicator, 

Compatibility Requirements, be found satisfactory. 

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

Adequate technical evaluations of SS&D designs are essential to ensure that SS&Ds will 

maintain their integrity and that the design is adequate to protect public health and 

safety. NUREG-1556, Volume 3, “Consolidated Guidance about Materials Licenses: 

Applications for Sealed Source and Device Evaluation and Registration,” provides 

information on conducting SS&D reviews and establishes useful guidance for review 

teams. Three sub elements, technical staffing and training, technical quality of the 

product evaluation program, and evaluation of defects and incidents regarding SS&D’s, 

will be evaluated to determine if the SS&D program is satisfactory. Agreement States 
California Final IMPEP Report Page 13 

with authority for SS&D evaluation programs who are not performing SS&D reviews are 

required to commit in writing to having an SS&D evaluation program in place before 

performing evaluations. 

a. Scope 

The review team used the guidance in State Agreements procedure SA-108, “Reviewing 

the Non-Common Performance Indicator: Sealed Source and Device Evaluation 

Program,” and evaluated California’s performance with respect to the following 

performance indicator objectives: 

Technical Staffing and Training 

• A well-conceived and balanced staffing strategy has been implemented throughout 

the review period. 

• Qualification criteria for new technical staff are established and are being followed or 

that qualification criteria will be established if new staff members are hired. 

• Any vacancies are filled in a timely manner. 

• Management is committed to training and staff qualification. 

• Individuals performing SS&D evaluation activities are adequately qualified and 

trained to perform their duties. 

• SS&D reviewers are trained and qualified in a reasonable period of time. 

Technical Quality of the Product Evaluation Program 

• SS&D evaluations are adequate, accurate, complete, clear, specific, and consistent 

with NUREG 1556, Volume 3. 

Evaluation of Defects and Incidents 

• SS&D incidents are reviewed to detect possible manufacturing defects and the root 

causes of these incidents. 

• Incidents are evaluated to determine if other products may be affected by similar 

problems. Appropriate action and notifications to the NRC, Agreement States, and 

others, as appropriate, should occur in a timely manner. 

b. Discussion 

Technical Staffing and Training 

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

authority to perform concurrence reviews. There are eight additional reviewers that are 

either partially qualified reviewers or are reviewers in training with limited initial reviewer 

signature authority. Currently, there are no vacancies in the SS&D program. The 

Branch has a training program equivalent to NRC training requirements listed in 

IMC 1248, Appendix D. 
California Final IMPEP Report Page 14 

Technical Quality of the Product Evaluation 

California has 26 Manufacturer/Distributor licensees with 227 active SS&D registrations. 

The review team evaluated 14 of 105 SS&D actions processed during the review period. 

These actions included eight amendments, two new applications, three inactivations, 

and one transfer. 

Evaluation of Defects and Incidents Regarding SS&Ds 

The review team evaluated one of three incidents involving SS&D registry sheets issued 

by the State during the review period. 

c. Evaluation 

The team determined that during the review, California met the performance indicator 

objectives listed in section 4.2.a. The review team did identify two areas for 

improvement in the California SS&D evaluation program. Those areas are described 

below. 

The review team identified a backlog of nine requests for new registration certificates, 

which were pending transfer from another jurisdiction and required a new evaluation. 

The majority of these requests were submitted to California in 2009 and 2010. The 

review team determined that the backlog was due to the prioritization of work on other 

SS&D actions (i.e., new registrations, amendments, etc.). Delay of the completion of 

transfer registrations may impact other regulatory agencies’ ability to inactivate the 

associated registrations in their jurisdictions and could cause confusion regarding which 

regulatory authority has jurisdiction over the registrations. The review team 

recommended, and the MRB agreed, that the Program develop and implement an action 

plan to complete pending transfer actions in a timely manner to ensure consistency and 

clarity in the licensing of the registered sources/devices across all jurisdictions. 

The review team noted that the Program did not have a formal process to verify the 

implementation of manufacturer/distributor’s quality assurance and quality control 

program commitments. The review team recommended, and the MRB agreed, that the 

Program develop and implement a procedure for reviewing the implementation of the 

manufacturer/distributor’s quality assurance and quality control program commitments 

during an onsite inspection. 

d. Results 

Based on the IMPEP evaluation criteria in MD 5.6, the review team recommended, and 

the MRB agreed, that California’s performance with respect to the indicator, Sealed 

Source and Device Evaluation Program, be found satisfactory. 

4.3 Low-level Radioactive Waste Disposal Program 

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

NRC in Discontinuance of NRC Regulatory Authority and Assumption Thereof by States 
California Final IMPEP Report Page 15 

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

as a separate category. Although the California Agreement State Program has LLRW 

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

LLRW disposal facility until such time as the State has been designated as a host State 

for a LLRW disposal facility. When an Agreement State has been notified or becomes 

aware of the need to regulate a LLRW disposal facility, they are expected to put in place 

a regulatory program which will meet the criteria for an adequate and compatible LLRW 

disposal program. There are no plans for a LLRW disposal facility in California. 

Accordingly, the review team did not review this indicator. 

5.0 SUMMARY 

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

for all seven performance indicators reviewed. The review team made two 

recommendations regarding program performance by the State and determined that the 

recommendation from the 2011 IMPEP review concerning compatibility should be 

closed. 

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

Agreement State Program be found adequate to protect public health and safety and 

compatible with the NRC's program. Further, the review team recommended, and the 

MRB agreed, to discontinue the period of monitoring. California showed sustained and 

substantial improvement in its rule development program since the 2011 IMPEP review. 

Based on the results of the current IMPEP review, the review team recommended, and 

the MRB agreed, that the next full IMPEP review take place in approximately four years. 

Below are the review team’s recommendations, as mentioned in the report, for 

evaluation and implementation by California: 

1. The review team recommends that the Program develop and implement an action 

plan to complete pending transfer actions in a timely manner to ensure consistency 

and clarity in the licensing of the registered sources/devices across all jurisdictions. 

(Section 4.2.c.) 

2. The review team recommends that the Program develop and implement a procedure 

for reviewing the implementation of the manufacturer/distributor’s quality assurance 

and quality control program commitments during an onsite inspection. (Section 

4.2.c)
LIST OF APPENDICES 

Appendix A IMPEP Review Team Members 

Appendix B Inspection Accompaniments 
APPENDIX A 

IMPEP REVIEW TEAM MEMBERS 

Name Area of Responsibility

Donna Janda, Region I Team Leader 

 Technical Staffing and Training 

 Inspector Accompaniments 

Randy Erickson, Region IV Technical Quality of Incident and Allegation Activities 

David Spackman, NMSS Status of Materials Inspection Program 

 Compatibility Requirements 

Lizette Roldan-Otero, NMSS Technical Quality of Licensing Actions 

Michelle Hammond, Region IV Technical Quality of Licensing Actions 

Leo Bakersmith, Florida Technical Quality of Inspections 

Jason Kelly, Texas Sealed Source and Device Evaluation Program 
 

APPENDIX B 

INSPECTION ACCOMPANIMENTS 

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

Accompaniment No.: 1 License No.: 1391 

License Type: Medical Institution, Written Directive 

(WD) Required 

Priority: 2 

Inspection Date: 08/03/15 Inspector: KH 

Accompaniment No.: 2 License No.: 0077 

License Type: Medical Institution, WD Required Priority: 3 

Inspection Date: 08/04/15 Inspector: EM 

Accompaniment No.: 3 License No.: 6408 

License Type: Nuclear Pharmacy Priority: 2 

Inspection Date: 08/05/15 Inspector: EF 

Accompaniment No.: 4 License No.: 2975 

License Type: Medical Institution, WD Required Priority: 3 

Inspection Date: 09/21/15 Inspector: AT 

Accompaniment No.: 5 License No.: 1880 

License Type: Industrial Radiography Priority: 1 

Inspection Date: 09/22/15 Inspector: AR 

Accompaniment No.: 6 License No.: 6885 

License Type: Medical Private Practice, WD Required Priority: 2 

Inspection Date: 09/23/15 Inspector: TR 

Accompaniment No.: 7 License No.: 2871 

License Type: Medical Institution, WD Required Priority: 3 

Inspection Date: 09/24/15 Inspector: GTM 

Accompaniment No.: 8 License No.: 3960 

License Type: Medical Institution, WD Required Priority: 3 

Inspection Date: 09/25/15 Inspector: KH