ML25055A161
| ML25055A161 | |
| Person / Time | |
|---|---|
| Issue date: | 03/04/2025 |
| From: | Robert Lewis NRC/EDO/DEDMRS |
| To: | Schneider I State of CA, Dept of Public Health |
| References | |
| Download: ML25055A161 (1) | |
Text
Ira Schneider, Chief Radiological Health Branch California Department of Public Health Radiologic Health Branch Environmental Management P.O. Box 997414 MS 7610 Sacramento, CA 95899-7414
SUBJECT:
CALIFORNIA FINAL IMPEP REPORT
Dear Ira Schnieder:
On February 20, 2025, the Management Review Board (MRB) met, which consisted of the U.S. Nuclear Regulatory Commission (NRC) senior managers and an Organization of Agreement States member, 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 NRC program.
The enclosed final report documents the IMPEP teams findings and summarizes the results of the MRB meeting. Since California has had at least two consecutive IMPEP reviews with all performance indicators being found satisfactory, the MRB Chair determined that the next periodic meeting will take place in approximately 2.5 years with the next IMPEP review of the California Agreement State Program taking place in approximately 5 years.
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, Robert J. Lewis Deputy Executive Director for Nuclear Materials, Administrative, and Corporate Programs Office of the Executive Director for Operations
Enclosures:
1.
Final FY2025 California IMPEP Report 2.
2025 California MRB Meeting Participants March 4, 2025 Signed by Lewis, Robert on 03/04/25
I. Schneider cc: David Hochschild, Chair California Energy Commission INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW OF THE CALIFORNIA AGREEMENT STATE PROGRAM November 4-8, 2024 FINAL REPORT
EXECUTIVE
SUMMARY
The results of the Integrated Materials Performance Evaluation Program (IMPEP) review of the California Agreement State Program are discussed in this report. The review was conducted from November 4-8, 2024. Inspector accompaniments were conducted on September 4-6, 16-19, and 23, 2024.
Based on the results of the 2024 IMPEP review, Californias performance was found satisfactory for all performance indicators reviewed: Technical Staffing and Training; Status of Materials Inspection Program; Technical Quality of Inspections; Technical Quality of Licensing Actions; Technical Quality of Incident and Allegation Activities; Legislation, Regulations, and Other Program Elements; and Sealed Source and Device Evaluation Program.
There were no recommendations from the previous review for the team to consider. The team did not make any new recommendations.
Accordingly, the Management Review Board (MRB) found the California radiation control program adequate to protect public health and safety and compatible with the U.S. Nuclear Regulatory Commissions program. Because California has had at least two consecutive IMPEP reviews with all performance indicators found satisfactory, the MRB Chair determined that the next periodic meeting take place in approximately 2.5 years with the next IMPEP review taking place in approximately 5 years.
California Final IMPEP Report Page 1
1.0 INTRODUCTION
The California Agreement State Program (California) Integrated Materials Performance Evaluation Program (IMPEP) review was conducted on November 4-8, 2024, by a team of technical staff members from the U.S. Nuclear Regulatory Commission (NRC) and the States of Oklahoma, New Jersey, Minnesota, Tennessee, and Kentucky. Team members are identified in Appendix A. Inspector accompaniments were conducted on September 4-5, 16-19, and 23, 2024 and are identified in Appendix B. The review was conducted in accordance with the Agreement State Program Policy Statement, published in the Federal Register on October 18, 2017 (82 FR 48535), and NRC Management Directive (MD) 5.6, Integrated Materials Performance Evaluation Program (IMPEP), dated July 24, 2019. Preliminary results of the review, which covered the period of October 25, 2019, to November 8, 2024, were discussed with California managers on the last day of the review.
In preparation for the review, a questionnaire addressing the common performance indicators and applicable non-common performance indicators was sent to California on August 28, 2024.
California provided its response to the questionnaire on October 22, 2024. A copy of the questionnaire response is available in the NRCs Agencywide Documents Access and Management System (ADAMS) Accession Number ML24313A129.
The team issued a draft report to California on December 16, 2024, for factual comment in ML24346A395. California responded with minor comments on the draft report by email dated January 6, 2025, from Ira Schneider, Radiological Health Branch Chief, California Department of Public Health in ML25041A009. The final IMPEP report was updated to address Californias comments, as appropriate.
California is administered by the Radiologic Health Branch which is located within the Division of Radiation Safety and Environmental Management in the California Department of Public Health.
Organization charts for California are available in ML24313A088.
At the time of the review, California regulated 1597 specific licenses authorizing possession and use of radioactive materials. The review focused on the radiation control program as it is carried out under Section 274b. (of the Atomic Energy Act of 1954, as amended) Agreement between the NRC and the State of California.
The team evaluated the information gathered against the established criteria for each common and applicable non-common performance indicator and made a preliminary assessment of the States performance.
2.0 PREVIOUS IMPEP REVIEW AND STATUS OF RECOMMENDATIONS The previous IMPEP review concluded on October 26, 2019. The final report is available in ML20024E166. The results of the review are as follows:
Technical Staffing and Training: Satisfactory Recommendation: None Status of Materials Inspection Program: Satisfactory Recommendation: None
California Final IMPEP Report Page 2 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 Legislation, Regulations, and Other Program Elements: Satisfactory Recommendation: None Sealed Source and Device (SS&D) Evaluation Program: Satisfactory Recommendation: None Overall finding: As a result of the 2019 IMPEP review, California was found adequate to protect public health and safety and compatible with the NRC's program. The team further recommended, and the Management Review Board (MRB) agreed, that a periodic meeting be held within 2.5 years and that a follow-up IMPEP review take place approximately 5 years.
3.0 COMMON PERFORMANCE INDICATORS Five common performance indicators are used to review the NRC and Agreement State radiation control 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 experienced, knowledgeable, well-trained technical personnel. Under certain conditions, staff turnover could have an adverse effect on the implementation of these programs and could affect public health and safety. Apparent trends in staffing must be assessed. Review of staffing also requires 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 team used the guidance in State Agreements procedure (SA) SA-103, Reviewing the Common Performance Indicator: Technical Staffing and Training, and evaluated Californias performance with respect to the following performance indicator objectives:
A well-conceived and balanced staffing strategy has been implemented throughout the review period.
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.
California Final IMPEP Report Page 3 Agreement State training and qualification program is equivalent to NRC Inspection Manual Chapter (IMC) IMC 1248, Formal Qualifications Program for Federal and State Material and Environmental Management Programs.
Qualification criteria for new technical staff are established and are followed, or qualification criteria will be established if new staff members are hired.
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.
b.
Discussion California is comprised of 61 staff members which includes 1 Branch Chief, 3 Section Chiefs, 8 Unit Chiefs, and 49 technical staff, equaling 59 full-time equivalents. There were four technical staff vacancies at the time of the review. During the review period, 10 staff members left the program and 11 staff members were hired. Vacancies were open from 5 months to 26.5 months. The extended time to fill vacancies did not affect the efficiency of the program as evidenced by the reduction of the licensing backlog during the review period.
California reduced the licensing backlog from over 128 actions in 2019, to 8 actions at the time of the review.
Staff were very knowledgeable, well-trained, and safety conscious. California ensured that all staff received the required core training courses and that progress in obtaining interim and full qualification for licensing and inspection modalities was well-documented.
Individuals who possessed a Bachelor of Science degree or higher in Health Physics or are certified by the American Board of Health Physics prior to joining California were evaluated on a case-by-case basis and the rationale for granting equivalency was thoroughly noted.
Training is well-documented for each staff member ensuring they have received the required core and refresher trainings. The team noted that Californias training and qualification program was compatible with the NRCs IMC 1248.
c.
Evaluation The team determined that, during the review period, California met the performance indicator objectives listed in Section 3.1.a. Based on the criteria in MD 5.6, the team recommends that Californias performance with respect to the indicator, Technical Staffing and Training, be found satisfactory.
d.
MRB Discussion and Chairs Determination The MRB Chair agreed with the teams recommendation and found Californias performance with respect to this indicator satisfactory.
3.2 Status of Materials Inspection Program Inspections of licensed operations are essential to ensure that activities are being conducted in compliance with regulatory requirements and consistent with good safety and security practices.
The frequency of inspections is specified in IMC 2800, Materials Inspection Program, and is dependent on the amount and type of radioactive 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.
California Final IMPEP Report Page 4 a.
Scope The team used the guidance in SA-101, Reviewing the Common Performance Indicator:
Status of the Materials Inspection Program, and evaluated Californias performance with respect to the following performance indicator objectives:
Initial inspections and inspections of Priority 1, 2, and 3 licensees are performed at the prescribed frequencies (https://www.nrc.gov/materials/miau/mat-toolkits.html).
Deviations from inspection schedules are normally coordinated between technical staff and management.
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.
Candidate licensees working under reciprocity are inspected in accordance with the criteria prescribed in IMC 2800 and other applicable guidance or compatible Agreement State Procedure.
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 679 Priority 1, 2, 3 inspections and 142 initial inspections during the review period. California conducted 33 Priority 1, 2, 3 inspections and 11 initial inspections overdue.
The team noted that Temporary Instruction (TI) TI-003 Evaluating the Impacts of the Coronavirus Disease 2019 Public Health Emergency as Part of the Integrated Materials Performance Evaluation Program, states, in part, that for inspections that exceed the scheduling window with overdue dates falling inside the defined time frame of the pandemic, the number of overdue inspections should be noted in the report but should not be counted, provided that the State continues to maintain health, safety, and security. All of the overdue inspections noted above, were due to impacts related to the pandemic, the majority of which were medical licensees. During Californias defined time frame of the pandemic, March 4, 2020, through February 28, 2023, California maintained health, safety, and security, therefore, the team did not include these inspections when performing the calculation, as such, California did not have any overdue inspections during the review period.
Californias inspection frequencies were consistent with the NRCs program for similar license types.
A sampling of 19 inspection reports indicated that none of the inspection findings were communicated to the licensees beyond 30 days after the inspection exit or 45 days after the team inspection exit.
California conducts reciprocity inspections using a procedure compatible with IMC 2800.
Candidates are identified using a risk-informed approach and submitted to the regional supervisor and inspectors for the geographical area of the upcoming work. During the review period, California completed the following percentages of reciprocity candidates:
25 percent in 2020, 50 percent in 2021, 50 percent in 2022, 25 percent in 2023, and
California Final IMPEP Report Page 5 50 percent in 2024 as of the date of the review, in accordance with the guidance provided in SA-101 and NRCs IMC 2800. Based on interviews with California staff and review of the IMPEP Questionnaire, the IMPEP team determined that reciprocity inspections were not impacted by the Public Health Emergency, therefore, the review team did not apply TI-003 when evaluating this aspect of the performance indicator.
c.
Evaluation The team determined that, during the review period, California met the performance indicator objectives listed in Section 3.2.a. Based on the criteria in MD 5.6, the team recommends that Californias performance with respect to the indicator, Status of Materials Inspection Program, be found satisfactory.
d.
MRB Discussion and Chairs Determination The MRB Chair agreed with the teams recommendation and found Californias performance with respect to this indicator satisfactory.
3.3 Technical Quality of Inspections Inspections, both routine and reactive, provide reasonable 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 an inspection program.
a.
Scope The team used the guidance in SA-102, Reviewing the Common Performance Indicator:
Technical Quality of Inspections, and evaluated Californias 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.
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, or senior staff as appropriate, conduct annual accompaniments of each inspector to assess performance and assure consistent application of inspection policies.
For Programs with separate licensing and inspection staffs, procedures are established and followed to provide feedback information to license reviewers.
Inspection guides are compatible with NRC guidance.
An adequate supply of calibrated survey instruments is available to support the inspection program.
California Final IMPEP Report Page 6 b.
Discussion The team evaluated 27 inspection reports and enforcement documentation, and interviewed inspector supervisors involved in materials inspections conducted during the review period.
The team reviewed casework for inspections conducted by 12 of Californias inspectors covering medical, industrial, commercial, academic, research, and service licenses.
A team member accompanied 7 inspectors on September 4-5, 16-19, and 23, 2024. The inspector accompaniments are identified in Appendix B. The team noted that the inspections were performance-based. Inspectors were well-prepared, thorough in their evaluation of the licensee, and demonstrated knowledge of appropriate regulations. Inspectors observed the use of radioactive material when opportunities were available and assessed the impact of licensed activities on health, safety, and security.
California consistently ensured that all active inspectors were accompanied by a supervisor annually. There was one instance during the review period where three inspector accompaniments exceeded 12 months. This did not result in any observed performance issues and all other inspector accompaniments were performed in a timely manner at least every 12 months.
During the pandemic, California was able to perform remote inspections and minimized the number of overdue inspections. The team did not observe any issues with technical quality of inspections due to the pandemic.
California separates its inspection load into four geographical regions: North, South, Los Angeles County, and San Diego County. The team observed that San Diego County had one inspector. This inspector was a supervisor in the San Diego Office and signed off on their own inspection reports. All other inspectors reports were observed to have a review and sign off from a supervisor who is not the inspector. The San Diego Office inspection reports were observed to have less detail than reports from other offices, and minor errors were also observed. These errors were not significant because the inspector included sufficient documentation of the corrective actions associated with the previous inspection.
Additionally, Californias inspection procedures require that the inspection office supervisor must review and concur in writing on the inspection report. IMC 2800 requires the inspection be signed by the inspector and supervisor. In both cases, the procedures do not specify that the supervisor must be a separate person. Therefore, the team concluded that Californias procedure was compatible with IMC 2800. The amount of detail and minor issues observed in the San Diego Offices reports did not have an impact on public health and safety. During the MRB meeting, California confirmed that all San Diego County inspection reports are now being reviewed by another supervisor.
Each of Californias inspection offices had radiation detection instrumentation available and each office appointed a person responsible for ensuring the equipment was calibrated. The inspection reports that were reviewed indicated that inspectors were bringing appropriate and calibrated radiation detection instruments with them on inspection and were taking measurements as part of the inspection. During the IMPEP teams inspector accompaniments, the California inspectors were observed to have appropriate detection equipment. During one accompaniment of a medical facility, a California inspector identified the presence of radioactive material in an unmarked garbage receptacle. This was identified by the team as a good example of appropriate use of detection equipment during an inspection.
California Final IMPEP Report Page 7 c.
Evaluation The team determined that, during the review period, California met the performance indicator objectives listed in Section 3.3.a. Based on the criteria in MD 5.6, the team recommends that Californias performance with respect to the indicator, Technical Quality of Inspections be found satisfactory.
California managed a large volume of inspections throughout a large state. The inspectors were well-trained and well-prepared. Californias inspectors used their training, experience, and instrumentation to identify compliance issues, and made recommendations to their licensees about how to improve their programs even when compliance issues were not identified. This method encourages a collaborative environment between the state and its licensees.
d.
MRB Discussion and Chairs Determination The final report will present the MRB Chairs determination regarding this indicator.
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, as well as security. An assessment of licensing procedures, implementation of those procedures, and documentation of communications and associated actions between the California licensing staff and regulated community is a significant indicator of the overall quality of the licensing program.
a.
Scope The team used the guidance in SA-104, Reviewing the Common Performance Indicator:
Technical Quality of Licensing Actions, and evaluated Californias 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 are consistent with current regulatory guidance (e.g., pre-licensing guidance, Title 10 of the Code of Federal Regulations (10 CFR) Part 37, financial assurance, etc.).
License reviewers, if applicable, have the proper signature authority for the cases they review independently.
License conditions are stated clearly and can be inspected.
Deficiency letters clearly state regulatory positions and are used at the proper time.
Reviews of renewal applications demonstrate a thorough analysis of a licensees 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 (RSRM) are appropriately implemented including the physical protection of Category 1 and Category 2 quantities of radioactive material (10 CFR Part 37 equivalent).
Documents containing sensitive security information are properly marked, handled, controlled, and secured.
California Final IMPEP Report Page 8 b.
Discussion During the review period, California performed 6,884 radioactive materials licensing actions.
The team evaluated 60 of those licensing actions. The licensing actions selected for review included 6 new applications, 29 amendments, 12 renewals, 3 terminations, 2 bankruptcy, and 8 financial assurance actions. The team evaluated casework which included the following license types and actions: broad scope, medical diagnostic and therapeutic, accelerator, commercial manufacturing and distribution, industrial radiography, research and development, academic, nuclear pharmacy, gauges, panoramic irradiator, well-logging, service providers, waste brokers, decommissioning, financial assurance, bankruptcies, and change of ownership notifications. The casework sample represented work from 21 license reviewers, whose program responsibilities include work in other areas, such as SS&D reviews, financial assurance reviews, and two-level reviews.
The team found that licensing actions were complete, consistent, and of acceptable quality with health, safety, and security concerns addressed. All licensing actions are reviewed by an assigned license reviewer from either the Medical Unit, Licensing Projects Unit, or the Industrial and General Licensed Devices Unit. The license reviewers use up-to-date guidance. Each action then undergoes a documented two-level review prior to approval and signature by the respective unit senior health physicist. This practice by California with the two-level review, provides on-the-job training (OJT) to be given by a core qualified peer reviewer or the core qualified supervisor. The work assignments of license reviewers who are not yet considered fully qualified are limited to selected licensing matters within their licensing unit for which they have demonstrated proficiency through OJT.
A one-on-one discussion was held with the licensing reviewers in training to discuss their licensing reviewer qualification progress in accordance with Californias Procedure 07-02 Rev. 3, Training Program for Radioactive Materials Licensing Health Physicists. The team received responses that confirmed the staff were knowledgeable of the training procedure, and licensing review references and documents, inclusive but not limited to, NUREG-1556 licensing guidance volumes, licensing guidance toolkits, applicable licensing review checklists, such as Pre-Licensing Guidance checklist, RSRM checklist, and protection of sensitive information.
The team verified that each unit under the Radioactive Materials Licensing Section (Medical, Academic, and Pharmacy Licensing, Licensing Projects Unit, Industrial and General Licensed Devices Unit, and Special Projects and Support Unit) meets weekly to address workflow volume and timeliness concerns. Each unit documents the close coordination with the Inspection, Compliance and Enforcement Section as the licensing action is being processed.
Licenses are issued for a 10-year period under a timely renewal system. The team noted that the Radioactive Materials Licensing Sections (RML) backlog for license renewals (pending greater than one year) dropped significantly from greater than 128 during the last IMPEP review period to 8 during this review period. Based on a review of the completed licensing actions, the team determined that health and safety and security were not impacted by the backlog in renewal actions.
The RML chiefs and supervising health physicists met and established the priority for which licensing actions should be processed with respect to health, safety, and security risks, as well as the licensees inspection interval. Based on continued prioritization, management
California Final IMPEP Report Page 9 ensures that licenses listed in the backlog continue to be inspected at their routine inspection intervals and that staff continues to confirm that the safe and secure use of radioactive materials remains in accordance with regulatory guidelines. The RML Section continues to issue amendments to licenses within established time frames to address health, safety, and security issues.
c.
Evaluation The team determined that, during the review period, California met the performance indicator objectives listed in Section 3.4.a. Based on the criteria in MD 5.6, the team recommends that Californias performance with respect to the indicator, Technical Quality of Licensing Actions, be found satisfactory.
d.
MRB Discussion and Chairs Determination The MRB Chair agreed with the teams recommendation and found Californias performance with respect to this indicator 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, safety and security. An assessment of incident response and allegation investigation procedures, actual implementation of these procedures internal and external coordination, timely incident reporting, and investigative and follow-up actions, are a significant indicator of the overall quality of the incident response and allegation programs.
a.
Scope The team used the guidance in SA-105, Reviewing the Common Performance Indicator:
Technical Quality of Incident and Allegation Activities, and evaluated Californias performance with respect to the following performance indicator objectives:
Incident response 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 NRC.
Incidents are reported to the Nuclear Material Events Database (NMED) and closed when all required information has been obtained.
Allegations are investigated in a prompt, appropriate manner.
Concerned individuals are notified within 30 days of investigation conclusions.
Concerned individuals identities are protected, as allowed by law.
California Final IMPEP Report Page 10 b.
Discussion During the review period, 159 incidents were reported to the NMED database by California.
The team evaluated 25 radioactive materials incidents which included 7 medical events, 1 event involving a damaged gauge, 4 industrial radiography events, 1 leaking source, 1 rejected foreign scrap shipment, 1 cremation of a body with an implant in place, 1 occupational dose over the limit, 1 pool irradiator source retraction event, 2 fire events involving gauges, 3 events involving thefts of radioactive material, 1 event involving a found gauge that went missing without the licensees knowledge, 1 event involving lost seeds, and 1 event involving a contaminated package received. The state quickly dispatched inspectors for on-site follow-up in all the cases reviewed by the team. A review of Californias procedures for follow-up to incidents and allegations found that they were compatible with NRC procedures.
When notification of an incident is received, it is routed to the senior staff member who manages the event and allegation program. After review, that individual then dispatches the incident to the manager in each of the regional offices who reviews it and subsequently assigns the event to a regional inspector for follow-up. In nearly all cases, inspectors perform an on-site inspection. Enforcement action is taken when warranted.
The team also evaluated Californias reporting of incidents to the NRCs Headquarters Operations Officer (HOO). The team noted that in each case requiring HOO notification, California reported the incidents within the required time frame. The team also evaluated whether California had not reported any required incidents to the HOO. The team did not identify any missed reporting requirements.
During the review period, 119 allegations were received by California including 56 received directly and 63 as referrals from NRC. A random sampling of some of the more risk-significant allegations received found that they took prompt and appropriate action in response to the concern raised. Documentation was complete, concise, and thorough.
Concerned individuals were notified within 30 days of the conclusion of the investigation whenever possible, and individuals identities were protected in accordance with state law.
c.
Evaluation The team determined that, during the review period, California met the performance indicator objectives listed in Section 3.5.a. Based on the criteria in MD 5.6, the team recommends that Californias performance with respect to the indicator, Technical Quality of Incident and Allegation Activities, be found satisfactory.
d.
MRB Discussion and Chairs Determination The MRB Chair agreed with the teams recommendation and found Californias performance with respect to this indicator satisfactory.
4.0 NON-COMMON PERFORMANCE INDICATORS Four non-common performance indicators are used to review Agreement State programs:
(1) Legislation, Regulations, and Other Program Elements; (2) SS&D Evaluation Program; (3) Low-Level Radioactive Waste (LLRW) Disposal Program; and (4) Uranium Recovery (UR)
California Final IMPEP Report Page 11 Program. The NRC retains regulatory authority for LLRW Disposal, and UR Programs; therefore, only the first two non-common performance indicators applied to this review.
4.1 Legislation, Regulations, and Other Program Elements 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 States agreement with the NRC. The statutes must authorize the State to promulgate regulatory requirements necessary to provide reasonable assurance of adequate 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 that have been designated as necessary for maintenance of an adequate and compatible program should be adopted and implemented by an Agreement State within 6 months following NRC designation. A Program Element Table indicating the Compatibility Categories for those program elements other than regulations can be found on the NRC web site at the following address: https://www.nrc.gov/materials/toolboxes/regulation.html.
a.
Scope The team used the guidance in SA-107, Reviewing the Non-Common Performance Indicator: Legislation, Regulations, and Other Program Elements, and evaluated Californias performance with respect to the following performance indicator objectives. A complete list of regulation amendments can be found on the NRC website at the following address: https://www.nrc.gov/materials/toolboxes/regulation.html.
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 of 1954, 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.
Sunset requirements, if any, do not negatively impact the effectiveness of the States regulations.
b.
Discussion Californias 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 Branch is designated as the
California Final IMPEP Report Page 12 States radiation control agency. No legislation affecting the radiation control program was passed during the review period.
Californias administrative rulemaking process takes approximately 3 years from drafting to finalizing a rule. The public, NRC, other agencies, and potentially impacted licensees and registrants are offered an opportunity to comment during the process. Comments were considered and incorporated, as appropriate, before the regulations were finalized and approved by the California Department of Public Healths Office of Regulations and by a separate California state agency, the Office of Administrative Law. The team noted that the States rules and regulations were not subject to sunset laws.
During the review period, California submitted 7 proposed regulation amendments, 10 final regulation amendments, and 23 license conditions to the NRC for a compatibility review.
One of the amendments, 2018-1, Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments, Parts 30, 32 and 35, was overdue by 6 months for State adoption at the time of submission. During the 3-year window to adopt 2018-1, the NRC issued other amendments providing 10 CFR Part 35 changes which California incorporates by reference. California considered issuing multiple rulemaking packages but determined that delaying adoption of 2018-1 to create one higher quality rulemaking package would result in greater process efficiencies and regulatory clarity for the public. Therefore, California strategically delayed 2018-1 so it could be completed with 6 other amendments in a single rulemaking package.
Additionally, California adopted NUREG-1556. The team confirmed with California that other program elements have been adopted and implemented within 6 months of NRC designation.
At the time of this review, California had adopted all amendments into their final regulations therefore no amendments are currently overdue.
c.
Evaluation The team determined that, during the review period, California met the performance indicator objectives listed in Section 4.1.a, except for the following:
Regulations adopted by the Agreement State for purposes of compatibility or health and safety were adopted later than 3 years after the effective date of the NRC regulation.
California adopted the provisions of amendment 2018-1 6 months after the date due for state adoption. However, California adopted the provisions of the other 9 amendments ahead of the due dates. Additionally, California regularly provided any legally binding requirements for compatibility review.
Based on the IMPEP evaluation criteria in MD 5.6, the team recommends that Californias performance with respect to the indicator, Legislation, Regulations, and Other Program Elements, be found satisfactory.
d.
MRB Discussion and Chairs Determination The MRB Chair agreed with the teams recommendation and found Californias performance with respect to this indicator satisfactory.
California Final IMPEP Report Page 13 4.2 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 the SS&D reviews and establishes useful guidance for teams. In accordance with MD 5.6, three sub-elements: Technical Staffing and Training, Technical Quality of the Product Evaluation Program, and Evaluation of Defects and Incidents Regarding SS&Ds, are evaluated to determine if the SS&D program is satisfactory. Agreement States 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 team used the guidance in SA-108, Reviewing the Non-Common Performance Indicator: Sealed Source and Device Evaluation Program, and evaluated Californias 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 qualification criteria will be established if new staff members are hired.
Any vacancies, especially senior-level positions, 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 the guidance in NUREG-1556, Volume 3.
Evaluation of Defects and Incidents SS&D incidents are reviewed to identify 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, occur in a timely manner.
b.
Discussion Technical Staffing and Training California has seven reviewers qualified to perform SS&D reviews and nine staff members are being trained. At the time of the review, there were no vacancies. During the review
California Final IMPEP Report Page 14 period, three SS&D staff members left the Program, and three staff members were hired.
The positions were vacant from 4-21 months. California has a training program equivalent to NRC training requirements listed in the NRCs IMC 1248, Appendix D.
California has a well-documented training program that details an SS&D first and second level reviewer. The training program is compatible with MD 5.6, Part II, Non-Common Performance Indicator: Technical Staffing and Training.
California does refresher training by reviewing other programs SS&D reviews.
Technical Quality of the Product Evaluation California has 22 SS&D licensees. The team evaluated 16 SS&D actions processed during the review period. These actions included amendments, new applications, and inactivations. The Program maintains all SS&D records in hardcopy with tracking by a database and spreadsheet maintained by the Unit Manager. The team observed that California referenced records that provided a readily accessible historical overview of all the current, as well as prior SS&D registration actions.
The team noted that SS&D reviewers used NUREG-1556, Volume 3, Revision 2, guidance, and followed applicable and pertinent American National Standards Institute standards when completing SS&D reviews. California uses checklists that meet the criteria of NUREG-1556 Volume 3, Revision 2. In addition, California has implemented a justification document to further clarify final determination of the review.
Based on the information reviewed, the team determined that technical evaluations of the applications were adequate, accurate, complete, clear, specific, and consistent with the guidance in NUREG-1556, Volume 3, Revision 2.
It should be noted that California also corrects SS&D sheets for any information that may need updating during reviews.
Evaluation of Defects and Incidents Regarding SS&Ds California had 47 incidents involving SS&D registered products that occurred during the review period and evaluated all related incidents found on NMED. None of the incidents were related to manufacturing or design of the sources/devices manufactured or distributed by a licensee with a SS&D registered in the State of California.
California reviews NMED on a quarterly basis for any incidents, root cause and trend analysis. Documentation is well maintained.
c.
Evaluation The team determined that, during the review period, California met the performance indicator objectives listed in Section 4.2.a. Based on the criteria in MD 5.6, the team recommends that Californias performance with respect to the indicator, SS&D Evaluation Program, be found satisfactory.
California Final IMPEP Report Page 15 d.
MRB Discussion and Chairs Determination The MRB Chair agreed with the teams recommendation and found Californias performance with respect to this indicator satisfactory.
5.0
SUMMARY
Based on the results of the 2024 IMPEP review, Californias performance was found satisfactory for all performance indicators reviewed: Technical Staffing and Training; Status of Materials Inspection Program; Technical Quality of Inspections; Technical Quality of Licensing Actions; Technical Quality of Incident and Allegation Activities; Legislation, Regulations, and Other Program Elements; and SS&D Evaluation Program.
There were no recommendations from the previous review for the team to consider. The team did not make any new recommendations.
Accordingly, the MRB Chair found the California radiation control program adequate to protect public health and safety and compatible with the NRC's program. Because California has had at least two consecutive IMPEP reviews with all performance indicators found satisfactory, the MRB Chair determined that the next periodic meeting take place in approximately 2.5 years with the next IMPEP review taking place in approximately 5 years.
LIST OF APPENDICES Appendix A IMPEP Review Team Members Appendix B Inspector Accompaniments
APPENDIX A IMPEP REVIEW TEAM MEMBERS Name Areas of Responsibility Sherrie Flaherty, NMSS Team Leader Inspector Accompaniments Keisha Cornelius, Oklahoma Team Leader in Training Technical Staffing and Training Nancy Stanley, New Jersey Team Leader in Training Status of Materials Inspection Program Tyler Kruse, Minnesota Technical Quality of Inspections Latischa Hanson, RIV Technical Quality of Licensing Actions Anjan Bhattacharyya, Kentucky Technical Quality of Licensing Actions Randy Erickson, RIV Technical Quality of Incident and Allegation Activities Huda Akhavannik, NMSS Legislation, Regulations, and Other Program Elements Ron Parsons, Tennessee Sealed Source and Device Evaluation Program
APPENDIX B INSPECTOR ACCOMPANIMENTS The following inspector accompaniments were performed prior to the IMPEP review:
Accompaniment No.: 1 License No.:0238-112 License Type: Medical Priority: 2 Inspection Date: 09/04/2024 Inspectors initials: DA Accompaniment No.: 2 License No.: 4886-149 License Type: Industrial Radiography Priority: 1 Inspection Date: 09/05/2024 Inspectors initials: NK Accompaniment No.: 3 License No.: 8087-19 License Type: Medical Priority: 3 Inspection Date: 09/16/2024 Inspectors initials: TM Accompaniment No.: 4 License No.:2541-19 License Type: Medical/HDR Priority: 2 Inspection Date: 09/17/2024 Inspectors initials: TA Accompaniment No.: 5 License No.: 7449-19 License Type: Industrial Radiography Priority: 1 Inspection Date: 09/18/2024 Inspectors initials: CH Accompaniment No.: 6 License No.: 8408-19 License Type: Industrial Radiography Priority: 1 Inspection Date: 09/19/2024 Inspectors initials: AR Accompaniment No.: 7 License No.: 2307-37 License Type: Medical Priority: 2 Inspection Date: 09/23/2024 Inspectors initials: RY
California Agreement State Program Management Review Board Meeting Participants February 20, 2025, 1:00 p.m. - 3:30 p.m. (ET), via Microsoft Teams Management Review Board:
Rob Lewis, Deputy Executive Director for Nuclear Materials, Administrative, and Corporate Programs, the Office of the Executive Director for Operations, and Management Review Board (MRB) Chair; Jessica Bielecki, Assistant General Counsel for Rulemaking, Agreement States and Fee Policy; John Lubinski, Director, Office of Nuclear Material Safety and Safeguards (NMSS);
Mohammed Shuaibi, Deputy Regional Administrator, U.S. Nuclear Regulatory Commission (NRC) Region III; and Sarah Sanderlin, Organization of Agreement States representative to the MRB, from the State of New Jersey.
California Program Management:
Anthony Chu, Chief, Division of Radiation Safety and Environmental Management (DRSEM), Center for Environmental Health (CEH); and Ira Schneider, Chief, Radiological Health Branch, DRSEM, CEH.
IMPEP Team:
Sherrie Flaherty, Team Leader, NMSS; Keisha Cornelius, Team Leader in Training, State of Oklahoma; Nancy Stanley, Team Leader in Training, State of New Jersey; Randy Erickson, RSAO, NRC Region IV; Huda Akhavannik, NMSS; Anjan Bhattacharyya, Commonwealth of Kentucky Latischa Hanson, NRC Region IV; Tyler Kruse, State of Minnesota; and Ron Parsons, State of Tennessee.
NRC, State of California, and Other Members of the Public:
Kathryn Brock, NMSS Tammy Bloomer, NMSS Adelaide Giantelli, NMSS Jazmin Flores, NMSS Lisa Forney, NMSS Robert Johnson, NMSS Karen Meyer, NMSS Lee Smith, NMSS Alexus Willis, NMSS Darren Piccirillo, NRC Region III Jackie Cook, NRC Region IV Robert Custidio, State of California John Fassell, State of California Robert Greger, State of California Truyen Hguyen, State of California Phillip Scott, State of California Kevin Myers, State of Texas Daisy Coffman, State of Indiana Courtney Eckstein, State of Indiana Kevin Stahl, State of Indiana Kaci Studer, State of Indiana Brend Tubbs, State of Indiana Patrick Turner, State of Indiana Aaron Short, State of Kansas Autumn Bailey, State of Tennessee Matt Greenwood, State of Tennessee Makalia Mynatt, State of Tennessee Matt Torrico, State of Tennessee
ML25055A161 OFFICE NMSS/MSST NMSS/MSST/SLPB NMSS/MSST/SLPB NMSS/MSST/SMPB NAME LSmith RJohnson SFlaherty AGiantelli DATE Feb 24, 2025 Feb 24, 2025 Feb 24, 2025 Feb 25, 2025 OFFICE RES/DSA/AAB NMSS NMSS NAME TBloomer JLubinski RLewis DATE Feb 25, 2025 Feb 26, 2025 Mar 4, 2025