ML25072A212
| ML25072A212 | |
| Person / Time | |
|---|---|
| Issue date: | 03/24/2025 |
| From: | Adelaide Giantelli NRC/NMSS/DMSST/ASPB |
| To: | Salow T State of AZ, Dept of Health Services |
| References | |
| Download: ML25072A212 (1) | |
Text
Thomas Salow, Assistant Director Department of Health Services Public Health Licensing Services 150 N. 18th Ave., Suite 510 Phoenix, AZ 85007
SUBJECT:
ARIZONA DRAFT IMPEP REPORT
Dear Thomas Salow:
The U.S. Nuclear Regulatory Commission (NRC) uses the Integrated Materials Performance Evaluation Program (IMPEP) to review radiation control programs. The enclosed draft report documents the results of the Arizona Agreement State Program (Arizona) review conducted on February 3-7, 2025. The teams preliminary findings were discussed with the State of Arizona on the last day of the review. The teams proposed recommendations are that Arizona be found adequate to protect public health and safety and compatible with the NRCs program.
The NRC conducts periodic reviews of radiation control programs to ensure that public health and safety are adequately protected from the potential hazards associated with the use of radioactive materials and that Agreement State programs are compatible with the NRCs program. The IMPEP reviews are conducted by a team of Agreement State and NRC staff. All reviews use common criteria in the assessment and place primary emphasis on performance.
The final determination of adequacy and compatibility of each program, based on the teams report, is made by the Management Review Board (MRB) Chair after receiving input from the MRB members, the IMPEP team, and the radiation control program being reviewed. The MRB is composed of NRC senior managers and an Organization of Agreement States program manager.
In accordance with the IMPEP implementation procedures, the NRC is providing you with a copy of the draft report for your review and comment prior to submitting the report to the MRB.
Comments are requested within 28 days. This schedule will permit the issuance of the final report in a timely manner. If there are no comments to the IMPEP report, the MRB will receive the draft IMPEP report. If there are comments to the report, the team will review your response, make the necessary changes, and issue a proposed final report to the MRB.
The MRB meeting is scheduled to be conducted as a hybrid meeting on May 15, 2025, at 1:00 PM EDT (10:00 AM MST) via Microsoft Teams. The NRC will provide you with Microsoft Teams connection information prior to the MRB meeting. Because the team has recommended all indicators be rated satisfactory, you have the option to attend the MRB meeting remotely and do not need to travel.
March 24, 2025
T Salow If you have any questions regarding the enclosed report, please contact Robert K. Johnson, IMPEP Project Manager, at (301) 415-7314 or Farrah Gaskins, IMPEP Team Leader, at (610) 337-5143.
Thank you for your cooperation.
Sincerely, Adelaide S. Giantelli, Chief State Agreement and Liaison Programs Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
Enclosure:
Arizona Draft IMPEP Report cc:
Brian Goretzki, Bureau Chief Bureau of Radiation Control Signed by Giantelli, Adelaide on 03/24/25
Enclosure INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW OF THE ARIZONA AGREEMENT STATE PROGRAM FEBRUARY 3-7, 2025 DRAFT REPORT
EXECUTIVE
SUMMARY
The results of the Integrated Materials Performance Evaluation Program (IMPEP) review of the Arizona Agreement State Program (Arizona) are discussed in this report. The review was conducted on February 3-7, 2025. Inspector accompaniments were conducted during the week of November 4, 2024.
The team found Arizonas performance to be 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; and Legislation, Regulations, and Other Program Elements.
There were no recommendations from the previous IMPEP review, and the team did not make any new recommendations.
Accordingly, the team recommends that the Arizona radiation control program be found adequate to protect public health and safety and compatible with the NRC's program. Because Arizona has had at least two consecutive IMPEP reviews with all performance indicators found satisfactory, the team recommends that a periodic meeting take place in approximately 2.5 years with the next IMPEP review taking place in approximately 5 years.
Arizona Draft IMPEP Report Page 1
1.0 INTRODUCTION
The Arizona Agreement State Program (Arizona) Integrated Materials Performance Evaluation Program (IMPEP) review was conducted on February 3-7, 2025, by a team of technical staff members from the U.S. Nuclear Regulatory Commission (NRC), the Commonwealth of Kentucky, and the State of Tennessee. Team members are identified in Appendix A. Inspector accompaniments were conducted between November 5-7, 2025. The specific inspector accompaniments 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 November 22, 2019, to February 7, 2025, were discussed with Arizona 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 Arizona on October 11, 2024.
Arizona provided its response to the questionnaire on January 18, 2025. A copy of the questionnaire response is available in the NRCs Agencywide Documents Access and Management System (ADAMS) Accession No. ML25023A011.
The Bureau of Radiation Control is administered by the Arizona Department of Health Services which is located within the Arizona Department of Health Services. The Bureau of Radiation implements the Agreement State Program. Organizational charts for Arizona are available in Arizonas questionnaire response cited above.
At the time of the review, Arizona regulated 354 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 Arizona.
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 Arizonas performance.
2.0 PREVIOUS IMPEP REVIEW AND STATUS OF RECOMMENDATIONS The previous IMPEP review concluded on November 21, 2019. The final report is available in ML20052C847. The results of the review 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
Arizona Draft IMPEP Report Page 2 Compatibility Requirements: Satisfactory Recommendation: None Legislation, Regulations, and Other Program Elements: Satisfactory Recommendation: None Overall finding: Adequate to protect public health and safety and compatible with the NRC's program.
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 Arizonas 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.
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 At the time of the review, Arizona was comprised of seven technical staff members which equals 6.5 full-time equivalent (FTE) for the radiation control program when fully staffed.
There were no vacancies at the time of the on-site review. During the review period, 10 staff members left the program and 10 staff members were hired. Arizona indicated that staff left the program to pursue other opportunities. The positions were vacant for approximately two
Arizona Draft IMPEP Report Page 3 to three months. Although Arizona is typically able to hire new staff, management provided that compensation is the primary challenge to retention. Arizona has experienced significant turnover but maintained at least two qualified inspectors and license reviewers during the review period.
Since the previous IMPEP, Arizona was able to increase the number of FTE allotted to the program from 4.5 FTE to 6.5 FTE. Of the seven technical staff, three were qualified as inspectors and license reviewers and four staff were working toward qualifications. The four staff have been with Arizona between three months and two years. The team noted that Arizonas training and qualification program was compatible with the NRC IMC 1248 and qualified staff maintain 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of training every 24 months.
c.
Evaluation The team determined that, during the review period, Arizona met the performance indicator objectives listed in Section 3.1.a. Based on the criteria in MD 5.6, the team recommends that Arizonas performance with respect to the indicator, Technical Staffing and Training, be found satisfactory.
d.
Management Review Board (MRB) Discussion and Chairs Determination The final report will present the MRB Chairs determination regarding this indicator.
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.
a.
Scope The team used the guidance in SA-101, Reviewing the Common Performance Indicator:
Status of the Materials Inspection Program, and evaluated Arizonas 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.
Arizona Draft IMPEP Report Page 4 b.
Discussion Arizona performed 231 Priority 1, 2, 3, and initial inspections during the review period. No inspections were conducted overdue during the review period. Arizonas inspection frequencies were the same for similar license types in NRCs program, except for the Priority 5 inspections. For Priority 5 licensees, Arizona performed inspections more frequently than the NRC, with a reduced frequency of three years.
The team reviewed 27 inspection reports and concluded that none of the inspections were conducted late during the review period and inspection findings were communicated to licensees in a timely manner; within 30 days of the inspection exit or 45 days for team inspections. Arizona maintains a spreadsheet database to track due dates of inspection activities.
Arizona conducts reciprocity inspections on a risk informed basis and the total number of reciprocity inspections conducted are dependent on the total number of entries into the State. During the review period, Arizona received 233 reciprocity requests and conducted 50 reciprocity inspections. The team reviewed three reciprocity inspection records and found that Arizonas reciprocity inspections were performed consistent with inspection procedures and inspection findings were communicated timely.
c.
Evaluation The team determined that, during the review period, Arizona met the performance indicator objectives listed in Section 3.2.a. Based on the criteria in MD 5.6, the team recommends that Arizonas performance with respect to the indicator, Status of Materials Inspection Program, be found satisfactory.
d.
MRB Discussion and Chairs Determination The final report will present the MRB Chairs determination regarding this indicator.
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 Arizonas 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
Arizona Draft IMPEP Report Page 5 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.
b.
Discussion The team evaluated 27 routine and 3 reciprocity inspection reports and associated enforcement documentation and interviewed staff performing materials inspections conducted during the review period. The team reviewed casework for inspections conducted by four of Arizonas inspectors and covered diagnostic medical, medical therapy, nuclear pharmacy, industrial radiography, gamma knife, broad scope academic, broad scope medical, fixed and portable gauges, research, and service provider licensees.
The team found that Arizonas inspection results were well documented with respect to health, safety, and security. Inspection findings were clearly communicated to the licensee and in the casework reviewed, previously identified open items and violations were addressed. Violations were well supported by the appropriate Arizonas regulations. Arizona has procedures in place for documenting violations and items of non-compliance. Inspection reports are reviewed and signed by the Program supervisor. The team also found that Arizonas inspection procedures were compatible with NRC guidance.
The team accompanied three inspectors during November 5-7, 2024. No performance issues were noted and the inspector accompaniments are identified in Appendix B. The inspectors were well-prepared and thorough; assessed the impact of licensed activities on health, safety, and security; and followed Arizonas inspection procedures during the inspections.
Arizona performed supervisory accompaniments each year of the review period for each inspector. The accompaniments were well documented including feedback provided to the inspector.
The team found that Arizona possesses a wide variety of appropriately calibrated survey instruments to support the inspection program and to respond to radioactive materials incidents and emergency situations. Calibration records for the instruments were kept on file.
c.
Evaluation The team determined that, during the review period, Arizona met the performance indicator objectives listed in Section 3.3.a. Based on the criteria in MD 5.6, the team recommends that Arizonas performance with respect to the indicator, Technical Quality of Inspections be found satisfactory.
d.
MRB Discussion and Chairs Determination The final report will present the MRB Chairs determination regarding this indicator.
Arizona Draft IMPEP Report Page 6 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 Arizona 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 Arizonas 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.
b.
Discussion During the review period, Arizona performed 1397 radioactive materials licensing actions.
The team evaluated 32 of those licensing actions. The licensing actions selected for review included 4 new applications, 16 amendments, 5 renewals, 3 terminations, 2 change of control/ownership, 1 reciprocity, and 1 financial assurance. The team evaluated casework which included the following license types and actions: broad scope, medical diagnostic and therapeutic, medical teletherapy, veterinary medicine, accelerator, industrial radiography, research and development, academic, nuclear pharmacy, portable and fixed gauges, self-shielded irradiators, well-logging, service provider, financial assurance, and change of ownership notifications. The casework sample represented work from four current and former license reviewers.
The team reviewed Arizonas procedures, license conditions, and use of a peer review system. All license actions are reviewed and completed by a primary reviewer then reviewed by two other license reviewers. The Bureau Chief then performs a final review and signs all license documents. Staff use Arizonas administrative licensing procedures, NUREG-1556 series, and other NRC licensing guidance.
Arizona Draft IMPEP Report Page 7 Licensing actions were well documented and addressed health, safety, and security issues.
Renewal applications demonstrated a thorough analysis of the licensees inspection and enforcement history. All necessary licensee commitments were obtained, and deficiency letters and license conditions were well supported by information contained in the licensing files. The team determined that appropriate financial assurance instruments were properly submitted when required, and that licenses containing security related information were properly marked. Arizona completed all licensing actions within the time frame specified for the license category type.
The team noted that Arizona performed pre-licensing visits on all new licenses and utilized an equivalent to NUREG-1556, Volume 15, Appendix E Information Needed for Transfer of Control Application for all change of controls. Additionally, the team noted that for all licensing actions, Arizona utilized an equivalent checklist to the NRCs RSRM checklist.
c.
Evaluation The team determined that, during the review period, Arizona met the performance indicator objectives listed in Section 3.4.a. Based on the criteria in MD 5.6, the team recommends that Arizonas performance with respect to the indicator, Technical Quality of Licensing Actions, be found satisfactory.
d.
MRB Discussion and Chairs Determination The final report will present the MRB Chairs determination regarding this indicator.
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 Arizonas 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.
Arizona Draft IMPEP Report Page 8 b.
Discussion During the review period, 40 radioactive materials incidents were reported to the NMED database by Arizona. The team evaluated 17 of the more risk significant incidents including 4 involving lost, stolen, or missing radioactive material; 2 involving leaking sources; 1 involving a damaged nuclear gauge; 8 medical events; and 2 overexposures. Arizona dispatched inspectors for on-site follow-up for each of the cases reviewed.
When notified of an incident, Arizona management and staff held discussions to determine the appropriate level of response, which ranged from an immediate on-site response to reviewing the incident during the next routine inspection. These determinations were made based on both the circumstances and the health and safety and security significance of the incident. The team found that Arizonas evaluation of incident notifications and its response to those incidents was thorough and comprehensive.
The team also evaluated Arizonas reporting of incidents to the NRCs Headquarters Operations Officer (HOO). The team noted that in each case requiring HOO notification, Arizona reported the incidents within the required time frame. The team also evaluated whether Arizona had not reported any required incidents to the HOO. The team did not identify any missed reporting requirements.
During the review period, six allegations were received by Arizona. The team evaluated all six allegations, including five radioactive materials allegations that the NRC referred to the State.
During the on-site review, Arizona received a concern related to potential wrongdoing by an individual working at a local licensees facility. The team was given the opportunity to accompany staff and observe how the program responded to these types of concerns. The team found the programs investigation to be detailed, thorough, probing, and covering in depth, the licensees actions related to the concern.
c.
Evaluation The team determined that, during the review period, Arizona met the performance indicator objectives listed in Section 3.5.a. Based on the criteria in MD 5.6, the team recommends that Arizonas performance with respect to the indicator, Technical Quality of Incident and Allegation Activities, be found satisfactory.
d.
MRB Discussion and Chairs Determination The final report will present the MRB Chairs determination regarding this indicator.
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) Sealed Source and Device (SS&D) Evaluation Program; (3) Low-Level Radioactive Waste (LLRW) Disposal Program; and (4) Uranium Recovery Program. The NRC retains regulatory authority for uranium recovery; therefore, only the first three non-common performance indicators applied to this review.
Arizona Draft IMPEP Report Page 9 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 website at the following address: https://scp.nrc.gov/regtoolbox.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 Arizonas 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://scp.nrc.gov/regtoolbox.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 Arizonas statutory authority is contained in the Title 30, Chapter 4, Control of Ionizing Radiation, of the Arizona Revised Statutes. The Department of Health Services is designated as Arizonas radiation control agency. No legislation affecting the radiation control program was passed during the review period.
Arizonas administrative rulemaking process takes approximately seven months 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 Governors Regulatory Review Council. The team noted that
Arizona Draft IMPEP Report Page 10 Arizonas rules and regulations were subject to sunset laws and each regulation must be reviewed at an interval not to exceed 5 years and be positively acted on to remain in effect.
During the review period, Arizona submitted 10 final regulation amendments to the NRC for a compatibility review. None of the amendments were overdue for State adoption at the time of submission. Other program elements that have been designated as necessary for maintenance of an adequate and compatible program were adopted within six months or other time frame specified in the State and Tribal Communication Letter.
The team identified that Arizona did not have an equivalent requirement to 10 CFR 35.41(b) which provides the elements required to be addressed in procedures for the administration of radiopharmaceuticals requiring a written directive. While this requirement is not a matter of compatibility, it does have health and safety significance and must be adopted. The team noted that procedures for administrations requiring a written directive, were reviewed during the licensing process in accordance with NUREG-1556, Volume 9, Appendix S Model Procedures for Developing, Maintaining, and Implementing Written Directives, which aligns with 10 CFR 35.41(b). Since these procedures are tied down to the license, Arizona had in place a legally binding requirement that embodies the basic health and safety aspects of 10 CFR 35.41(b). To enhance regulatory certainty, Arizona has committed to updating their regulations within the next year and will implement, in the interim, a license condition essentially identical to 10 CFR 35.41(b).
c.
Evaluation The team determined that, during the review period, Arizona met the performance indicator objectives listed in Section 4.1.a. Based on the criteria in MD 5.6, the team recommends that Arizonas performance with respect to the indicator, Legislation, Regulations, and Other Program Elements, be found satisfactory.
d.
MRB Discussion and Chairs Determination The final report will present the MRB Chairs determination regarding this indicator.
4.2 SS&D Evaluation Program Although Arizona has authority to conduct SS&D evaluations for byproduct, source, and certain special nuclear materials, Arizona did not conduct any SS&D evaluations during the review period, nor did they have any pending applications for an SS&D evaluation. Accordingly, the team did not review this indicator.
4.3 LLRW Disposal Program In 1981, the NRC amended its Policy Statement, Criteria for Guidance of States and NRC in Discontinuance of NRC Regulatory Authority and Assumption Thereof by States Through Agreement, to allow a State to seek an amendment for the regulation of LLRW as a separate category. Although Arizona has authority to regulate a LLRW disposal facility, the NRC has not required States to have a program for licensing a disposal facility until 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, it is expected to put in place a regulatory program that will meet the criteria for an adequate and compatible LLRW disposal program. There are no plans for a LLRW disposal facility in Arizona. Accordingly, the team did not review this indicator.
Arizona Draft IMPEP Report Page 11 5.0
SUMMARY
The team found Arizonas performance to be 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; and Legislation, Regulations, and Other Program Elements.
There were no recommendations from the previous IMPEP review and the team did not make any new recommendations.
Accordingly, the team recommends that the Arizona radiation control program be found adequate to protect public health and safety and compatible with the NRC's program. Because Arizona has had at least two consecutive IMPEP reviews with all performance indicators found satisfactory, the team recommends that a 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 Farrah Gaskins, RI Team Leader Technical Staffing and Training Allyce Bolger, NMSS Team Leader in Training Legislation, Regulations, and Other Program Elements Inspector Accompaniments Anjan Bhattacharyya, Status of Materials Inspection Program Commonwealth of Kentucky Technical Quality of Inspections Matthew Greenwood, Technical Quality of Licensing Actions State of Tennessee Randy Erickson, RSAO RIV Technical Quality of Incident and Allegation Activities
APPENDIX B INSPECTOR ACCOMPANIMENTS The following inspector accompaniments were performed prior to the on-site IMPEP review:
Accompaniment No.: 1 License No.: 07-591 License Type: Nuclear Medicine Priority: 5 Inspection Date: 11/05/2024 Inspectors initials: KD Accompaniment No.: 2 License No.: 07-424 License Type: Gamma Stereotactic Radiosurgery Priority: 2 Inspection Date: 11/06/2024 Inspectors initials: BG Accompaniment No.: 3 License No.: 07-241 License Type: Nuclear Medicine and Brachytherapy Priority: 2 Inspection Date: 11/07/2024 Inspectors initials: PK
ML25072A212 OFFICE NMSS/MSST/SLPB NMSS/MSST R-I/DNMS NMSS/MSST/SMPB NAME RJohnson LSmith FGaskins AGiantelli DATE Mar 13, 2025 Mar 14, 2025 Mar 13, 2025 Mar 19, 2025 OFFICE RES/DSA/AAB NMSS/MSST/SMPB NAME TBloomer AGiantelli DATE Mar 21, 2025 Mar 24, 2025