ML19351E257

Letter to C. Bower Arizona 2019 Impep Draft Report

ML19351E257
Person / Time
Issue date:	12/18/2019
From:	Cuadrado-Caraballo L NRC/NMSS/DMSST/ASPB
To:	Bower C State of AZ, Dept of Health & Human Services
Ford M
References
Download: ML19351E257 (20)

Text

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 December 18, 2019 Colby Bower, Assistant Director Department of Health Services Public Health Licensing Services 150 N. 18th Avenue, Suite 510 Phoenix, AZ 85007

Dear Mr. Bower:

The U.S. Nuclear Regulatory Commission (NRC) uses the Integrated Materials Performance Evaluation Program (IMPEP) in the evaluation of Agreement State and NRC radioactive materials programs. Enclosed for your review is the draft IMPEP report, which documents the results of the Agreement State review held in Arizona on November 18-21, 2019. The teams preliminary findings were discussed with you and your staff on the last day of the review. The teams proposed recommendations are that the Arizona Agreement State Program be found adequate to protect public health and safety and compatible with the NRCs program.

The NRC conducts periodic reviews of radioactive materials 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 process uses a team comprised of NRC and Agreement State staff to perform the reviews. 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 a Management Review Board (MRB) composed of NRC managers and an Agreement State program manager who serves as a liaison to the MRB.

In accordance with procedures for implementation of IMPEP, we are 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 4 weeks from your receipt of this letter. This schedule will permit the issuance of the final report in a timely manner that will be responsive to your needs.

The team will review the response, make any necessary changes to the report, and issue it to the MRB as a proposed final report. The MRB meeting is scheduled for February 13, 2020, at 1:30 p.m. ET. The NRC will provide invitational travel for you or your designee to attend the MRB meeting at the NRC Headquarters in Rockville, Maryland. The NRC has Skype capability if it is more convenient for the State to participate through this medium. Please contact me if you desire to participate in the meeting using Skype.

C. Bower If you have any questions regarding the enclosed report, please contact me at 301-415-5804 or Monica Ford at 610-337-5214.

Thank you for your cooperation.

Sincerely,

/RA/

Leira Cuadrado, Acting Chief State Agreement and Liaison Programs Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards

Enclosure:

2019 Draft IMPEP Report Cc w/enclosure:

Brian Goretzki, Bureau Chief Bureau of Radiation Control

SUBJECT:

ARIZONA FY2020 DRAFT IMPEP REPORT DISTRIBUTION:

RErickson, RIV JCook, RIV MAndrews, TN VDanese, TX MMuessle, RIV LHowell, RIV MLayton, NMSS KWilliams, NMSS LRoldan-Otero, NMSS DWhite, NMSS DCrowley, NC AStrainingandtravel.Resource@nrc.gov ML19351E257 *via E-Mail OFFICE TL ASPB:PM ASPB:Acting BC NAME MFord RJohnson* LCuadrado*

DATE 12/20/19* 12/17/2019 12/18/19 OFFICIAL RECORD COPY

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW OF THE ARIZONA PROGRAM November 18-21, 2019 DRAFT REPORT Enclosure

EXECUTIVE

SUMMARY

The results of the Integrated Materials Performance Evaluation Program (IMPEP) review of the Arizona Agreement State Program are discussed in this report. The review was conducted during the period of November 18-21, 2019.

Based on the results of this review, Arizonas performance was found satisfactory, for all performance indicators reviewed. The team did not make any recommendations and there were no recommendations from the previous review for the team to consider.

Accordingly, the team recommends that Arizona be found adequate to protect public health and safety and compatible with the NRC's program. Since this was the second consecutive IMPEP review with all performance indicators being found satisfactory, the team recommends that the next IMPEP review take place in approximately 5 years with a periodic meeting in approximately 2.5 years.

Arizona Draft IMPEP Report Page 1

1.0 INTRODUCTION

The Arizona Agreement State Program review was conducted during the period of November 18-21, 2019, by a team comprised of technical staff members from the U.S.

Nuclear Regulatory Commission (NRC) and the States of Tennessee and Texas. Team members are identified in Appendix A. 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 February 26, 2004.

Preliminary results of the review, which covered the period of April 2, 2016, to November 21, 2019, 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 indicator was sent to Arizona on August 27, 2019. Arizona provided its response to the questionnaire on November 5, 2019. A copy of the questionnaire response is available in the NRCs Agencywide Documents Access and Management System (ADAMS) using the Accession Number ML19310D800.

The Bureau of Radiation Control (the Bureau) is administered by the Arizona Department of Health Services. Organization charts are available in ADAMS (Accession Number ML19310D798). On December 31, 2017, the Agreement State Program transferred from the Arizona Radiation Regulatory Agency to the Arizona Department of Health Services. No negative impacts to the Agreement State Program were seen as a result of this transfer.

At the time of the review, Arizona regulated 349 specific licenses authorizing possession and use of radioactive materials. The review focused on the radioactive materials 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 the 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 April 1, 2016. The final report is available in ADAMS (Accession Number ML16188A002). The results of the review are as follows:

Technical Staffing and Training: Satisfactory Recommendation: None Status of Materials Inspection Program: Satisfactory Recommendation: None

Arizona Draft 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 Compatibility Requirements: 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 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 could affect public health and safety. Apparent trends in staffing must be explored. 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-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.

• Agreement State training and qualification program is equivalent to NRC Inspection Manual Chapter (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.

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

Arizona Draft IMPEP Report Page 3

• 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 Agreement State Program is comprised of a Bureau Chief and four licensing/ inspection staff. The total amount of effort dedicated to the Agreement State Program is 4.5 full-time equivalents. There were no vacancies at the time of the IMPEP review.

The team noted that the 2016 final IMPEP report stated that there were two vacancies at the time of that IMPEP review. Arizona hired two new staff in August 2016 and September 2016, respectively. The individual who was hired in September 2016 left for medical reasons in February 2017. Another individual was hired in February 2017 to fill this position. Additionally, the Agreement State Program used to have a Program Manager. The Program Manager retired in October 2016. This position was used to create an additional Health Physicist position within the Bureau. This individuals primary responsibility is licensing and inspecting particle accelerators and is not a part of the Agreement State Program. As a result of this change, staff report directly to the Bureau Chief. Finally, during the review period one technical staff person retired on November 2, 2017. This employee rejoined the Bureau as a rehired annuitant after his retirement. The team did not identify any performance issues associated with the turnover experienced.

The team determined that Arizona has a training and qualification manual compatible to the NRCs IMC 1248. This training manual is being used by staff currently going through the qualification process. Additionally, qualified inspection and licensing staff are meeting the refresher training requirements of 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of continuing education 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. MRB Decision The final report will present the MRBs conclusion regarding this indicator.

Arizona Draft IMPEP Report Page 4 3.2 Status of 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 team used the guidance in State Agreements procedure 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 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.

• 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 Arizona performed 195 Priority 1, 2, 3, and initial inspections during the review period.

No inspections were conducted overdue. The team reviewed 23 inspection reports and found that in each instance, inspection findings were communicated to the licensee within 30 days after the inspection exit. Additionally, more than 20 percent of candidate reciprocity licensees were inspected during each year of the review period. Inspections are performed at the same frequency, and in some instances more frequent than, the NRC IMC 2800 inspection frequency categories for similar license types.

Arizona Draft IMPEP Report Page 5

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 Decision The final report will present the MRBs conclusion regarding this indicator.

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 an Agreement States inspection program.

a. Scope The team used the guidance in State Agreements procedure 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 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 consistent with NRC guidance.

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

b. Discussion The team evaluated 23 inspection reports, associated enforcement documentation, and interviewed inspectors involved in materials inspections conducted during the review period. The casework reviewed included inspections conducted by six former and current inspectors and covered diagnostic medical, medical therapy, nuclear pharmacy, industrial radiography, gamma knife, well logging, broadscope academic, broadscope

Arizona Draft IMPEP Report Page 6 medical, fixed and portable gauges, research, and service provider licensees. The team found that inspection documents were thorough, complete, consistent, and of acceptable technical quality with health, safety, and security issues properly addressed. Inspection findings were clearly communicated to the licensee and in the casework reviewed, previously identified open items and violations were addressed. The team also found that Arizonas Inspection Procedures were compatible with equivalent NRC inspection procedures.

The team accompanied four inspectors in November 2019. No performance issues were noted during the inspector accompaniments. The inspectors were well-prepared and thorough; assessed the impact of licensed activities on health, safety, and security; and followed Arizonas documented inspection procedures during the inspections. The inspector accompaniments are identified in Appendix B.

Supervisory accompaniments were performed 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. Detection instruments were available for detection of gamma, beta, and alpha contamination, as well as for measuring dose rates.

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 Decision The final report will present the MRBs conclusion 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, actual 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 State Agreements procedure SA-104, Reviewing the Common Performance Indicator: Technical Quality of Licensing Actions, and evaluated Arizonas performance with respect to the following performance indicator objectives:

Arizona Draft IMPEP Report Page 7

• 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., 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 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 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, Arizona performed 922 radioactive materials licensing actions.

The team evaluated 21 of those licensing actions. The licensing actions selected for review included 3 new applications, 11 amendments, 4 renewals, and 3 terminations.

The team evaluated casework which included the following license types and actions:

broadscope, medical diagnostic and therapy, industrial radiography, research and development, academic, nuclear pharmacy, portable and fixed gauges, well-logging, decommissioning, financial assurance, and one denial. The casework sample represented work from four current and former license reviewers.

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 the license document. Arizonas goal is to complete licensing actions within 30 days from the date of receipt. All incoming licensing actions are logged on a spreadsheet by administrative staff. Additionally, administrative staff send a weekly email to the Bureau Chief and all license reviewers to notify them of any actions that are nearing the 30-day mark. Arizona has adopted an equivalent checklist to the NRCs Risk-Significant Radioactive Material Checklist and completes a checklist for each license action. There is also an equivalent guidance document to the NRCs Pre-Licensing Guidance that is used for all initial license applications and transfers of control. The team noted that Arizona performs an on-site visit for all new applicants.

Arizona Draft IMPEP Report Page 8

a. 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.

b. MRB Decision The final report will present the MRBs conclusion 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 and safety. An assessment of incident response and allegation investigation procedures, actual implementation of these procedures, internal and external coordination, and investigative and followup actions, are a significant indicator of the overall quality of the incident response and allegation programs.

a. Scope The team used the guidance in State Agreements procedure 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, 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 followup actions are taken to ensure prompt compliance by licensees.

• Followup 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).

• Allegations are investigated in a prompt, appropriate manner.

• Concerned individuals are notified of investigation conclusions.

• Concerned individuals identities are protected, as allowed by law.

b. Discussion During the review period, 25 reportable incidents were received by Arizona. The team evaluated 10 radioactive materials incidents which included 4 lost/stolen radioactive materials, 1 potential overexposure, 4 medical events, and 1 contamination event.

Arizona dispatched inspectors for onsite followup for all cases reviewed. The Bureau

Arizona Draft IMPEP Report Page 9 Chief and staff discuss each event notification to determine what actions will be taken in response to the event. The team determined that Arizona responds to events in accordance with its established procedure and that the Arizona Radioactive Materials Program Procedure 4.02 Rev. 2 Incident Response dated August 23, 2019, is compatible with the equivalent NRC incident response procedure.

The team evaluated Arizonas reporting of events to the NRCs Headquarters Operations Officer (HOO). The team determined that Arizona notifies the HOO for all reportable events involving radioactive material and that all reports were received within the required timeframe.

During the review period, Arizona received one allegation. No allegations were transferred to Arizona by the NRC. The team evaluated the allegation and found that the Arizona took prompt and appropriate action in response to the concern raised.

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 Decision The final report will present the MRBs conclusion regarding this indicator.

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 (SS&D)

Evaluation Program; (3) Low-Level Radioactive Waste Disposal (LLRW) Program; and (4) Uranium Recovery Program. The NRCs Agreement with Arizona retains regulatory authority for uranium recovery; 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.

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

Arizona Draft IMPEP Report Page 10 Identification for NRC Regulations and 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. Scope The team used the guidance in State Agreements procedure SA-107, Reviewing the Non-Common Performance Indicator: Compatibility Requirements, 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, 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 Arizona became an Agreement State on May 15, 1967. The current effective statutory authority is contained in Title 30, Chapter 4, Control of Ionizing Radiation, of the Arizona Revised Statutes. The Department of Health Services is designated as the States radiation control agency. As mentioned in Section 1.0 of this report, during the review period the Arizona Agreement State Program was moved from the Arizona Radiation Regulatory Agency to the Department of Health Services. This move was effective on December 31, 2017. Title 30, Chapter 4 of the Arizona Revised Statutes was revised to reflect this change. The team did not identify any negative impacts to the Agreement State Program as a result of this change.

Arizonas administrative rulemaking process takes approximately 7 months from drafting to finalizing a rule. The public 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 approved and then submitted to the Secretary of States Office where they are finalized. The team noted that Arizonas

Arizona Draft IMPEP Report Page 11 rules and regulations are subject to sunset laws. Each regulation must be reviewed at an interval not to exceed 5 years and positively acted on to remain in effect.

Additionally, the team noted that the current Governor placed a moratorium on rule promulgation. All rule promulgation requires prior approval and only allows those rules that promote jobs or prove to be public health and safety related to be adopted without a court order. Regulations pertinent to the Agreement State Program are necessary to protect public health and safety and therefore to date this moratorium has not impacted state adoption of compatible regulations.

During the review period, Arizona submitted 5 proposed regulation amendments, 5 final regulation amendments, and 13 revisions to final rules to address open NRC comments, to the NRC for a compatibility review. Two of the amendments were overdue for State adoption at the time of submission. These two amendments were part of a larger rule package that was being promulgated during the time the Agreement State Program was moved from the Arizona Radiation Regulatory Agency to the Department of Health Services. A decision was made to place a hold on the rulemaking package until the organizational change was effective. Subsequently the rules became effective on July 12, 2018, 6 months after both regulation amendments were due for adoption.

At the time of this review, the following amendment was overdue for adoption:

• Distribution of Source Material to Exempt Persons and to General Licensees and Revision of General License and Exemptions, 10 CFR Parts 30, 40, and 70 due for Agreement State adoption by August 27, 2016.

The Bureau Chief stated that this regulation amendment was inadvertently missed. A request was submitted to the Governors office to obtain approval to proceed with rulemaking to address this overdue regulation while the team was onsite.

c. Evaluation The team determined that, except as noted below, during the review period Arizona met the performance indicator objectives listed in Section 4.1.a.

• Two regulation amendments required for adoption for purposes of compatibility or health and safety were adopted greater than 3 years after the effective date of the NRC regulation. Additionally, one regulation amendment was overdue for adoption at the time of the IMPEP review.

As discussed in Section 4.1.b. Arizona adopted two regulation amendments 6 months past the required adoption due date and one regulation amendment was overdue for adoption at the time of the review. The team did not identify any gaps or conflicts resulting from the late adoption of compatible regulations.

Based on the IMPEP evaluation criteria in MD 5.6, the team recommends that Arizonas performance with respect to the indicator, Compatibility Requirements, be found satisfactory.

Arizona Draft IMPEP Report Page 12

d. MRB Decision The final report will present the MRBs conclusion regarding this indicator.

4.2 Sealed Source and Device (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 Low-Level Radioactive Waste (LLRW) Disposal Program In 1981, the NRC amended its Policy Statement, Criteria for Guidance of States and NRC in Discontinuance of NRC 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.

5.0

SUMMARY

As noted in Sections 3.0 and 4.0 above, Arizonas performance was found to be satisfactory for all performance indicators reviewed. The team did not make any recommendations and there were no recommendations from the previous review for the team to consider.

Accordingly, the team recommends that Arizona be found adequate to protect public health and safety and compatible with the NRC's program. Since, this is the second consecutive IMPEP review with all indicators being found satisfactory the team recommends that the next full IMPEP review take place in approximately 5 years, with a periodic meeting in approximately 2.5 years.

LIST OF APPENDICES Appendix A IMPEP Review Team Members Appendix B Inspection Accompaniments

APPENDIX A IMPEP REVIEW TEAM MEMBERS Name Areas of Responsibility Monica Ford, Region I Team Leader Technical Quality of Incident and Allegation Activities Compatibility Requirements Randy Erickson, Region IV Technical Quality of Inspections Inspection Accompaniments Mark Andrews, Tennessee Technical Staffing and Training Status of Materials Inspection Program Vanessa Danese, Texas Technical Quality of Licensing Actions

APPENDIX B INSPECTION ACCOMPANIMENTS The following inspection accompaniments were performed prior to the on-site IMPEP review:

Accompaniment No.: 1 License No.: 07-695 License Type: Nuclear Medicine Priority: 3 Inspection Date: 11/4/19 Inspector: WY Accompaniment No.: 2 License No.: 07-681 License Type: HDR and PET Priority: 2 Inspection Date: 11/5/19 Inspector: ZM Accompaniment No.: 3 License No.: 07-172 License Type: Nuclear Medicine Priority: 3 Inspection Date: 11/6/19 Inspector: TR Accompaniment No.: 4 License No.: 07-423 License Type: Panoramic Irradiator Priority: 2 Inspection Date: 11/7/19 Inspector: PK