ML24164A107

06-21-2024 Letter to S. Stack Re Kentucky Final Impep Report

ML24164A107
Person / Time
Issue date:	06/21/2024
From:	John Lubinski Office of Nuclear Material Safety and Safeguards
To:	Stack S State of KY, Dept for Public Health
References
Download: ML24164A107 (1)

Text

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 Steven Stack, MD, Commissioner Department for Public Health Cabinet for Health and Family Services 275 East Main Street, HS1C-A Frankfort, KY 40621-0001

SUBJECT:

KENTUCKY FY2024 FINAL IMPEP REPORT

Dear Dr. Stack:

On June 6, 2024, the Management Review Board (MRB) met, which consisted of the U.S.

Nuclear Regulatory Commission (NRC) senior managers and an Organization of Agreement States Liaison to the MRB, to consider the proposed final Integrated Materials Performance Evaluation Program (IMPEP) report on the Kentucky Agreement State Program. The MRB found the Kentucky program adequate to protect public health and safety, and compatible with the NRC program.

The enclosed final report contains a summary of the IMPEP teams findings and recommendations. There were no open recommendations, and the team did not make any new recommendations. Based on the results of the current IMPEP review, the next full review of the Kentucky Agreement State Program will take place in approximately 4 years, with a periodic meeting tentatively scheduled in approximately 2 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, John W. Lubinski, Director Office of Nuclear Material Safety and Safeguards

Enclosures:

1. 2024 Kentucky IMPEP Report

2. 2024 Kentucky MRB ParticipantsJune 21, 2024 Signed by Lubinski, John on 06/21/24

S. Stack

cc:

M. McKinley, Program Director Radiation Health Branch Russell Hestand, Supervisor Radioactive Materials Section INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM

REVIEW OF THE KENTUCKY AGREEMENT STATE PROGRAM

February 26, 2024-March 1, 2024

FINAL REPORT

Enclosure 1 EXECUTIVE

SUMMARY

The results of the Integrated Materials Performance Evaluation Program (IMPEP) review of the Kentucky Agreement State Program are discussed in this report. The review was conducted February 26, 2024-March 1, 2024. Inspector accompaniments were conducted during the week of January 22, 2024.

Kentuckys performance was found to be satisfactory for all seven performance indicators reviewed.

There were no open recommendations, and the team did not make any new recommendations.

Accordingly, the team recommended and the MRB Chair agreed that the Kentucky radioactive materials section be found adequate to protect public health and safety and compatible with the NRCs program. The team also recommended and the MRB Chair agreed that a periodic meeting take place in approximately 2 years with the next IMPEP review taking place in approximately 4 years.

Kentucky Final IMPEP Report Page 1

1.0 INTRODUCTION

The Kentucky Agreement State Program (Kentucky) Integrated Materials Performance Evaluation Program (IMPEP) review was conducted February 26, 2024-March 1, 2024, by a team of technical staff members from the U.S. Nuclear Regulatory Commission (NRC) and the States of Florida and Kansas. Team members are identified in Appendix A. Inspector accompaniments were conducted January 23-25, 2024. The 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 January 18, 2020, to March 1, 2024, were discussed with Kentucky 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 Kentucky on December 11, 2023. Kentucky provided its response to the questionnaire on February 1, 2024. An updated response to the questionnaire was given to us on February 29, 2024. A copy of the questionnaire response is available in the NRCs Agencywide Documents Access and Management System Accession Number ML24071A097.

The Kentucky Agreement Sate Program is administered by the Radiation Health Branch (the Branch) which is located within the Division for Public Health Protection and Safety which is within the Department for Public Health. The Branch is comprised of three sections: the Radioactive Materials Section (the Section), the Radiation Producing Machine Section, and the Radiation/Environmental Monitoring Section. Organization charts for Kentucky are available in ML24071A100.

At the time of the review, Kentucky regulated 310 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 Commonwealth of Kentucky.

The team evaluated the information gathered against the established criteria for each common and applicable non-common performance indicators and made a preliminary assessment of Kentuckys performance.

2.0 PREVIOUS IMPEP REVIEW AND STATUS OF RECOMMENDATIONS

The 2020 IMPEP review concluded on January 17, 2020. The final report is available in ML20113F017. The results of the review are as follows:

Technical Staffing and Training: Satisfactory

Status of Materials Inspection Program: Satisfactory

Technical Quality of Inspections: Satisfactory

Technical Quality of Licensing Actions: Satisfactory

Technical Quality of Incident and Allegation Activities: Satisfactory Kentucky Final IMPEP Report Page 2

Legislation, Regulations, and Other Program Elements: Satisfactory but Needs Improvement Sealed Source and Device (SS&D) Evaluation Program: Satisfactory

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 Kentuckys 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 the NRC Inspection Manual Chapter (IMC) IMC 1248, 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

Kentuckys Radioactive Materials Section is comprised of eight staff members (e.g., one director, one supervisor, and six staff members) which equals 7.2 full-time equivalent (FTE) when fully staffed. During the review period, five staff members left the program and three staff members were hired. These positions have been vacant for 10 months to 1 year. Of the three hires, one person was transferred to the Radiation Producing Machines Section, one Kentucky Final IMPEP Report Page 3

staff member was promoted to supervisor, and the third left the program for another opportunity. The Section hired highly qualified individuals with experience in certain modalities, such as medical (e.g., nuclear medicine technicians). At the time of the review, the Section was comprised of one director, one supervisor, four staff members, and two vacancies. To attract high quality candidates and to help with retention, the program has increased salaries (by 37 percent). It is worth noting that three of the staff remained constant throughout the review period. The turnover rate did not negatively impact any other aspects of their work in implementing the Agreement State Program.

Kentucky has a training and qualification program compatible with the NRCs IMC 1248. The Section uses a combination of on-the-job training along with the NRC sponsored courses as part of its qualification process. Staff is fully qualified in a modality before they can perform licensing and inspection tasks independently. Staff is considered fully qualified when they are qualified in all modalities. At the time of the review, one staff member was undergoing the qualification process.

c. Evaluation

The team determined that, during the review period, Kentucky met the performance indicator objectives listed in Section 3.1.a. Based on the criteria in MD 5.6, the team recommends that Kentuckys performance with respect to the indicator, Staffing and Training, be found satisfactory.

d. Management Review Board (MRB) Discussion and Chairs Determination

The MRB Chair agreed with the teams recommendation and found Kentuckys 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.

a. Scope

The team used the guidance in SA-101, Reviewing the Common Performance Indicator:

Status of the Materials Inspection Program, and evaluated Kentuckys 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.

Kentucky Final IMPEP Report Page 4

• 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

Kentucky performed 119 Priority 1, 2, and 3 inspections, and 4 initial inspections during the review period. One of these inspections was overdue because the licensee added a high dose remote afterloader (HDR) device and the inspection frequency went from a three-year inspection cycle to a two-year inspection cycle. When the device was added, the inspection immediately became overdue. This typically occurs when a licensee adds a modality that increases the inspection frequency and was outside of the programs control. During the review period, Kentucky had no overdue inspections. Of the 236 inspections performed during the review period, 10 of the inspection findings were communicated to the license beyond 30 days after the inspection exit. Four of the inspection findings were communicated to the licensee beyond 30 days after the inspection exit due to the pandemic; six of the inspection findings were communicated to the licensee beyond 30 days after the inspection exit because of a lack of management oversight. The team determined that the root cause of the timeliness of inspection findings was due in part to the vacancy in the supervisory position and multiple day inspections being delayed due to the pandemic. The team noted that since the supervisory position was filled in August 2023, there have been no reports issued beyond the 30-day goal. The team did not identify any health, safety, or security impacts due to the late issuance of the inspection reports. Kentuckys inspection frequencies were the same for similar license types in the NRCs program.

Kentuckys annual reciprocity goal is 20 percent and for every year since the last IMPEP review, Kentuckys reciprocity inspections were completed greater than 20 percent.

c. Evaluation

The team determined that, during the review period, Kentucky met the performance indicator objectives listed in Section 3.2.a. Based on the criteria in MD 5.6, the team recommends that Kentuckys 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 Kentuckys 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.

Kentucky Final IMPEP Report Page 5

a. Scope

The team used the guidance in SA-102, Reviewing the Common Performance Indicator:

Technical Quality of Inspections, and evaluated Kentuckys 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 the NRC guidance.

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

b. Discussion

The team evaluated 22 inspection reports and interviewed inspectors involved in materials inspections conducted during the review period. The team reviewed casework for inspections conducted by five of Kentuckys inspectors (current and former) and covered medical, industrial, commercial, academic, research, and service licenses. The team found that the Sections inspection results were well documented with respect to health, safety, and security. The Section conducts unannounced, performance-based inspections.

Violations were well supported by appropriate Kentucky regulations. The Section has procedures in place for documenting violations and items of non-compliance. Inspection reports are reviewed and signed by the Section supervisor. Ultimately, the Section supervisor signs all letters before being sent to the licensee.

The team completed accompaniments of three inspectors on January 23-25, 2024. The team found that the inspectors were well-prepared, were thorough in their evaluation of each licensee, and assessed the impact of licensed activities on health, safety, and security.

Inspectors observed the use of radioactive materials whenever possible. During interviews of licensee staff, inspectors used open-ended questions, and were able to develop a basis of confidence that radioactive materials were being used safely and securely. Any findings observed were brought to the licensee staff members attention at the time of the inspection and again to the licensees management during the inspection closeout. All findings and conclusions were well-founded and appropriately documented. The inspector accompaniments are identified in Appendix B.

With one exception, supervisory accompaniments were performed of each qualified inspector for each year in the review period. In 2022, one qualified inspector was not accompanied due to a vacancy in the supervisory position, and Kentucky was unaware of alternate methods. The team explained who could perform supervisory accompaniments to Kentucky Final IMPEP Report Page 6

Kentucky so as not to encounter this situation in the future. There was no impact to public health and safety and the inspector is a senior individual who has a significant amount of experience.

The team determined that the Section maintained an adequate supply of radiation survey instrumentation to support the radioactive materials inspection program, such as Geiger-Mueller meters, scintillation detectors, ion chambers, and micro-R meters to support its inspection program. Each inspector is assigned instruments commensurate with the type of inspections they perform. The survey instruments used during the inspector accompaniments were operational and calibrated.

c. Evaluation

The team determined that, during the review period, Kentucky met the performance indicator objectives listed in Section 3.3.a., except for:

• Supervisors, or senior staff as appropriate, conduct annual accompaniments of each inspector to assess performance and assure consistent application of inspection policies.

With one exception, supervisory accompaniments were performed of each qualified inspector for each year in the review period. In 2022, one qualified inspector was not accompanied due to a vacancy in the supervisory position, and Kentucky was unaware of alternate methods. There was no impact to public health and safety and the qualified inspector is a senior individual who has a significant amount of experience.

Based on the IMPEP evaluation criteria in MD 5.6, the team recommends that Kentuckys 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 Kentuckys performance with respect to this indicator satisfactory.

3.4 Technical Quality of Licensing Actions

The quality, thoroughness, and timeliness of licensing actions can have a direct bearing on public health and safety, as well as security. An assessment of licensing procedures, implementation of those procedures, and documentation of communications and associated actions between Kentucky licensing staff and the 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 Kentuckys 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.

Kentucky Final IMPEP Report Page 7

• 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, Kentucky performed 767 radioactive materials licensing actions.

The team evaluated 24 of those licensing actions. The licensing actions selected for review included 2 new applications, 17 amendments, 2 renewals (amendments in entirety), and 3 terminations (1 of which was also a bankruptcy).

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

medical broad scope, medical diagnostic and therapy, medical academic, mobile medical, industrial radiography, nuclear pharmacy, fixed and portable gauges, well-logging, service providers, financial assurance, and bankruptcies. The casework sample represented work from 3 former and 4 current license reviewers.

Licensing actions were well documented and properly addressed health, safety, and security issues. All documentation for each licensing action is found in paper files, with security licenses locked in a cabinet when not in use. The team determined that documents containing sensitive security information were marked and handled in accordance with applicable Section procedures.

The team found that Kentucky requires amendment in entirety (also known as renewals) to be submitted every 5 years unless a deviation is authorized by management discretion. The discretion is based on review of the license and compliance. Every license has an annual renewal amendment associated with annual fee payment in which the license documentation and the licensees compliance history is reviewed. The staff notifies the licensee when the license is due for renewal. At the time of the review, no renewals were pending.

The team evaluated the implementation of the Pre-Licensing Guidance (PLG) and RSRM checklists. Kentucky conducted pre-licensing site visits for all unknown entities in accordance with the checklist, and properly implemented the PLG. For applications with RSRM, Kentucky issues a license after completing the checklist and performing an on-site security review. In addition, for applications requesting to possess radioactive material equal Kentucky Final IMPEP Report Page 8

to or exceeding Category 2 quantities, Kentucky ensures all 10 CFR Part 37 equivalent security requirements are in place prior to license issuance.

c. Evaluation

The team determined that, during the review period, Kentucky met the performance indicator objectives listed in Section 3.4.a. Based on the criteria in MD 5.6, the team recommends that Kentuckys 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 Kentuckys 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 Kentuckys 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 the 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.

b. Discussion

During the review period, 20 radioactive materials incidents were reported to Kentucky. The team evaluated all incidents, which included: eight medical events; six equipment failures; three lost or stolen radioactive materials; two damaged equipment; and one contamination event. The Section dispatched inspectors for on-site follow-up for 11 of the reviewed Kentucky Final IMPEP Report Page 9

incidents, including 2 reactive inspections. Nine incidents were reviewed at the next routine inspection. The team found that Kentucky properly evaluated each incident, interviewed involved individuals, and documented its findings. When an incident was reported, the Kentucky staff worked with management to evaluate the information received to determine its health and safety significance and then decide on the appropriate response. The response ranged from an immediate on-site response to reviewing the event during the next routine inspection. The team determined that Kentucky responded to incidents in accordance with its established procedure and were reported in a timely manner to the NRC.

During the review period, six allegations were received by Kentucky. The team evaluated all six allegations, including one allegation that the NRC referred to the Commonwealth, and found that Kentucky took prompt and appropriate action to the concerns raised. Each allegation was appropriately closed, concerned individuals were notified of the actions taken as appropriate, and allegers identities were protected.

The team evaluated Kentuckys reporting of incidents to the NRCs Headquarters Operations Officer (HOO). The team noted that in each case requiring HOO notification, Kentucky reported the incidents within the required time frame. The team also evaluated whether Kentucky had additional incidents that required reporting but were missed. The team did not identify any additional incidents that required reporting.

c. Evaluation

The team determined that, during the review period, Kentucky met the performance indicator objectives listed in Section 3.5.a. Based on the IMPEP evaluation criteria in MD 5.6, the team recommends that Kentuckys 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 Kentuckys 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)

Program. The NRC retains regulatory authority for the UR program; therefore, only the first 3 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 Kentucky Final IMPEP Report Page 10

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 the 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://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 Kentuckys 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 the 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

The Kentucky Agreement State Programs current effective statutory authority is contained in the Kentucky Revised Statues (KRS) 194A.050, 211.090, 211.842 to 211.852, 211.859, 211.990(4), and 211.861 to 211.869. The Cabinet is designated as Kentuckys radiation control agency. No legislation affecting the radiation control program was passed during the review period.

Kentuckys administrative 11-step rulemaking process takes approximately 17 months from drafting to finalizing a rule, with the longest part of the process being Cabinet review and approval which takes approximately 6 months. The public, the 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. The team noted that the Commonwealths rules and regulations were subject to sunset laws, meaning if the regulations are amended or certified that they are still required after 7 years, they will be extended another 7 years.

Kentucky Final IMPEP Report Page 11

On February 27, 2024, 7 regulation amendment packages were submitted during the review period including 7 regulations adopted by reference: 10 CFR Parts 19 (Notices, Instructions and Report to Workers: Inspection and Investigations), 20 (Standards for Protection Against Radiation), 31 (General Domestic Licenses for Byproduct Material), 32 (Specific Domestic Licenses to Manufacturer or Transfer Certain Items Containing Byproduct Material), 36 (Licenses and Radiation Safety Requirements for Irradiators), 70 (Domestic Licensing of Special Nuclear Material), and 150 (Exemptions and Continued Regulatory Authority in Agreement States and in Offshore Waters Under 274).

At the time of the review, according to Kentuckys State Regulations Status Sheets, of the seven regulation amendments submitted, three were submitted in a timely manner.

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

• Miscellaneous Corrections - Organizational Changes, 10 CFR Parts 37, 40, 70, and 71, that was due for Agreement State adoption on December 21, 2021 (time overdue:

2 years and 2 months overdue).

• Organizational Changes and Conforming Amendments, 10 Parts 37, 40, 71, 150, that was due for Agreement State adoption on December 30, 2022 (time overdue: 1 year and 2 months overdue).

• Individual Monitoring Devices, 10 CFR Parts 34, 36, 39, that was due for Agreement State adoption on June 16, 2023 (time overdue: 8 months overdue).

• Miscellaneous Corrections, 10 Parts 19, 20, 30, 34, 35, 40, 61, 70, 71, that was due for Agreement State adoption on November 16, 2023 (time overdue: 3 months overdue).

Kentuckys regulation amendments were promulgated by Kentucky on December 14, 2023.

Kentucky submitted them to the NRC Agreement State Regulations Branch on February 27, 2024, for final approval.

All checklists were updated when new guidance documents were issued in a timely manner (i.e., Pre-Licensing Site Visit guidance, RSRM checklist, Inspection Manual Chapter 2800, Inspection Procedures, medical licensing guidance, use of standard license conditions).

c. Evaluation

The team determined that, during the review period, Kentucky met the performance indicator objectives listed in Section 4.1.a, except for:

• 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.

Kentucky Final IMPEP Report Page 12

Three of the four overdue regulation amendments were minor in nature (i.e., miscellaneous corrections) and did not impact the health and safety of Kentucky licensees. Although, not considered minor in nature, the regulation amendment, Individual Monitoring Devices, did not impact the health and safety of Kentucky licensees during the review period. In addition, Kentucky has submitted proposed regulations adopting 10 CFR Part 36 by reference; however, Kentucky does not have any licensees subject to Part 36 regulations at this time.

During the review period, Kentucky submitted seven regulation amendment packages which includes all regulations needed to be adopted by reference. The team also noted that Kentucky recently submitted, for the NRC approval, the remaining seven regulations to be adopted by reference.

Based on the IMPEP evaluation criteria in MD 5.6, the team recommends that Kentuckys 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 Kentuckys performance with respect to this indicator satisfactory.

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 Kentuckys 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.

Kentucky Final IMPEP Report Page 13

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

Kentucky has three staff qualified to perform SS&D reviews. The team determined that the Section is appropriately staffed and trained to carry out the SS&D program.

Kentucky has a training program for SS&D reviewers equivalent to the NRC training requirements listed in the NRCs IMC 1248, Appendix D. The team interviewed staff involved in SS&D reviews and determined that they were familiar with the procedures used in the evaluation of sources and devices and had access to applicable reference documents. The Sections qualified reviewers with full signature authority have at least a Bachelor of Science degree in physical or life sciences.

Technical Quality of the Product Evaluation

Kentucky has one device manufacturer who has 12 active SS&D registrations. There were two SS&D actions during the review period.

The team verified that SS&D reviewers had access to the guidance from the NRCs SS&D workshop; NUREG-1556, Volume 3, Revision 1; and applicable American National Standards Institute standards.

Kentucky is committed to going outside of the program, as necessary, to seek expertise in any areas that it needs while conducting SS&D evaluations. This includes working with engineering programs at the University of Kentucky in Lexington, other SS&D programs in neighboring Agreement States like Ohio, or the NRC SS&D program at the NRC Headquarters. Kentucky also works with other Agreement States like North Carolina to provide training opportunities in the reviewing of SS&Ds and serving as a peer review.

Evaluation of Defects and Incidents Regarding SS&Ds

There were 8 incidents related to SS&D defects involving devices registered by Kentucky reported during the review period. The program determined that these incidents were caused by environmental or age-related issues. Incident procedures are in place for such SS&D-related incidents. The incidents were reviewed and determined not to be related to any kind of generic issue.

Kentucky Final IMPEP Report Page 14

c. Evaluation

The team determined that, during the review period, Kentucky met the performance indicator objectives listed in Section 4.2.a. Based on the criteria in MD 5.6, the team recommends that Kentuckys performance with respect to the indicator, SS&D Evaluation Program, be found satisfactory.

d. MRB Discussion and Chairs Determination

The MRB Chair agreed with the teams recommendation and found Kentuckys performance with respect to this indicator satisfactory.

4.3 LLRW Disposal Program

The Kentucky Agreement State Programs LLRW disposal program consists of the oversight of the Maxey Flats Disposal Site which operated as a commercial LLRW disposal facility from May 1963 through December 1977. The site was listed on the National Priority list in 1986 and a Record of Decision was issued in September 1991, by the Environmental Protection Agency under its Comprehensive Environmental Response, Compensation, and Liability Act authority to stabilize the site and treat contaminated leachate (mainly tritium as a marker - leachate is water from the trenches) from tanks and trenches. Because Maxey Flats is a closed LLRW site in its Final Closure Period, in accordance with SA-109, Reviewing the Non-Common Performance Indicator, Low-Level Radioactive Waste Disposal Program, and in coordination with the NRC Headquarters management through the IMPEP Program Coordinator, it was determined that this indicator did not need to be reviewed during this review period because there were no changes or issues in the closure phase and status of Maxey Flats since the last IMPEP review that would impact safety.

Although this indicator was not assessed by the review team, the team discussed the site status with Kentuckys Management. The Energy & Environment Cabinet receives and keeps copies of the Environmental Protection Agency reports which are done every 5 years with the 2017 being the latest report and the 2022 report needing to be processed into final report format. Kentucky is ensuring consistent and timely inspection results for Maxey Flats in accordance with IMC 2800 (every 3 years) and licensing actions (mostly administrative amendments due to the paying and receipt of annual fees). During the current review period, Kentucky received one licensing action and performed one inspection.

5.0

SUMMARY

The team found Kentuckys performance to be satisfactory for all seven performance indicators reviewed.

There were no open recommendations, and the team did not make any new recommendations.

Accordingly, the team recommended, and the MRB Chair agreed that the Kentucky radiation control program be found adequate to protect public health and safety and compatible with the NRC's program. The team also recommended, and the MRB Chair agreed that a periodic meeting take place in approximately 2 years with the next IMPEP review taking place in approximately 4 years.

LIST OF APPENDICES

Appendix A IMPEP Review Team Members

Appendix B Inspector Accompaniments APPENDIX A

IMPEP REVIEW TEAM MEMBERS

Name Areas of Responsibility

Jacqueline D. Cook, RIV Team Leader Legislation, Regulations, and Other Program Elements

Michelle Hammond, NMSS Team Leader in Training Technical Staffing and Training Inspector Accompaniments

Dave Ganesh, State of Florida Status of Materials Inspection Program Technical Quality of Inspections

David Lawrenz, State of Kansas Technical Quality of Licensing Actions

Shawn Seeley, RI Technical Quality of Incident and Allegation Activities

Lymari Sepulveda, NMSS Sealed Source and Device Evaluation Program APPENDIX B

INSPECTOR ACCOMPANIMENTS

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

Accompaniment No.: 1 License No.: 201-754-05 License Type: Industrial Radiography Priority: 1 Inspection Date: 1/23/2024 Inspectors initials: AB

Accompaniment No.: 2 License No.: 202-238-08 License Type: Research & Development Priority: 3 Inspection Date: 1/24/2024 Inspectors initials: CP

Accompaniment No.: 3 License No.: 202-029-22 License Type: Medical Broadscope (with HDR) Priority: 2 Inspection Date: 1/25/2024 Inspectors initials: AW KENTUCKY MANAGEMENT REVIEW BOARD ATTENDANCE June 6, 2024, 1:00 - 3:00 EST, OWFN17-B04 and via Microsoft Teams

Management Review Board:

• John Lubinski, the Director, Office of Nuclear Material Safety and Safeguards, Acting MRB Chair;

• Jessica Bielecki, the Deputy Assistant General Counsel for Rulemaking, Agreement States and Fee Policy;

• Rob Lewis, the Deputy Director, Office of Nuclear Material Safety and Safeguards;

• Julio Lara, the Deputy Regional Administrator, NRC Region IV;

• David Howe, the Organization of Agreement States representative to the MRB, from the State of Oregon.

Commonwealth of Kentucky:

• Matthew W. McKinley, Radiation Health Branch Manager and Program Director;

• Russell Hestand, Radioactive Materials Section, Supervisor;

• Curt Pendergrass, Radioactive Materials Section; and

• David Rich, Radioactive Materials Section.

IMPEP Team:

• Jackie Cook, Team Leader, NRC Region IV;

• Michelle Hammond, NRC HQ, Office of Nuclear Materials Safety and Safeguards;

• Dave Ganesh, State of Florida;

• Shawn Seeley, NRC Region I; and

• Lymari Sepulveda, NRC Office of Nuclear Materials Safety and Safeguards.

NRC and OTHER MEMBERS OF THE PUBLIC:

• Jacob Zimmerman, Region I

• Adelaide Giantelli, NMSS

• Lee Smith, NMSS

• Robert Johnson, NMSS

• Sherrie Flaherty, NMSS

• Karen Meyer, NMSS

Enclosure 2

ML24164A107 OFFICE NMSS/MSST/SLPB NMSS/MSST R-IV/DNMS/MIB NMSS/MSST/SMPB NAME RJohnson RJ LSmith LSJCook JC AGiantelli AG DATE Jun 12, 2024 Jun 12, 2024 Jun 12, 2024 Jun 14, 2024 OFFICE NMSS/MSST NMSS NAME KWilliams KW JLubinski JL DATE Jun 17, 2024 Jun 21, 2024