ML25178B390

July 9 2025 Letter to S. Dunkel Re Virginia Draft Impep Report

ML25178B390
Person / Time
Issue date:	07/09/2025
From:	Adelaide Giantelli NRC/NMSS/DMSST/ASPB
To:	Dunkel S State of VA, Dept of Health
References
Download: ML25178B390 (1)

Text

Stephanie Dunkel, Deputy Commissioner Population Health and Preparedness Virginia Department of Health James Madison Building 109 Governor Street, 13th Floor Richmond, VA 3219

SUBJECT:

VIRGINIA DRAFT IMPEP REPORT

Dear Stephanie Dunkel:

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 Virginia Agreement State Program (Virginia) review conducted on June 2-6, 2025. The teams preliminary findings were discussed with Virginia on the last day of the review. The teams proposed recommendations are that Virginia 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 on the draft 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 virtual meeting on September 18, 2025, at 1 pm ET via Microsoft Teams. The NRC will provide you with the Microsoft Teams connection information prior to the MRB meeting.

July 9, 2025

S. Dunkel 2

If you have any questions regarding the enclosed report, please contact Robert K. Johnson, IMPEP Project Manager, at 301-415-7314 or Allyce Bolger, IMPEP Team Leader, at 301-415-0855.

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:

Virginia Draft IMPEP Report cc:

Cameron Rose, MPH, Deputy Director Office of Radiological Health Sheila Nelson, CNMT, Director Radioactive Materials Program Signed by Giantelli, Adelaide on 07/09/25

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW OF THE VIRGINIA AGREEMENT STATE PROGRAM JUNE 2-6, 2025 DRAFT REPORT

EXECUTIVE

SUMMARY

The results of the Integrated Materials Performance Evaluation Program (IMPEP) review of the Virginia Agreement State Program (Virginia) are discussed in this report. The review was conducted by the IMPEP team on June 2-6, 2025. Inspector accompaniments were conducted during the week of April 14, 2025.

The team found Virginias performance to be satisfactory for all six 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 2020 IMPEP review for the team to consider. The team is proposing one new recommendation:

Implement a process to provide oversight of inspection report timeliness to provide high confidence that inspection reports are issued within 30 days of the inspection exit date or 45 days for team inspections.

Accordingly, the team recommends that Virginias radiation control program be found adequate to protect public health and safety and compatible with the NRC's program. Because Virginia has had at least two consecutive IMPEP reviews with all performance indicators found satisfactory, the team recommends that a periodic meeting be conducted in approximately 2.5 years with the next IMPEP review taking place in approximately 5 years.

Virginia Draft IMPEP Report Page 1 1.0 INTRODUCTION(

The Virginia Integrated Materials Performance Evaluation Program (IMPEP) review was conducted on June 2-6, 2025, by a team of technical staff members from the U.S. Nuclear Regulatory Commission (NRC) and the State of North Dakota. Team members are identified in Appendix A. Inspector accompaniments were conducted during the week of April 14, 2025, and are identified in Appendix B. The review was conducted in accordance with the Agreement State Program Policy Statement, published in the Federal Register on October 18, 2017 (82 FR 48535), and NRC Management Directive (MD) 5.6, Integrated Materials Performance Evaluation Program (IMPEP), dated July 24, 2019. Preliminary results of the review, which covered the period of September 26, 2020 - June 6, 2025, were discussed with Virginia 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 Virginia on February 19, 2025.

Virginia provided its response to the questionnaire on May 19-20, 2025. A copy of the questionnaire response is available in the NRCs Agencywide Documents Access and Management System Accession No. ML25160A291.

The Virginia Agreement State Program was administered by the Radioactive Materials Program in the Office of Radiological Health. Organization charts for Virginia are available in ML25153A212.

At the time of the review, Virginia regulated 360 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 Virginia.

The team evaluated the information gathered against the established criteria for each common and applicable performance indicator and made a preliminary assessment of Virginias performance.

2.0 PREVIOUS IMPEP REVIEW AND STATUS OF RECOMMENDATIONS The previous IMPEP review concluded on September 21-25, 2020. The final report is available in ML20353A138. 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

Virginia Draft IMPEP Report Page 2 Technical Quality of Incident and Allegation Activities: Satisfactory Recommendation: None Legislation, Regulations, and Other Program Elements: Satisfactory Recommendation: None Overall finding: based on the results of the 2020 IMPEP review, Virginia was found adequate to protect public health and safety and compatible with the NRC's program. The Management Review Board (MRB) Chair determined that a periodic meeting should take place in approximately 2.5 years with the next IMPEP review in approximately 5 years.

3.0 COMMON PERFORMANCE INDICATORS Five common performance indicators are used to review the NRC and Agreement State radiation control programs. These indicators are: (1) Technical Staffing and Training, (2) Status of Materials Inspection Program, (3) Technical Quality of Inspections, (4) Technical Quality of Licensing Actions, and (5) Technical Quality of Incident and Allegation Activities.

3.1 Technical Staffing and Training The ability to conduct effective licensing and inspection programs is largely dependent on having experienced, knowledgeable, well-trained technical personnel. Under certain conditions, staff turnover could have an adverse effect on the implementation of these programs and could affect public health and safety. Apparent trends in staffing must be assessed. Review of staffing also requires consideration and evaluation of the levels of training and qualification. The evaluation standard measures the overall quality of training available to, and taken by, materials program personnel.

a. Scope The team used the guidance in State Agreements procedure (SA) SA-103, Reviewing the Common Performance Indicator: Technical Staffing and Training, and evaluated Virginias 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.

Virginia Draft IMPEP Report Page 3

b. Discussion At the time of the review, Virginia was comprised of 11 staff members. This included one supervisor, six technical staff, and four administrative staff that provided part-time support to the program. The team determined that the program had 8.75 full-time equivalent (FTE),

comprising 7 technical FTE and 1.75 administrative FTE. Technical staff were dual-qualified for licensing and inspection, and as of the review, all six staff were fully qualified for licensing activities and two were fully qualified for inspection activities. The other four staff were working to complete inspector qualifications for all modalities. The supervisor was also qualified as a license reviewer and inspector.

During the review period, three technical staff, one administrative staff, and one supervisor left their positions with Virginia. Virginia hired seven staff between October 2020 and June 2024. The longest vacant position took approximately seven months to fill, from September 2021 to April 2022. The current supervisor was promoted internally from within the program in May 2023. One staff member left the program in July 2023 but continued to support the program as a contractor until March 2024, equating to approximately 0.2 FTE.

Since November 2024, there has been one vacant administrative position that the program does not plan to fill.

Virginia management was very supportive of the training program and staff was encouraged to attend the NRC training courses. Virginia has a training and qualification program compatible with IMC 1248. Virginias qualification process uses a combination of on-the-job training and NRC sponsored training courses. Staff must be qualified in a modality before they can perform tasks independently. Staff were considered fully qualified once they qualified in all applicable modalities. Fully qualified license reviewers and inspectors maintain at least 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of refresher training every 24 months. Virginia maintains Excel spreadsheets for the staffs qualification journals and refresher training.

c.

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

d. 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.

Virginia Draft IMPEP Report Page 4

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

Status of the Materials Inspection Program, and evaluated Virginias performance with respect to the following performance indicator objectives:

Initial inspections and inspections of Priority 1, 2, and 3 licensees are performed at the prescribed frequencies (https://www.nrc.gov/materials/miau/mat-toolkits.html).

Deviations from inspection schedules are normally coordinated between technical staff and management.

There is a plan to perform any overdue inspections and reschedule any missed or deferred inspections or a basis has been established for not performing any overdue inspections or rescheduling any missed or deferred inspections.

Candidate licensees working under reciprocity are inspected in accordance with the criteria prescribed in IMC 2800 and other applicable guidance or compatible Agreement State Procedure.

Inspection findings are communicated to licensees in a timely manner (30 calendar days, or 45 days for a team inspection), as specified in IMC 0610, Nuclear Material Safety and Safeguards Inspection Reports.

b. Discussion During the review period, Virginia performed 280 Priority 1, 2, and 3 inspections and 11 initial inspections. Of those inspections, 15 were performed overdue, 11 routine inspections, and 4 initial inspections. One overdue Priority 2 inspection had not been completed at the time of the review; but was planned to be completed in June 2025. This equates to 4.9 percent of Priority 1, 2, and 3 inspections performed overdue during the review period; meeting the Management Directive 5.6 satisfactory rating evaluation criteria of less than 10 percent overdue. The team notes that while Virginia used an Access Database to track inspection completion timeliness, there were several occurrences of human error in the data entry that led to the late performance of inspections.

Virginias inspection frequencies were mostly identical to the NRCs program except for a few modalities, which were inspected more frequently. For instance, some Priority 5 medical and industrial license types were inspected at a Priority 3 frequency.

Virginia follows their equivalent procedures to IMC 2800 for the performance of reciprocity inspections. Virginia uses a risk-informed checklist to identify the reciprocity candidates for inspection. The team reviewed Virginias inspection of candidate licensees working under reciprocity. The team determined that during the review period Virginia typically inspected between 31 to 50 percent of the candidate licensees working under reciprocity annually. The team determined that Virginias performance of reciprocity inspections aligned with their procedures.

The team evaluated 24 inspection reports and noted that 4 written findings were transmitted to the licensee beyond Virginias 30-day time frame and ranged from 27 days to approximately five months overdue. Two of the four inspections identified violations, though it was noted that for one inspection the violation was fixed during the inspection. Virginias database did not specifically track inspection report issuance, and could only provide the inspection start date and inspection closure date (i.e., inspection results had been issued to

Virginia Draft IMPEP Report Page 5 the licensee and any required response from the licensee was reviewed and found to be adequate) which often exceeded 30 days.

c.

Evaluation The team determined that, during the review period, Virginia met the performance indicator objectives listed in Section 3.2.a. except for:

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.

The team reviewed the timeliness of the issuance of inspection findings and found during the second half of the review period Virginia communicated inspection findings to licensees greater than 30 days (or 45 days for a team inspection) of completing each inspection approximately 33 percent of the time. During the 2020 IMPEP, it was identified that Virginia communicated inspection findings late seven percent of the time. The team identified that a contributing cause to the late issuance of inspection reports was that the radiation program supervisor had competing priorities of qualifying technical staff to perform inspections while also performing managerial tasks such as supervisory reviews of inspection documentation prior to report issuance. Additionally, Virginia did not have a process to readily track inspection report timeliness.

At the time of the review, Virginia was taking steps to delegate a senior technical staff member to take over some managerial tasks such as reviewing low safety significant inspection reports. The team also determined that the radiation program supervisor would be dedicating more time to management oversight tasks as their workload shifts away from inspector qualifications. Additionally, the team verified, during the inspector accompaniments and inspection casework review, that inspectors communicated the preliminary findings and violations to the licensee during the inspection exit briefing.

Therefore, the team determined this finding to be of low significance to Virginias overall performance for this indicator.

Based on the criteria in MD 5.6, the team recommends that Virginias performance with respect to the indicator, Status of Materials Inspection Program, be found satisfactory with one recommendation:

Implement a process to provide oversight of inspection report timeliness to provide high confidence that inspection reports are issued within 30 days of the inspection exit date or 45 days for team inspections.

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.

Virginia Draft IMPEP Report Page 6

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

Technical Quality of Inspections, and evaluated Virginias 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 24 inspection reports and enforcement documentation, and interviewed inspectors involved in materials inspections conducted during the review period. The reviewed casework included 19 routine inspections, 2 initial inspections, and 3 reciprocity inspections. The inspection casework is identified in Appendix C. The team reviewed casework for inspections conducted by eight staff, including all six current staff and two former staff, and covered a cross-section of medical, industrial, commercial, academic, and research license types. Inspection documentation was complete, and when required, marked to prevent public disclosure. Issued citations were fully supported in the inspection reports. Inspection documentation indicated that inspections were performed with enough detail to evaluate licensee performance in meeting regulatory and license condition requirements.

During the week of April 14, 2025, the team accompanied four inspectors. The team found that each inspector was well-prepared, knowledgeable of the requirements for each license type, and thoroughly assessed licensed activities to identify potential health, safety, and security concerns. The inspector accompaniments are identified in Appendix B. Any findings observed were brought to the attention of the licensee at the time of the inspection and again to the licensees management during the inspection exit meeting.

The team verified that Virginias inspection results were well documented with respect to health, safety, and security. Virginia conducted both unannounced and announced performance-based inspections and implemented procedures for documenting violations identified during inspections. Violations were well supported by appropriate regulations and license conditions and were signed by the supervisor before being transmitted to the licensee.

Virginia Draft IMPEP Report Page 7 The team determined that Virginia has a sufficient type and number of radiation survey instruments to support the program. Survey instruments were calibrated by an outside commercial vendor. Reviewed records indicated all survey instruments were calibrated on an annual basis.

c.

Evaluation The team determined that, during the review period, Virginia met the performance indicator objectives listed in Section 3.3.a. Based on the criteria in MD 5.6, the team recommends that Virginias 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.

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 Virginia 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 Virginias 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.

Virginia Draft IMPEP Report Page 8 b.

Discussion During the review period, Virginia performed 1,226 radioactive materials licensing actions.

The team evaluated 22 licensing actions including new applications, amendments, renewals, terminations and transfers of control. The licensing casework is identified in Appendix D. The team evaluated casework which included the following license types:

medical and academic broadscopes, diagnostic and therapeutic nuclear medicine, brachytherapy, emerging medical technology, gamma knife, radiopharmacy, industrial radiography, source material, veterinary research and development, well logging, portable gauges, and distribution. The casework sample represented work from seven current license reviewers and three former license reviewers.

Virginia reviewed and processed licensing actions in a timely manner and in accordance with its established metrics for timeliness. There was no backlog throughout the review period. Virginia utilized a peer review process for each licensing action, ensuring that two qualified license reviewers evaluated each action for completeness and technical quality.

The peer review process did not delay Virginias licensing efforts. Rather, it offered additional oversight of licensing actions to promote consistency as well as to minimize correcting minor licensing errors. The peer review process also provided opportunities for newer staff to review less common or more complex modalities while working with a fully qualified license reviewer.

Virginias license application clearly stated the commitments that each licensee needed to make and effectively tied each expectation to existing regulatory requirements. Requests for additional information were clear, and licensees were timely in providing the information needed for the program to complete the license action. All actions reviewed were thorough and well documented with a clear basis established. Deficiency letters were used at the proper time and clearly stated the regulatory position. Virginia consistently utilized compatible licensing guidance as well as a pre-licensing and RSRM checklists when appropriate. Virginia developed model licenses with standard license conditions to promote a consistent approach to licensing. The licensing casework reviewed was consistent and clearly articulated license conditions that were enforceable.

The review team did not identify any new bankruptcy filings over the review period, but did verify that Virginia had procedures to appropriately handle bankruptcy actions. Virginia conducted a financial assurance review for each licensee at a three-year frequency and during renewal, which occurred every five years. Files containing sensitive and security related information were appropriately marked to prevent unintended release of this information.

c.

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

Virginia Draft IMPEP Report Page 9 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 Virginias 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 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, 31 radioactive material incidents were reported to Virginia, 20 of which were reportable to the NRC. The team evaluated 11 incidents which included one lost or stolen radioactive material, three medical events, five damaged safety-related equipment, one industrial radiography source disconnect, and one leaking sealed source. Virginia dispatched inspectors for on-site follow-up for 9 of the cases reviewed.

When notified of an incident, Virginia management and staff met to discuss the incident and determine the appropriate level of response, which ranged from an immediate on-site inspection to reviewing the incident during the next routine inspection. Those determinations were made based on both the circumstances and the health, safety, and security significance of the incident. The team found that Virginias evaluation of incident notifications and its response to those incidents was appropriate to the safety and security significance of the event and provided a comprehensive evaluation of licensed activities.

The team also evaluated Virginias reporting of incidents to the NRCs Headquarters Operations Officers (HOO). Except for two events that required HOO notification, Virginia reported the incidents within the required time frame. In the first instance, an event was called into the Virginia afterhours emergency management notification system on a Friday, but the on-call duty officer did not forward the information to the radiation program

Virginia Draft IMPEP Report Page 10 supervisor. On Monday, the licensee followed up on the event with the radiation program supervisor, who immediately reported the event to the HOO. The other event was discovered during a routine inspection in late 2024 and had not been reported to Virginia by the licensee, therefore Virginia did not immediately recognize that a HOO notification was required. During the IMPEP review Virginia submitted the required report to the HOO.

During the review period, 22 allegations were received by Virginia, 14 of which were referred from the NRC. The team evaluated 11 allegations, including 6 of the allegations referred from the NRC. The team found Virginia took prompt and appropriate action in response to each concern raised. The team found that allegations were thoroughly reviewed, allegers identities were protected in accordance with State law, and allegers were notified within 30 days of investigation conclusions when contact information was available.

c.

Evaluation The team determined that, during the review period, Virginia met the performance indicator objectives listed in Section 3.5.a. Based on the criteria in MD 5.6, the team recommends that Virginias 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 (UR) Program. The NRC retains regulatory authority for SS&D Evaluation, LLRW Disposal, and UR Programs; therefore, only the first non-common performance indicator applied to this review.

4.1 Legislation, Regulations, and Other Program Elements State statutes should authorize the State to establish a program for the regulation of agreement material and provide authority for the assumption of regulatory responsibility under the States agreement with the NRC. The statutes must authorize the State to promulgate regulatory requirements necessary to provide reasonable assurance of adequate protection of public health, safety, and security. The State must be authorized through its legal authority to license, inspect, and enforce legally binding requirements, such as regulations and licenses. The NRC regulations that should be adopted by an Agreement State for purposes of compatibility or health and safety should be adopted in a time frame so that the effective date of the State requirement is not later than three 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 six 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 website at the following address: https://www.nrc.gov/materials/toolboxes/regulation.html.

Virginia Draft IMPEP Report Page 11

a. Scope The team used the guidance in SA-107, Reviewing the Non-Common Performance Indicator: Legislation, Regulations, and Other Program Elements, and evaluated Virginias performance with respect to the following performance indicator objectives. A complete list of regulation amendments can be found on the NRC website at the following address:

https://www.nrc.gov/materials/toolboxes/regulation.html.

The Agreement State program does not create conflicts, duplications, gaps, or other conditions that jeopardize an orderly pattern in the regulation of radioactive materials under the Atomic Energy Act of 1954, as amended.

Regulations adopted by the Agreement State for purposes of compatibility or health and safety were adopted no later than 3 years after the effective date of the NRC regulation.

Other program elements, as defined in SA-200 that have been designated as necessary for maintenance of an adequate and compatible program, have been adopted and implemented within 6 months of NRC designation.

The State statutes authorize the State to establish a program for the regulation of agreement material and provide authority for the assumption of regulatory responsibility under the agreement.

The State is authorized through its legal authority to license, inspect, and enforce legally binding requirements such as regulations and licenses.

Sunset requirements, if any, do not negatively impact the effectiveness of the States regulations.

b. Discussion Virginias current effective statutory authority was designated the Radiation Control Act and was defined in the Code of Virginia Sections 32.1-227 - 32.1-238. The Department of Health was designated as the Commonwealths radiation control agency. No legislation affecting the radiation control program was passed during the review period.

Virginias administrative rulemaking process takes approximately three months from drafting to finalizing a rule. Due to the requirement for compatibility, rulemaking relating to the Agreement State program was exempt from the traditional regulatory process. Under this exempt regulatory action, final regulations were published in the Virginia Register for a 30day comment period and will become effective following that period unless the action is suspended by the Governor, the General Assembly, or by a request from 25 or more persons. The team noted that the States rules and regulations were not subject to sunset laws.

During the review period, Virginia submitted 3 proposed regulation amendments and 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. Additionally, at the time of this review, no amendments were overdue.

The team also reviewed other program elements the NRC has designated as necessary for the maintenance of an adequate and compatible program that fall within this non-common performance indicator. These include elements such as Pre-Licensing Guidance, Inspection Procedures, RSRM checklist, and standard license conditions, etc. Virginia had adopted and

Virginia Draft IMPEP Report Page 12 implemented other program elements designated as necessary for an adequate and compatible program.

c.

Evaluation The team determined that, during the review period, Virginia met the performance indicator objectives listed in Section 4.1.a. Based on the criteria in MD 5.6, the team recommends that Virginias 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.

5.0

SUMMARY

The team found Virginias performance to be satisfactory for all six 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 2020 IMPEP review for the team to consider. The team is proposing one new recommendation:

Implement a process to provide oversight of inspection report timeliness to provide high confidence that inspection reports are issued within 30 days of the inspection exit date or 45 days for team inspections.

Accordingly, the team recommends that Virginias radiation control program be found adequate to protect public health and safety and compatible with the NRC's program. Because Virginia has had at least two consecutive IMPEP reviews with all performance indicators found satisfactory, the team recommends that a periodic meeting be conducted 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 C Inspection Casework Appendix D Licensing Casework

APPENDIX A IMPEP REVIEW TEAM MEMBERS Name Areas of Responsibility Allyce Bolger, NMSS Team Leader Legislation, Regulations, and Other Program Elements Darren Piccirillo, Region III Technical Staffing and Training David Stradinger, North Dakota Status of Materials Inspection Program Technical Quality of Inspections Lisa Forney, NMSS Technical Quality of Licensing Actions Shawn Seeley, Region I Technical Quality of Incident and Allegation Activities Inspector Accompaniments

APPENDIX B INSPECTOR ACCOMPANIMENTS The following inspector accompaniments were performed prior to the IMPEP review:

No.: 1 License No.: 041-404-1 License Type: Medical - High-dose rate (HDR)

Brachytherapy Priority: 2 Inspection Date: 4/15/2025 Inspectors initials: TH No.: 2 License No.: 087-581-1 License Type: Radiopharmacy Priority: 2 Inspection Date: 4/15/2025 Inspectors initials: RY No.: 3 License No.: 630-535-1 License Type: Medical - Witten Directive Required Priority: 2 Inspection Date: 4/16/2025 Inspectors initials: TT No.: 4 License No.: 760-527-1 License Type: Industrial Radiography Priority: 1 Inspection Date: 6/17/2025 Inspectors initials: CU

APPENDIX C INSPECTION CASEWORK The following inspections were reviewed during the IMPEP review:

No.: 1 License No.: 041-401-1 License Type: Medical - HDR Brachytherapy Priority: 2 Inspection Date: 4/14/2025 & 4/16/2025 Inspectors initials: TH No.: 2 License No.: 760-527-1 License Type: Industrial Radiography Priority: 1 Inspection Date: 4/17/2025 and 5/29/2025 Inspectors initials: CU No.: 3 License No.: 087-581-1 License Type: Radiopharmacy Priority: 2 Inspection Date: 4/15/2025 Inspectors initials: RY No.: 4 License No.: 680-535-1 License Type: Medical - Written Directive required and Yttrium-90 (Y-90) microspheres Priority: 2 Inspection Date: 4/16/2025 Inspectors initials: TT No.: 5 License No.: 600-522-1 License Type: Medical - Written Directive required and HDR Brachytherapy Priority: 2 Inspection Date: 6/25/2024 Inspectors initials: RV, TT No.: 6 License No.: 153-574-1 License Type: Medical - Written Directive required and HDR Brachytherapy Priority: 2 Inspection Date: 11/20/2024 Inspectors initials: TT No.: 7 License No.: 185-136-1 License Type: Well Logging and Portable Gauge Priority: 3 Inspection Date: 5/15/2024 Inspectors initials: KF No.: 8 License No.: 710-080-1 License Type: Academic Broadscope Priority: 3 Inspection Date: 10/28/2021 Inspectors initials: SN, RY No.: 9 License No.: 680-515-1 License Type: Source Material Priority: 3 Inspection Date: 9/17/2024 Inspectors initials: SN, CU, CR No.: 10 License No.: 000-667-1 License Type: Industrial Radiography Priority: 1 Inspection Date: 3/20/2024 Inspectors initials: KF, TT

No.: 11 License No.: 540-248-1 License Type: Medical Broadscope w/ Self-Shielded Irradiator and Gamma Stereotactic Radiosurgery Priority: 2 Inspection Date: 3/28-30/2023 Inspectors initials: KV, KF, KG, SN No.: 12 License No.: 760-215-1 License Type: Medical Broadscope Priority: 2 Inspection Date: 4/21-23/2025 Inspectors initials: RY, TH, CR, TT, CU No.: 13 License No.: 121-225-1 License Type: Academic Broadscope Priority: 3 & 5 Inspection Date: 11/29-30/2022, 12/1/2022, 1/20/2023 Inspectors initials: KV, SN No.: 14 License No.: 700-521-1 License Type: Medical - Gamma Stereotactic Radiosurgery Priority: 2 Inspection Date: 8/23/2022 Inspectors initials: RY, KF, SN No.: 15 License No.: 700-383-2 License Type: Self-Shielded Irradiator Priority: 3 Inspection Date: 12/11/2024 Inspectors initials: RY No.: 16 License No.: 570-222-1 License Type: Medical - Nuclear Medicine Priority: 3 Inspection Date: 12/16/2024 Inspectors initials: CR, RY No.: 17 License No.: 041-498-1 License Type: Industrial Radiography Priority: 1 Inspection Date: 11/21/2024 Inspectors initials: CU, RY No.: 18 License No.: 710-157-1 License Type: Research & Development (R&D)

Broadscope Priority: 3 Inspection Date: 12/14/2021 Inspectors initials: RY, SN No.: 19 License No.: 161-687-1 License Type: Medical - Y-90 microspheres Priority: 2 Inspection Date: 6/11/2024 Inspectors initials: KF No.: 20 License No.: 000-667-1 License Type: Industrial Radiography Priority: 1 Inspection Date: 3/16/2022, 3/30/2022 Inspectors initials: KV, SN No.: 21 License No.: NRC 47-31316-01 License Type: Industrial Radiography Priority: 1 Inspection Date: 3/6/2024 Inspectors initials: KF

No.: 22 License No.: LA 13351-01 License Type: Well Logging Priority: 3 Inspection Date: 4/26/2023 Inspectors initials: KG No.: 23 License No.: NRC 15-35544-01 License Type: Industrial Radiography Priority: 1 Inspection Date: 2/22/2023 Inspectors initials: KG No.: 24 License No.: 700-138-1 License Type: Medical - Nuclear Medicine Priority: 3 Inspection Date: 11/7/2024 Inspectors initials: TH, RY

APPENDIX D LICENSING CASEWORK The following licensing actions were reviewed during the IMPEP Review:

No.: 1 License No.: 760-703-1 License Type: Medical - Written Directive Required Action: New License Action Date: 03/07/2025 Reviewer's initials: TH No.: 2 License No.: 710-024-1 License Type: Medical - Nuclear Medicine Action: Termination Action Date: 04/02/2021 Reviewer's initials: KV No.: 3 License No.: 087-034-1 License Type: Radiopharmacy Action: Amendment Action Date: 03/24/2024 Reviewer's initials: KV, TT No.: 4 License No.: 015-015-1 License Type: Medical - Brachytherapy Action: Amendment Action Date: 06/30/2023 Reviewer's initials: KG No.: 5 License No.: 195-378-1 License Type: Medical - Nuclear Medicine Action: Amendment Action Date: 09/03/2021 Reviewer's initials: AS No.: 6 License No.: 760-527-1 License Type: Industrial Radiography Action: Renewal Action Date: 05/29/2025 Reviewer's initials: RY No.: 7 License No.: 600-122-1 License Type: Medical - Emerging Medical Technology Action: Renewal Action Date: 10/18/2024 Reviewer's initials: CR No.: 8 License No.: 710-189-1 License Type: Medical Broadscope Action: Renewal Action Date: 12/06/2024 Reviewer's initials: CU No.: 9 License No.: 540-248-1 License Type: Medical & Academic Broadscope Action: Amendment Action Date: 04/25/2025 Reviewer's initials: SN No.: 10 License No.: 540-430-1 License Type: Medical - Gamma Stereotactic Radiosurgery Action: Amendment Action Date: 08/28/2024 Reviewer's initials: RY No.: 11 License No.: 183-348-3 License Type: Source Material Action: Transfer of Control

Action Date: 11/13/2023 Reviewer's initials: SN No.: 12 License No.: 089-156-1 License Type: Medical - Nuclear Medicine Action: Termination Action Date: 05/14/2025 Reviewer's initials: KF No.: 13 License No.: 107-113-1 License Type: Radiopharmacy Action: Amendment Action Date: 12/03/2024 Reviewer's initials: TT No.: 14 License No.: 540-692-1 License Type: Academic R&D (Veterinary)

Action: New Action Date: 12/01/2023 Reviewer's initials: RY No.: 15 License No.: 185-136-1 License Type: Well Logging & Portable Gauge Action: Renewal Action Date: 05/25/2023 Reviewer's initials: RY No.: 16 License No.: 660-119-1 License Type: Academic R&D Action: Amendment Action Date: 03/28/2025 Reviewer's initials: CU No.: 17 License No.: 760-215-1 License Type: Medical & Academic Broadscope Action: Renewal Action Date: 05/15/2025 Reviewer's initials: RY No.: 18 License No.: 059-018-1 License Type: Distribution Action: Renewal Action Date: 08/15/2022 Reviewer's initials: RY No.: 19 License No.: 710-157-1 License Type: Academic Broadscope Action: Amendment Action Date: 05/09/2025 Reviewer's initials: CU No.: 20 License No.: 041-327-1 License Type: Industrial Radiography Action: Amendment Action Date: 11/23/2022 Reviewer's initials: SN No.: 21 License No.: 191-502-1 License Type: Industrial Radiography Action: Transfer of Control Action Date: 04/20/2022 Reviewer's initials: RY No.: 22 License No.: 630-535-1 License Type: Medical - Nuclear Medicine and Emergent Medical Technology Action: Renewal Action Date: Pending Reviewer's initials: KF

ML25178B390 OFFICE NMSS/MSST NMSS/MSST/SLPB R-IV/DNMS/MIB NMSS/MSST/SMPB NAME LSmith RJohnson ABolger AGiantelli DATE Jun 30, 2025 Jun 30, 2025 Jun 29, 2025 Jun 30, 2025 OFFICE NMSS NMSS/MSST/SMPB NAME DSilberfeld AGiantelli DATE Jun 30, 2025 Jul 9, 2025