ML25094A088
| ML25094A088 | |
| Person / Time | |
|---|---|
| Issue date: | 04/15/2025 |
| From: | Adelaide Giantelli NRC/NMSS/DMSST/ASPB |
| To: | Menefee C State of NE, Dept of Health & Human Services |
| References | |
| Download: ML25094A088 (1) | |
Text
Charity Menefee, Director Division of Public Health Department of Health & Human Services 301 Centennial Mall South PO Box 95026 Lincoln, NE 68509-5026
SUBJECT:
NEBRASKA DRAFT IMPEP REPORT
Dear Charity Menefee:
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 Nebraska Agreement State Program (Nebraska) IMPEP review conducted on February 24-28, 2025. The teams preliminary findings were discussed with Nebraska on the last day of the review. The teams proposed recommendations are that the Nebraska Agreement State Program 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 the NRC senior managers and an Organization of Agreement States program manager.
In accordance with the IMPEP implementation procedures, the NRC is providing you with a copy of the draft report for your review and comment prior to submitting the report to the MRB.
Comments are requested within 28 days. This schedule will permit the issuance of the final report in a timely manner. If there are no comments to the IMPEP report, the MRB will receive the draft IMPEP report. If there are comments to the report, the team will review your response, make the necessary changes, and issue a proposed final report to the MRB.
The MRB meeting is scheduled to be conducted as a hybrid meeting on May 29, 2025, at 1:00 pm ET via Microsoft Teams. The NRC will provide you with Microsoft Teams connection information prior to the MRB meeting. Because the team has recommended five indicators be rated satisfactory, and just one indicator be rated satisfactory but needs improvement, you have the option to attend the MRB meeting remotely and do not need to travel.
April 14, 2025
C. Menefee If you have any questions regarding the enclosed report, please contact Lee Smith, IMPEP Project Manager, at (301) 415-5139 or IMPEP Team Leader Ryan Craffey, at (630) 829-9655.
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:
Nebraska Draft IMPEP Report cc: Becki Harisis, Manager Office of Radiological Health Becky Wisell, Deputy Director Licensure & Environmental Health Section Russ Fosler, Administrator Investigations & Environmental Health Signed by Giantelli, Adelaide on 04/14/25
Enclosure INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW OF THE NEBRASKA AGREEMENT STATE PROGRAM FEBRUARY 24-28, 2025 DRAFT REPORT
EXECUTIVE
SUMMARY
The results of the Integrated Materials Performance Evaluation Program (IMPEP) review of the Nebraska Agreement State Program (Nebraska) are discussed in this report. The review was conducted from February 24-28, 2025. Inspector accompaniments were conducted during the week of January 13, 2025.
The team found Nebraskas performance satisfactory for four of the five common performance indicators: Technical Staffing and Training; Status of Materials Inspection Program; Technical Quality of Inspections; Technical Quality of Licensing Actions. The team found Nebraskas performance satisfactory but needs improvement for the fifth common performance indicator:
Technical Quality of Incident and Allegation Activities. The team also found Nebraskas performance satisfactory for the non-common performance indicator Legislation, Regulations, and Other Program Elements.
There were no recommendations from the previous review for the team to consider, and the team made three new recommendations.
Accordingly, the team recommends that the Nebraska radiation control program be found adequate to protect public health and safety and compatible with the NRC's program. The team recommends that a periodic meeting be conducted in approximately 2 years with the next IMPEP review taking place in approximately 4 years.
Nebraska Draft IMPEP Report Page 1
1.0 INTRODUCTION
The Nebraska Agreement State Program (Nebraska) Integrated Materials Performance Evaluation Program (IMPEP) review was conducted on February 24-28, 2025, by a team of technical staff members from the U.S. Nuclear Regulatory Commission (NRC) and the Commonwealth of Kentucky. Team members are identified in Appendix A. Inspector accompaniments were conducted during the week of January 13, 2025. The specific inspector accompaniments are identified in Appendix B. The review was conducted in accordance with the Agreement State Program Policy Statement, published in the Federal Register on October 18, 2017 (82 FR 48535), and NRC Management Directive (MD) 5.6, Integrated Materials Performance Evaluation Program (IMPEP), dated July 24, 2019. Preliminary results of the review, which covered the period of February 6, 2021 - February 28, 2025, were discussed with Nebraska 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 Nebraska on November 17, 2024. Nebraska provided its response to the questionnaire on January 2, 2025. A copy of the questionnaire response is available in the NRCs Agencywide Documents Access and Management System Accession No. ML25049A251.
The Nebraska program is administered by its Office of Radiological Health which is located within the Division of Public Health in the Department of Health and Human Services (the Department). Organization charts for the State of Nebraska are available in ML25044A285.
At the time of the review, Nebraska regulated 116 specific licenses authorizing possession and use of radioactive materials. The review focused on the radiation control program as it is carried out under Section 274b. (of the Atomic Energy Act of 1954, as amended) Agreement between the NRC and the State of Nebraska.
The team evaluated the information gathered against the established criteria for each common and applicable non-common performance indicator and made a preliminary assessment of Nebraskas performance.
2.0 PREVIOUS IMPEP REVIEW AND STATUS OF RECOMMENDATIONS The previous IMPEP review concluded on February 5, 2021. The final report is available in ML21130A207. The results of that review are as follows:
Technical Staffing and Training: Satisfactory Recommendation: None Status of Materials Inspection Program: Satisfactory Recommendation: None Technical Quality of Inspections: Satisfactory Recommendation: None Technical Quality of Licensing Actions: Satisfactory Recommendation: None Technical Quality of Incident and Allegation Activities: Satisfactory Recommendation: None
Nebraska Draft IMPEP Report Page 2 Legislation, Regulations, and Other Program Elements: Satisfactory Recommendation: None Overall finding: Adequate to protect public health and safety and compatible with the NRCs 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 Nebraskas performance with respect to the following performance indicator objectives:
A well-conceived and balanced staffing strategy has been implemented throughout the review period.
Any vacancies, especially senior-level positions, are filled in a timely manner.
There is a balance in staffing of the licensing and inspection programs.
Management is committed to training and staff qualification.
Agreement State training and qualification program is equivalent to NRC Inspection Manual Chapter (IMC) IMC 1248, Formal Qualifications Program for Federal and State Material and Environmental Management Programs.
Qualification criteria for new technical staff are established and are followed, or qualification criteria will be established if new staff members are hired.
Individuals performing materials licensing and inspection activities are adequately qualified and trained to perform their duties.
License reviewers and inspectors are trained and qualified in a reasonable period.
b.
Discussion Nebraskas Program is comprised of six staff members (one director, three health physicists, and two administrative staff) which equals 5.8 full-time equivalent (FTE) for the radiation control program when fully staffed. The 5.8 FTE is comprised of 3.85 technical FTE and 1.95 administrative FTE. There were no vacancies at the time of the on-site review. During the review period, one of the health physicists was promoted to the Director position and the vacated position was replaced by another health physicist. The second health physicist position was staffed for the entire review period. The third health physicist position
Nebraska Draft IMPEP Report Page 3 experienced two attritions during the review period. The third position is currently staffed; but, was vacant for 5 months before being staffed and then vacant again for 4 months.
The team noted that Nebraskas training and qualification program was compatible with the NRCs IMC 1248. All technical staff do both licensing and inspections, and at the time of the review, the director and all three of the health physicists were qualified to conduct materials licensing reviews. The director and all but one of the health physicists were qualified to conduct inspections. Two of the health physicists licensing qualifications were newly certified during the review period, and one of those health physicists inspection qualifications was certified during the review period. The Programs qualification process uses a combination of on-the-job training and NRC sponsored courses. The qualifications are documented in a journal and indicated complete when signed off by the Program manager. The team noted that qualified staff received the 24-hour refresher training as detailed in the NRC IMC 1248.
c.
Evaluation The team determined that, during the review period, Nebraska met the performance indicator objectives listed in Section 3.1.a. Based on the criteria in MD 5.6, the team recommends that Nebraskas performance with respect to the indicator, Technical Staffing and Training, be found satisfactory.
d.
Management Review Board (MRB) Discussion and Chairs Determination The final report will present the MRB Chairs determination regarding this indicator.
3.2 Status of Materials Inspection Program Inspections of licensed operations are essential to ensure that activities are being conducted in compliance with regulatory requirements and consistent with good safety and security practices.
The frequency of inspections is specified in IMC 2800, Materials Inspection Program, and is dependent on the amount and type of radioactive material, the type of operation licensed, and the results of previous inspections. There must be a capability for maintaining and retrieving statistical data on the status of the inspection program.
a.
Scope The team used the guidance in SA-101, Reviewing the Common Performance Indicator:
Status of the Materials Inspection Program, and evaluated Nebraskas 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.
Nebraska Draft IMPEP Report Page 4 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 Nebraska performed 96 Priority 1, 2, 3, and initial inspections during the review period. No Priority 1, 2, 3 or initial inspections were conducted overdue during the review period, and none were overdue at the time of the review.
Nebraskas inspection frequencies were the same or more frequent for similar license types in the NRCs program.
Nebraska tracks the timely issuance of inspection reports with a web-based licensing (WBL) query run weekly on all open inspections. A review of inspection data in WBL and subsequent sampling of inspection reports indicated that none of the inspection findings were communicated to the licensees beyond 30 days after the completion of an inspection or 45 days after completion of a team inspection.
Per Radioactive Materials Program Procedure 3.01, Nebraska attempts to conduct reciprocity inspections as time allows and in accordance with IMC 2800, Section 7.04.
Nebraska prioritizes the licensees inspection priority as well as its inspection, enforcement, and incident history with the issuing state to make risk-informed, performance-based decisions on when to attempt a reciprocity inspection.
During the review period, Nebraska approved 13 priority 1, 2, and 3 licensees to operate under reciprocity in 2021, 14 in 2022, 13 in 2023, and 14 in 2024. One such licensee, approved in December 2023, was prioritized for inspection based on an unfavorable inspection, enforcement, and incident history with the issuing state. Nebraska conducted an inspection of this licensee the same month. This was the only reciprocity inspection Nebraska performed during the review period.
Many licensees operating in Nebraska under reciprocity during the review period worked on short notice in remote areas of the far western and southwestern portions of the state.
Moreover, early in the review period Nebraska only had one qualified inspector who was also the only qualified license reviewer. Nebraska consciously prioritized routine inspections and licensing over the conduct of reciprocity inspections at the time to ensure that it continued to complete timely licensing actions and conduct timely routine and initial inspections. However, the review team noted that the prioritization of routine inspections and licensing over reciprocity inspections was still evident in the program even as a second inspector became qualified and a third was imminently approaching qualification.
c.
Evaluation The team determined that, during the review period, Nebraska met the performance indicator objectives listed in Section 3.2.a. Based on the criteria in MD 5.6, the team recommends that Nebraskas performance with respect to the indicator, Status of Materials Inspection Program, be found satisfactory, with one recommendation:
The review team therefore recommends that Nebraska should re-evaluate its workload balance between program areas and re-prioritize the conduct of reciprocity inspections accordingly to complete more of them during the next review period.
Nebraska Draft IMPEP Report Page 5 d.
MRB Discussion and Chairs Determination The final report will present the MRB Chairs determination regarding this indicator.
3.3 Technical Quality of Inspections Inspections, both routine and reactive, provide reasonable assurance that licensee activities are carried out in a safe and secure manner. Accompaniments of inspectors performing inspections and the critical evaluation of inspection records are used to assess the technical quality of an inspection program.
a.
Scope The team used the guidance in SA-102, Reviewing the Common Performance Indicator:
Technical Quality of Inspections, and evaluated Nebraskas performance with respect to the following performance indicator objectives:
Inspections of licensed activities focus on health, safety, and security.
Inspection findings are well-founded and properly documented in reports.
Management promptly reviews inspection results.
Procedures are in place and used to help identify root causes and poor licensee performance.
Inspections address previously identified open items and violations.
Inspection findings lead to appropriate and prompt regulatory action.
Supervisors, or senior staff as appropriate, conduct annual accompaniments of each inspector to assess performance and assure consistent application of inspection policies.
For Programs with separate licensing and inspection staffs, procedures are established and followed to provide feedback information to license reviewers.
Inspection guides are compatible with NRC guidance.
An adequate supply of calibrated survey instruments is available to support the inspection program.
b.
Discussion The team evaluated 16 inspection reports and enforcement documentation, and interviewed inspectors involved in materials inspections conducted during the review period. The team reviewed casework for inspections conducted by all of Nebraskas qualified inspectors and covered medical, industrial, commercial, and academic licenses.
Team members accompanied both of Nebraskas qualified inspectors during the week of January 13, 2025. Specific inspector accompaniments are identified in Appendix B. The team determined that the inspectors performances observed during the inspector accompaniments indicated that the inspectors were knowledgeable of the requirements for each license type and maintained a strong focus on health, safety, and security while conducting the inspections in a professional, risk-informed and performance-based manner.
The inspectors were well-prepared and thorough, addressing all previously identified open violations.
The team confirmed that findings from both accompaniments led to prompt and appropriate regulatory action. The team noted that findings were verbally communicated at the conclusion of the on-site inspections using varied terminology which impacted the clarity of these findings and expectations. However, all findings and expectations were clearly and
Nebraska Draft IMPEP Report Page 6 crisply communicated in final inspection documentation. The team discussed this with Nebraska during the accompaniment debriefs to stress the value of clarity and consistency throughout the inspection process.
Nebraska maintains an adequate supply of calibrated radiation detection equipment, including alpha, beta, gamma, identification, and air monitoring capabilities. Neutron monitoring capabilities were available from the University of Nebraska on request.
c.
Evaluation The team determined that, during the review period, Nebraska met the performance indicator objectives listed in Section 3.3.a. Based on the criteria in MD 5.6, the team recommends that Nebraskas 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 Nebraska 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 Nebraskas 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.
Nebraska Draft IMPEP Report Page 7 b.
Discussion During the review period, Nebraska performed 547 radioactive materials licensing actions.
The team evaluated 28 of those licensing actions. The licensing actions selected for review included 2 new applications, 13 amendments, 7 renewals, 3 terminations, 1 change of ownership, and 2 financial assurance actions. The team evaluated casework which included the following license types and actions: broad scope, medical diagnostic, medical therapy, gamma knife, commercial manufacturing and distribution, industrial radiography, academic, nuclear pharmacy, gauges, self-shielded irradiators, and financial assurance. The casework sample represented work from 6 license reviewers.
In all licensing actions reviewed, the team found licensing actions to be thorough, complete, consistent, and of high quality with health, safety, and security issues properly addressed.
No renewal applications have been pending for one year or more. The team found that licensing reviewers factored inspection and enforcement history into their evaluations. The team discussed benefits of adding a section to Nebraskas renewal checklist to clarify that the Program reviewed past inspection and enforcement actions during the review.
The team evaluated the implementation of the Pre-Licensing Guidance and RSRM checklists. The Program conducted pre-licensing visits for unknown entities in accordance with the checklist and properly implemented the Pre-Licensing Guidance. For applications with RSRM, the Program completed the RSRM checklist and performed on-site security reviews, as necessary.
The team determined that documents containing sensitive security information were marked, handled, and secured appropriately.
c.
Evaluation The team determined that, during the review period, Nebraska met the performance indicator objectives listed in Section 3.4.a. Based on the criteria in MD 5.6, the team recommends that Nebraskas performance with respect to the indicator, Technical Quality of Licensing Actions, be found satisfactory.
d.
MRB Discussion and Chairs Determination The final report will present the MRB Chairs determination regarding this indicator.
3.5 Technical Quality of Incident and Allegation Activities The quality, thoroughness, and timeliness of response to incidents and allegations of safety concerns can have a direct bearing on public health, safety and security. An assessment of incident response and allegation investigation procedures, actual implementation of these procedures internal and external coordination, timely incident reporting, and investigative and follow-up actions, are a significant indicator of the overall quality of the incident response and allegation programs.
Nebraska Draft IMPEP Report Page 8 a.
Scope The team used the guidance in SA-105, Reviewing the Common Performance Indicator:
Technical Quality of Incident and Allegation Activities, and evaluated Nebraskas performance with respect to the following performance indicator objectives:
Incident response and allegation procedures are in place and followed.
Response actions are appropriate, well-coordinated, and timely.
On-site responses are performed when incidents have potential health, safety, or security significance.
Appropriate follow-up actions are taken to ensure prompt compliance by licensees.
Follow-up inspections are scheduled and completed, as necessary.
Notifications are made to the NRC Headquarters Operations Center for incidents requiring a 24-hour or immediate notification to the Agreement State or NRC.
Incidents are reported to the Nuclear Material Events Database (NMED) and closed when all required information has been obtained.
Allegations are investigated in a prompt, appropriate manner.
Concerned individuals are notified within 30 days of investigation conclusions.
Concerned individuals identities are protected, as allowed by law.
b.
Discussion During the review period, four radioactive materials incidents were reported to Nebraska.
The team evaluated all four incidents, which included three equipment failures and one lost radioactive source. Nebraska did not dispatch inspectors for on-site follow-up for any of the cases reviewed, electing instead to follow-up via phone or email.
When notified of an incident, management and staff met to discuss the incident to determine the appropriate level of response, which could range from an immediate response to reviewing the incident during the next routine scheduled inspection. Determinations were made based on both the circumstances of the incident and its associated health and safety significance. The team found it difficult to determine whether Nebraskas evaluation of incident notifications and subsequent response were thorough, well balanced, complete, and comprehensive, as Nebraskas Radioactive Materials Procedure 4.02, Radioactive Material Events, did not address or require documentation of decision-making. The team noted that Nebraska documented its decision for only one of the four incidents. Despite limitations in the documentation available for review, staff interviews provided insight into Nebraskas evaluation and response to incidents and communicated that health and safety were maintained during the process.
Nebraska initiated a response to all four incidents on the date they were reported. Nebraska recorded incident information in NMED, including a description of events that contributed to the incidents occurrence and additional details from subsequent correspondence provided by licensees. The team noted that, in response to two of the four incidents, Nebraska issued a Notice of Non-Compliance to the licensee. However, in both cases Nebraska did not complete a narrative inspection report or field notes, as required by Radioactive Materials Procedure 3.04, Documentation of Inspection Results, to document its review of the incident during the inspection.
The team noted that Nebraskas response to one of the four incidents did not include any follow-up on the licensees corrective actions during the next routine inspection. The Program did not record the event in its inspection history log sheet, which summarized past licensee activities and was routinely reviewed by staff prior to the next inspection. The team
Nebraska Draft IMPEP Report Page 9 learned that documents were removed from the file during the license renewal, which occurred after the event. The team also noted that Nebraska did not record a second incident in its inspection history log for follow-up on the next routine inspection. While the inspection report did include a brief description of the incident, it did not document confirmation that the licensees corrective actions were complete and effective. Nebraska indicated that incident documentation would be placed in a different part of the file to ensure that staff could access incident investigation information for future follow-up.
The team also evaluated Nebraskas reporting of incidents to the NRCs Headquarters Operations Officer (HOO). In each case requiring HOO notification, Nebraska reported the incidents within the required time frame. The team also evaluated whether Nebraska had missed reporting any required incidents to the HOO and did not identify any missed reporting requirements. This included a review of an event that was retracted from NMED during the on-site review of Nebraskas Program. Staff adhered to the NRCs established guidance in making the determination. All reportable incidents were closed and complete in NMED. The team observed that Nebraska used a peer review process to ensure that entries into NMED were complete.
During the review period, two allegations were received by Nebraska. The team evaluated both allegations including one that the NRC referred to the State. Nebraska employed appropriate controls to protect sensitive and confidential information related to allegations received. The Nebraska Program operated in a controlled area requiring badge access and allegation investigation information was stored in color coded locked files within the controlled area. Documents were appropriately marked to prevent inadvertent release of the information to the public in accordance with applicable state law. Access was limited to staff with a need to know who were the only staff with access to the file keys. Staff were designated as need to know by the Radiation Control Program Director. Prior to releasing information, Nebraska provided records to the Program attorney who reviewed the documents to ensure that information was protected and not inadvertently released.
Confidential informants or allegers were provided with a nondisclosure form to complete.
Inspection documentation demonstrated follow-up during a subsequent 2024 routine inspection, and Nebraska demonstrated that the alleger was advised of the investigation findings in a timely manner.
c.
Evaluation The team determined that, during the review period, Nebraska met the performance indicator objectives listed in Section 3.5.a, except:
Incident response and allegation procedures are in place and followed. In two instances documentation required by procedure was not generated for a reactive inspection.
Response actions are appropriate, well-coordinated, and timely. It was difficult for the team to evaluate this, due to limited documentation.
Follow-up inspections are scheduled and completed, as necessary. In one instance, an event related to lost material was not reviewed during the next inspection due to missing documentation.
Based on these findings, the team considered whether Nebraskas performance met the performance criteria for a rating of satisfactory but needs improvement as established in MD 5.6 and SA-105. Specifically, the team noted that MD 5.6 states in Section III.F.2 that
Nebraska Draft IMPEP Report Page 10 consideration should be given to a finding of satisfactory but needs improvement when a review demonstrates the presence of one or more of the following conditions:
(a) Incident response and allegation procedures are not compatible with more than a few, but less than most, of the criteria specified in NMSS procedure SA-105.
Section V.C.3 of NMSS procedure SA-105 provides the following criteria:
(f) Reviewers should confirm that inquiries made to evaluate the need for on-site investigation are conducted in accordance with procedures.
(h) Reviewers should confirm that follow-up of incidents is conducted during the next scheduled inspection.
Nebraskas incident response procedure was not compatible with these criteria because it did not formalize a method to ensure that follow-up inspections were completed, as necessary. Further, it did not formalize a decision-making process or require documentation of decisions for future review.
In addition, the review demonstrated the presence of the following condition from Section III.F.2:
(b) Incident response and allegation procedures are not implemented for the type of incident or allegation consistent with the criteria specified in NMSS procedure SA-105 or compatible Agreement State procedure in more than a few, but less than most, of the cases reviewed.
Nebraska did not follow its incident response procedure in two instances when it issued a Notice of Non-Compliance to the respective licensee without documenting findings without completing a narrative inspection report or field notes to document their analysis and findings.
Based on the IMPEP evaluation criteria in MD 5.6, the team recommends that Nebraskas performance with respect to the indicator, Technical Quality of Incident and Allegation Activities, be found satisfactory, but needs improvement.
The Team made one new recommendation as follows:
Nebraska should revise its incident response procedures to: (1) ensure that the full scope of its incident evaluation and response measures, including decision-making as to the appropriate level of response, and independent assessment as to the adequacy of licensee-supplied information and corrective actions, is documented; and to (2) ensure appropriate incident follow-up during the next routine inspection.
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
Nebraska Draft IMPEP Report Page 11 (4) Uranium Recovery (UR) Program. The NRC retained regulatory authority for the UR Program for the entirety of the review period; therefore, only the first three non-common performance indicators applied to this review.
4.1 Legislation, Regulations, and Other Program Elements State statutes should authorize the State to establish a program for the regulation of agreement material and provide authority for the assumption of regulatory responsibility under the States agreement with the NRC. The statutes must authorize the State to promulgate regulatory requirements necessary to provide reasonable assurance of adequate protection of public health, safety, and security. The State must be authorized through its legal authority to license, inspect, and enforce legally binding requirements, such as regulations and licenses. The NRC regulations that should be adopted by an Agreement State for purposes of compatibility or health and safety, should be adopted in a time frame so that the effective date of the State requirement is not later than 3 years after the effective date of the NRC's final rule. Other program elements that have been designated as necessary for maintenance of an adequate and compatible program should be adopted and implemented by an Agreement State within 6 months following NRC designation. A Program Element Table indicating the Compatibility Categories for those program elements other than regulations can be found on the NRC web site at the following address: https://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 Nebraskas performance with respect to the following performance indicator objectives. A complete list of regulation amendments can be found on the NRC website at the following address: https://scp.nrc.gov/regtoolbox.html.
The Agreement State program does not create conflicts, duplications, gaps, or other conditions that jeopardize an orderly pattern in the regulation of radioactive materials under the Atomic Energy Act of 1954, as amended.
Regulations adopted by the Agreement State for purposes of compatibility or health and safety were adopted no later than 3 years after the effective date of the NRC regulation.
Other program elements, as defined in SA-200 that have been designated as necessary for maintenance of an adequate and compatible program, have been adopted and implemented within 6 months of NRC designation.
The State statutes authorize the State to establish a program for the regulation of agreement material and provide authority for the assumption of regulatory responsibility under the agreement.
The State is authorized through its legal authority to license, inspect, and enforce legally binding requirements such as regulations and licenses.
Sunset requirements, if any, do not negatively impact the effectiveness of the States regulations.
b.
Discussion The Nebraska Agreement State Programs current effective statutory authority is contained in Title 180 of the Nebraska Administrative Code, of the Nebraska Statutes. The Department of Health and Human Services is designated as the States radiation control agency. There are eight pieces of legislation that affect the radiation control program. Because none of these existing or amended pieces of legislation had a direct impact on the radiation control program, they were not submitted to NRC for review. This legislation included:
Nebraska Draft IMPEP Report Page 12 Radiation Control Act 71-3501 to 71-3520 (Existing)
Transportation of High-level Radioactive Waste and Transuranic Waste 71-3523 to -
3528 (Existing)
Certified Registered Nurse Anesthetist Practice Act 38-701 to -711 (Existing)
Advanced Practice Registered Nurse Practice Act 38-201 to -213 (Amended 2022)
Nebraska Emergency Management Act 81-829.36 to -829.75 (Amended 2024)
Emergency, Governor, Civil Defense Assumption of Control of State Communication System 81-1120.25 (Existing)
Administrative Procedures Act 84-901 to -920 (Amended 2024)
Low-Level Radioactive Waste Disposal Act 81-1578 to -15,116 (Existing)
Nebraskas administrative rulemaking process takes approximately 17 months from drafting to finalizing a rule. The public, NRC, other agencies, and potentially impacted licensees and registrants are offered an opportunity to comment during the process. Comments were considered and incorporated, as appropriate, before the regulations were finalized and approved by the Department. The team noted that the States rules and regulations were not subject to sunset laws.
During the review period, Nebraska submitted 9 proposed regulation amendments, 12 final regulation amendments, and no legally binding requirements or license conditions to the NRC for a compatibility review. At the time of the review, none of the amendments were overdue for adoption.
The team also reviewed other program elements designated as necessary for the maintenance of an adequate and compatible program. The other program elements included: licensing guidance, inspection guidance, and new or revised medical guidance.
Program elements require adoption by Nebraska within 6 months of NRC issuance. The team determined that Nebraska implemented these program elements, as required.
The team noted that Nebraskas allegations procedure was inconsistent with NRCs (and other) allegations procedures in one respect, by allowing a six-month response window for less safety significant allegations. The threshold of safety significance to allow such a long response window was not defined in the procedure. The review team discussed this inconsistency and the challenges it could pose with Nebraska. Because Nebraska has never utilized this six-month response allowance, and does not anticipate ever needing it in the future, given the small number of allegation responses required, Nebraska agreed to update its allegations procedure to remove the extended window for low priority allegations. The review team made a recommendation to revise that procedure, accordingly.
c.
Evaluation The team determined that, during the review period, Nebraska met the performance indicator objectives listed in Section 4.1.a. Based on the criteria in MD 5.6, the team recommends that Nebraskas performance with respect to the indicator, Legislation, Regulations, and Other Program Elements, be found satisfactory.
The team made one new recommendation as follows:
Nebraska should revise its allegations procedure to remove the six-month allowance for responding for lower priority items.
Nebraska Draft IMPEP Report Page 13 d.
MRB Discussion and Chairs Determination The final report will present the MRB Chairs determination regarding this indicator.
4.2 SS&D Evaluation Program Although Nebraska has authority to conduct SS&D evaluations for byproduct, source, and certain special nuclear materials, Nebraska did not conduct any SS&D evaluations during the review period, nor did they have any pending applications for an SS&D evaluation. There are currently no SS&D manufacturers in Nebraska and the Program has no qualified reviewers. If Nebraska were to receive an application for an SS&D action, it would have to outsource the action. Accordingly, the team did not review this indicator.
4.3 LLRW Disposal Program In 1981, the NRC amended its Policy Statement, Criteria for Guidance of States and NRC in Discontinuance of NRC Regulatory Authority and Assumption Thereof by States Through Agreement, to allow a State to seek an amendment for the regulation of LLRW as a separate category. Although Nebraska has authority to regulate a LLRW disposal facility, the NRC has not required States to have a program for licensing a disposal facility until the State has been designated as a host State for a LLRW disposal facility. When an Agreement State has been notified or becomes aware of the need to regulate a LLRW disposal facility, it is expected to put in place a regulatory program that will meet the criteria for an adequate and compatible LLRW disposal program. There are no plans for a LLRW disposal facility in Nebraska. Accordingly, the team did not review this indicator.
5.0
SUMMARY
The team found Nebraskas performance satisfactory for four of the five common performance indicators: Technical Staffing and Training; Status of Materials Inspection Program; Technical Quality of Inspections; Technical Quality of Licensing Actions. The team found Nebraskas performance satisfactory but needs improvement for the fifth common performance indicator:
Technical Quality of Incident and Allegation Activities. The team also found Nebraskas performance satisfactory for the non-common performance indicator Legislation, Regulations, and Other Program Elements.
There were no recommendations from the previous review for the team to consider, and the team made three new recommendations:
Nebraska should re-evaluate its workload balance between program areas and re-prioritize the conduct of reciprocity inspections accordingly to complete more of them during the next review period.
Nebraska should revise its incident response procedures to: (1) ensure that the full scope of its incident evaluation and response measures including decision-making as to the appropriate level of response, and independent assessment as to the adequacy of licensee supplied information and corrective actions is documented; and to (2) ensure appropriate incident follow-up during the next routine inspection.
Nebraska should revise its allegations procedure to remove the six-month allowance for responding for lower priority items.
Nebraska Draft IMPEP Report Page 14 Accordingly, the team recommends that the Nebraska radiation control program be found adequate to protect public health and safety and compatible with the NRC's program. The team recommends that a periodic meeting be conducted 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 Ryan Craffey, NRC, Region III Team Leader Status of Materials Inspection Program Technical Quality of Inspections Inspector Accompaniments Sara Forster, NRC, Region III Team Leader in Training Inspector Accompaniments Randy Erickson, NRC, Region IV Technical Staffing and Training Legislation, Regulations, and Other Program Elements Russell Hestand, KY, DPH Technical Quality of Licensing Actions Lisa Forney, NRC, NMSS Technical Quality of Incident and Allegation Activities
APPENDIX B INSPECTOR ACCOMPANIMENTS The following inspector accompaniments were performed prior to the on-site IMPEP review:
Accompaniment No.: 1 License No.: 14-03-01 License Type: Medical Institution Priority: 2 Inspection Date: 1/14/2025 Inspectors initials: MG & BM Accompaniment No.: 2 License No.:10-08-01 License Type: Panoramic Irradiator Priority: 2 Inspection Date: 01/15-16/2025 Inspectors initials: MG & BM
ML25094A088 OFFICE R-III/DNMS/MIB R-III/DNMS/MLB NMSS/MSST NMSS/MSST/SLPB NAME RCraffey SForster LSmith RJohnson DATE Apr 8, 2025 Apr 8, 2025 Apr 8, 2025 Apr 8, 2025 OFFICE NMSS/MSST/SMPB RES/DSA/AAB NMSS/MSST/SMPB NAME AGiantelli TBloomer AGiantelli DATE Apr 10, 2025 Apr 14, 2025 Apr 14, 2025