ML25027A353
| ML25027A353 | |
| Person / Time | |
|---|---|
| Issue date: | 02/13/2025 |
| From: | Robert Lewis NRC/EDO/DEDMRS |
| To: | Werner M State of WI, Dept of Public Health |
| References | |
| Download: ML25027A353 (1) | |
Text
Mark Werner, Ph.D., Director Bureau of Environmental and Occupational Health Division of Public Health Department of Health Services 1 West Wilson Street, Room 150 Madison, WI 53701-2659
SUBJECT:
WISCONSIN FINAL IMPEP REPORT
Dear Dr. Werner:
On January 23, 2025, the Management Review Board (MRB) met, which consisted of the U.S. Nuclear Regulatory Commission (NRC) senior managers and an Organization of Agreement States member, to consider the proposed final Integrated Materials Performance Evaluation Program (IMPEP) report on the Wisconsin Agreement State Program. The MRB found the Wisconsin program adequate to protect public health and safety, and compatible with the NRC program.
The enclosed final report documents the IMPEP teams findings and summarizes the results of the MRB meeting. Since Wisconsin has had at least two consecutive IMPEP reviews with all performance indicators being found satisfactory, the MRB Chair determined that the next periodic meeting will take place in approximately 2.5 years with the next IMPEP review of the Wisconsin Agreement State Program taking place in approximately 5 years.
I appreciate the courtesy and cooperation extended to the IMPEP team during the review. I also wish to acknowledge your continued support for the Agreement State program. I look forward to our agencies continuing to work cooperatively in the future.
Sincerely, Robert J. Lewis Deputy Executive Director for Nuclear Materials, Administrative, and Corporate Programs Office of the Executive Director for Operations
Enclosures:
1.
Final FY2024 Wisconsin IMPEP Report 2.
2024 Wisconsin MRB Meeting Participants February 13, 2025 Signed by Lewis, Robert on 02/13/25
M. Werner cc: Mark Paulson, Section Manager Radiation Protection Section Megan Shober, Supervisor Radiation Protection Section INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW OF THE WISCONSIN AGREEMENT STATE PROGRAM SEPTEMBER 23-27, 2024 FINAL REPORT
EXECUTIVE
SUMMARY
The results of the Integrated Materials Performance Evaluation Program (IMPEP) review of the Wisconsin Agreement State Program (Wisconsin) are discussed in this report. The review was conducted from September 23-27, 2024. Inspector accompaniments were conducted during the week of August 27-29, 2024.
Based on the results of the 2024 IMPEP review, Wisconsins performance was found satisfactory for all performance indicators reviewed: Technical Staffing and Training; Status of Materials Inspection Program; Technical Quality of Inspections; Technical Quality of Licensing Actions; Technical Quality of Incident and Allegation Activities; and Legislation, Regulations, and Other Program Elements.
There were no recommendations from the previous IMPEP review for consideration, and the team did not make any new recommendations.
Accordingly, the Management Review Board (MRB) Chair found the Wisconsin radiation control program adequate to protect public health and safety and compatible with the U.S. Nuclear Regulatory Commissions (NRC's) program. Since Wisconsin has had at least two consecutive IMPEP reviews with all performance indicators being found satisfactory, the MRB Chair determined that the next periodic meeting be held in approximately 2.5 years and the next IMPEP review takes place in approximately 5 years.
Wisconsin Final IMPEP Report Page 1
1.0 INTRODUCTION
The Wisconsin Agreement State Program (Wisconsin) Integrated Materials Performance Evaluation Program (IMPEP) review was conducted from September 23-27, 2024, by a team of technical staff members from the U.S. Nuclear Regulatory Commission (NRC), the Commonwealth of Kentucky, and the Commonwealth of Massachusetts. Team members are identified in Appendix A. Inspector accompaniments were conducted between August 27-29, 2024. The inspector accompaniments are identified in Appendix B. The review was conducted in accordance with the Agreement State Program Policy Statement, published in the Federal Register on October 18, 2017 (82 FR 48535), and NRC Management Directive (MD) 5.6, Integrated Materials Performance Evaluation Program (IMPEP), dated July 24, 2019.
Preliminary results of the review, which covered the period of July 13, 2019, through September 27, 2024, were discussed with Wisconsin 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 the State of Wisconsin on July 29, 2024. Wisconsin provided its response to the questionnaire on September 9, 2024. A copy of the questionnaire response is available in the NRCs Agencywide Documents Access and Management System Accession No. ML24255A863.
The team issued a draft report to Wisconsin on November 5, 2024, for factual comment in ML24295A154. Wisconsin responded with minor comments on the draft report by letter dated November 19, 2024, from Mark Warner, Ph.D. Director, Bureau of Environmental and Occupational Health, Department of Health in ML24339B777. The team addressed Wisconsins comments, as appropriate, in the proposed final IMPEP report dated December 16, 2024 ML24346A070.
Wisconsin is administered by the Radiation Protection Section. The Section is part of the Bureau of Environmental and Occupational Health within the Division of Public Health (the Division). The Division is part of the Department of Health Services (the Department).
Organization charts for State of Wisconsin are available in ML24255A109.
At the time of the review, Wisconsin regulated 260 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 Wisconsin.
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 the Wisconsins performance.
2.0 PREVIOUS IMPEP REVIEW AND STATUS OF RECOMMENDATIONS The previous IMPEP review concluded on July 12, 2019. The final report is available in ML19273B726. The results of the review are as follows:
Technical Staffing and Training: Satisfactory Recommendation: None Status of Materials Inspection Program: Satisfactory Recommendation: None
Wisconsin Final IMPEP Report Page 2 Technical Quality of Inspections: Satisfactory Recommendation: None Technical Quality of Licensing Actions: Satisfactory Recommendation: None Technical Quality of Incident and Allegation Activities: Satisfactory Recommendation: None Legislation, Regulations and Other Program Elements: Satisfactory Recommendation: None Overall finding: Adequate to protect public health and safety and compatible with the NRC's program. The team further recommended, and the Management Review Board (MRB) agreed, that a periodic meeting be held within 2.5 years and that a follow-up IMPEP review take place 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 Wisconsins performance with respect to the following performance indicator objectives:
A well-conceived and balanced staffing strategy has been implemented throughout the review period.
Any vacancies, especially senior-level positions, are filled in a timely manner.
There is a balance in staffing of the licensing and inspection programs.
Management is committed to training and staff qualification.
Agreement State training and qualification program is equivalent to the NRC Inspection Manual Chapter (IMC) IMC 1248, 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.
Wisconsin Final IMPEP Report Page 3 b.
Discussion Wisconsin is comprised of nine technical staff members which equals 7.5 full-time equivalent (FTE) for the radiation control program when fully staffed. There was one vacancy at the time of the review. During the review period, six staff members left the program and six staff members were hired. The positions were vacant from 5-9 months. There was no impact to the program due to the open positions.
Wisconsin has a training and qualification program compatible with the NRCs IMC 1248.
Four of the employees hired during the review period had a bachelors degree in science, nuclear medicine technology, health physics, and/or engineering, and two members of the staff had masters degrees in science. The program attracts and retains highly qualified candidates with a competitive salary increase during the review period. Wisconsin management is very supportive of the training program, and the staff is encouraged to attend NRC training courses. Continuing education and professional development are promoted and tracked by the supervisor. The training qualification records that are used to track qualification milestones are comprehensive and includes self-study, in-house training, on-the-job training, and formal courses. A mentoring program has been implemented where the supervisor, senior inspectors, and license reviewers provide on-the-job training for the junior staff. The mentoring program incorporates training modules for advanced technical licensees and emerging technologies, such as fusion. The fully qualified staff also receive support for the 24-hour refresher training that is detailed in IMC 1248.
c.
Evaluation The team determined that, during the review period, Wisconsin met the performance indicator objectives listed in Section 3.1.a. Based on the criteria in MD 5.6, the team recommends that Wisconsins performance with respect to the indicator, Technical Staffing and Training, be found satisfactory.
d.
MRB Discussion and Chairs Determination The MRB Chair agreed with the teams recommendation and found Wisconsins performance with respect to this indicator satisfactory.
3.2 Status of Materials Inspection Program Inspections of licensed operations are essential to ensure that activities are being conducted in compliance with regulatory requirements and consistent with good safety and security practices.
The frequency of inspections is specified in IMC 2800, Materials Inspection Program, and is dependent on the amount and type of radioactive material, the type of operation licensed, and the results of previous inspections. There must be a capability for maintaining and retrieving statistical data on the status of the inspection program.
a.
Scope The team used the guidance in SA-101, Reviewing the Common Performance Indicator:
Status of the Materials Inspection Program, and evaluated Wisconsins 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).
Wisconsin Final IMPEP Report Page 4 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 Wisconsin performed 241 Priority 1, 2, 3, and initial inspections during the review period.
Four Priority 1, 2, or 3; and five initial inspections were conducted overdue resulting in less than one percent overdue inspection. The team noted that Temporary Instruction (TI) TI-003 states, in part, that for inspections that exceed the scheduling window with overdue dates falling inside the defined time frame of the pandemic, the number of overdue inspections should be noted in the report but should not be counted. Wisconsin continued to maintain health, safety, and security during this time frame. Four of the overdue initial inspections and all of the overdue Priority 1, 2, and 3 inspections were overdue because of impacts related to the pandemic. Therefore, the team did not include these eight inspections when performing the calculation. Wisconsins inspection frequencies were consistent for similar license types in NRCs program.
In a sampling of 20 inspection reports, the team found that all inspection findings were communicated to the licensees within 30 days after the inspection exit.
Wisconsin performed greater than 25 percent of candidate reciprocity inspections for each year of the review period.
c.
Evaluation The team determined that, during the review period, Wisconsin met the performance indicator objectives listed in Section 3.2.a. Based on the criteria in MD 5.6, the team recommends that Wisconsins performance with respect to the indicator, Status of Materials Inspection Program, be found satisfactory.
d.
MRB Discussion and Chairs Determination The MRB Chair agreed with the teams recommendation and found Wisconsins performance with respect to this indicator satisfactory.
3.3 Technical Quality of Inspections Inspections, both routine and reactive, provide reasonable assurance that licensee activities are carried out in a safe and secure manner. Accompaniments of inspectors performing inspections, and the critical evaluation of inspection records are used to assess the technical quality of an inspection program.
Wisconsin Final IMPEP Report Page 5 a.
Scope The team used the guidance in SA-102, Reviewing the Common Performance Indicator:
Technical Quality of Inspections, and evaluated Wisconsins 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.
Adequate supply of calibrated survey instruments is available to support the inspection program.
b.
Discussion The team evaluated 20 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 eight of Wisconsins inspectors and covered medical, industrial, commercial, academic, research, and service licenses.
The team determined that the inspection plans and reports generated by the inspectors were exceptional. The team found that inspection documents were thorough, complete, consistent, and of acceptable technical quality with health, safety, and security issues properly addressed, and that management promptly reviewed inspection results. Inspection findings were well-founded, clearly communicated to the licensee and violations were written with direct link to a regulation or license condition. In the casework reviewed, every inspection addressed previously identified open items and violations. Wisconsin implemented a narrative inspection report template which is particularly effective in painting a clear picture of licensed activities. These reports included thorough discussion of licensees enforcement history to ensure successful implementation of corrective actions. In addition, the team determined that supervisory accompaniments were conducted annually for all inspectors, except for part of 2020 and 2021, due to the pandemic. The inspectors that were not accompanied during that time frame performed remote inspections and adequately addressed any potential health and safety concerns.
The team lead accompanied four inspectors in August of 2024. The inspector accompaniments are identified in Appendix B. The team determined that the inspectors performance observed during the inspector accompaniments indicated that the inspectors were knowledgeable of the requirements for each license type and were able to identify potential health, safety, and security concerns.
The team found an adequate supply of calibrated survey instruments is available to support the program and are calibrated at the required frequency. Calibration records for the instruments are maintained on file.
Wisconsin Final IMPEP Report Page 6 c.
Evaluation The team determined that, during the review period, Wisconsin met the performance indicator objectives listed in Section 3.3.a. Based on the criteria in MD 5.6, the team recommends that Wisconsins performance with respect to the indicator, Technical Quality of Inspections be found satisfactory.
d.
MRB Discussion and Chairs Determination The MRB Chair agreed with the teams recommendation and found Wisconsins performance with respect to this indicator satisfactory.
3.4 Technical Quality of Licensing Actions The quality, thoroughness, and timeliness of licensing actions can have a direct bearing on public health and safety, as well as security. An assessment of licensing procedures, implementation of those procedures, and documentation of communications and associated actions between the Wisconsin 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 Wisconsins performance with respect to the following performance indicator objectives:
Licensing action reviews are thorough, complete, consistent, and of acceptable technical quality with health, safety, and security issues properly addressed.
Essential elements of license applications have been submitted and elements are consistent with current regulatory guidance (e.g., pre-licensing guidance, Title 10 of the Code of Federal Regulations (10 CFR) Part 37, financial assurance, etc.).
License reviewers, if applicable, have the proper signature authority for the cases they review independently.
License conditions are stated clearly and can be inspected.
Deficiency letters clearly state regulatory positions and are used at the proper time.
Reviews of renewal applications demonstrate a thorough analysis of a licensees inspection and enforcement history.
Applicable guidance documents are available to reviewers and are followed (e.g., NUREG-1556 series, pre-licensing guidance, regulatory guides, etc.).
Licensing practices for Risk-Significant Radioactive Materials (RSRM) are appropriately implemented including the physical protection of Category 1 and Category 2 quantities of radioactive material (10 CFR Part 37 equivalent).
Documents containing sensitive security information are properly marked, handled, controlled, and secured.
b.
Discussion During the review period, Wisconsin performed 1118 radioactive materials licensing actions. The team evaluated 29 of those licensing actions. The licensing actions selected for review included 2 new applications, 11 amendments, 7 renewals, 3 terminations, 3 change of control/ownership, 2 financial assurance actions, and 1 bankruptcy. The team evaluated casework which included the following license types: broad scope, medical diagnostic and therapeutic, accelerator, commercial manufacturing and distribution,
Wisconsin Final IMPEP Report Page 7 industrial radiography, research and development, academic, nuclear pharmacy, gauges, self-shielded irradiators, waste brokers, mobile medical imaging, medical emerging technology. The casework sample represented work from 14 license reviewers.
The team found licensing actions were thorough, complete, consistent, and of high quality with health, safety, and security issues properly addressed. A second technical peer review is performed, and a final supervisory review for all licensing actions. License tie-down conditions were clearly stated and were supported by information contained in the file.
License conditions were evaluated for continued necessity with each new amendment or license renewal. Deficiency letters clearly stated regulatory positions, were used at the proper time, and identified substantive deficiencies in the licensees documents.
Responses to deficiencies were tracked. Terminated licensing actions were well documented, showing appropriate disposition of materials and survey records. All financial assurance instruments were maintained securely, and well documented in the license actions record.
Wisconsin has implemented an in-house modular training program assuring staff are trained for both general and more complex license actions. Licensing procedures were updated in 2024, use of up-to-date pre-licensing and amendment review checklists assure consistent quality with health, safety, and security issues properly addressed. Wisconsin uses licensing guides based on the NRC licensing guidance (NUREG-1556 series), and where appropriate and when needed, uses NUREG-1556 series to assure current guidance.
The team confirmed that Wisconsin uses the most up to date RSRM Radiation Control Program Directors18-011 checklist with current licensing procedures and assures compliance with 10 CFR Part 37 requirements prior to issuance of a new license or license amendment.
The team found that sensitive information documents were clearly and consistently marked, and that only qualified licensing staff had access to and maintained control of all documents, electronic forms of licenses and information in handling, preparation, transportation, transmission, and destruction of documents that contain sensitive information related to 10 CFR Part 37.
c.
Evaluation The team determined that, during the review period, Wisconsin met the performance indicator objectives listed in Section 3.4.a. Based on the criteria in MD 5.6, the team recommends that Wisconsins performance with respect to the indicator, Technical Quality of Licensing Actions, be found satisfactory.
d.
MRB Discussion and Chairs Determination The MRB Chair agreed with the teams recommendation and found Wisconsins performance with respect to this indicator satisfactory.
3.5 Technical Quality of Incident and Allegation Activities The quality, thoroughness, and timeliness of response to incidents and allegations of safety concerns can have a direct bearing on public health, safety and security. An assessment of incident response and allegation investigation procedures, actual implementation of these procedures internal and external coordination, timely incident reporting, and investigative and
Wisconsin Final IMPEP Report Page 8 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 Wisconsins 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, 30 incidents were reported to Wisconsin. The team evaluated 23 radioactive materials incidents which included 12 lost or stolen radioactive materials, 6 medical events, 4 equipment failures, and 1 leaking source. Wisconsin performs on-site follow-up for the majority of incidents. The team reviewed seven incidents where Wisconsin dispatched inspectors for on-site follow-up.
When notified of an incident, management and staff meet to discuss the incident and determine the appropriate level of response, which can range from an immediate response to reviewing the incident during the next routine scheduled inspection. Those determinations were made based on both the circumstances and the health and safety significance of the incident. The team found that Wisconsins evaluation of incident notifications and its response to those incidents was thorough, well balanced, complete, and comprehensive.
The team also evaluated the Wisconsins reporting of incidents to the NRCs Headquarters Operations Officer (HOO). The team noted that in each case requiring HOO notification, Wisconsin reported the incidents within the required time frame. The team also evaluated whether Wisconsin had not reported any required incidents to the HOO. The team did not identify any missed reporting requirements.
During the review period, Wisconsin received nine allegations. The team evaluated all nine allegations, including two allegations referred by the NRC. The team found that Wisconsin took prompt and appropriate action in response to the concerns raised. All the allegations were appropriately closed, concerned individuals were notified of the actions taken, and allegers identities were protected whenever possible in accordance with State law.
Wisconsin Final IMPEP Report Page 9 c.
Evaluation The team determined that, during the review period, Wisconsin met the performance indicator objectives listed in Section 3.5.a. Based on the criteria in MD 5.6, the team recommends that Wisconsins performance with respect to the indicator, Technical Quality of Incident and Allegation Activities, be found satisfactory.
d.
MRB Discussion and Chairs Determination The MRB Chair agreed with the teams recommendation and found Wisconsins performance with respect to this indicator satisfactory.
4.0 NON-COMMON PERFORMANCE INDICATORS Four non-common performance indicators are used to review Agreement State programs:
(1) Legislation, Regulations, and Other Program Elements; (2) 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 Program; 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 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 Wisconsins performance with respect to the following performance indicator objectives. A complete list of regulation amendments can be found on the NRC web site 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.
Wisconsin Final IMPEP Report Page 10 Other program elements, as defined in SA-200 Compatibility Categories and Health and Safety Identification for NRC Regulations and Other Program Elements, 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 State of Wisconsin became an Agreement State on August 11, 2003. The State of Wisconsins current effective statutory authority is found in Chapter 254, Sections 254.31 through 254.45 of the Wisconsin Statutes. The Department is designated as the States radiation control agency and Wisconsin implements the radiation control program. The States rules and regulations are not subject to sunset laws. No new legislative changes were made during to this review period.
The Program has an administrative review process that take between 7.5 to 13 months and is limited to 24 months. The Program staff develops a rulemaking plan that provides overview information (reason for rule changes, potential costs, stakeholder involvement, etc.), and details of the existing rule. Once approved, the plan is submitted to the Office of Legal Counsel for review and Department approval. In the beginning of the administrative review process, a Statement of Scope is then submitted by the Office of the Secretary to the Governors office. After approval, the Statement of Scope is published in the Wisconsin Administrative Register. The Statement of Scope is valid for 2 years and the remaining process must be completed within that time. After the Statement of Scope is approved the rulemaking package is developed, an economic impact analysis is performed, the need for public informational or listening sessions is determined, and an advisory committee is established, if needed. Wisconsin monitors comments received from all sources and provided comments that differ from the Statement of Scope to the Office of the Secretary and Governors office for review. Revisions to the rulemaking package are made and the draft rule language and summary economic impact analysis are submitted to the Office of the Secretary and Governors office for approval. Following the approval, the rulemaking package is sent to the Wisconsin Legislative Council for review and filing of a hearing notice.
The rulemaking package is subsequently published for public comment.
During the review period, Wisconsin submitted 10 proposed regulation amendments, 10 final regulation amendments, and 2 legally binding requirements or license conditions to the NRC for a compatibility review. None of the amendments were overdue for State adoption at the time of submission. Legally binding requirements have been used in the past to meet adoption deadline and will be used again by the Program as necessary.
During the review period, Wisconsin submitted regulatory amendments and received NRC correspondence stating No Comments for RATS 2018-1, 2018-2, 2019-1, 2019-2, 2020-1, 2020-2, 2020-3, 2021-1, and 2021-2. At the time of the review, there was one outstanding regulatory amendment (RATS 2021-2 due December 30, 2024). Wisconsin shared in the MRB that this amendment was implemented on December 3, 2024.
Wisconsin Final IMPEP Report Page 11 The team also reviewed other program elements that fall within this non-common performance indicator. Those other program elements are the use of compatible procedures such as the RSRM checklist, Pre-licensing guidance, IMC 1248, NUREG 1556, and NRC inspection procedures, and license conditions.
c.
Evaluation The team determined that, during the review period, Wisconsin met the performance indicator objectives listed in Section 4.1.a. Based on the criteria in MD 5.6, the team recommends that Wisconsins performance with respect to the indicator, Legislation, Regulations, and Other Program Elements, be found satisfactory.
d.
MRB Discussion and Chairs Determination The MRB Chair agreed with the teams recommendation and found Wisconsins performance with respect to this indicator satisfactory.
5.0
SUMMARY
The results of the IMPEP review of the Wisconsin Agreement State Program are discussed in this report. The review was conducted from September 23-27, 2024. Inspector accompaniments were conducted during the week of August 27-29, 2024.
Based on the results of the 2024 IMPEP review, Wisconsins performance was found satisfactory for all performance indicators reviewed: Technical Staffing and Training; Status of Materials Inspection Program; Technical Quality of Inspections; Technical Quality of Licensing Actions; Technical Quality of Incident and Allegation Activities; and Legislation, Regulations, and Other Program Elements.
There were no recommendations from the previous IMPEP review for consideration, and the team did not make any new recommendations.
Accordingly, the MRB Chair found the Wisconsin radiation control program adequate to protect public health and safety and compatible with the NRC's program. Since Wisconsin received at least two consecutive IMPEP reviews with all performance indicators being found satisfactory, the MRB Chair determined that the next periodic meeting be held in approximately 2.5 years and the next IMPEP review takes place in approximately 5 years.
LIST OF APPENDICES Appendix A IMPEP Review Team Members Appendix B Inspector Accompaniments
APPENDIX A IMPEP REVIEW TEAM MEMBERS Name Areas of Responsibility Michelle Hammond, NRC NMSS Team Leader Technical Staffing and Training Inspector Accompaniments Robert Locke, Commonwealth Status of Materials Inspection Program of Massachusetts Technical Quality of Inspections Angela Wilbers, Commonwealth Technical Quality of Licensing Actions of Kentucky Zahid Sulaiman, NRC Region III Technical Quality of Incident and Allegation Activities Darren Piccirillo, NRC Region III Legislation, Regulations, and Other Program Elements
APPENDIX B INSPECTOR ACCOMPANIMENTS The following inspector accompaniments were performed prior to the on-site IMPEP review:
Accompaniment No.: 1 License No.: 079-2005-01 License Type: Industrial Radiography Priority: 1 Inspection Date: 8/27/2024 Inspectors initials: KW Accompaniment No.: 2 License No.: 079-1362-01 License Type: Portable Guage Priority: 5 Inspection Date: 8/28/2024 Inspectors initials: MC Accompaniment No.: 3 License No.: 202-029-22 License Type: Academic, R&D, Irradiator Priority: 2 Inspection Date: 8/28/2024 Inspectors initials: DR Accompaniment No.: 4 License No.: 202-029-22 License Type: Medical (WD required; Y-90 therapy)
Priority: 2 Inspection Date: 8/29/2024 Inspectors initials: JR Wisconsin Agreement State Program Management Review Board Meeting Participants January 23, 2025, 1:00 p.m. - 3:30 p.m. (ET), via Microsoft Teams Management Review Board:
Rob Lewis, Deputy Executive Director for Nuclear Materials, Administrative, and Corporate Programs, the Office of the Executive Director for Operations, and Management Review Board (MRB) Chair; Jessica Bielecki, Assistant General Counsel for Rulemaking, Agreement States and Fee Policy; John Lubinski, Director, Office of Nuclear Material Safety and Safeguards (NMSS);
Julio Lara, Deputy Regional Administrator, U.S. Nuclear Regulatory Commission (NRC)
Region IV; and Becki Harisis, Organization of Agreement States representative to the MRB, from the State of Nebraska.
Wisconsin Program Management:
Megan Shober, Megan Shober, Radioactive Materials Program Supervisor; Mark Paulson, Radiation Protection Section Manager.
IMPEP Team:
Michelle Hammond, Team Leader, NMSS; Zahid Sulaiman, NRC Region III; Robert Locke, Commonwealth of Massachusetts, and; Angela Wilbers, Commonwealth of Kentucky.
NRC, State of Wisconsin, and Other Members of the Public:
Tammy Bloomer, NMSS Lee Smith, NMSS Dafna Silberfeld, NMSS Farrah Gaskins, NRC Region I David Curtis, NRC Region III Shawn Seeley, NRC Region I Jonathan Feibus, NRC Region III Randy Erickson, NRC Region IV Adelaide Giantelli, NMSS Luther Loehrke, State of Wisconsin Jackson Barth, NMSS Ira Schneider, State of California Sherrie Flaherty, NMSS Kaci Studer, State of Indiana Lisa Forney, NMSS Aaron Short, State of Kansas Robert Johnson, NMSS Keisha Cornelius, State of Oklahoma Karen Meyer, NMSS Sarah Sanderlin. State of New Jersey Solomon Sahle, NMSS
ML25027A353 OFFICE NMSS/MSST NMSS/MSST/SLPB NMSS/MSST NMSS/MSST/SMPB NAME LSmith RJohnson MHammond AGiantelli DATE Jan 27, 2025 Jan 27, 2025 Jan 27, 2025 Jan 31, 2025 OFFICE RES/DSA/AAB NMSS NAME TBloomer RLewis DATE Feb 3, 2025 Feb 13, 2025