ML24128A052
| ML24128A052 | |
| Person / Time | |
|---|---|
| Issue date: | 05/17/2024 |
| From: | Adelaide Giantelli NRC/NMSS/DMSST/ASPB |
| To: | Shah U State of WA, Dept of Health |
| References | |
| Download: ML24128A052 (1) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 Umair A. Shah, MD, MPH Secretary of Health 101 Israel Road SE Tumwater, WA 98501
SUBJECT:
WASHINGTON FY2024 DRAFT FOLLOW-UP IMPEP REPORT
Dear Dr. Umair Shah:
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 Washington Agreement State Program (Washington) review conducted on April 8-12, 2024. The teams preliminary findings were discussed with Washington managers on the last day of the review. The teams proposed recommendations are that Washington be found adequate to protect public health and safety but needs improvement, 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 regulatory 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 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 Thursday, July 25, 2024, at 1:00 pm ET (10:00 am PT) via Microsoft Teams. The NRC will provide you with Microsoft Teams connection information prior to the MRB meeting. The NRC will also provide invitational travel for you or your designee to attend the MRB meeting at the NRC Headquarters in Rockville, Maryland.
May 17, 2024
U. Shah If you have any questions regarding the enclosed report, please contact Robert K. Johnson, IMPEP Project Manager, at (301) 415-7314 or Geoffrey Warren, IMPEP Team Leader, at (630) 829-9742.
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:
Washington Draft IMPEP Report cc: Jill Wood, Director Office of Radiation Protection Signed by Giantelli, Adelaide on 05/17/24
Enclosure INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW OF THE WASHINGTON AGREEMENT STATE PROGRAM APRIL 8-12, 2024 DRAFT REPORT
EXECUTIVE
SUMMARY
The results of the follow-up Integrated Materials Performance Evaluation Program (IMPEP) review of the Washington Agreement State Program (Washington) are discussed in this report.
The review was conducted from April 8 through 12, 2024. Inspector accompaniments were conducted September 7 and 10, 2023; and February 26 through 29, 2024. The follow-up IMPEP review focused on the performance indicators 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.
Based on the results of the 2024 follow-up IMPEP review, the team found that Washingtons performance had improved since the 2022 IMPEP review. The team found Washingtons performance satisfactory for the two performance indicators Technical Quality of Inspections; and Legislation, Regulations, and Other Program Elements. The team also found Washingtons performance satisfactory but needs improvement for the three performance indicators:
Technical Staffing and Training, Technical Quality of Licensing Actions, and Technical Quality of Incident and Allegation Activities. Furthermore, the team found Washingtons performance unsatisfactory for the performance indicator Status of Materials Inspection Program. The team did not review the Sealed Source and Device Evaluation Program, Low-Level Radioactive Waste Disposal Program, or Uranium Recovery Program indicators because they were found to be satisfactory during the 2022 IMPEP review. These three indicators were discussed at a periodic meeting held on April 11, 2024, concurrent with the follow-up review. The Washington Periodic Meeting Summary is provided in Appendix C.
The team is proposing one new recommendation that:
Washington should develop and implement a process to ensure that financial assurance mechanisms are received and maintained for each licensee subject to financial assurance, and that the mechanisms meet the criteria of NRCs NUREG-1757, Volume 3, Revision 1, Financial Assurance, Recordkeeping, and Timeliness.
Of the nine recommendations from the 2022 IMPEP review, that are applicable to the performance indicators evaluated during this follow-up IMPEP review, the team proposes:
Four recommendations be closed; Two recommendations: (1) revising incident and allegation procedures, and (2) locating and assessing allegation files, be modified and kept open; and Three recommendations: (1) updating training and qualification requirements, (including Low-Level Radioactive Waste Disposal and Uranium Recovery Program elements),
(2) revising the licensing procedure, and (3) reviewing licensing conditions, be kept open.
Accordingly, the team recommends that the Washington radiation control program be found adequate to protect public health and safety but needs improvement and compatible with the NRC's program. The team also recommends that a periodic meeting take in approximately 1 year with the next IMPEP review taking place in approximately 2 years. Further, the team recommended that the period of heightened oversight be continued.
Washington Draft Follow-Up IMPEP Report Page 1
1.0 INTRODUCTION
The Washington Agreement State Program (Washington) follow-up Integrated Materials Performance Evaluation Program (IMPEP) review was conducted on April 8-12, 2024, by a team of technical staff members from the U.S. Nuclear Regulatory Commission (NRC), the State of Colorado, the Commonwealth of Kentucky, and the Commonwealth of Massachusetts.
Team members are identified in Appendix A. Inspector accompaniments were conducted September 7 and 10, 2023, and February 26-29, 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 April 2, 2022-April 12, 2024, were discussed with Washington 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 Washington on September 14, 2023. Washington provided its response to the questionnaire on March 25, 2024. A copy of the questionnaire response is available in the NRCs Agencywide Documents Access and Management System Accession Number ML24099A203.
Washington is administered by the Office of Radiation Protection which is in the Environmental Public Health Division. The Division is part of the Department of Health. Organization charts for Washington are available in ML24099A204. The radiation control program is composed of a Radiation Control Program Director (RCPD), a deputy, a radioactive materials section, and a waste section.
At the time of the review, Washington regulated 310 specific licenses authorizing possession and use of radioactive materials. The review focused on the radiation control program as it is carried out under Section 274b. (of the Atomic Energy Act of 1954, as amended) Agreement between the NRC and the State of Washington.
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 Washingtons performance. The team did not review the Sealed Source and Device (SS&D)
Evaluation Program, Low-Level Radioactive Waste (LLRW) Disposal Program, or Uranium Recovery (UR) Program indicators; these three indicators were discussed at a periodic meeting held concurrent with the 2024 follow-up IMPEP review on April 11, 2024. The Washington Periodic Meeting Summary is provided in Appendix C.
2.0 PREVIOUS IMPEP REVIEW AND STATUS OF RECOMMENDATIONS The previous IMPEP review concluded on April 1, 2022. The final report is available in ML22206A205. The results of the review and the status of the associated recommendations are as follows:
Technical Staffing and Training: Satisfactory but Needs Improvement Recommendation: Washington should review, revise, and update the training and qualification requirements for all aspects of its Agreement State Program to ensure the essential objectives of the Inspection Manual Chapter (IMC) 1248 appendices A, B, E, H, and I are adopted.
Washington Draft Follow-Up IMPEP Report Page 2 Status: The team is proposing that this recommendation be kept open. Details related to the work performed by Washington to address this recommendation and the 2024 teams evaluation of that effort can be found in Section 3.1 of this report.
Status of Materials Inspection Program: Satisfactory Recommendation: None Technical Quality of Inspections: Satisfactory but Needs Improvement Recommendation: Washington should revise their Radioactive Material Section Standard Operating Procedure, and train staff on the revised procedure.
Status: The team is proposing that this recommendation be closed. Details related to the work performed by Washington to address this recommendation and the 2024 teams evaluation of that effort can be found in Section 3.3 of this report.
Technical Quality of Licensing Actions: Unsatisfactory Recommendation 1: Washington should perform an extent of condition review across all licensing categories by performing a smart sampling of licenses issued since May 4, 2018, to:
Ensure that maximum possession limits are accurate and in accordance with applicable licensing guidance (e.g., applicable SS&D registration);
Ensure that only the radioactive material requested by the licensee remains on the license (such as, remove additional gauge models placed on the license by Washington);
Ensure that locations of use and storage are accurate; Ensure that license reviewers considered the licensees inspection and enforcement history for license renewal reviews; and Revise the license templates to be consistent with the NRCs licensing guidance.
Status: The team is proposing that this recommendation be closed. Details related to the work performed by Washington to address this recommendation and the 2024 teams evaluation of that effort can be found in Section 3.4 of this report.
Recommendation 2: Washington should revise their licensing procedure to be compatible with the NRCs NUREG-1556 licensing guidance. The revised licensing procedure should also include a periodic assessment or audit to review a smart sampling of completed licensing actions to ensure proper issuance of licenses in accordance with the appropriate NUREG-1556 volume.
Status: The team is proposing that this recommendation remain open. Details related to the work performed by Washington to address this recommendation and the 2024 teams evaluation of that effort can be found in Section 3.4 of this report.
Recommendation 3: Washington should revise their Radioactive Material Section Standard Operating Procedure to provide guidance for electronic transfers of sensitive security-related documents.
Status: The team is proposing that this recommendation be closed. Details related to the work performed by Washington to address this recommendation and the 2024 teams evaluation of that effort can be found in Section 3.4 of this report.
Technical Quality of Incident and Allegation Activities: Unsatisfactory
Washington Draft Follow-Up IMPEP Report Page 3 Recommendation 1: Washington should document the actions they took in response to the University of Washington (UW) contamination incident in 2019. These include actions taken and basis for release at a personal residence, a restaurant, and with a state vehicle. The written report should document the dose assessments (e.g., external dosimetry, urinalysis, and whole-body scans) of the two contaminated inspectors involved in the incident.
Status: The team is proposing that this recommendation be closed. Details related to the work performed by Washington to address this recommendation and the 2024 teams evaluation of that effort can be found in Section 3.5 of this report.
Recommendation 2: Washington should revise their allegation and incident procedures to include all necessary actions (e.g., require protection of alleger identity as allowed by law, ensure proper and complete documentation of the receipt and closure of incidents and allegations, ensure that follow-up inspections are scheduled and completed, ensure allegations are properly maintained with allegations and not mixed with incidents, and ensure that allegations are documented and easily retrievable).
Status: The team is proposing that this recommendation be modified and retained. Details related to the work performed by Washington to address this recommendation and the 2024 teams evaluation of that effort can be found in Section 3.5 of this report.
Recommendation 3: Washington should locate all allegation records received during the review period and assess whether appropriate closure actions were taken; and verify that the allegation files were complete, accurate, and documented in the tracking system.
Status: The team is proposing that this recommendation be modified and retained. Details related to the work performed by Washington to address this recommendation and the 2024 teams evaluation of that effort can be found in Section 3.5 of this report.
Legislation, Regulations, and Other Program Elements: Satisfactory but Needs Improvement Recommendation: Washington should perform a review of all their license conditions, identify non-standard license conditions, and submit the non-standard license conditions to the NRC for a compatibility review.
Status: The team is proposing that this recommendation remain open. Details related to the work performed by Washington to address this recommendation and the 2024 teams evaluation of that effort can be found in Section 3.5 of this report.
SS&D Evaluation Program: Satisfactory Recommendation: None LLRW Disposal Program: Satisfactory Recommendation: Washington should review, revise, and update the training and qualification requirements for all aspects of its Agreement State Program to ensure the essential objectives of the IMC 1248 appendices A, B, E, H, and I are adopted.
Status: The team did not evaluate this indicator during this review. The team recommends that the recommendation remain open.
UR Program: Satisfactory
Washington Draft Follow-Up IMPEP Report Page 4 Recommendation: Washington should review, revise, and update the training and qualification requirements for all aspects of its Agreement State Program to ensure the essential objectives of the IMC 1248 appendices A, B, E, H, and I are adopted.
Status: The team did not evaluate this indicator during this review. The team recommends that this recommendation remain open.
Overall finding: Based on the results of the 2022 Washington IMPEP review, Washington was found adequate to protect public health and safety but needs improvement and not compatible with the NRC's program. Also, based on the results of the 2022 Washington IMPEP review, the team recommended, and the Management Review Board (MRB) agreed, that NRC initiate a period of heightened oversight for Washington. The team further recommended and the MRB agreed that in approximately 2 years a follow-up IMPEP review be conducted for the less than satisfactory indicators and a periodic meeting be conducted for the satisfactory indicators.
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 SA-103, Reviewing the Common Performance Indicator:
Technical Staffing and Training, and evaluated Washingtons 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 IMC 1248.
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.
Washington Draft Follow-Up IMPEP Report Page 5 b.
Discussion The Washington Radioactive Materials Section is composed of 1 manager, 8 technical staff members, 1 database manager, and 1 administrative staff member, which equals 11 full-time equivalents (FTE) when fully staffed. There were two vacancies at the time of the on-site review, but both vacancies had been offered to and accepted by individuals who were completing the final stages of the hiring process. During the review period, four of the staff members left the program and four staff members were hired. Most positions remained open for a few weeks to a few months, except for the Section Manager position which remained open for almost a year. Washington supplemented the technical staff with contract staff to perform inspection and licensing actions.
The team evaluated Washingtons training and qualification program for radioactive material inspectors and license reviewers. Washingtons Radioactive Material Section divides technical staff into three program areas: medical, industrial, and laboratories. Each of these program areas has an assigned lead, which is a senior technical position in the section. The 2022 IMPEP review team found that Washington had a training and qualification procedure in place, but the team determined that it was not compatible with NRCs IMC 1248. As a result, a recommendation was made for Washington to review, revise, and update the training and qualification requirements for all aspects of its Agreement State Program to ensure the essential objectives of the NRC's IMC 1248 appendices A, B, E, H, and I were adopted. In response to this recommendation, Washington revised its training and qualification process during the review period and published a new supplementary procedure on completing qualification cards for Inspectors and License Reviewers in January 2024. Although elements of the revised training process were captured in the new supplementary procedure, the primary Washington Training and Qualification Procedure had not been revised since June 2022, and it still did not meet the essential objectives of the NRCs IMC 1248. For example, the team found:
Washingtons training and qualification procedure included general qualification requirements and referenced journals that were saved on an internal network drive where staff would track the training they had completed. During the review period, the electronic qualification journals had undergone revisions, and staff were not always clear what electronic documents should be updated or referenced for their qualifications. No official format for the qualification journal was referenced within Washington primary training procedure, and the new supplemental procedure on qualification cards referenced a Training Courses and Reading table that did not include all of the requirements found in the appendices to IMC 1248. Specifically, the procedures did not list the core training courses, Individual Study Activities, and On-the-Job Training activities that were explicitly required to become qualified as an inspector, license reviewer, or other technical position, as outlined in IMC 1248.
Although Washingtons training procedure included a requirement for staff to successfully complete core courses such as the G-108 Inspection Procedures, G-109 Licensing Practices, and the G-205 Root Cause courses, the team found that certain staff had been interim qualified without taking these courses. In some cases, there was no documented memo or justification written for granting interim qualification without taking the courses. In addition, there was no specific requirement in the training procedure for staff to take the H-308 Transportation of Radioactive Materials course, which is a core NRC training course in IMC 1248.
Washington Draft Follow-Up IMPEP Report Page 6 Washingtons current training procedure still included a see one, do one; lead one approach for inspector qualification, even though this approach had been replaced with a more robust training method. The current approach to training inspectors within the Washington program is to allow trainees to complete as many inspection accompaniments as necessary before a qualified observer or supervisor recommends them to management for qualification under a given modality. This approach is captured under the new supplementary qualification card procedure that Washington published in January 2024, but the primary training and qualification procedure needs to be revised to remove the old approach.
The team observed that some senior technical staff positions were vacant during the review period, and once senior positions were filled, it took time for the senior staff to achieve interim qualification. Because of this, Washington experienced periods of time where no qualified staff were available to accompany inspectors in training, to review case work for license reviewers in training, or to recommend the trainees for interim qualification under specific modalities. For these periods of time, Washington put contracts in place with other state programs and private contractors to fill technical gaps and take on the role of accompanying, observing, and mentoring new staff. These contractors made the final recommendation to management to grant interim qualification to certain staff members.
Interviews with staff in training, as well as program management, indicated that this process served to expedite the qualification of staff to meet Washingtons inspection and licensing workload. Washingtons current training and qualification procedure did not provide guidance on how to use contractors in these roles, and the procedure did not include a requirement to verify the qualifications of contractor staff. The team determined that contractors were being evaluated to ensure they had formally completed a qualification program that is equivalent to NRCs IMC 1248 or had equivalent experience.
The team determined that, through a combination of contractors and staff who had been hired during the review period, Washington was able to inspect and license all modalities. At the time of the on-site review, Washington was still heavily depended on contractors for certain modalities or program areas that it did not have staff qualified in, but all the lead technical positions had been filled and staff were working towards interim qualification to cover these critical program areas. Some staff were already interim qualified in one or more program areas and were cross-qualifying in other modalities in order to prevent single-point failures in the program. During the on-site review, Washington reported that they had interviewed candidates, they had made offers for the remaining two technical vacancies, the candidates had accepted those offers, and the program was on track to be fully staffed by May 2024.
c.
Evaluation The team determined that, during the review period, Washington met the performance indicator objectives listed in Section 3.1.a, except for:
The Washington training and qualification program is not equivalent to IMC 1248.
Washingtons training and qualification procedure for the license reviewers and inspectors should be revised to be consistent with the applicable IMC 1248 requirements, to ensure that all required core and specialized training courses, individual self-study activities, and on-the-job training activities are successfully completed prior to qualifying staff to work independently as an inspector or license reviewer. Any supporting qualification cards, databases, or electronic tracking tools that are used in conjunction with the qualification procedure should be maintained to comply with the revised procedure. In situations where
Washington Draft Follow-Up IMPEP Report Page 7 interim qualifications are granted prior to completion of all training activities, the training procedure should provide clear guidance on how to justify and document interim qualification. The revision should include the appropriate NRC training courses such as NRCs G-108 or equivalent; NRCs G-109 or equivalent; NRCs G-205 for inspectors, and NRCs H-201 and H-308 courses for inspectors and license reviewers, as appropriate.
Contractors who are completing work for the Washington program will be required to meet the same qualifications as Washington staff. A compatible and robust qualification procedure is a critical element to Washingtons program due to the large number of new staff and staff who are not fully qualified.
The 2022 IMPEP team made the following recommendation (Section 3.1 of the 2022 IMPEP Report): Washington should review, revise, and update the training and qualification requirements for all aspects of its Agreement State Program to ensure the essential objectives of the IMC 1248 appendices A, B, E, H, and I are adopted. Although Washington has made improvements to their training process, the primary procedure that is being used to qualify new staff is not yet fully compatible with IMC 1248, so the team recommends that this recommendation remain open.
Based on the IMPEP evaluation criteria in MD 5.6, the team recommends that Washingtons performance with respect to the indicator, Technical Staffing and Training, be found satisfactory, but needs improvement.
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.
a.
Scope The team used the guidance in SA-101, Reviewing the Common Performance Indicator:
Status of the Materials Inspection Program, and evaluated Washingtons 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.
Washington Draft Follow-Up IMPEP Report Page 8 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 Washington performed 53 Priority 1, 2, and 3 inspections and 5 initial inspections during the review period. Washington conducted 51 percent of Priority 1, 2, 3, and initial inspections overdue. Of the overdue inspections, 18 Priority 1, 2, and 3 inspections and 3 initial inspections were performed overdue and 11 Priority 1, 2, and 3 inspections and 7 initial inspections were overdue at the time of the review.
The IMPEP team found that Washingtons lack of qualified inspectors over the review period led to several inspections going overdue. Washington has contracted with qualified individuals to assist with completing inspections and training staff to perform the high priority inspections.
Washingtons inspection frequencies were more frequent for similar license types in NRCs program until September of 2023 when Washington changed inspection frequencies to match those of the NRC.
A sampling of 20 inspection reports indicated that all of the inspection findings were communicated to the licensees within Washingtons goal of 30 days after the inspection exit or 45 days after the team inspection exit.
Washington revised its reciprocity procedures in December 2022 to standardize the process for reviewing reciprocity licensees. The IMPEP review team found these procedures were consistent with IMC 2800 and that Washington was making risk informed decisions regarding reciprocity inspections.
c.
Evaluation The team determined that, during the review period, Washington met the performance indicator objectives listed in Section 3.2.a, except for:
Initial inspections and inspections of Priority 1, 2, and 3 licensees were not performed at the prescribed frequencies.
Washington performed 51 percent (more than 25 percent) of all initial inspections and inspections of priority 1, 2, and 3 licensees less frequently than the IMC 2800 frequencies.
To prevent additional inspections becoming overdue, Washington stated that they have prioritized upcoming inspections and will continue to use qualified contractors to complete these high priority inspections.
Based on the IMPEP evaluation criteria in MD 5.6, the team recommends that Washingtons performance with respect to the indicator, Status of Materials Inspection Program, be found unsatisfactory.
d.
MRB Discussion and Chairs Determination The final report will present the MRB Chairs determination regarding this indicator.
Washington Draft Follow-Up IMPEP Report Page 9 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 Washingtons 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 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 nine of Washingtons inspectors and covered medical, industrial, commercial, academic, research, and service licenses.
Team members accompanied four inspectors on September 7 and 10, 2023; and February 26-29, 2024. The 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 were able to identify potential health, safety, and security concerns.
The team observed that Washington inspectors were accompanied annually by either a supervisor or an experienced inspector.
Inspection reports reviewed from the review period indicate that inspectors had functional, calibrated survey meters during inspections. Interviewed staff all indicated that survey meter calibration dates and meter response were verified prior to inspections.
To address issues identified during the 2022 IMPEP review, the team observed that Washington management had developed a corrective action plan which included revising the Washington inspection manual and training all Washington inspectors on the revised inspection manual, and that the revisions and training had been effective.
Washington Draft Follow-Up IMPEP Report Page 10 c.
Evaluation The 2022 IMPEP team made the following recommendation (Section 3.3 of the 2022 IMPEP Report): Washington should revise their Radioactive Material Section Standard Operating Procedure, and train staff on the revised procedure. The Washington program revised the inspection procedure in 2022 and again in 2024. The NRC determined that the inspection procedure is compatible with the NRC inspection manual chapter 2800, and inspection staff appear to be aware of and following the procedure. Accordingly, the team proposes that this recommendation be closed.
The team determined that, during the review period, Washington met the performance indicator objectives listed in Section 3.3.a. Based on the criteria in MD 5.6, the team recommends that Washingtons 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 Washington 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 Washingtons 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.
Washington Draft Follow-Up IMPEP Report Page 11 b.
Discussion During the review period, Washington performed 250 radioactive materials licensing actions. The team evaluated 23 of those licensing actions. The licensing actions selected for review included new applications, amendments, renewals, and terminations.
The team evaluated casework that included the following license types and actions:
broad scope, medical diagnostic and therapy, industrial radiography, research and development, academic, nuclear pharmacy, nuclear laundry, portable and fixed gauges, decommissioning actions, financial assurance, production of radioactive material using an accelerator, and veterinarian. The casework sample represented work from 10 license reviewers.
In 14 of the 23 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. License tie-down conditions were stated clearly and were supported by information contained in the file. Deficiency letters clearly stated regulatory positions, were used at the proper time, and identified deficiencies in the licensees documents. Terminated licensing actions were well-documented and showed appropriate transfer and survey records. For medical licenses, Washingtons review of preceptor attestations was found to be thorough.
The team identified inconsistencies in nine of the 23 licensing actions reviewed. For example:
Non-standard license conditions: The team identified the use of non-standard license conditions in 8 cases of issued licenses. The use of non-approved non-standard license conditions may affect the licensing process by creating conflicts, duplications, gaps, or other conditions that would jeopardize an orderly pattern in the regulation of agreement material on a nationwide basis. The use of non-standard conditions is addressed further in Section 4.1 of this report.
Guidance Review and Quality Assurance (QA) Checklists: Reviews of licensing files did demonstrate that Washington was in possession of the correct checklists (e.g., pre-licensing checklist for RSRM), but the team noted concerns with the implementation. For example, in one case pre-licensing guidance was incorrectly implemented to conclude and mark on the checklist that the applicant was a known entity when it was not. The QA reviewer did not identify the discrepancy and approved the review.
Protection of Sensitive and Security-Related Information: The Radioactive Material Section Standard Operating Procedure did not contain guidance for identifying, marking, handling and transmitting sensitive security-related documents. During the review period, a stand-alone procedure for transmitting sensitive security-related documents was established and implemented; however, there was no written procedure for identifying, marking, and handling the sensitive security-related documents. In one case reviewed, the license reviewer inappropriately handled a sensitive security-related document. The license reviewer sent the NRC guidance on Pre-licensing Site Visits to the applicant in advance of a site visit. The guidance sent is marked OFFICIAL USE ONLY - SECURITY RELATED INFORMATION and the license reviewer had not established or documented whether the applicant had a need to know the sensitive security-related guidance that Washington uses in performing the pre-licensing site visit.
Financial Assurance: Washington receives and reviews decommissioning funding plans submitted by its licensees, but required financial assurance mechanisms to support those funding plans could not be located by Washington or did not meet the
Washington Draft Follow-Up IMPEP Report Page 12 criteria of the NUREG-1556 series guidance that refers to NUREG-1757, for all three cases reviewed. For one case requiring financial assurance, a financial assurance mechanism was not submitted to Washington nor was Washington able to identify if one was in place. For another case, a financial assurance mechanism had been received by Washington, but it did not meet the criteria of NUREG-1757 because the statement of intent financial assurance mechanism used did not include document of evidence that the person making the statement was authorized to make the statement of intent. For another case, Washington located a letter of credit financial assurance mechanism that was for less than the cost estimate of the decommissioning funding plan most recently approved by Washington. In this case, Washington reached out to the licensee during the IMPEP teams on-site review and received the licensees updated financial assurance mechanism.
The reviewed team noted that, at the time of the review, Washington had approximately 20 renewal licensing actions overdue greater than 1 year. The review team noted that Washington had indicated that it had hired a consultant to help address work down this backlog.
Regarding non-standard license conditions, the team noted that Washingtons management had performed an extent of condition review across all licensing categories by performing a smart sampling of licenses issued since May 4, 2018. The team confirmed that, since that review, in Washingtons issuance of license amendments and renewals, Washington had ensured that: (1) maximum possession limits are accurate and in accordance with applicable licensing guidance; (2) only the radioactive material requested by the licensee remains on the license; (3) locations of use and storage are accurate; and (4) license reviewers considered the licensees inspection and enforcement history for license renewal reviews.
Regarding guidance review, the team noted that Washington management had developed a corrective action plan which included revising the Washington licensing manual and training all Washington license reviewers on the licensing manual.
c.
Evaluation The team determined that, during the review period, Washington met the performance indicator objectives listed in Section 3.4.a, except for:
In some cases, essential elements of license applications were not submitted, and elements were not 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.).
In some cases, license conditions were not stated clearly and cannot be inspected.
Applicable guidance was sometimes not followed (e.g., NUREG-1556 series, pre-licensing guidance, regulatory guides, etc.).
Documents containing sensitive security information are sometimes not properly marked, handled, controlled, and secured.
Washington developed templates and checklists but did not compare them to NRCs NUREG-1556 licensing guidance to ensure that reviews were thorough, complete, consistent, and of acceptable technical quality with respect to health, safety, and security.
Washington acquired standard conditions from NRC NUREG-1556 guidance that attributes those standard conditions to specific NRC program codes. Washington, however, had not yet correlated its licenses with NRC program codes and instead relied upon guesswork
Washington Draft Follow-Up IMPEP Report Page 13 correlating its licenses to its fee codes that did not lead to a correct NRC program codes nor (for inspection purposes) correct priority code. Washington plans to correlate each of its specific licenses to appropriate program codes by viewing each license by summer 2024, then work to attribute correct license conditions to each license beyond that date.
Financial assurance mechanisms were not received and reviewed in accordance with NUREG-1757.
The 2022 IMPEP team made three recommendations (Section 3.4 of the 2022 IMPEP Report). The first recommendation was that Washington should perform an extent of condition review across all licensing categories to ensure that licenses were accurate and in accordance with applicable licensing guidance. During the 2024 IMPEP review, the team confirmed that the Program had performed condition reviews across all licensing categories.
Possession limits are accurate and in accordance with applicable licensing guidance.
Materials requested by the licensee are correct. Locations are accurate. During license renewals, inspection and enforcement history were reviewed. The team recommends that this recommendation be closed.
The second recommendation was that Washington should revise their licensing procedure to be compatible with NRCs NUREG-1556 licensing guidance and to include a periodic assessment or audit to ensure proper issuance of licenses in accordance with the appropriate NUREG-1556 volume. Washingtons licensing procedure was revised on April 4, 2024, in response to the 2022 IMPEP review recommendation. Based on the teams findings, this procedure will need to be revised again to include use of 1556 guidance.
Washington is already planning to include reference to 1556 guidance in its next revised licensing procedure that it hopes to issue by summer 2024. The team recommends that this recommendation be kept open.
The third recommendation was that Washington should revise their Radioactive Material Section Standard Operating Procedure to provide guidance for electronic transfers of sensitive security-related documents. The team found that during the review period, a stand-alone procedure for transmitting sensitive Security related documents was established and implemented. The team recommends that this recommendation be closed.
Based on the IMPEP evaluation criteria in MD 5.6, the team recommended that Washingtons performance with respect to the indicator, Technical Quality of Licensing Actions, be found satisfactory, but needs improvement.
As a result of this review, the team will make one new recommendation:
Washington should develop and implement a process to ensure that financial assurance mechanisms are received and maintained for each licensee subject to financial assurance, and that the mechanisms meet the criteria of NRCs NUREG-1757, Volume 3, Revision 1, Financial Assurance, Recordkeeping, and Timeliness.
d.
MRB Discussion and Chairs Determination The final report will present the MRB Chairs determination regarding this indicator.
Washington Draft Follow-Up IMPEP Report Page 14 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 Washingtons 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, 66 incidents were reported to Washington. At least 22 were related to radiation monitor alarms at scrap yards or disposal facilities; approximately 8 were calls from citizens with unwanted radioactive items or other radiation concerns; and 4 were related to possible possession and exempt quantity distribution without a license. Of the 66 incidents, approximately 11 were allegations and 28 were reported to NMED. The team evaluated 11 radioactive materials incidents which included 3 lost, stolen, or unsecured radioactive sources; 1 potential transportation contamination event; 4 potential medical events; 1 damaged or failed equipment; 1 radiography stuck source; and 1 potential scrapyard contamination event. Although Washington dispatched inspectors for on-site follow-up for 2 of the incidents (non-allegations) reviewed, those follow-up inspections were either during the next routine inspection or within greater than 20 days following the initial reporting of the incidents. For the remaining incidents, all follow-ups were either via phone or e-mail, or reserved for follow-up during the next routine inspection.
When notified of an incident, management and staff did not routinely meet to discuss the incident and determine the appropriate level of response, which should range from an immediate response to reviewing the incident during the next routine scheduled inspection.
The team found that Washingtons evaluations of incident notifications and its responses to those incidents were not focused, well-coordinated, and timely for incidents and allegations involving health, safety, or security issues in more than a few, but less than most, of the cases reviewed.
Washington Draft Follow-Up IMPEP Report Page 15 The team also evaluated Washingtons reporting of incidents to the NRCs Headquarters Operations Officer (HOO). The team noted that in each case requiring HOO notification, Washington reported the incidents within the required time frame. The team also evaluated whether Washington had not reported any required incidents to the HOO. The team did not identify any missed reporting requirements.
During the review period, 11 allegations were received or managed as open allegations by Washington. The team evaluated 10 allegations, including 8 allegations that the NRC referred to the State, during or prior to (if the allegation remained open) the review period.
Of those 10 reviewed allegations, 10 were indicated as non-allegations in Washingtons Incident and Allegations electronic database. For one of those, it was determined that the knowledge had come from a local emergency department official. For the second, the team determined that it was referred by the NRC to Washington as an allegation, including concerned individual information within the item details. For both incidents, the team observed that Washington had not followed up with the concerned individuals.
The team reviewed Washingtons incident response and allegation procedures to determine whether appropriate procedures were in place and were followed. The team noted that Washington had updated its incident response and allegations procedures, respectively, on October 10, 2023, and September 19, 2023. The team noted that both updates incorporated log sheets and checklists for documenting incident response that, when followed, would assure adequate consideration of follow-up and completion of follow-up actions. In addition, the team observed that the new allegations procedure described actions for properly handling allegations, commensurate with NRCs MD 8.8, Management of Allegations.
Although the incident response procedure included checklists to document follow-up actions taken, it lacked clarity as to how Washington would evaluate the appropriateness and adequacy of response actions, such as written information requests, informal communications, and on-site investigations, and the timeliness in which those actions should occur.
For a few, but not most, of the incidents and allegations reviewed, the team found that Washington had implemented the use of its updated incident and allegation procedure, but that implementation was limited. For example, the Attachment 2, Checklist for Documenting Allegations, and Attachment 2, Incident Investigation Checklist, could not be found in most of the reviewed case files. Further, the reviewer was unable to confirm consistent follow-up with either the concerned individuals or entities, such as licensees, responsible for responding to the incidents or allegations. Incident and allegation files were not thorough enough to discern whether response actions and follow-up, or the lack thereof, had been intended by Washington or overlooked. Although both procedures indicated oversight roles for Washington supervisory staff, the team observed that incident and allegation files lacked clarity that management was consulted in determining response and follow-up actions. The teams conversations with Washington management and staff confirmed the lack of coordinated response efforts, which was not consistent with the revised procedures.
Although Washingtons inspection procedures included the expectation that inspectors review NMED prior to performing routine inspections, the team observed that neither NMED nor Washingtons incident and allegations database was being reviewed as part of routine inspection preparations. Concerns with the integrity of one licensees training program and other personnel records, which Washington staff agreed would merit a closer review during the inspection, was missed in preparations for two inspections. A few potential medical events had neither been investigated promptly, nor flagged for follow-up during the next routine inspection of each licensee. In cases where follow-up was adequate, this generally
Washington Draft Follow-Up IMPEP Report Page 16 was due to the diligence of staff and not due to the comprehensive implementation of the revised procedures.
The team reviewed Washingtons follow-up actions for a contamination incident that occurred on May 2, 2019, at the University of Washington. The team noted that, during the review period, Washington staff issued written reports regarding actions taken by the Washington Department of Health, in response to that incident. Documentation reviewed included dose assessments for two Washington inspectors, and a report summarizing the basis for the release of one of those inspectors personal residence, a restaurant, and a contaminated state vehicle. Documents concerning the follow-up actions omitted the name of the documenting inspector and were undated. These documents were discussed with knowledgeable Washington staff, and the team determined that they contained sufficient information to close the item in Washingtons events database.
c.
Evaluation The team determined that, during the review period, Washington met the performance indicator objectives listed in Section 3.5.a, except that:
Incident response and allegation procedures were in place, but were 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; Response actions were not focused, well-coordinated, and timely for incidents and allegations involving health, safety, or security issues in more than a few, but less than most, of the cases reviewed; Response efforts were not commensurate with the potential health, safety, and security significance of the incident, including on-site investigation of incidents, in more than a few, but less than most, of the cases reviewed; Follow-up inspections were not scheduled and completed, as necessary, in more than a few, but less than most, of the cases reviewed; and Results of allegation investigations are not provided to known allegers within 30 days of the investigation conclusions, in more than a few, but less than most, of the cases reviewed.
During the review period, Washington had updated its incident and allegations procedures, to be compatible with NRC procedures and directives. The team noted that, during the review period, those procedures had not been implemented. The program had improved its protection of the identities of concerned individuals, under its allegation response program, but program staff were not consistently following up with those concerned individuals or documenting the completion of follow-up activities. When following its new incidents and allegations procedures, the program did generate close-out memos, and document its follow-up activities, in its electronic filing system for incidents and allegations. Washington did not consistently record those follow-up activities in either NMED or its own electronic incidents and allegations tracking database.
The 2022 IMPEP team made three recommendations (Section 3.5 of the 2022 IMPEP Report). Based on the review, the team made the following assessments of those recommendations:
The first recommendation was that Washington should document the actions they took in response to the UW contamination incident in 2019. During the review period, Washington has documented those actions. The documentation included actions taken
Washington Draft Follow-Up IMPEP Report Page 17 and basis for release at a personal residence, a restaurant and with a state vehicle. The written reports - stored in Washingtons electronic filing system - document the dose assessments (e.g., external dosimetry, urinalysis, and whole-body scans) of the two contaminated inspectors involved in the incident. The team found that the actions taken by Washington were sufficient to close this recommendation.
The second recommendation was that Washington should revise their allegation and incident procedures to include all necessary actions (e.g., require protection of alleger identity as allowed by law, ensure proper and complete documentation of the receipt and closure of incidents and allegations, ensure that follow-up inspections are scheduled and completed, ensure allegations are properly maintained with allegations and not mixed with incidents, and ensure that allegations are documented and easily retrievable).
During the review period, Washington had revised its allegation and incident procedures to include most necessary actions. Washington had not fully implemented those procedures during the review period. The revisions also did not fully address all aspects of the recommendation. The team observed that - to be fully effective - the procedures need to include additional necessary actions (e.g., ensure that follow-up inspections are scheduled and completed, ensure allegations are properly maintained with allegations and not mixed with incidents, and ensure that allegations - once documented - are easily retrievable). The team found that the actions taken by Washington were sufficient to close this recommendation, in part, but insufficient to fully close the recommendation.
The team also found that this recommendation should be expanded, to clarify the need for management oversight in the determination of appropriate follow-up actions for incidents and allegations.
The third recommendation was that Washington should locate all allegation records received during the review period and assess whether appropriate closure actions were taken; and verify that the allegation files were complete, accurate, and documented in the tracking system. During the review period, Washington located most allegation records received during the review period but was unable to confirm that all such records had been received. Washington also had not yet assessed whether appropriate closure actions had been taken for allegations received during either of the prior or the current review periods. Finally, Washington had not verified that the allegation files were complete, accurate, and documented in the tracking system. The team found that Washington had taken insufficient actions during the review period to close this recommendation. The team also found that this recommendation should be expanded, to clarify the need for management oversight and approval of the audit of its electronic allegation files and tracking system.
Based on the IMPEP evaluation criteria in MD 5.6, the team recommends that Washingtons performance with respect to the indicator, Technical Quality of Incident and Allegation Activities, be found satisfactory, but needs improvement. The team recommends that two recommendations, regarding the updated incident and allegation procedures and allegation oversight, be retained and modified. The revised recommendations are as follows:
Washington should revise its allegation and incident procedures to include necessary follow-up actions (e.g., ensure proper and complete documentation of the closure of incidents and allegations, ensure that follow-up inspections are scheduled and completed, ensure that management is consulted in follow-up and closure activities),
and to assure that the updated procedures are implemented and followed.
Washington should locate all allegation records received during the review period and assess whether appropriate closure actions were taken; and verify that the allegation files were complete, accurate, and documented in the tracking system, including management oversight and approval of any audits of the electronic allegation files and tracking system.
Washington Draft Follow-Up IMPEP Report Page 18 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) SS&D Evaluation Program; (3) LLRW Disposal Program; and (4) UR Program. While Washington has regulatory authority for SS&D Evaluation, LLRW Disposal, and UR Programs, these indicators were not evaluated as part of this follow-up review because they were found to be satisfactory during the 2022 review; therefore, only the first of these indicators was evaluated during 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 the NRC designation. A Program Element Table indicating the Compatibility Categories for those program elements other than regulations can be found on the NRC Web site at the following address: https://scp.nrc.gov/regtoolbox.html.
a.
Scope The team used the guidance in SA-107, Reviewing the Non-Common Performance Indicator: Legislation, Regulations, and Other Program Elements, and evaluated Washingtons 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.
Washington Draft Follow-Up IMPEP Report Page 19 Sunset requirements, if any, do not negatively impact the effectiveness of the States regulations.
b.
Discussion The Washington Agreement State Programs current effective statutory authority is contained in Revised Code of Washington (RCW) 70A.388 Nuclear Energy and Radiation.
The Office of Radiation Protection is designated as the States radiation control agency. The Radioactive Materials and Waste Management Section is located within the Office of Radiation Protection. The radiation control program is implemented by Washington Administrative Code, Title 246, Chapters 220 through 254. No legislation affecting the radiation control program was passed during the review period.
Washingtons administrative rulemaking process takes approximately 6 to 12 months from drafting to finalizing a rule. Washington creates a draft rule and forwards it to rule coordinators in the Office of the Assistant Secretary, Division of Environmental Public Health, for review. Once the review is completed, the draft rule is sent to the Assistant Attorney General for a legal review. Once the legal review is completed, the draft rule is sent to the NRC for a proposed regulation review. The public, NRC, other agencies, and potentially impacted licensees and registrants are offered an opportunity to comment during the process. Comments are considered and incorporated, as appropriate, before the regulations are finalized and approved by the Office of the Assistant Secretary of State, Division of Environmental Public Health. The draft rule is forwarded to the Office of Code Revisor Order Typing Service where it is officially formatted, typed, and filed. A public hearing and comment period is scheduled and held. Comments are considered and resolved, as appropriate, and 31 days after filing, the rule becomes effective. The final rule is then forwarded to the NRC for a final regulation review. The team noted that the States rules and regulations are not subject to sunset laws.
Washington can adopt the NRC amendments using the exception rulemaking process. The Secretary of Health delegated the responsibility to the Assistant Secretary to sign exception rule packages. Most rule packages associated with the NRC regulation amendments meet the requirements of the exception rule package. Washington uses a rulemaking intake form Code Reviser 102 to coordinate and develop their regulations. The form includes linked references to NRC State Communications Portal, NRCs Regulation Toolbox, State Agreements procedures, and State Regulation Review Coordinators contact information.
During the review period, Washington submitted nine proposed and nine final regulation amendments, and one legally binding license condition to the NRC for a compatibility review. None of the amendments were overdue for State adoption at the time of submission.
At the time of this review no amendments were currently overdue for adoption.
The team also reviewed guidance documents that Washington uses to meet the requirements of other program elements (e.g., Pre-Licensing Guidance, Inspection Procedures, etc.) that the NRC has designated as necessary for the maintenance of an adequate and compatible program. The team found that some of the procedures used by Washington, identified by the 2022 IMPEP team as not compatible with NRC procedures, remained not fully compatible throughout this review period. The extent and types of non-compatibility of these procedures are described in each of the respective sections of this report.
Washington Draft Follow-Up IMPEP Report Page 20 c.
Evaluation At the time of the 2022 IMPEP review, the team found that Washington had been significantly behind on several regulation amendments, that Washington was using multiple non-standard license conditions without understanding the full extent of their use, and that most of their procedures were not compatible with NRCs procedures.
The 2024 IMPEP team found that not only had the regulation amendment backlog been eliminated, even amendments due for future adoption had already been completed; that Washington had realized there was still work to be done on completing a comprehensive extent of condition review regarding the use of non-standard license conditions and was developing plans for that review; and, that while additional changes were still necessary in achieving compatibility with all of NRCs procedures, that Washington had made progress towards meeting the essential objectives of this requirement for several of the program areas.
The team determined that, during the review period, Washington met the performance indicator objectives listed in Section 4.1.a, except for:
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.
At the time of the 2022 IMPEP review, the team found that Washington had placed non-standard license conditions on Washington licenses prior to sending them to NRC for a compatibility review. As a result, that team recommended that Washington review all their license conditions, identify non-standard license conditions, and submit any non-standard license conditions identified to the NRC for a compatibility review. Washington informed the 2024 team that this task had been assigned to a former employee who had performed a review of all their license conditions and identified one non-standard license condition which Washington then submitted to NRC for a compatibility review. During the 2024 review, the team identified additional non-standard license conditions that had not been previously identified during Washingtons extent of condition review. Because of this, the team is recommending that the previously issued recommendation be kept open so that Washington has additional time to reexamine all their license conditions to ensure that all non-standard conditions are properly identified and submitted to NRC for a compatibility review.
The team discussed the previous rating of Satisfactory but needs Improvement for this indicator and reviewed available guidance and believed that although additional changes were still necessary, that enough progress had been made in this indicator to elevate the rating from Satisfactory but needs Improvement, to Satisfactory.
Therefore, based on the criteria in MD 5.6, the team recommends that Washingtons 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.
Washington Draft Follow-Up IMPEP Report Page 21 5.0
SUMMARY
Based on the results of the 2024 follow-up IMPEP review, the team found Washingtons performance satisfactory for the two performance indicators Technical Quality of Inspections; and Legislation, Regulations, and Other Program Elements. The team also found Washingtons performance satisfactory but needs improvement for the three performance indicators:
Technical Staffing and Training, Technical Quality of Licensing Actions, and Technical Quality of Incident and Allegation Activities. Furthermore, the team found Washingtons performance unsatisfactory for the performance indicator Status of Materials Inspection Program.
The 2024 IMPEP team did not review the SS&D, LLRW Disposal, or UR Program indicators.
These three performance indicators were discussed at a periodic meeting held on April 11, 2024, concurrent with the IMPEP review. The Washington Periodic Meeting Summary is provided in Appendix C.
Of the nine recommendations from the 2022 IMPEP review that are applicable to the performance indicators evaluated during this follow-up IMPEP review, the team proposes that:
Four recommendations be closed; Two recommendations: (1) revising incident and allegation procedures, and (2) locating and assessing allegation files, be modified, and kept open; and Three recommendations: (1) updating training and qualification requirements, (including LLRW program and UR program elements), (2) revising the licensing procedure, and (3) reviewing licensing conditions, be kept open.
Accordingly, the team recommends that the Washington radiation control program be found adequate to protect public health and safety but needs improvement and compatible with the NRC's program. The team also recommends that a periodic meeting take in approximately 1 year with the next IMPEP review taking place in approximately 2 years. Further, the team recommended that Washington remain on heightened oversight.
LIST OF APPENDICES Appendix A IMPEP Review Team Members Appendix B Inspector Accompaniments Appendix C Periodic Meeting Summary
APPENDIX A IMPEP REVIEW TEAM MEMBERS Name Areas of Responsibility Geoffrey Warren Team Leader NRC Region III Inspector Accompaniments Sara Forster Team Leader in Training NRC Region III Technical Quality of Incident and Allegation Activities Jeff Griffis Technical Staffing and Training NRC Technical Training Center Sherrie Flaherty Status of Materials Inspection Program NRC Headquarters Phillip Peterson Technical Quality of Inspections State of Colorado Joshua Daehler Technical Quality of Licensing Actions Commonwealth of Massachusetts Russell Hestand Technical Quality of Licensing Actions Commonwealth of Kentucky Randy Erickson Legislation, Regulations, and Other Program Elements NRC Region IV Inspector Accompaniments
APPENDIX B INSPECTOR ACCOMPANIMENTS The following inspector accompaniments were performed prior to the on-site IMPEP review:
Accompaniment No.: 1 License No.: RECIP-027 License Type: Service Provider/Reciprocity Priority: 2 Inspection Date: 9/7/23 and 9/10/23 Inspectors initials: JH Accompaniment No.: 2 License No.: WN-IR011-1 License Type: Industrial Radiography Priority: 1 Inspection Date: 2/26/24 Inspectors initials: JH Accompaniment No.: 3 License No.: WN-IO526-1 License Type: Portable Gauge Priority: 5 Inspection Date: 2/27/24 Inspectors initials: CD Accompaniment No.: 4 License No.: WN-IR066-1 License Type: Industrial Radiography Priority: 1 Inspection Date: 2/28/24 Inspectors initials: BG Accompaniment No.: 5 License No.: WN-MO318-1 License Type: Medical / HDR Priority: 2 Inspection Date: 2/29/24 Inspectors initials: BT
APPENDIX C INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM WASHINGTON AGREEMENT STATE PERIODIC MEETING
SUMMARY
TYPE OF OVERSIGHT: HEIGHENTED OVERSIGHT APRIL 11, 2024
PERIODIC MEETING PARTICIPANTS NRC Kevin Williams, Director, Division of Materials Safety, Security, State, and Tribal Programs, NMSS Tammy Bloomer, Director, Division of Radiological Safety and Security, NRC Region IV Randy Erickson, RSAO, Division of Radiological Safety and Security, NRC Region IV State of Washington Jill Wood, Director, Office of Radiation Protection Earl Fordham, Associate Director, Office of Radiation Protection John Martell, Associate Director, Office of Radiation Protection Kristen Schwab, Waste Section Supervisor
1.0 INTRODUCTION
This report presents the results of the periodic meeting held between the U.S. Nuclear Regulatory Commission (NRC) and the State of Washington. The meeting was held on April 11, 2024, and was conducted in accordance with Nuclear Materials Safety and Safeguards (NMSS)
Procedure SA-116, Periodic Meetings between IMPEP Reviews, dated October 29, 2021; and was held concurrently with the 2024 follow-up Integrated Materials Performance Evaluation Program (IMPEP) review.
Washington is administered by the Office of Radiation Protection which is in the Environmental Public Health Division. The Division is part of the Department of Health. Organization charts for Washington are available in NRCs Agencywide Documents Access and Management System Accession Number ML24099A204. The radiation control program is composed of a Radiation Control Program Director (RCPD), two Associate Directors, a radioactive materials section, and a waste section.
At the time of the meeting, Washington regulated approximately 310 specific licenses authorizing possession and use of radioactive materials. The meeting focused on the radioactive materials program as it is carried out under the Section 274b. (of the Atomic Energy Act of 1954, as amended) Agreement between the NRC and the State of Washington.
Washington last underwent a full IMPEP review from March 28-April 1, 2022. That report is available in ML22206A205. A Management Review Board (MRB) meeting to discuss the outcome of the IMPEP review was held on July 14, 2022.
During the 2022 MRB meeting, Washingtons performance was found to be satisfactory for the following four performance indicators: Status of Materials Inspection Program; Sealed Source and Device (SS&D) Evaluation Program; Low-Level Radioactive Waste (LLRW) Disposal Program; and Uranium Recovery (UR) Program. Washingtons performance was found to be satisfactory but needs improvement for the following three performance indicators: Technical Staffing and Training; Technical Quality of Inspections; and Legislation, Regulations, and Other Program Elements. Washingtons performance was found to be unsatisfactory for the following two performance indicators: Technical Quality of Incident and Allegation Activities; and Technical Quality of Licensing Actions. The team recommended and the MRB agreed that one of the two 2018 IMPEP review recommendations be closed which involved implementing a technical evaluation report for licensing decisions at the LLRW disposal facility. The team also recommended and the MRB agreed with modifying the remaining 2018 IMPEP review recommendation involving training and qualification requirements. The team also initially made 10 new recommendations. The MRB suggested combining some of the recommendations, so the team made changes and reduced that number to eight new recommendations. Accordingly, the team recommended and the MRB agreed that the Washington Agreement State Program be found adequate to protect public health and safety but needs improvement. Since the team noted that Washingtons program had the potential to create gaps, conflicts, duplication, or other conditions that could jeopardize an orderly pattern in the collective national effort to regulate agreement materials, the team also recommended and the MRB agreed that the Washington Agreement State Program be found not compatible with the NRC's program.
Based on the results of the 2022 IMPEP review and the decline in performance, the team recommended and the MRB agreed that Washington be placed on a period of heightened oversight. The team recommended and the MRB agreed that in approximately two years a follow-up IMPEP review be conducted for the less than satisfactory indicators, and a periodic
meeting be conducted for the satisfactory indicators. Then after the follow-up IMPEP review, the MRB will determine when the next full IMPEP review will be conducted. Because the Status of the Materials Inspection Program performance indicator and the Technical Quality of Inspections performance indicators are so closely related, the NRC expanded the scope of the 2024 follow-up IMPEP review to include a full review of the Status of the Materials Inspection Program performance indicator.
2.0 COMMON PERFORMANCE INDICATORS Five common performance indicators are used to review the NRCs Regional Office and Agreement State radioactive materials programs during an IMPEP review. 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.
Because the periodic meeting was held concurrently with the follow-up IMPEP review and the focus of that review was limited in scope, the periodic meeting, also limited in scope, was a discussion of those indicators not reviewed during the follow-up IMPEP.
2.1 Technical Staffing and Training (2022 IMPEP Rating: Satisfactory but needs Improvement)
The performance indicator Technical Staffing and Training was reviewed during the 2024 follow-up IMPEP review. See 2024 follow-up IMPEP report for the results.
2.2 Status of the Materials Inspection Program (2022 IMPEP Rating: Satisfactory)
The performance indicator Status of the Materials Inspection Program was reviewed during the 2024 follow-up IMPEP review. See 2024 follow-up IMPEP report for the results.
2.3 Technical Quality of Inspections (2022 IMPEP Rating: Satisfactory but needs Improvement)
The performance indicator Technical Quality of Inspections was reviewed during the 2024 follow-up IMPEP review. See 2024 follow-up IMPEP report for the results.
2.4 Technical Quality of Licensing Actions (2022 IMPEP Rating: Unsatisfactory)
The performance indicator Technical Quality of Licensing Actions was reviewed during the 2024 follow-up IMPEP review. See 2024 follow-up IMPEP report for the results.
2.5 Technical Quality of Incident and Allegation Activities (2022 IMPEP Rating:
Unsatisfactory)
The performance indicator Technical Quality of Incident and Allegation Activities was reviewed during the 2024 follow-up IMPEP review. See 2024 follow-up IMPEP report for the results.
3.0 NON-COMMON PERFORMANCE INDICATORS Four non-common performance indicators are used to review Agreement State programs: (1) Legislation, Regulations, and Other Program Elements; (2) SS&D Evaluation Program; (3) LLRW Disposal Program; and (4) UR Program. The NRC relinquished regulatory authority for these non-common performance indicators. The first non-common indicator was reviewed by the IMPEP team; therefore, only the second, third, and fourth non-common indicators applied to this meeting.
3.1 Legislation, Regulations and Other Program Elements (2022 IMPEP Rating:
Satisfactory but needs Improvement)
The performance indicator Legislation, Regulations and Other Program Elements was reviewed during the 2024 follow-up IMPEP review. See 2024 follow-up IMPEP report for the results.
3.2 SS&D Evaluation Program (2022 IMPEP Rating: Satisfactory)
Washingtons agreement with the NRC authorizes an SS&D program but it is not a highly active program. Prior to the 2022 IPEP review, the materials section did have qualified individuals who performed safety and product evaluations of SS&D applications. Shortly after the 2022 IMPEP review, qualified staff had been reduced to one due to terminations, and shortly after that, the only remaining qualified individual also left employment. At the time of the 2024 IMPEP review, Washington had no qualified staff and had entered into a contract with California to perform any necessary SS&D reviews. California performed two amendments over the review period to assist Washington. Washington has discussed returning the SS&D portion of the agreement back to the NRC but as of the date of this meeting, no action has been taken.
3.2 LLRW Disposal Program (2022 IMPEP Rating: Satisfactory)
At the time of the periodic meeting, the Waste Section licensed two sites, the U.S.
Ecology site for LLRW and the Perma-Fix Northwest, Inc., (Perma-Fix) site as a waste processing facility. The U.S. Ecology site is located northwest of the City of Richland, Washington, on approximately 100 acres of land which is entirely within the U.S.
Department of Energy (DOE) Hanford site and has been in operation since 1965. The Waste Section licenses U.S. Ecology to receive, handle, process, store, and dispose of LLRW at this facility, and is authorized to dispose of the Class A, B, and C LLRW from the Northwest and Rocky Mountain Compact regions. Perma-Fix, operating since the early 1990s, is located on 35 acres adjacent to the DOE Hanford site and is a commercial waste processing facility, licensed by the Waste Section for storing and treating both LLRW (thermal and non-thermal methods) and mixed waste (non-thermal method only).
Waste Section staff involved with LLRW and UR activities includes the section supervisor, five license reviewers/inspectors, and one administrative assistant. This totals approximately three FTE for LLRW licensing, inspections, and technical reviews.
The technical staff and manager have diversified backgrounds in health physics, engineering, and earth sciences which meets or exceeds the educational levels necessary to perform licensing and inspection activities. There is also no longer a
resident inspector position at the U.S. Ecology site. During the meeting the waste section supervisor announced that following the 2024 IMPEP review, that she would be terminating employment and transitioning to a management position with the Northwest Interstate Compact for LLRW. Washington stated that they would be replacing this position as soon as possible.
The Waste Section continues to perform annual inspections at both the U.S. Ecology and Perma-Fix sites. In addition to the annual inspections, they also conduct limited monthly inspections based on the licensees operations. The Waste Section completes LLRW inspections in accordance with the frequency established in the NRCs IMC 2401, Near-Surface Low-Level Radioactive Waste Disposal Facility Inspection Program.
There were no overdue inspections at the time of the periodic meeting and inspection findings are communicated to the licensee within 30 days of the exit. The Waste Section supervisor reviews and approves all letters and inspection reports.
The Program reported that no allegations were received directly by the Program or referred by the NRC in the LLRW or UR program areas. The Waste Section also experienced no significant events.
Washingtons waste section currently has a training and qualification manual compatible with NRCs IMC 1248, Appendix E. The training program is managed by the waste section supervisor who determines when staff are sufficiently trained to work independently while performing LLRW and UR licensing and inspection-related activities.
The waste section supervisor is also responsible for ensuring that the 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of continuing education requirements are met.
3.2 UR Program (2022 IMPEP Rating: Satisfactory)
At the time of the periodic meeting, the Waste Section licensed the Dawn Mining Company (Dawn), a former conventional mill site covering approximately 800 acres in Ford, Washington, currently undergoing decommissioning and reclamation. There are no other operating uranium mills in the state. Activities performed included continued soil cleanup, continuing the process water evaporation and completion of final radon barriers. The Waste Section continues to perform environmental monitoring at the site.
Currently the Waste Section staff involved with UR activities includes the waste section supervisor, one three technical staff, and an engineer who serves as the Waste Sections subject matter expert in geotechnical engineering. This totals approximately two FTE for UR licensing, inspections, and technical reviews.
The Waste Section continues to perform inspections at Dawn including both annual radiation safety and field inspections. The field inspections were performed whenever there were key decommissioning, reclamation, or construction activities being conducted by the licensee, or there was a need to evaluate the site condition. There were no overdue inspections at the time of the periodic meeting, and inspection findings are communicated to the licensee within 30 days of the exit. The waste section supervisor reviews and approves all letters and inspection reports. The waste section supervisor reported that to speed up closure activities at the site, that the licensee is introducing new technology to facilitate the evaporation process. Washington is evaluating that process.
Washingtons waste section currently has a training and qualification manual compatible with NRCs IMC 1248, Appendices H, and I for UR staff. The training program is managed by the waste section supervisor who determines when staff are sufficiently trained to work independently while performing LLRW and UR licensing and inspection-related activities. The waste section supervisor is also responsible for ensuring that the 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of continuing education requirements are met.
4.0
SUMMARY
During this periodic meeting, only three performance indicators were discussed. Those were the SS&D Evaluation Program, the LLRW Disposal Program, and the UR Program indicators. The remaining performance indicators were reviewed during the follow-up IMPEP review.
ML24128A052 OFFICE NMSS/MSST/SLPB R-III/DNMS/MLB R-III/DNMS/MIB*
NMSS/MSST NAME RJohnson SForster GWarren LSmith DATE May 7, 2024 May 8, 2024 May 8, 2024 May 7, 2024 OFFICE NMSS/MSST/SMPB NAME AGiantelli DATE May 17, 2024