ML21293A321
| ML21293A321 | |
| Person / Time | |
|---|---|
| Issue date: | 10/27/2021 |
| From: | Brian Anderson NRC/NMSS/DMSST/ASPB |
| To: | Catherine Haney, John Lubinski, Mohammed Shuaibi, Mary Spencer NRC/EDO/DEDMRS, Office of Nuclear Material Safety and Safeguards, NRC/OGC, NRC/RGN-III |
| Poynter S | |
| References | |
| Download: ML21293A321 (21) | |
Text
MEMORANDUM TO:
Catherine Haney Deputy Executive Director for Materials, Waste, Research, State, Tribal, Compliance, Administration, and Human Capital Programs Office of the Executive Director for Operations John W. Lubinski, Director Office of Nuclear Material Safety and Safeguards Mary B. Spencer, Assistant General Counsel for Rulemaking, Agreement States, and Fee Policy Office of the General Counsel Mohammed Shuaibi, Regional Administrator Region III FROM:
Brian C. Anderson, Chief State Agreement and Liaison Programs Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
SUBJECT:
PROPOSED FINAL OREGON AGREEMENT STATE INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REPORT This memorandum transmits to the Management Review Board (MRB) the proposed final report (Enclosure 1) documenting the Integrated Materials Performance Evaluation Program (IMPEP) review of the State of Oregon. The IMPEP review was conducted in person by a team of U.S. Nuclear Regulatory Commission (NRC) and Agreement State technical staff on August 9-13, 2021. Three in-person inspector accompaniments were conducted on June 15-17, 2021. The teams preliminary findings were discussed with representatives of the State of Oregon on August 13, 2021. The team issued a draft report to Oregon on September 22, 2021, for factual comment (Agencywide Documents Access and Management System (ADAMS) Accession Number ML21256A172). Oregon responded to the draft report by letter dated October 20, 2021, from David Howe, Program Director, Radiation Protection Services Section (ADAMS Accession Number ML21293A021).
CONTACT: Robert K. Johnson, NMSS/MSST Robert.Johnson@NRC.gov October 27, 2021 Signed by Anderson, Brian on 10/27/21
MRB Members Overall, the team is recommending that Oregons performance be found satisfactory for all six performance indicators reviewed:
Technical Staffing and Training;
Status of Materials Inspection Program;
Technical Quality of Inspections;
Technical Quality of Licensing Actions;
Technical Quality of Incident and Allegation Activities; and
Legislation, Regulations, and Other Program Elements.
The team made one new recommendation regarding proper event documentation under the Technical Quality of Incident and Allegation Activities performance indicator and determined that the recommendation from the 2017 IMPEP review be closed.
Accordingly, the team is recommending that overall, Oregon be found adequate to protect public health and safety and compatible with the NRC's program. Since this is the second consecutive IMPEP review with all performance indicators being found satisfactory, the team also recommends that the next periodic meeting take place in approximately 2.5 years and the next full IMPEP review take place in approximately 5 years.
The MRB meeting for Oregons IMPEP review is scheduled to be conducted on November 10, 2021, from 1:00 p.m. to 3:00 p.m. ET, via Microsoft Teams. In accordance with Management Directive 5.6, the meeting is open to the public, and characterized as an NRC Observation Public Meeting. The agenda for the meeting is enclosed (Enclosure 2).
Enclosures:
- 1. Oregon Agreement State Program IMPEP Review
- 2. Oregon Agreement State Program MRB Meeting Agenda cc: Debra Shults, OAS Representative to the MRB Tennessee Department of Environment and Conservation Division of Radiological Health
ML21293A321 OFFICE NMSS/MSST NMSS/MSST NMSS/MSST NMSS/MSST NAME SPoy RJohnson ERaphael BAnderson DATE 10/21/2021 10/21/2021 10/20/21 10/27/21 OREGON AGREEMENT STATE PROGRAM INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW AUGUST 9-13, 2021 PROPOSED FINAL REPORT
EXECUTIVE
SUMMARY
The results of the Integrated Materials Performance Evaluation Program (IMPEP) review of the Oregon Agreement State Program (Oregon) are discussed in this report. The review was conducted on site from August 9-13, 2021, by a team of technical staff members assembled from the U.S. Nuclear Regulatory Commission (NRC) and the States of Kansas and North Dakota. Three in-person inspector accompaniments were conducted on June 15-17, 2021 The team found Oregons performance to be satisfactory for all 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.
The team made one new recommendation from its review of the Technical Quality of Incidents and Allegation Activities performance indicator and determined that the recommendation from the 2017 IMPEP review be closed. The new recommendation is:
The team recommends that Oregon develop written protocols for maintaining logs to ensure incident response and allegation procedures are in place, followed, and follow-up inspections are scheduled and completed to ensure compliance with Oregon Protocol 606. As part of this recommendation, Oregon will perform a retrospective review of events from 2017 to present to ensure appropriate supporting information is documented in the log.
Accordingly, the team recommends that the Oregon Agreement State Program be found adequate to protect public health and safety and compatible with the NRC's program. Since this was Oregons second consecutive IMPEP review with all indicators rated as satisfactory, the team recommends that the next periodic meeting take place in approximately 2.5 years with the next full IMPEP review taking place in approximately 5 years.
Oregon Proposed Final IMPEP Report Page 1
1.0 INTRODUCTION
The Oregon Agreement State Program (Oregon) review was conducted in person from August 9-13, 2021, by a team of technical staff members from the U.S. Nuclear Regulatory Commission (NRC) and the States of Kansas and North Dakota. Team members are identified in Appendix A. This review was conducted onsite and in-person inspector accompaniments were conducted on June 15-17, 2021.
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. In addition, the team considered IMPEP Temporary Instruction 003, Evaluating the Impacts of the COVID-19 Public Health Emergency as Part of Integrated Materials Performance Evaluation Program (IMPEP),
dated October 21, 2020, to evaluate the impact of the COVID-19 Public Health Emergency (PHE) on the Program. Preliminary results of the review, which covered the period of August 12, 2017 to August 13, 2021, were discussed with the Oregon 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 Oregon on January 13, 2021. Oregons June 21, 2021 response to the questionnaire is available in the NRCs Agencywide Documents Access and Management System (ADAMS) using the Accession Number ML21256A258.
The Oregon Agreement State Program is administered by the Radiation Protection Services Section (the Section) which is located within the Center for Health Protection (the Center). The Center is part of the Oregon Public Health Division (the Division). The Division is a part of the Oregon Health Authority. Organization charts for Oregon are available in ADAMS (Accession Number ML21256A142).
At the time of the review, Oregon regulated 276 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 Oregon.
The team evaluated the information gathered against the established criteria for each common and applicable non-common performance indicator and made a preliminary assessment of the Oregons performance.
2.0 PREVIOUS IMPEP REVIEW AND STATUS OF RECOMMENDATIONS The previous IMPEP review concluded on August 11, 2017. The final report is available in ADAMS (Accession Number ML17304A423). The results of the review are as follows:
Technical Staffing and Training: Satisfactory Recommendation: None Status of Materials Inspection Program: Satisfactory Recommendation: None
Oregon Proposed Final IMPEP Report Page 2 Technical Quality of Inspections: Satisfactory Recommendation: The MRB recommended that Oregon complete a quality assurance (QA) review of licenses to ensure their program code, description, and inspection frequency accurately reflect the authorizations on the license.
Status: The team noted that prior to the August 2019 periodic meeting, the Program completed a QA review of their licensing database. As a result of this QA review, the Program made corrections to the program codes, descriptions, and inspection frequencies, where necessary. The review team also noted that the Program continues to routinely verify that the program codes, description, and inspection frequencies are accurately reflected in the licensing authorizations, prior to completing any licensing action or inspection. Based on the results of the review, the team recommends that this recommendation be closed.
Technical Quality of Licensing Actions: Satisfactory Recommendation: None Technical Quality of Incident and Allegation Activities: Satisfactory Recommendation: None Legislation, Regulations and Other Program Elements: Satisfactory Recommendation: None Overall finding: Adequate to protect public health and safety and compatible with the NRC's program.
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 a sufficient number of experienced, knowledgeable, and well-trained technical personnel. Under certain conditions, staff turnover could have an adverse effect on the implementation of these programs and could affect public health and safety. Apparent trends in staffing must be assessed. Review of staffing also requires consideration and evaluation of the levels of training and qualification. The evaluation standard measures the overall quality of training available to, and taken by, materials program personnel.
a.
Scope The team used the guidance in State Agreements procedure SA-103, Reviewing the Common Performance Indicator: Technical Staffing and Training, and evaluated Oregons 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.
Oregon Proposed Final IMPEP Report Page 3
There is a balance in staffing of the licensing and inspection programs.
Management is committed to training and staff qualification.
Agreement State training and qualification program is equivalent to NRC Inspection Manual Chapter (IMC) 1248, Formal Qualifications Program for Federal and State Material and Environmental Management Programs.
Qualification criteria for new technical staff are established and are followed, or qualification criteria will be established if new staff members are hired.
Individuals performing materials licensing and inspection activities are adequately qualified and trained to perform their duties.
License reviewers and inspectors are trained and qualified in a reasonable period of time.
b.
Discussion When fully staffed Oregon is comprised of 15 staff members (nine technical staff members, three administrative staff members, two first line supervisors, and the Program Director) which equals 6.75 full-time equivalent. At the time of the review, Oregon had two vacancies; one technical position and one administrative position which have been approved by the Oregon Program managers to fill. During the review period, four staff members left the Program, and three staff members were hired. The positions were vacant from 4 to 5 months. Recent legislation passed will allow Oregon to hire two additional technical positions in calendar year 2022.
Oregon has a well-documented training and qualification program that is compatible with the NRCs IMC 1248. The Oregon Program staff uses a Licensing and Inspection Training Journal to document competency. The journal contains completion of training, on the job training, qualifications, and continuing education. Full qualification requires approval by first line supervision and the Program Director. Oregon mentors new employees in the field during inspections and performs peer reviews of all licensing actions.
c.
Evaluation The team determined that, during the review period, Oregon met the performance indicator objectives listed in Section 3.1.a. Based on the criteria in MD 5.6, the team recommends that Oregons performance with respect to the indicator, Technical Staffing and Training, be found satisfactory.
d.
MRB Chairs Determination The final report will present the MRB Chairs determination regarding this indicator.
3.2 Status of Materials Inspection Program Periodic 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.
Oregon Proposed Final IMPEP Report Page 4 a.
Scope The team used the guidance in State Agreements procedure SA-101, Reviewing the Common Performance Indicator: Status of the Materials Inspection Program, and evaluated Oregons 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 prescribed in IMC 2800.
Deviations from inspection schedules are normally coordinated between technical staff and management.
There is a plan to perform any overdue inspections and reschedule any missed or deferred inspections, or a basis has been established for not performing any overdue inspections or rescheduling any missed or deferred inspections.
Candidate licensees working under reciprocity are inspected in accordance with the criteria prescribed in IMC 2800 and other applicable guidance or compatible Agreement State Procedure.
Inspection findings are communicated to licensees in a timely manner (30 calendar days, or 45 days for a team inspection), as specified in IMC 0610, Nuclear Material Safety and Safeguards Inspection Reports.
b.
Discussion Oregon performed 98 Priority 1, 2, 3, and initial inspections during the review period.
Oregon conducted two overdue inspections as a result of the COVID-19 PHE. The team noted that Temporary Instruction 003, Evaluating the Impacts of the COVID-19 Public Health Emergency as part of the Integrated Materials Performance Evaluation Program (IMPEP), states, in part, that for inspections that exceed the scheduling window with overdue dates falling inside the defined timeframe of the COVID-19 PHE, the number of overdue inspections should be noted in the report but should not be counted in the calculation of overdue inspections, provided that Oregon continues to maintain health, safety, and security. The team concluded that Oregon continued to maintain health, safety, and security during the PHE and therefore, did not include these two inspections when performing the calculation. No other Priority 1, 2, 3 or initial inspections were conducted overdue during the review period.
A sampling of five inspection reports indicated that the inspection findings were communicated to the licensees within Oregons goal of 30 days after the inspection exit or 45 days after the team inspection exit. Inspectors provide an inspection report which details the findings of the inspection to the licensee at the inspection exit meeting.
Each year of the review period, Oregon performed greater than 20 percent of candidate reciprocity inspections. In the future, Oregon plans to perform 10 percent of candidate reciprocity inspections, which is consistent with guidance in NRC IMC 2800.
c.
Evaluation The team determined that, during the review period, Oregon met the performance indicator objectives listed in Section 3.2.a. Based on the criteria in MD 5.6, the team recommends that Oregons performance with respect to the indicator, Status of Materials Inspection Program, be found satisfactory.
Oregon Proposed Final IMPEP Report Page 5 d.
MRB Chairs Determination The final report will present the MRB Chairs determination regarding this indicator.
3.3 Technical Quality of Inspections Inspections, both routine and reactive, provide reasonable assurance that licensee activities are carried out in a safe and secure manner. Accompaniments of inspectors performing inspections and the critical evaluation of inspection records are used to assess the technical quality of an inspection program.
a.
Scope The team used the guidance in State Agreements procedure SA-102, Reviewing the Common Performance Indicator: Technical Quality of Inspections, and evaluated Oregons 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 26 inspection reports and enforcement documentation, and interviewed inspectors involved in materials inspections conducted during the review period. The team reviewed casework for inspections conducted by eight current and former Oregon inspectors and covered medical, industrial, commercial, academic, research, and service licenses.
Team members accompanied three inspectors on June 15-17, 2021. The inspector accompaniments were conducted in person. The inspector accompaniments are identified in Appendix B of this report. No performance issues were noted during the inspector accompaniments. The inspectors were well-prepared, thorough, and appropriately assessed the impact of licensed activities on health, safety, and security.
The inspectors clearly communicated the inspection findings to licensees at the exit meeting.
Supervisory accompaniments were conducted annually for all inspectors.
Because of travel restrictions in place due to the COVID-19 PHE, the Oregon Program performed virtual inspections between March-August, 2020.
Oregon Proposed Final IMPEP Report Page 6 The team found that inspection results were well documented with respect to health, safety, and security. The team also found that cited violations were supported by the State of Oregon regulations and that inspection findings led to appropriate and prompt regulatory actions. Oregons inspection documentation included the closure of previous violations and the documenting of open items.
The team noted that Oregon holds monthly Materials Program staff meetings. Items discussed during these meetings included open licensing actions, status of inspections, open inspection reports, open incidents, reciprocity status and staff training. The Oregon Program uses this information to keep staff updated, remain current in their actions, and prioritize workload.
The team determined that Oregon has a sufficient supply of calibrated radiation survey instruments to support the inspection program. Records indicate that all survey instrumentation is calibrated on an annual basis.
c.
Evaluation The team determined that, during the review period, Oregon met the performance indicator objectives listed in Section 3.3.a. Based on the criteria in MD 5.6, the team recommends that Oregons performance with respect to the indicator, Technical Quality of Inspections be found satisfactory.
d.
MRB 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 Oregon 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 State Agreements procedure SA-104, Reviewing the Common Performance Indicator: Technical Quality of Licensing Actions, and evaluated Oregons 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 Code of Federal Regulation (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.
Oregon Proposed Final IMPEP Report Page 7
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 are appropriately implemented including the physical protection of Category 1 and Category 2 quantities of radioactive material (10 CFR Part 37 equivalent).
Documents containing sensitive security information are properly marked, handled, controlled, and secured.
b.
Discussion During the review period, Oregon performed 743 radioactive materials licensing actions.
The team evaluated 16 of those licensing actions which were selected based on the guidance in SA-104. The licensing actions selected for review included five new applications, eight amendments, two renewals, and one termination. The team evaluated casework which included the following license types and actions: source material manufacturer, portable gauge, nuclear pharmacy, nuclear medicine, Type A broad scope, temporary job site industrial radiography, radiopharmaceutical therapy and Y-90 microspheres, mobile PET imaging, and self-shielded irradiators. The casework sample represented work from four current and former license reviewers.
In each of the licensing actions reviewed, the team found the casework completed in accordance with the current NUREG-1556 series guidance and followed sound health physics principles. The team observed that the most current Pre-Licensing Guidance and Risk-Significant Radioactive Material checklists were used by the license reviewers.
Oregons equivalent to 10 CFR Part 37 security licenses were marked and stored appropriately.
In March 2020, Oregon implemented process improvements to track licensing correspondence (from both Oregon and the licensees), licensing action tracking sheets, and licenses in an electronic database.
Oregon also instituted a 90-day metric to complete all licensing actions. This metric is reviewed during the supervisor monthly meetings. The team observed that Oregon assigns a licensing action tracking sheet that provides a chronology of each licensing action from receipt to issuance of the licensing action.
The team verified that Oregon ensured that licensees that were required to demonstrate financial assurance submitted the appropriate financial assurance instrument.
c.
Evaluation The team determined that, during the review period, Oregon met the performance indicator objectives listed in Section 3.4.a. Based on the criteria in MD 5.6, the team recommends that Oregons performance with respect to the indicator, Technical Quality of Licensing Actions, be found satisfactory.
d.
MRB Chairs Determination The final report will present the MRB Chairs determination regarding this indicator.
Oregon Proposed Final IMPEP Report Page 8 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 State Agreements procedure SA-105, Reviewing the Common Performance Indicator: Technical Quality of Incident and Allegation Activities, and evaluated Oregons 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, 50 radioactive materials incidents were reported to Oregon.
The team evaluated 13 of those incidents: two leaking sources, two lost sources, two found sources, one potential overexposure, four medical events, one missing shipment, and one broken device. Oregon reviews all cases with regard to public health and safety and will dispatch inspectors for on-site follow-up on a case-by-case basis. Those cases not followed-up on with on-site visits are closed out with phone calls and reviewed during their next inspection.
The team also evaluated Oregons reporting of incidents to the NRCs Headquarters Operations Center (HOC). The team noted that in each case requiring HOC notification, Oregon reported the incidents within the required timeframe. The team also evaluated whether Oregon had failed to report any required incidents to the HOC and did not identify any missed reports.
Oregon received 14 allegations related to radioactive materials. The team evaluated 13 allegations, including the 4 allegations that the NRC referred to the State, during the review period.
Oregons allegation process allows for confidentiality. Investigators are well-trained and knowledgeable. The Oregon Program also has a good rapport with major hospitals in the State of Oregon that enables them to investigate problems in a constructive and
Oregon Proposed Final IMPEP Report Page 9 open manner.
The team identified that the documentation needed for auditing of allegations was sometimes found only on inspectors individual e-mail accounts or through interviews.
The logbook designated for this information required under Oregon Protocol 606 was not consistently used. The team had difficulty ensuring that all documentation related to an incident was present. During the IMPEP review, inspectors were available to help find this documentation; however, this may not be the case in the future when investigators retire. Oregon is aware of this and is currently developing the ability to save documents directly to their online incident database.
The team noted that documentation was lacking for the following cases: a large hospital event in 2018, a potential unlicensed neutron generator referred to the Oregon Program by the NRC in 2019, and an NMED reportable event concerning a found tritium exit sign in 2020. In each of the cases, follow-up investigation was performed according to interviews with the inspector, but documentation about the investigation was not present in the report. Oregon informed the team that the lack of written documentation was caused by a database software issue that is in the process of being fixed. Other documentation issues can be traced to a time when there were a limited number of inspectors available who were qualified to handle a growing number of incidents and allegations leading to rushed work. Oregon has hired staff to address this issue and is in the process of hiring additional staff in this area. Based on interviews with the inspectors involved, cases were completed to the satisfaction of the Oregon Program to protect public health and safety.
The team noted that the Programs monthly Materials Program staff meetings discussed reviews of incidents and allegations, which keeps the staff aware of issues in the State even for those not directly involved. The Oregon Program is also active in supporting and investigating community concerns, as evidenced by incidents reported by concerned citizens.
The team noted that actions taken were appropriate, with effort commensurate to the potential safety concern. Procedures concerning health and safety of the public or allegers were followed, follow-up occurred on corrective actions, the NRC was notified appropriately when required for all incidents and allegations, and NMED information was submitted properly. Allegers received information where applicable.
c.
Evaluation The team determined that during the review period Oregon met the performance indicator objectives listed in Section 3.5.a, except for:
Allegation procedures are in place but not followed consistently.
One record did not include a coordinated follow-up inspection.
Three allegations did not include follow-up inspections and did not meet completeness requirements for investigation records.
Because Oregon is able to add supporting documentation and assign Notices of Violation for both investigations and inspections, the team considers the above exceptions to have been corrected.
Oregon Proposed Final IMPEP Report Page 10 The team also made one new recommendation from its review of the Technical Quality of Incidents and Allegation Activities performance indicator:
The team recommends that Oregon develop written protocols for maintaining logs to ensure incident response and allegation procedures are in place, followed, and follow-up inspections are scheduled and completed to ensure compliance with Oregon Protocol 606. As part of this recommendation, Oregon will perform a retrospective review of events from 2017 to present to ensure appropriate supporting information is documented in the log.
Based on the IMPEP evaluation criteria in MD 5.6, the team recommends that Oregons performance with respect to the indicator, Technical Quality of Incident and Allegation Activities, be found satisfactory.
d.
MRB Chairs Determination The final report will present the MRB Chairs determination regarding this indicator.
4.0 NON-COMMON PERFORMANCE INDICATORS Four non-common performance indicators are used to review Agreement State programs: (1) Legislation, Regulations, and Other Program Elements; (2) Sealed Source and Device (SS&D) Evaluation Program; (3) Low-Level Radioactive Waste (LLRW) Disposal Program; and (4) Uranium Recovery Program. The NRC retains regulatory authority for SS&D Evaluation, LLRW Disposal, and Uranium Recovery Programs; therefore, only the first non-common performance indicator applied to this review.
4.1 Legislation, Regulations, and Other Program Elements State statutes should authorize the State to establish a program for the regulation of agreement material and provide authority for the assumption of regulatory responsibility under the States agreement with the NRC. The statutes must authorize the State to promulgate regulatory requirements necessary to provide reasonable assurance of adequate protection of public health, safety, and security. The State must be authorized through its legal authority to license, inspect, and enforce legally binding requirements, such as regulations and licenses. The NRC regulations that should be adopted by an Agreement State for purposes of compatibility or health and safety should be adopted in a time frame so that the effective date of the State requirement is not later than 3 years after the effective date of the NRC's final rule. Other program elements that have been designated as necessary for maintenance of an adequate and compatible program should be adopted and implemented by an Agreement State within 6 months following NRC designation. A Program Element Table indicating the Compatibility Categories for those program elements other than regulations can be found on the NRC Web site at the following address: https://scp.nrc.gov/regtoolbox.html.
a.
Scope The team used the guidance in State Agreements procedure SA-107, Reviewing the Non-Common Performance Indicator: Legislation, Regulations, and Other Program Elements, and evaluated Oregons performance with respect to the following performance indicator objectives. A complete list of regulation amendments can be
Oregon Proposed Final IMPEP Report Page 11 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, as amended.
Regulations adopted by the Agreement State for purposes of compatibility or health and safety were adopted no later than 3 years after the effective date of the NRC regulation.
Other program elements, as defined in SA-200 that have been designated as necessary for maintenance of an adequate and compatible program, have been adopted and implemented within 6 months of NRC designation.
The State statutes authorize the State to establish a program for the regulation of agreement material and provide authority for the assumption of regulatory responsibility under the agreement.
The State is authorized through its legal authority to license, inspect, and enforce legally binding requirements such as regulations and licenses.
Sunset requirements, if any, do not negatively impact the effectiveness of the States regulations.
b.
Discussion The Oregon Agreement State Programs current effective statutory authority is contained in volume 11, Chapter 453, of the Oregon Revised Statutes. The Oregon Health Authority is designated as the States radiation control agency. One legislative amendment affecting the radiation control program was passed during the review period.
During the 2021 legislative assembly, Oregon Radiation Protection Services (RPS) proposed a 2021-2023 Legislative Concept which was accepted and became House Bill 2075 and a Policy Options Package (POP 448) to increase all RPS program user-fees including x-ray and tanning registration fees by statute, and the Radioactive Material Licensing fees by administrative rule, respectively. Both completed the legislative process and were passed by the Oregon Legislature on June 26, 2021 and enacted by the Governor on July 19, 2021.
Oregons administrative rulemaking process takes approximately 30 months from drafting to finalizing a rule. The public, NRC, other agencies, and potentially impacted licensees and registrants are offered an opportunity to comment during the rulemaking process. Comments are considered and incorporated, as appropriate, before the regulations are finalized and approved by the Oregon Secretary of State. The team noted that the States rules and regulations are not subject to sunset laws. However, Oregons regulations are subject to administrative review on a 5-year period. During the review period, Oregon submitted eight final regulation amendments and three proposed regulation amendments to the NRC for a compatibility review. All of the final regulation amendments were adopted by Oregon during the review period. At the time of this review, no amendments were overdue. The program is very responsive in addressing NRC comments on proposed and final regulations.
c.
Evaluation The team determined that, during the review period, Oregon met the performance indicator objectives listed in Section 4.1.a. Based on the criteria in MD 5.6, the team recommends that Oregons performance with respect to the indicator, Legislation, Regulations, and Other Program Elements, be found satisfactory.
Oregon Proposed Final IMPEP Report Page 12 d.
MRB Chairs Determination The final report will present the MRB Chairs determination regarding this indicator.
5.0
SUMMARY
Oregons performance was found to be satisfactory for all performance indicators reviewed.
The team made one new recommendation from its review of the Technical Quality of Incidents and Allegation Activities performance indicator and determined that the recommendation from the 2017 IMPEP review be closed. The new recommendation is:
The team recommends that Oregon develop written protocols for maintaining logs to ensure incident response and allegation procedures are in place, followed, and follow-up inspections are scheduled and completed to ensure compliance with Oregon Protocol 606. As part of this recommendation, Oregon will perform a retrospective review of events from 2017 to present to ensure appropriate supporting information is documented in the log.
Accordingly, the team recommends that Oregon be found adequate to protect public health and safety and compatible with the NRC's program. Since this was Oregons second consecutive IMPEP review with all indicators rated as satisfactory, the team recommends that the next periodic meeting take place in approximately 2.5 years with the next full IMPEP review taking place in approximately 5 years.
LIST OF APPENDICES Appendix A IMPEP Review Team Members Appendix B Inspector Accompaniments
APPENDIX A IMPEP REVIEW TEAM MEMBERS Name Areas of Responsibility Stephen Poy, NMSS Team Leader Status of Materials Inspection Program Legislation, Regulations, and Other Program Elements Inspector Accompaniments Joe OHara, NMSS Technical Staffing and Training David Stradinger, North Dakota Technical Quality of Inspections Inspector Accompaniments Jackie Cook, Region IV Technical Quality of Licensing Actions James Uhlemeyer, Kansas Technical Quality of Incident and Allegation Activities
APPENDIX B INSPECTOR ACCOMPANIMENTS The following inspector accompaniments were performed prior to the on-site IMPEP review:
Accompaniment No.: 1 License No.: ORE-90800 License Type: Medical Imaging and Localization Priority: 5 Inspection Date: 06/15/2021 Inspectors initials: BH Accompaniment No.: 2 License No.: ORE-91190 License Type: Portable Gauge Priority: 4 Inspection Date: 06/16/2021 Inspectors initials: JE Accompaniment No.: 3 License No.: ORE-90529 License Type: Portable Gauge Priority: 4 Inspection Date: 06/17/2021 Inspectors initials: RW Oregon Agreement State Program Management Review Board Meeting Agenda November 10, 2021, 1:00 p.m. - 3:00 p.m. (ET), via Microsoft Teams 1.
Meeting Convened.
a.
Announcement of NRC Public Observation Meeting.
b.
Introduction of MRB members, review team members, Agreement State representatives, and other participants.
c.
Request for members of the public to identify themselves and their affiliation.
2.
MRB Chair Convenes the Business Portion of the Meeting.
a.
Consideration of the Agreement States IMPEP Report.
b.
Presentation of Performance Indicator Findings for the Agreement States Program and Discussion:
i.
Technical Staffing and Training ii.
Status of Materials Inspection Program iii.
Technical Quality of Inspections iv.
Technical Quality of Licensing Actions v.
Technical Quality of Incident and Allegation Activities vi.
Legislation, Regulations, and Other Program Elements c.
IMPEP Team Recommendations.
d.
MRB Consultation/Comments on Issuance of Report.
e.
Request for comments from the Agreement State representatives, OAS Liaison, and IMPEP team members.
f.
Overall MRB Chair Determination.
3.
MRB Chair Closes the Business Portion of the Meeting 4.
Questions or comments from members of the public.
5.
Meeting adjournment.