ML23291A442
| ML23291A442 | |
| Person / Time | |
|---|---|
| Issue date: | 12/19/2023 |
| From: | Lizette Roldan-Otero NRC/NMSS/DMSST |
| To: | Catherine Haney NRC/EDO/DEDMRT |
| References | |
| Download: ML23291A442 (8) | |
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 THRU:
John W. Lubinski, Director Office of Nuclear Material Safety and Safeguards FROM:
Kevin Williams, Director Division of Materials Safety, Security, State, And Tribal Programs Office of Nuclear Material Safety and Safeguards
SUBJECT:
ASSESSMENT OF THE WASHINGTON AGREEMENT STATE PROGRAM PURPOSE The purpose of this memorandum is to provide the outcome of the Nuclear Regulatory Commission (NRC) staff assessment of the State of Washington Agreement State Program (Washington or Washington program) with respect to inspection, licensing, staff qualifications, and incidents and allegations. The memorandum also includes the basis for the staffs conclusion that there is no immediate threat to adequate protection of public health and safety and describes the NRCs plan to assist Washington.
BACKGROUND:
Following the 2022 Integrated Material Performance Evaluation Program (IMPEP) review, the Washington program was placed on heightened oversight. The NRC staff has been monitoring the Washington program and, during August 2023, based on communications with the Washington program and the IMPEP heightened oversight process, it was identified that Washington had experienced additional setbacks that could impact their ability to adequately protect public health and safety. In response, the NRC chartered the Washington Agreement State Program Support Assessment Team (the Assessment Team). This Assessment Team was sent to conduct an in-person, independent review of Washingtons program from September 11-22, 2023. The Assessment Teams scope of work, as described in their charter (NRCs Agencywide Documents Access and Management System (ADAMS)
CONTACT: Adelaide Giantelli 301-415-3521 December 16, 2023 Signed by Lubinski, John on 12/16/23 Signed by Williams, Kevin on 12/15/23
C. Haney 2
Accession No. ML23331A792)1, was to: (a) assess the current situation in Washington with respect to staff qualifications, licensing, inspection, and incidents and allegations; (b) recommend whether Washingtons program is adequate to protect public health and safety; and (c) in coordination with the Division of Materials Safety, Security, State, and Tribal Programs (MSST), identify potential support from the NRC or other Agreement States that would enable Washington to recover its program performance. When the Assessment Team returned from Washington, they documented their activities and recommendations in a report to the MSST Director (ML23331A800).2 DISCUSSION:
First and foremost, the Assessment Team determined that, while Washington is under heightened oversight and recently experienced serious setbacks, there is no immediate threat to the adequate protection of public health and safety.
In assessing whether there was an immediate threat to the adequate protection of public health and safety, the Assessment Team took into consideration the criteria in NMSS procedures SA-114, "Suspension of a Section 274b Agreement" or SA-112, Emergency Suspension of a Section 274b Agreement. In these procedures, it states that the Management Review Board (MRB) will consider recommending suspension of all or part of an agreement when any of the following conditions occur:
(a)
The MRB Chair determines that program deficiencies related to either adequacy or compatibility require immediate NRC action.
(b)
The Agreement State program has not complied with one or more requirements of the Atomic Energy Act of 1954, as amended, (i.e., the Agreement State program is not compatible with the NRC program, and the State has refused or is unable to address those areas with previously identified compatibility concerns), and the lack of compatibility is disruptive to the National Materials Program for the regulation of material under the Atomic Energy Act of 1954, as amended.
The Assessment Team reviewed whether there were program deficiencies related to either adequacy or compatibility that required immediate NRC action. The Assessment Team evaluated the technical qualifications of licensing and inspection staff, and found:
Washington has one individual fully qualified both as an inspector and fully qualified as a license reviewer. In addition, there are two personnel that are interim qualified3 for both industrial and medical inspections. This means that Washington currently is able to perform reactive and routine inspections.
1 The Assessment Team Charter contains Official Use Only - Sensitive Internal Information, a publicly redacted version is provided in ML23331A792.
2 The Assessment Team Report contains Official Use Only - Sensitive Internal Information, a publicly available, redacted version is provided in ML23331A800.
3 The team uses the term interim-qualified to describe staff that has significant expertise in radiation protection from previous employment and has made reasonable progress towards being fully qualified as a license reviewer or inspector. An interim-qualified person will conduct the majority of the license review or inspection activity; however, together with the interim-qualified person, appropriately fully qualified staff will review and finalize the licensing action or inspection activity.
C. Haney 3
In addition to the fully qualified license reviewer, up until August 2023, Washington had agreements in place with three Agreement States to assist them with reducing the backlog of licensing actions as well as providing training to licensing staff. While assistance from the three Agreement States ended in August 2023, in September 2023, Washington began contract discussions with additional qualified license reviewers to assist with reducing the backlog of overdue licensing actions and to provide training to Washington staff.
In addition to qualified and interim qualified inspectors, up until August 2023, Washington had contracted with a qualified inspector to assist in the backlog of overdue inspections as well as training new staff to be fully qualified. While this contract ended in August 2023, Washington began the process of renewing this contract in September 2023.
Next, the Assessment Team considered whether the State has refused or is unable to address those areas with previously identified compatibility concerns. Washington has not refused to address those areas with previously identified compatibility concerns and has attempted to correct deficiencies since its 2022 IMPEP. Due to significant staff turnover in 2023, Washington is challenged with respect to performing routine inspections and license reviews in a timely manner; however, Washington is aware of their situation and is actively working towards correcting these deficiencies. As noted above, their external contracts for qualified license reviewers and inspectors to support their program ended in August 2023. However, Washington quickly reinstated the inspection assistance contract in September 2023. They also quickly moved towards initiating a new contract for licensing assistance, planned for October 2023. The license assistance contract is currently being reviewed by the respective attorneys, and it is expected to be in place by the end of this calendar year.
The Assessment Team concluded, given Washingtons qualified and interim qualified staff, combined with external assistance from qualified license reviewers and inspectors, that Washington currently has the ability to adequately protect public health and safety. MSST agrees with the Assessment Teams conclusion and determined that providing external support from the NRC and Agreement States is sufficient such that NRC does not need to take immediate action to protect public health and safety.
During the two weeks that the Assessment Team was on-site, the Assessment Team performed a review of the Washington program, and, in parallel, provided training, assistance, and advice to Washington staff. A detailed discussion of the Assessment Team efforts is provided in their report to the MSST Director. The four recommendations for assistance provided by the Assessment Team, and endorsed by MSST, are:
1.
The NRC should support the collaboration between the NRC and Washington staff on the ongoing effort of the licensing template development until they are complete.
2.
The NRC should provide additional licensing support in addition to the contracted license reviewers to help interim qualify key staff until they are capable to perform licensing actions for all modalities independently.
3.
The NRC should provide additional inspection support in addition to the contracted inspector to help interim qualify key staff that can then continue to provide on-the-job training to other Washington staff.
C. Haney 4
4.
The NRC should ensure that Washington pursues the expired licenses identified by the Assessment Team and that Washington creates a procedure/process for timely renewals and expired licenses.
After reviewing the teams report, MSST added a fifth recommendation:
5.
The NRC should ensure that Washington updates their Performance Improvement Plan (PIP) to include the above recommendations provided by the NRC.
CONCLUSION:
NMSS Path Forward to Assist Washington Based on the Assessment Teams report and recommendations, NRC is providing the following assistance to Washington:
Recommendation 1:
The NRC should support the collaboration between the NRC and Washington staff on the ongoing effort of the licensing template development until they are complete.
Radioactive material possession limits and physical form should be well defined on a license; radioactive material not requested or used by the licensee should not be authorized. To ensure adequate protection of the public health and safety and the environment, it is essential that licenses appropriately characterize, describe, and include conditions on authorized activities.
The Assessment Team identified numerous Washington licenses that are not compatible with the NRC. The Assessment Team identified numerous licenses that:
Did not properly describe and limit the radioactive material for possession, for example, for portable gauge licensees, possession limits were set for an arbitrary number rather than what the licensee possessed or requested; and had a significant number of license conditions, including non-standard conditions, that conflicted with NRC regulations and guidance.
To address this recommendation:
NRC staff will create eight license templates for Washington, by November 2023.4 Washington staff will create the remaining license templates and submit them to the NRC for review and comment, by December 2023.
NRC staff will review the remaining licensing templates and assist with finalizing the templates with Washington by January 2024.
4 NRC staff completed this effort on November 1, 2023.
C. Haney 5
Recommendation 2:
The NRC should provide additional licensing support in addition to the contracted license reviewers to help interim qualify key staff until they are capable to perform licensing actions for all modalities independently.
Presently, Washington has a significant licensing backlog. For example, Washington does not have sufficient qualified staff, without additional assistance, to review new applications and amendment applications for medical uses of radioactive material. Washington is falling behind on review of authorized users, and licensees are pushing for approvals such that they have sufficient staff in place to ensure patient care is not negatively impacted. Understandably, licensee needs are creating pressure for Washington staff and could inadvertently result in an incomplete review prior to approval. To ensure continued adequate protection of public health and safety, Washington staff needs additional assistance with their licensing backlog, specifically with medical licenses, and additional training opportunities to move staff to independence. The Assessment Team identified the licensing program as the area with the highest need for additional training and attention. Washington does not have a strategy in place for qualifying staff to conduct licensing reviews; does not have a solid process for assigning license reviews, conducting quality assurance reviews, and managing a licensing action to completion; and does not have a defined process for coordinating license reviews with groups outside of their immediate organization.
To address this recommendation:
NRC staff will provide assistance with the review of medical licenses, in particular medical applications that have been in backlog for some time where patient care may be affected, by April 2024.
NRC staff will provide additional training focused by license type (e.g., medical, radiopharmaceutical, radiography, etc.) to Washington staff by April 2024.
Recommendation 3:
The NRC should provide additional inspection support in addition to the contracted inspector to help interim qualify key staff that can then continue to provide on-the-job training to other Washington staff.
The Assessment Team determined that the Washington inspector qualification program is progressing slowly. To ensure continued adequate protection of public health and safety, it is best to provide assistance with qualifying key staff sooner and move Washington staff to independence. In turn, the key staff would provide on-the-job training to other Washington inspection staff.
To address this recommendation:
NRC inspectors will accompany two Washington inspectors and provide in-person training by March 2024.
C. Haney 6
In parallel, Washington staff will continue to move towards qualifying their staff. Once the two Washington inspectors are fully qualified, they will take a lead role in qualifying remaining staff.
Recommendation 4:
The NRC should ensure that Washington pursues the expired licenses identified by the Assessment Team and that Washington creates a procedure/process for timely renewals and expired licenses.
The Assessment Team found that Washington is not assuring timely renewals and is not pursuing expired licenses. In its review, the Assessment Team identified 10 expired licenses and could not find a clear path by Washington to address these expired licensees. To continue to ensure adequate protection of public health and safety, it is important that Washington identify the status of licensed material, i.e., whether it is in secure storage, transferred to an authorized recipient, or disposed of.
To address this recommendation:
Washington staff will determine the status of the 10 expired licenses and ensure that the possessed radioactive material is under licensee control by November 2023.5 NRC staff will follow the status of these licenses during Washingtons monthly heightened oversight meetings.
Recommendation 5:
The NRC should ensure that Washington updates their PIP to include the recommendations provided by the NRC.
The activities of the Assessment Team were completed with their issuance of a non-public report on October 4, 2023, and this report will be shared with Washington. The NRC staff will work together with the Washington program to add the NRCs recommendations for tracking as part of the PIP. To address this recommendation:
Washington staff will update the PIP with recommendations from the Assessment Team and NRC, as appropriate.
NRC staff will follow the status of the PIP during Washingtons monthly heightened oversight meetings.
Next Steps The next steps will be to share the Assessment Teams report with Washington and to offer NRCs assistance as described above. Assuming Washingtons acceptance of NRCs support, the Organization of Agreement States Board will be briefed on the recommendations to the Washington Program and given an opportunity to supplement NRC assistance. NRC support to Washington will be balanced across NMSS and the Regions existing workload and planned for 5 Washington completed this effort November 6, 2023.
C. Haney 7
completion by April 2024. It is expected that licensing support will be provided remotely, and inspection support will be in-person.
ML23291A442 OFFICE RGN-IV/DRSS RGN-IV/DNMS NMSS/MSST NMSS NMSS NMSS NAME LRoldan-Otero JThompson AGiantelli JLubinski KWilliams JLubinski DATE 10/19/2023 10/19/2023 11/28/2023 12/15/2023 12/15/2023 12/16/2023