ML24079A160
| ML24079A160 | |
| Person / Time | |
|---|---|
| Issue date: | 03/25/2024 |
| From: | Monica Ford NRC Region 1 |
| To: | Nair E State of MD, Dept of Environment |
| References | |
| Download: ML24079A160 (1) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION REGION I 475 ALLENDALE ROAD, SUITE 102 KING OF PRUSSIA, PA 19406-1415 March 25, 2024
Eva Nair, Program Manager Radiological Health Program Air & Radiation Management Administration Maryland Department of the Environment 1800 Washington Boulevard, Suite 750 Baltimore, Maryland 21230
Dear Eva Nair:
A periodic meeting with you and your staff was held on February 22, 2024. The purpose of this meeting was to review and discuss the status of the Maryland Agreement State Program. The U.S. Nuclear Regulatory Commission (NRC) was represented by Theresa Clark, Adelaide Giantelli, Shawn Seeley, Lisa Forney, and me.
I have completed and enclosed a general meeting summary. If you feel that the summary and its conclusion do not accurately reflect the meeting discussion or have any additional remarks about the meeting in general, please contact me at (610) 337-5 214 or via email at Monica.Ford@nrc.gov to discuss your concerns.
Sincerely,
Monica Lynn Ford, Chief Commercial, Industrial, Research and Development, and Academic Branch Division of Radiological Safety and Security U.S. NRC Region I
Enclosure:
Periodic Meeting Summary for Maryland
cc w/encl.: Atnatiwos Meshesha, Radioactive Materials Division, Program Manager III Distribution:
K. Williams, NMSS T. Clark, NMSS A. Giantelli, NMSS R. Johnson, NMSS E. Raphael, NMSS P. Krohn, RI DRSS J. Zimmerman, RI DRSS L. Forney, RI DRSS S. Seeley, RI DRSS
SUNSI Review Complete: MLF ADAMS ACCESSION NO. ML24079A160 https://usnrc.sharepoint.com/teams/Region-I-DNMS1/Shared Documents/SAO Documents/Letter and PM Summary - 2024 MD Periodic meeting.docx After declaring this document An Official Agency Record it will be released to the Public.
To receive a copy of this document, indicate in the box: C = Copy without attachment/enclosure E = Copy with attachment/enclosure N = No copy OFFICE DRSS/RI DRSS/RI
NAME PKrohn MFord DATE 3/25/24 3/25/24 OFFICIAL RECORD COPY INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM
PERIODIC MEETING WITH THE STATE OF MARYLAND
TYPE OF OVERSIGHT: NONE
February 22, 2024
FINAL
Enclosure PERIODIC MEETING PARTICIPANTS
Nuclear Regulatory Commission (NRC)
- Theresa Clark, Deputy Director, Division of Materials Safety, Security, State and Tribal Programs
- Adelaide Giantelli, Chief, State Agreement and Liaison Programs Branch
- Monica Ford, Chief, Commercial, Industrial, Research and Development, and Academic Branch
- Shawn Seeley, Regional State Agreements Officer
- Lisa Forney, Regional State Agreements Officer
Maryland Department of the Environment
- Angelo Bianca, Air and Radiation Administration, Deputy Director
- Eva Nair, Radiological Health Program, Program Manager
- Atnatiwos Meshesha, Radioactive Materials Division, Division Chief
- Shannon Page, Radiation Machines Division, Division Chief
- Norman Brown, Licensing Supervisor
- Paul Kovach, Inspection Supervisor
2
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 Maryland. The meeting was conducted in accordance with the Office of Nuclear Material Safety and Safeguards Procedure SA-116 Periodic Meetings between IMPEP Reviews, dated October 6, 2021.
The Agreement State Program is administered by the Radioactive Materials Division of the Radiological Health Program. The Radiological Health Program is within the Air and Radiation Administration of the Maryland Department of the Environment. There have been no changes to the organizational structure since the August 2022 periodic meeting.
The Agreement State Program regulates approximately 475 specific licenses authorizing possession and use of radioactive materials and is 100 percent fee funded. Fees collected from licensees go into a special fund for use by the Radiological Health Program. Fees for radioactive materials licensees have not increased in several years, other than to reflect cost of living. Fees for portable gauge licensees are currently being evaluated and a tiered fee system, based on the number of gauges possessed, is being considered. This effort could result in decreased fees for some of the Agreement State Programs licensees.
The Agreement State Program underwent a Follow-up Integrated Materials Performance Evaluation Program (IMPEP) review focused on the indicator Technical Quality of Licensing Actions, in August 2022. A periodic meeting to discuss the status of other common and non-common performance indicators was also conducted at that time. A Management Review Board (MRB) meeting to discuss the outcome of both the IMPEP and periodic meeting was held on December 8, 2022. The team recommended and the MRB agreed that Marylands performance remained satisfactory but needs improvement for the indicator Technical Quality of Licensing Actions. Additionally, one recommendation from the 2021 IMPEP review was closed, one recommendation from the 2021 IMPEP review remained open, and a new recommendation for improved program performance related to updating licensing procedures to ensure reviewers conduct a thorough analysis of the licensees inspection and enforcement history during review of renewal applications was opened. Overall, Maryland was found adequate to protect public health and safety and compatible with the NRCs program. The MRB determined the next full IMPEP review should take place in approximately three years (August 2025) and that a periodic meeting should take place in approximately 18 months (February 2024). This meeting summary reflects the directed periodic meeting at approximately 18 months and focuses on the radioactive materials program as it is conducted under the Section 274b. (of the Atomic Energy Act of 1954, as amended)
Agreement between the NRC and the State of Maryland.
2.0 COMMON PERFORMANCE INDICATORS
Five common performance indicators are used to review the NRC regional 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.
3 2.1 Technical Staffing and Training (2021 IMPEP review: Satisfactory)
The Agreement State Program is comprised of 11 full time equivalents (FTE) which includes 10 technical staff and the Radioactive Materials Division Chief. Also included in the Agreement State Program, but not included in the 11 FTE, is the Radiation Control Program Director (RCPD). The RCPD splits their time between the Agreement State Program and the Radiation Machines Division. The specific amount of FTE can vary depending on the workload. The technical staff include six license reviewers and four inspectors. Since the August 2022 periodic meeting six staff have left the program and six staff were hired into those vacant positions. Reasons for staff departure vary and include retirement and taking higher paying jobs outside of State Government. The positions were vacant between two to seven months. At the time of the periodic meeting the Agreement State Program was fully staffed.
The Agreement State Program has a qualification journal that is compatible with NRCs Manual Chapter 1248. No changes have been made to the qualification journal since the 2021 IMPEP review. There are currently eight technical staff members undergoing qualification training (three inspectors and five license reviewers). Additionally, the Agreement State Program has hired another Agreement State employee as a contract employee to help with the performance of licensing actions. NRC staff asked if Program Management obtained and verified the employees Inspection Manual 1248 Appendix A qualifications to independently perform licensing actions on all license types regulated by Maryland. Program Management stated they had not. A discussion was held about the importance of obtaining data related to prior qualifications achieved by employees to ensure each employee has the proper qualifications to sign license actions they work on.
Program Management committed to obtaining that information for that employee.
Refresher training for qualified staff is being tracked and all staff requiring refresher training are currently meeting the 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> every 24 months requirement.
2.2 Status of the Materials Inspection Program (2021 IMPEP review: Satisfactory)
The Agreement State Program reported it has conducted 90 Priority 1, 2, and 3 and 10 initial inspections since August 2022. No Priority 1, 2, 3 or initial inspections were completed overdue, and no inspections are currently overdue.
The Agreement State Program has implemented a risk-informed process for inspection of reciprocity licensees. This process involves analyzing whether the applicant has been inspected by Maryland within the last two years, has had a major event in the last two years, and information obtained from the regulator the license is issued under. The goal is to inspect a minimum of four reciprocity licensees each calendar year. This number is based on insights from the previous criteria used to perform inspections of 20 percent reciprocity candidate licensees. On average, four to five reciprocity inspections were being performed each year to meet the 20 percent criteria. Since the 2021 IMPEP review, Maryland conducted five reciprocity inspections in 2021; seven reciprocity inspections in 2022; and five reciprocity inspections in 2023.
4 2.3 Technical Quality of Inspections (2021 IMPEP review: Satisfactory)
The Agreement State Program uses inspection procedures that are equivalent with the inspection guidance outlined in Inspection Manual Chapter (IMC) 2800 and the NRCs Inspection Procedures for specific modalities. Inspection reports are reviewed by the Inspection Supervisor and by the Division Chief. Inspection findings are routinely sent to licensees within 30 days of completing an inspection. All qualified inspectors received a supervisory accompaniment in calendar year 2022 and 2023. The Agreement State Program has a sufficient supply of radiation survey instruments to support the inspection program.
2.4 Technical Quality of Licensing Actions (2021 IMPEP Review: Satisfactory, but needs improvement)
(2022 Follow-up IMPEP Review: Satisfactory, but needs improvement)
The Agreement State Program has approximately 475 specific licenses. Since August 2022, 345 licensing action have been completed. This includes 11 new licenses issued, 45 license terminations, 225 amendments, 63 renewals, and 1 sealed source and device registration. There are 273 actions currently being tracked. These actions include 15 new license applications, 129 renewals, 26 terminations, and 103 amendments. Of the 273 actions with the Program, 104 have been with the Agreement State Program for more the 365 days. Most of the 104 actions outstanding greater than 365 days are renewals. The longest standing initial application has been in house since August 23, 2022. Staff are actively working on processing this initial application action. Additionally, Maryland is prioritizing work to ensure the actions with the most health, safety, and security significance are completed first.
The Agreement State Program follows the NRCs NUREG 1556 series as guidance when completing licensing actions along with the most current versions of the NRCs Pre-Licensing Guidance and the Risk Significant Radioactive Materials Checklist.
License reviewers are responsible for the performance of pre-licensing visits when warranted.
During the 2022 Follow-up IMPEP review, the team noted that progress had been made to address the performance concerns identified during the 2021 IMPEP review in the indicator Technical Quality of Licensing Actions. This resulted in one recommendation from the 2021 IMPEP review being closed, and one recommendation being left open.
Additionally, the 2022 Follow-up IMPEP review opened a new recommendation related to program performance. The open recommendations and their status are discussed below.
Recommendation: Maryland will review the qualifications of all Radiation Safety Officers (RSOs), Authorized Users (AUs), and Authorized Medical Physicists (AMPs) listed on their medical licenses to ensure that they meet the qualifications in accordance with Marylands regulations for medical use of byproduct material.
5 Status: The Agreement State Program has approximately 250 medical licensees. As of November 2023, all RSOs, AUs, and AMPs had been reviewed to ensure that they met the qualifications in accordance with Maryland regulations. Additional documentation was obtained and revisions to licenses were made as appropriate. None of the individuals associated with the 250 medical licenses were determined to have been placed on a license improperly.
Recommendation: Maryland update licensing procedures to ensure the reviewer conducts a thorough analysis of the licensees inspection and enforcement history of renewal applications and that Maryland conduct training on the updated procedures.
Status: The Agreement State Program updated its procedures and checklists to include review of inspection documentation and enforcement history during renewal processing shortly after the 2022 IMPEP review. All licensing staff were trained on the procedure update and are now incorporating a thorough review of this documentation when processing renewal applications.
2.5 Technical Quality of Incident and Allegation Activities (2021 IMPEP review: Satisfactory)
The Agreement State Program received 26 incidents since the last IMPEP review. Of these 26 incidents, eight met the criteria to be considered reportable to the NRC. These eight incidents were reported timely to the NRC; however, it appeared that in one instance the wrong reporting method was used. The incident in question occurred in November 2021 and appeared to involve lost material in a quantity greater than 10 times that listed in 10 CFR Part 20 Appendix C. The incident information was reported directly to Nuclear Materials Events Database (NMED) but if accurate would require a telephone notification to the NRCs Headquarters Operations Center. The Agreement State Program reviewed this incident after the periodic meeting was conducted and determined that it did not meet the criteria to be considered a reportable event.
Therefore, no further action will be taken by the Agreement State Program. This event has been closed in NMED. Additionally, there is one incident that occurred in October 2021 that has a request for additional information associated with it. This information is needed to determine the reportability of the incident. Agreement State Program staff communicated with the NMED contractor to determine if any additional information was still needed. Staff will continue to work with the NMED contractors to bring this item to resolution.
Since the 2021 IMPEP, Maryland has received two allegations, and no allegations were transferred to Maryland by the NRC. Maryland performs and documents its investigations into allegations received. Additionally, procedures are in place for receipt and follow-up of both incidents and allegations.
3.0 NON-COMMON PERFORMANCE INDICATORS
Four non-common performance indicators are used to review Agreement State programs: (1) Legislation Regulation and Other Program Elements (LROPE), (2) Sealed Source and Device (SS&D) Evaluation Program, (3) Low-Level Radioactive Waste Disposal Program, and (4) Uranium Recovery Program. The NRCs Agreement with Maryland only includes the non-common performance indicators LROPE and SS&D.
6 3.1 Legislation, Regulation, and Other Program Elements (2021 IMPEP review: Satisfactory)
Maryland became an Agreement State on July 1, 1971. The current effective statutory authority is contained in the Annotated Code of Maryland, Environment Article, Title 8, Radiation. The Department is designated as the States radiation control agency. No legislation affecting the radiation control program was passed during the review period.
Marylands administrative rulemaking process takes approximately ten months from drafting to finalizing a rule. The public, NRC, other agencies, potentially impacted licensees, and registrants are offered and opportunity to comment during the process.
Comments are considered and incorporated, as appropriate, before the regulations are finalized, and approved by the Secretary of the Environment. That Radiation Control Advisory Board also consults with and advises the Secretary of the Environment on matters related to radiation. The States rules and regulations are not subject to sunset requirements.
Since the 2021 IMPEP, Maryland submitted six final regulation amendments, two revised final amendments and seven proposed amendments to the NRC for review. No regulatory amendment changes were overdue for adoption at the time of this meeting.
Additionally, other program elements necessary for the maintenance of a compatible program were discussed. Program Management stated no revisions made by the NRC to procedures and guidance documents were overdue for implementation by the Agreement State Program.
3.2 Sealed Source and Device Evaluation (SS&D)
(2021 IMPEP review: Satisfactory)
Technical Staffing and Training
The Agreement State Program has three staff going through the qualification process and no fully qualified SS&D reviewers. The three staff going through qualification attended the NRCs SS&D training in September 2023 and are working on the remaining elements necessary for qualification. Program management stated that since it does not have a qualified SS&D reviewer, assistance from the National Materials Program will be needed to complete SS&D actions received. Maryland has a training and qualification manual for SS&D reviewers that is equivalent to the NRCs IMC 1248 Appendix D.
Technical Quality of Product Evaluation Program
Maryland has four SS&D registrations. There have been three amendments since the 2021 IMPEP review.
Evaluation of Defects and Incidents Regarding SS&Ds
No incidents involving SS&D registered products occurred since the last IMPEP review.
A discussion on the importance of evaluating NMED for events occurring across the nation involving SS&Ds issued by the Maryland program was had. Program management agreed and committed to reviewing NMED for these type of events on a periodic basis.
7 4.0 TECHNICAL ASSISTANCE REQUEST
The Agreement State Program submitted a technical assistance request to the NRC via letter dated March 21, 2023. The NRC responded to the request via letter dated April 23, 2023, and identified four items for assistance.
- 1. Training and mentoring for license reviewers pursuing licensing qualifications.
- 2. Completing the 2021 IMPEP recommendation to verify training and qualifications of AUs, AMPs, and RSOs on the 50 remaining medical licenses.
- 3. Training and mentoring new SS&D reviewers and reviewing open SS&D actions and future submittals.
- 4. Training and mentoring staff on the review of financial assurance documents.
The Agreement State Program feels that sufficient assistance has been received for item number 1 and has received assistance and completed the actions associated with item number 2. Items number 3 and 4 remain open. Item number 3 will remain open until Maryland has sufficient staff qualified to perform SS&D reviews. Item 4 w ill remain open until Maryland receives a financial assurance action and can coordinate that review with trained staff to ensure the proper training and mentoring has been achieved.
5.0
SUMMARY
The Agreement State Program has worked to implement and complete corrective actions relative to the two open recommendations from the 2022 Follow-up IMPEP review. Maryland has experienced a large amount of staff turnover but has been able to fill the positions timely and is currently fully staffed. There were no inspections overdue at the time of the periodic meeting. A backlog of licensing actions exists, however most of those actions are renewals. Staff are prioritizing actions relative to health safety and security significance. The Agreement State Program responds to incidents and allegations as appropriate. There are no staff qualified to perform SS&D evaluations.
Three staff are going through qualifications to become SS&D reviewers and until they become qualified, assistance will be sought from the National Materials Program to complete any reviews received. No new concerns were identified during this periodic meeting. Therefore, the next full IMPEP review should be held as scheduled in August 2025.
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