ML20346A077

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12-10-20 Letter to J. Priest Re FY20 Periodic Meeting
ML20346A077
Person / Time
Issue date: 12/10/2020
From: Farrah Gaskins
Division of Nuclear Materials Safety I
To: Priest J
State of MA, Dept of Public Health
References
Download: ML20346A077 (8)


Text

UNITED STATES NUCLEAR REGULATORY COMMISSION REGION I 2100 RENAISSANCE BLVD., SUITE 100 KING OF PRUSSIA, PA 19406-2713 December 10, 2020 Jack Priest, Director Radiation Control Program Department of Public Health Schrafft Center, Suite 1M2A 529 Main Street Charlestown, MA 02129

Dear Mr. Priest:

A periodic meeting with you and your staff was held virtually on October 6, 2020. The purpose of this meeting was to review and discuss the status of the Massachusetts Agreement State Program. The U.S. Nuclear Regulatory Commission (NRC) was represented by Blake Welling, Acting Director, Division of Nuclear Materials Safety, U.S. NRC Region I and me.

I have completed and enclosed a general meeting summary. If you feel that 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) 337-5143 or via e-mail at Farrah.Gaskins@nrc.gov to discuss your concerns.

Sincerely, Farrah C. Digitally signed by Farrah C. Gaskins Gaskins Date: 2020.12.10 11:51:04 -05'00' Farrah C. Gaskins Regional State Agreements Officer Division of Nuclear Materials Safety U.S. NRC Region I

Enclosure:

Periodic Meeting Summary for Massachusetts cc w/encl.: Joshua Daehler, Radioactive Materials Unit Supervisor Radiation Control Program

2 Distribution:

K. Williams, NMSS T. Clark, NMSS D. White, NMSS K. Meyer, NMSS B. Anderson, NMSS R. Johnson, NMSS M. Ford, RI B. Welling, RI J. Nick, RI SUNSI Review Complete: FCG (Reviewers Initials)

S:\State Agreement Files\Massachusetts\Letter transmitting the final 10-2020 MA Periodic Meeting Summary.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 DNMS/RI DNMS/RI DNMS/RI NAME FGaskins BWelling FGaskins DATE 11/5/2020 12/09/2020 via email 12/10/2020 OFFICIAL RECORD COPY

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM PERIODIC MEETING WITH THE COMMONWEALTH OF MASSACHUSETTS TYPE OF OVERSIGHT: NONE October 6, 2020 FINAL

PERIODIC MEETING PARTICIPANTS NRC

  • Blake Welling, Acting Director, Division of Nuclear Materials Safety, Region I
  • Jack Priest, Director, Massachusetts Radiation Control Program Director
  • Joshua Daehler, Radioactive Materials Unit Supervisor
  • Anthony Carpenito, Inspections Supervisor
  • Kenath Traegde, Licensing Supervisor 2

Massachusetts Periodic Meeting Summary

1.0 INTRODUCTION

This report presents the results of the periodic meeting held between the U.S. Nuclear Regulatory Commission (NRC) and the Commonwealth of Massachusetts. The meeting was held virtually on October 6, 2020. The meeting was conducted in accordance with the Office of Nuclear Material Safety and Safeguards (NMSS) Procedure SA-116 Periodic Meetings between IMPEP Reviews, dated June 3, 2009.

The Massachusetts Agreement State Program (the Program) is administered by the Radiation Control Program (RCP), which is part of the Bureau of Environmental Health within the Department of Public Health. The Program is managed by the RCP Director, the Radioactive Materials Unit Supervisor, the Licensing Supervisor, and the Inspections Supervisor. No changes to the organizational structure have occurred since the 2018 Integrated Materials Performance Evaluation Program (IMPEP) review.

At the time of the periodic meeting, the Program regulated approximately 402 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 Commonwealth of Massachusetts. The Program is 100 percent fee funded. The Programs fiscal year runs July 1-June 30.

The Program underwent an IMPEP review in June 2018. A Management Review Board (MRB) meeting to discuss the outcome of the IMPEP review was held on September 13, 2018. The team found the Programs performance satisfactory for all indicators evaluated.

The team closed recommendations regarding program performance from the 2014 IMPEP and did not make any new recommendations. Overall, the MRB found the Program adequate to protect public health and compatible with the NRCs program. The MRB directed that a periodic meeting be held approximately in June 2020 and the next full IMPEP review be held approximately in June 2022.

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. Each of these indicators was discussed during the October 2020 periodic meeting.

2.1 Technical Staffing and Training (2018 IMPEP review: Satisfactory)

The Program is comprised of nine full time equivalents (FTE) which includes nine technical staff. The technical staff includes the Radioactive Materials Supervisor, the Licensing Supervisor, and the Inspections Supervisor. This is about the same since the 2018 IMPEP review. There was one new hire in February 2019 to replace a staff member who transferred to a different position. Of the technical staff, eight are qualified in both licensing and inspections. The Licensing Supervisor only performs licensing duties.

During the COVID-19 Public Health Emergency (PHE), staff continue to primarily work from home. The Program currently has no vacancies.

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Massachusetts Periodic Meeting Summary Massachusetts qualification journal is commensurate with the NRCs Manual Chapter 1248. The most recently hired staff member completed inspection qualifications in September 2020 and there are currently no staff undergoing qualifications. The Program also tracks required annual refresher training and all staff completed the required training annually since the 2018 IMPEP.

2.2 Status of the Materials Inspection Program (2018 IMPEP review: Satisfactory)

The Program reported it has conducted 83 Priority 1, 2, and 3 inspections and 26 initial inspections since the 2018 IMPEP review. No Priority 1, 2, 3 or initial inspections were completed overdue. No inspections are currently overdue. Due to the (PHE), the Program suspended routine inspections but continued to respond to incidents as necessary. During that time, no inspection went overdue. At the time of the meeting, the Program began performing routine inspections again. Due to the PHE, inspections are announced, and remote inspections are performed when necessary. The Programs goal is to issue inspection findings within 30 days of the inspection exit. RCP stated that they are meeting that goal.

With respect to reciprocity, the Program conducted four of 13 candidate licensees in 2018, three of 10 candidate licensees in 2019, and two so far in 2020. Updates to Manual Chapter 2800 were discussed specifically highlighting the changes in performing reciprocity inspections. The Program aims to perform inspections on 20% of reciprocity candidate licensees.

2.3 Technical Quality of Inspections (2018 IMPEP review: Satisfactory)

The Program sets its goal for inspections frequencies to be more restrictive than NRC Manual Chapter 2800. As such, there are currently no overdue inspections. All staff performing inspections are qualified. The Inspections Supervisor routinely meets with inspection staff to discuss inspection findings and inspection related issues. The Program has a goal to perform at least one supervisory accompaniment per calendar year. In 2018 and 2019, the Inspection Supervisor performed an inspection accompaniment for each inspector. Due to the PHE, only one inspection accompaniment has been performed in 2020.

At the beginning of the PHE, approximately from March through July 2020, the Program suspended inspection activities. The Program also conducted check-in with licensees authorized for category 1 and Category 2 risk significant materials during this period via telephone. At the time of the meeting, the Program resumed conducting routine inspections. Some inspections are being performed remotely and some are performed onsite. Inspections that are being performed onsite are being announced. The Program issued temporary exemptions from regulations which allowed licensees to request relief from requirements during the PHE. The Program reported that exemptions were granted to a few hospitals that requested relief from survey requirements. The RCP required the licensees to confirm when they returned to compliance.

The Program uses inspection procedures that are commensurate with the NRCs Manual Chapter (MC) 2800. The inspection supervisor reviews and signs off on all inspection reports.

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Massachusetts Periodic Meeting Summary 2.4 Technical Quality of Licensing Actions (2018 IMPEP Review: Satisfactory)

The Program reported having 402 specific licenses. The Program had 50 licensing actions in house at the time of the meeting. There is currently no backlog in licensing actions except for one renewal action which has been in house for over a year. The renewal action is for low risk activities and was initially assigned to a reviewer in training.

The action has been reviewed by the Licensing Supervisor and is expected to be issued in the near future. The Program has completed the process of increasing licensing terms from five years to ten years which also helped to decrease the number of renewal actions received. The RCP Director signs all licensing actions that the Program issues.

2.5 Technical Quality of Incident and Allegation Activities (2018 IMPEP review: Satisfactory)

The Program reported 28 incidents to NRC since the 2018 IMPEP review. Event follow up actions are assigned to an inspector and tracked through completion.

The Program uses procedures equivalent to the NRCs allegation procedures for processing allegations. The Program received and responded to 10 allegations since the last IMPEP review. Of the 10, four were referred by the NRC. All 10 allegations have been completed and closed.

3.0 NON-COMMON PERFORMANCE INDICATORS Four non-common performance indicators are used to review Agreement State programs:

(1) Compatibility Requirements, (2) Sealed Source and Device (SS&D) Evaluation Program, (3) Low-Level Radioactive Waste Disposal (LLRW) Program, and (4) Uranium Recovery (UR) Program. The NRCs Agreement with Massachusetts only include non-common performance indicators Compatibility Requirements, SS&D, and LLRW apply.

3.1 Legislation, Regulation, and Other Program Elements (2018 IMPEP review: Satisfactory)

The Commonwealth of Massachusetts became an Agreement State on March 21, 1997.

The authority under which the Program administers the Agreement is in Massachusetts General Law Chapter 111H and Chapter 111. The statute authorizing the Governor to enter into the Agreement is contained in Chapter 111H, and the statute under which the Program operates is in Chapter 111. RCP is designated as the Commonwealths radiation control agency. No legislation affecting the Program was passed during the review period.

The rulemaking process takes approximately 9 months to complete. Regulations are drafted by the Program, reviewed by Program managers and staff, and then sent to the NRC for a compatibility review. After the Program addresses any compatibility comments, the regulations are reviewed by the Programs legal counsel. A memorandum containing the regulations, revised to reflect legal counsel comments, is presented to the Department Commissioner for review. The regulations are then presented to the Commonwealths Public Health Council (PHC), which meets monthly and approves the proposed regulations for public comment. Once comments are addressed, the revised regulations are submitted to the PHC for promulgation. After PHC approval, the final regulations are 5

Massachusetts Periodic Meeting Summary submitted to the Secretary of the Commonwealth, who establishes an effective date for the regulations. A copy of the final promulgated regulations is then sent to the NRC for a compatibility review as final regulations.

Since the 2018 IMPEP, the Program has submitted five proposed regulations amendments (2018-1, 2018-2, 2018-3, 2019-1, and 2019-2) and four final regulation amendments (RATS ID 2011-1, 2012-4, 2013-2, and 2015-3). There is one overdue regulation package, RATS ID 2015-3. This regulation was due to be incorporated by the Commonwealth on August 15 and is being reviewed by the Programs legal counsel.

3.2 Sealed Source and Device Evaluation (SS&D)

(2018 IMPEP review: Satisfactory)

  • Technical Staffing and Training The Program has four fully qualified SS&D reviewers. No vacancies existed at the time of the periodic meeting. RCP 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 The Program has 14 active manufacturers and distributors with a total of 58 active SS&D registrations and has completed 39 SS&D applications (new, amendment, correction, or termination) since the last IMPEP review. There was no backlog of SS&D actions at the time of the periodic meeting.
  • Evaluation of Defects and Incidents Regarding SS&Ds No incidents involving SS&D registered products occurred since the last IMPEP review.

4.0

SUMMARY

The Program continues to be an effective, well maintained program. There were no vacancies at the time of the periodic meeting. The Program is effectively managing its licensing and inspection activities and responds to incidents and allegations as appropriate. During the PHE, although most of the staff worked from home, the Program continued operating effectively. The RCP put procedures in place to ensure continuity which included performing check-in for risk significant licensees. The next IMPEP should be conducted as scheduled in approximately June 2022.

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