ML18291A582
| ML18291A582 | |
| Person / Time | |
|---|---|
| Issue date: | 10/16/2018 |
| From: | Monica Ford NRC Region 1 |
| To: | Mary Bennett State of RI, Dept of Health |
| References | |
| Download: ML18291A582 (8) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION REGION I 2100 RENAISSANCE BLVD., SUITE 100 KING OF PRUSSIA, PA 19406-2713 October 16, 2018 Mary Bennett, Chief Center for Health Facilities Regulation Rhode Island Department of Health 3 Capitol Hill, Room 305 Providence, RI 02908-5097
Dear Ms. Bennett:
A periodic meeting with your staff was held on September 17, 2018. The purpose of this meeting was to review and discuss the status of the Rhode Island Agreement State Program.
The U.S. Nuclear Regulatory Commission (NRC) was represented by James Trapp, Director, Division of Nuclear Materials Safety, U.S. NRC Region I, John Miller, Regional State Agreements Officer, U.S. NRC Region I, and me.
I have completed and enclosed a general meeting summary, including any specific actions resulting from the discussions. A Management Review Board (MRB) meeting to discuss the outcome of the periodic meeting has been scheduled for October 30, 2018 at 1:00pm. Meeting information for the MRB will be provided to you in a separate transmission.
If you feel that our conclusions do not accurately summarize the meeting discussion, or have any additional remarks about the meeting in general, please contact me at (610) 337-5214 or via e-mail at Monica.Ford@nrc.gov to discuss your concerns.
Sincerely,
/RA J. J. Miller for/
Monica Lynn Ford Regional State Agreements Officer Division of Nuclear Materials Safety U.S. NRC Region I
Enclosure:
Periodic Meeting Summary for Rhode Island cc w/encl.: Charma Waring, Supervisor Radioactive Materials Section
October 16, 2018 Mary Bennett, Chief Center for Health Facilities Regulation Rhode Island Department of Health 3 Capitol Hill, Room 305 Providence, RI 02908-5097
Dear Ms. Bennett:
A periodic meeting with your staff was held on September 17, 2018. The purpose of this meeting was to review and discuss the status of the Rhode Island Agreement State Program.
The U.S. Nuclear Regulatory Commission (NRC) was represented by James Trapp, Director, Division of Nuclear Materials Safety, U.S. NRC Region I, John Miller, Regional State Agreements Officer, U.S. NRC Region I, and me.
I have completed and enclosed a general meeting summary, including any specific actions resulting from the discussions. A Management Review Board (MRB) meeting to discuss the outcome of the periodic meeting has been scheduled for October 30, 2018 at 1:00pm. Meeting information for the MRB will be provided to you in a separate transmission.
If you feel that our conclusions do not accurately summarize the meeting discussion, or have any additional remarks about the meeting in general, please contact me at (610) 337-5214 or via e-mail at Monica.Ford@nrc.gov to discuss your concerns.
Sincerely,
/RA J. J. Miller for/
Monica Lynn Ford Regional State Agreements Officer Division of Nuclear Materials Safety U.S. NRC Region I
Enclosure:
Periodic Meeting Summary for Rhode Island cc w/encl.: Charma Waring, Supervisor Radioactive Materials Section Distribution:
D. White, NMSS K. Meyer, NMSS P. Michalak, NMSS R. Johnson, NMSS D. Collins, NMSS S. Atack, NMSS L. Roldan-Otero, NMSS J. Miller, RI M. Ford, RI J. Trapp, RI J. Nick, RI SUNSI Review Complete: MLF (Reviewers Initials)
S:\State Agreement Files\Rhode Island\9-17-18 Periodic meeting summary with Letter.docx After declaring this document An Official Agency Record it will be released to the Public.
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DATE 10/16/18 OFFICIAL RECORD COPY
AGREEMENT STATE PERIODIC MEETING
SUMMARY
FOR RHODE ISLAND DEPARTMENT OF HEALTHS RADIATION CONTROL PROGRAM DATE OF MEETING: September 17, 2018 NRC Attendees Rhode Island Department of Health Attendees Monica Ford, Regional State Stephen Morris, Associate Director of Health, Agreements Officer, US NRC Region I Division of Customer Services James Trapp, Director, Division of Mary Bennett, Chief, Center for Health Facilities Nuclear Materials Safety, US NRC Regulation Region I John Miller, Regional State Charma Waring, Supervisor, Radiation Control Agreements Officer, US NRC Region I Program Bill Dundulis, Risk Assessment Toxicologist Dennis Klaczynski, Radiological Health Specialist Maria Barnes, Radiological Health Specialist Thomas Caruolo, Radiological Health Specialist DISCUSSION:
The March 2016 Integrated Materials Performance Evaluation Program (IMPEP) review of the Rhode Island Agreement State Program, resulted in the States performance being found satisfactory for the performance indicators Technical Quality of Inspections, Technical Quality of Licensing Actions, Technical Quality of Incidents and Allegations, and Compatibility Requirements; satisfactory but needs improvement for the performance indicator Technical Staffing and Training; and unsatisfactory for the performance indicator Status of Materials Inspection Program. The team left one recommendation open from the 2011 IMPEP review and made no new recommendations. On June 16, 2016, the Management Review Board (MRB) met to consider the proposed final IMPEP report. The MRB found Rhode Island adequate to protect public health and safety, but needs improvement, and compatible with the U.S. Nuclear Regulatory Commissions (NRC) program. Upon deliberation, the MRB issued two additional recommendations to Rhode Island. The MRB directed that Rhode Island continue on monitoring, that calls between the Rhode Island Department of Health staff and NRC staff be conducted quarterly, that a periodic meeting take place approximately one year from the 2016 IMPEP review, and a second periodic meeting be held approximately 18 months after the first periodic meeting.
A periodic meeting was held with the Rhode Island Agreement State Program on March 9, 2017. The March 9, 2017 periodic meeting summary can be found in the NRCs Agency-wide Document Access and Management System at accession number ML17095A297. A second periodic meeting was held on September 17, 2018. This summary is a reflection of the second periodic meeting.
2 TOPICS COVERED DURING THE MEETING INCLUDED:
Feedback on the NRCs Program The Rhode Island Agreement State Program commented that both the overall relationship and communications with the NRC are good and that they appreciated the NRCs continued support of the Agreement States.
Organization The Rhode Island Agreement State Program is administered by the Radiation Control Program which is located within the Center for Health Facilities Regulation in the Division of Customer Service. The Division of Customer Service is located within the Rhode Island Department of Health.
Program Budget and Funding The Rhode Island Agreement State Program is fully fee-funded. Licensees are charged 100 percent of the NRC fees that were established in 2007. The Rhode Island Agreement State Program has not increased its fees since 2007. The funds are placed into a restricted receipt account that can only be accessed by the programs under Radiological Health. These programs include radioactive materials, x-ray, and tanning.
Technical Staffing and Training (2016 IMPEP: Satisfactory, but needs improvement)
The Rhode Island Agreement State Program is composed of four technical staff members and a Program Supervisor. The total effort allocated to support the Rhode Island Agreement State Program by all five positions is approximately 1.42 full-time equivalents. At the time of the March 2017 periodic meeting, there was one vacancy. This was created in January 2017 when a staff member left to take another job within the Rhode Island Department of Health. The position was posted and a new employee started in April 2017. The newly hired employee has experience in both nuclear medicine and industrial radiography. Additionally, after the 2016 IMPEP review, the Rhode Island Agreement State Program hired a licensing assistant to help with filing and other administrative duties, however at the time of this periodic meeting this position was vacant. Temporary administrative staff are being used on a part time basis while work is being done to fill the vacancy.
The Rhode Island Agreement State Program has a training and qualification manual compatible with the NRCs Inspection Manual Chapter (IMC) 1248. The two staff going through the qualification process have been assigned a training and qualification journal to complete.
Refresher training for qualified staff is being tracked to ensure staff are 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.
The 2016 MRB generated one recommendation for this performance indicator. The recommendation and its status are listed below.
Recommendation 1: The MRB recommends that the program management take measures to ensure proper documentation of inspection tracking dates and ensure the Rhode Island Agreement State Programs licensing and inspection files are complete.
3 Status: To address the first part of the recommendation, the Program Supervisor has placed a white board in her office and has populated it with all of the Priority 1, 2, and 3 licensees (which are separated by Priority and color coded). This is easily accomplished since there are approximately 20 Priority 1, 2, and 3 licensees. The white board shows the last inspection completed and the next inspection due as well as the expiration date of the license. This keeps the information prominently displayed and can be easily consulted should a question about inspection due dates arise. Additionally a spreadsheet is maintained on the Program Supervisors computer which shows the history of the inspections performed since the last IMPEP review.
To address the second part of the recommendation, after the 2016 IMPEP review, the administrative support staff went through all of the files and color coded them by inspection Priority and placed them in the correct order. Additionally, each file is being audited to ensure that the appropriate documentation is contained in the file. Currently, the licensing assistant position within the Rhode Island Agreement State Program is vacant and at the time of the periodic meeting was in the process of being posted. The Rhode Island Agreement State Program is training several temporary administrative support staff to support filing efforts while it works on filling the licensing assistant position. The Rhode Island Agreement State Program hopes to use the temporary staff going forward as the need arises and envisions cross training several staff for administrative help throughout Radiological Health.
Status of the Materials Inspection Program (2016 IMPEP: Unsatisfactory)
During the 2016 IMPEP review, the team determined that 11 of 41 Priority 1, 2, 3, and initial inspections had been completed overdue resulting in 27 percent of inspections being completed overdue. During the periodic meeting, the Rhode Island Agreement State Program stated that it has made inspections a focus area and has completed all Priority 1, 2, and 3 inspections in accordance with their assigned inspection frequencies. One new license has been issued since the last IMPEP review. The licensee did not receive any material within the first year after license issuance. Staff will need to ensure that an initial inspection is completed within 18 months of license issuance in order to meet the criteria established in the newly revised NRC IMC 2800. The Rhode Island Agreement State Program has continued to be attentive to reciprocity inspections. Staff completed two inspections of five candidate licensees in calendar year 2016 (40%); two inspections of six candidate licensees in calendar year 2017 (33%); and to date in calendar year 2018 three inspections of four candidate licensees (75%).
The 2016 IMPEP team kept open one recommendation from the 2011 IMPEP review for the performance indicator Status of the Materials Inspection Program. The recommendation along with its status are listed below.
Recommendation 2: The team recommends that the State take appropriate measures to conduct priority 1, 2, and 3 inspections and initial inspections in accordance with the inspection priority in IMC 2800.
Status: Since the 2016 IMPEP review, the Rhode Island Agreement State Program has made inspections a focus area. All Priority 1, 2, and 3 inspections have been completed in accordance with the inspection Priority listed in the NRCs IMC 2800. One new license application requiring an initial inspection was issued since the 2016 IMPEP review. Staff is working on completing that initial inspection in the time frame established in IMC 2800. The new licensee has not yet received material.
4 Technical Quality of Inspections (2016 IMPEP: Satisfactory)
The Rhode Island Agreement State Program uses a form similar to the NRCs Form 591 called a MAT 6 to document inspection results. This form can be issued in the field for clear inspections. Inspection findings are routinely sent to licensees within 30 days of the completion of an inspection. All supervisory accompaniments were completed for calendar years 2016 and 2017. No supervisory accompaniments for calendar year 2018 have been completed, but all three are scheduled to take place before the end of the year.
Technical Quality of Licensing Actions (2016 IMPEP: Satisfactory)
The Rhode Island Agreement State Program has approximately 42 specific licensees. All licensing actions received are worked on by qualified staff. Once the work on each incoming action is complete, the action under goes a concurrence review by a senior staffer before being signed by either the Program Supervisor or Chief. At the time of the periodic meeting, there were two renewal applications that had been in house for greater than one year. One is an outstanding action from 2012 and the other is outstanding from 2014. Staff were unaware that the 2014 renewal action had not been completed until the files were audited few months before the periodic meeting. The L2K license system used to help track Rhode Island Agreement State Program licensees and associated fees mistakenly indicated the renewal had been completed. Staff are actively working on both actions and hope to have the renewed licenses issued before the end of the calendar year. All other actions that have been received (amendments, initials, terminations) have been in process for less than six months. The Rhode Island Agreement State Programs goal is to complete each amendment request within 30 days.
Licenses are on a 10 year renewal cycle. Staff is aware of the continuing revisions to the NRCs NUREG 1556 series and plans to update licensing guidance as appropriate.
The MRB for the 2016 IMPEP review generated one recommendation for this performance indicator.
Recommendation 3: The MRB recommends that program management develop and implement an action plan to reduce the licensing renewal backlog.
Status: The Rhode Island Agreement State Program did not specifically develop and implement a specific action plan to address this recommendation. Staff is, however, actively working to complete all backlogged renewals. There are two remaining renewals to complete and the expectation is that both renewed licenses will be issued by the end of the calendar year.
This is an improvement from the 2017 periodic meeting where a backlog of nine renewal actions existed. The Rhode Island Agreement State Program is aware of the need to complete the renewals in a timely manner and will ensure timely completion of renewal actions received going forward.
Technical Quality of Incidents and Allegations (2016 IMPEP: Satisfactory)
The Rhode Island Agreement State Program has processes in place to maintain an effective response to incidents and allegations. A system called Aspen Complaints Tracking System (ACTS) is used to track all incidents and allegations that are received. Incidents are quickly reviewed for their effect on public health and safety and staff is dispatched to perform onsite investigations, when necessary. The Rhode Island Agreement State Program has demonstrated in previous reviews that it communicates reportable incidents to the NRC
5 Operations Center and Region I, as appropriate. No reportable events or allegations have been received since the 2016 IMPEP review.
Compatibility Requirements (2016 IMPEP: Satisfactory)
In 2016 Rhode Island enacted state statute 42-35-5 into its General Laws. Section (b) states the following:
(b) The secretary of state shall oversee the publication of an updated code of state regulations. The code of state regulations shall be compiled and published in a format and medium prescribed by the secretary of state. Upon completion of the updated code, it shall be made available on the secretary of state's website. The rules of an agency shall be published and indexed in the code of state regulations. Agencies must resubmit all existing rules with the secretary of state for publication into the code of state regulations by December 31, 2018. All rules shall be written in plain language. To promote the efficient development of a code of state regulations, the office of regulatory reform is authorized to coordinate and direct agencies in the effort to develop a regulatory code. The office of regulatory reform shall establish a phased approach which requires agencies to submit portions of regulatory content prior to December 31, 2018. Any rule that is not resubmitted by December 31, 2018, and is not published in the code of state regulations, shall not be enforceable until the rule appears in the code of state regulations. The secretary of state shall make the code of state regulations available for public inspection and, for a reasonable charge, copying.
This statute required the Rhode Island Agreement State Program to recodify all of their rules into the new format as described by the Rules and Regulations Formatting and Filing Manual by December 31, 2018. Final regulations meeting the recodification requirements have been filed with the Secretary of State and will become effective on January 1, 2019. Since the Rhode Island Agreement State Program had to recodify its already existing rules, staff took this opportunity to repeal its current radioactive rules and adopt the NRCs regulations by reference.
The final rule changes are currently with the NRC for review. The changes required by the legislative mandate lead to the adoption of five regulation amendments overdue since the last IMPEP review. However, going forward, the adoption by reference of NRC regulations will make it easier for the Rhode Island Agreement State Program to ensure timely adoption of compatible regulations.
The regulations are subject to sunset requirements. The Rhode Island Agreement State Program must refile their regulations every five years. The last refiling was completed in January 2017. The next refiling is scheduled for 2022.
Current State Initiatives No items were identified for discussion.
Emerging Technologies Staff stated that they were not aware of any new/emerging technologies being used (or requested to be used) in Rhode Island.
Large, Complicated, or Unusual Authorizations No items were identified for discussion.
6 States Mechanisms to Evaluate Performance
- The Program Supervisor reviews and signs all inspection reports. Additionally, staff are accompanied in the field to evaluate inspection technique and performance.
- All licensing actions are reviewed by senior level staff or management before being issued.
Current NRC Initiatives NRC staff presented several initiatives ongoing at the NRC. These included:
- Updates to Management Directive 5.6
- Updates to Inspection Manual Chapter 2800
- Updates to the Pre-licensing Guidance and Risk Significant Radioactive Materials Checklists
- Vermont Agreement State Status
- Licensing of Lutetium-177 CONCLUSIONS:
NRC staff recommends that Rhode Island continue on Monitoring and the next IMPEP review be conducted as scheduled in March 2020. Additionally, the NRC staff recommends that quarterly calls continue to be held with the Rhode Island Agreement State Program as a part of the Monitoring process and specifically focus on efforts to: 1) get appropriate administrative support so that licensing and inspection files are complete, 2) reduce the backlog of renewal actions and ensure that renewal actions received are completed in a timely manner, and 3) address the recommendations made as a result of the 2016 IMPEP review.