ML21267A454

09-19-2021 Vermont Impep Questionnaire

ML21267A454
Person / Time
Issue date:	09/19/2021
From:	Office of Nuclear Material Safety and Safeguards
To:
Cook J
References
OMB 3150-0183
Download: ML21267A454 (11)

Text

Approved by OMB1 Control No.: 3150-0183 Expires: 02/28/2023 INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM QUESTIONNAIRE Reporting Period:

Prepared for delivery to the U.S. Nuclear Regulatory Commission (NRC) on 20 September 2021 Note: If there has been no change in the response to a specific question since the last IMPEP questionnaire, the State or Region may copy the previous answer, if appropriate.

A. GENERAL

1. Please prepare a summary of the status of the State's or Region's actions taken in response to each of the open recommendations from previous IMPEP reviews.

As this is Vermonts first IMPEP review since the State assumed jurisdiction for the regulation of radioactive materials as an NRC Agreement State on 1 October 2019, there are no open recommendations from previous IMPEP reviews.

B. COMMON PERFORMANCE INDICATORS I. Technical Staffing and Training

2. Please provide the following organization charts, including names and positions:

(a) A chart showing positions from the Governor down to the Radiation Control Program Director; See Attachment 1.

(b) A chart showing positions of the radiation control program, including management; and See Attachment 1.

(c) Equivalent charts for sealed source and device evaluation, low-level radioactive waste and uranium recovery programs, if applicable.

Not Applicable in Vermont.

1Estimated burden per response to comply with this voluntary collection request: 53 hours6.134259e-4 days <br />0.0147 hours <br />8.763227e-5 weeks <br />2.01665e-5 months <br />. Forward comments regarding burden estimate to the Records Management Branch (T-5 F52), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, and to the Paperwork Reduction Project (3150-0183), Office of Management and Budget, Washington, DC 20503. If an information collection does not display a currently valid OMB control number, NRC may not conduct or sponsor, and a person is not required to respond to, the information collection.

3. Please provide a staffing plan, or complete a listing using the suggested format below, of the professional (technical) full-time equivalents (FTE) applied to the radioactive materials program by individual. Include the name, position, and, for Agreement States, the fraction of time spent in the following areas: administration, materials licensing &

compliance, emergency response, low-level radioactive waste, uranium recovery, other.

If these regulatory responsibilities are divided between offices, the table should be consolidated to include all personnel contributing to the radioactive materials program.

If consultants were used to carry out the program's radioactive materials responsibilities, include their efforts. The table heading should be:

Name Position Area of Effort FTE%

William Irwin RCPD Licensing and 25 Inspection Littia Mann RHS Licensing and 25 Inspection Fran ONeill RMPM Licensing and 100 Inspection RCPD is Radiation Control Program Director, RMPM is Radioactive Materials Program Manager and RHS is Radiological Health Specialist.

RMPM and RHS qualified as license reviewers and inspectors by training and RCPD by exemption.

4. Please provide a listing of all new professional personnel hired into your radioactive materials program since the last review, indicate the date of hire; the degree(s) they received, if applicable; additional training; and years of experience in health physics or other disciplines, as appropriate.

There have been no new hires since 1 October 2019.

5. Please list all professional staff who have not yet met the qualification requirements for a radioactive materials license reviewer or inspector. For each, list the courses or equivalent training/experience they need and a tentative schedule for completion of these requirements.

All staff meet full qualification as license reviewers and inspectors. Fran ONeill and Littia Mann accomplished qualification prior to the Agreement taking affect on 1 October 2019. Bill Irwin is qualified because he is the Radiation Control Program Director. See individual Qualification Journals.

6. Identify any changes to your qualification and training procedure that occurred during the review period.

There have been no changes to qualification and training procedure since 1 October 2019.

7. Please identify the technical staff that left your radioactive materials program during the review period and indicate the date they left.

There have been no employee changes since 1 October 2019.

8. List any vacant positions in your radioactive materials program, the length of time each position has been vacant, and a brief summary of efforts to fill the vacancy.

There are no vacant positions and there have not been any since 1 October 2019.

9. For Agreement States, does your program have an oversight board or committee which provides direction to the program and is composed of licensees and/or members of the public? If so, please describe the procedures used to avoid any potential conflict of interest.

There is no oversight board or committee in Vermont.

II. Status of Materials Inspection Program

10. Please identify individual licensees or categories of licensees the State is inspecting less frequently than called for in NRCs Inspection Manual Chapter (IMC) 2800 and explain the reason for the difference. The list only needs to include the following information:

license category or licensee name and license number, your inspection interval, and rationale for the difference.

No inspections are done with a frequency less than the frequencies called for in the NRCs Inspection Manual Chapter (IMC) 2800 and the Materials Licensees Toolkit at https://www.nrc.gov/materials/miau/mat-toolkits.html.

11. Please provide the number of routine inspections of Priority 1, 2, and 3 licensees, as defined in IMC 2800 and the number of initial inspections that were completed during each year of the review period.

Priority 1 - Two

• Baker Testing

• JDH Inspectors Priority 2 - Two

• University of Vermont Medical Center

• Pharmalogic Priority 3 - Seven

• University of Vermont

• Insight Health

• Alliance Healthcare

• Cardiac Imaging Solutions

• Brattleboro Memorial Hospital

• Rutland Regional Medical Center

• Norwich University (Possession Only)

Initial - One

• Alliance Healthcare Pre-licensing - One; None were an unknown entity.

12. Please submit a table, or a computer printout, that identifies inspections of Priority 1, 2, and 3 licensees and initial inspections that were conducted overdue.

None were conducted overdue.

At a minimum, the list should include the following information for each inspection that was conducted overdue during the review period:

Not applicable.

(1) Licensee Name (2) License Number (3) Priority (IMC 2800)

(4) Last inspection date or license issuance date, if initial inspection (5) Date Due (6) Date Performed (7) Amount of Time Overdue (8) Date inspection findings issued

13. Please submit a table or computer printout that identifies any Priority 1, 2, and 3 licensees and initial inspections that are currently overdue, per IMC 2800. At a minimum, the list should include the same information for each overdue inspection provided for Question 12 plus your action plan for completing the inspection. Also include your plan for completing the overdue inspections.

None are currently overdue.

14. Please provide the number of reciprocity licensees that were candidates for inspection per year as described in IMC 1220 and indicate the number of reciprocity inspections of candidate licensees that were completed each year during the review period.

2019 Number of candidates - One; Number inspected - One:

• Varian 2020 Number of candidates - Six; Number inspected - Four:

• JDH Inspectors

• Baker testing

• Lixi Inc.

• Varian was by remote inspection 2021

Number of candidates - Six; Number inspected - Four

• JDH Inspectors

• Lixi

• Flood Testing Laboratories

• Siemens Healthcare III. Technical Quality of Inspections

15. What, if any, changes were made to your written inspection procedures during the reporting period?

RMPP 2.4 was revised 20 April 2021 for lessons learned in inspections and in documenting those inspections in files and Web-Based Licensing

16. Prepare a table showing the number and types of supervisory accompaniments made during the review period. Include:

Inspector Supervisor License Category Date Fran ONeill William Irwin Service Provider 13 November 2019 Fran ONeill William Irwin Medical 15 January 2020 Fran ONeill William Irwin Industrial 5 August 2021 Fran ONeill William Irwin Nuclear Pharmacy 5 August 2021 Fran ONeill William Irwin Industrial 3 September 2021

17. Describe or provide an update on your instrumentation, methods of calibration, and laboratory capabilities. Are all instruments properly calibrated at the present time? Were there sufficient calibrated instruments available throughout the review period?

Each of the three members of the Radioactive Materials Program staff are assigned a Thermo RadEye B20-ER beta-gamma survey instrument and a Ludlum 2401-P beta-gamma survey meter for use during inspections or incident response.

The program also has additional instruments including Ludlum Model 3 alpha detection instruments, beta-gamma survey meters and Thermo IdentiFinder R400 portable gamma spectrometer for use in inspections and incident response.

These instruments are calibrated annually by a licensed vendor, Radiation Safety

& Control Services, of Stratham, New Hampshire. The instruments are calibrated to National Institute of Standards and Technology-traceable standards.

All instruments are calibrated as of 20 September 2021 with the exception of the Thermo IdentiFinder R400 portable gamma spectrometers. Three of these are being calibrated at that time and one other will be calibrated after the other three are returned from their calibration.

These instruments have been sufficient for staff work.

The Health Department has an excellent radiochemistry laboratory that analyzes samples from our Vermont Yankee Nuclear Station environmental surveillance program. Its instrumentation provides for high purity germanium gamma

spectroscopy, alpha and beta gas flow proportional counting and alpha and beta liquid scintillation counting.

IV. Technical Quality of Licensing Actions

18. How many specific radioactive material licenses does your program regulate at this time?

33

19. Please identify any major, unusual, or complex licenses which were issued, received a major amendment, were terminated, decommissioned, submitted a bankruptcy notification or renewed in this period.

John Turner Consulting as the States first renewal, February 2020 Westinghouse change of ownership and Financial Assurance

• Norwich as a Possession Only license

• Lixi reciprocity and determination as to radiography or portable gauge Pharmalogic adding an Authorized Nuclear Pharmacist requiring refresher training after greater than 7 years since listed on an NRC or Agreement State radioactive materials license

20. Discuss any variances in licensing policies and procedures or exemptions from the regulations granted during the review period.

No licensing variances granted.

21. What, if any, changes were made in your written licensing procedures (new procedures, updates, policy memoranda, etc.) during the reporting period?

RMPP 1.1 Review of an Initial License Application or an Amendment Request was revised on April 13, 2021 for lessons learned and to incorporate guidance on WBL input.

22. Identify by licensee name and license number any renewal applications that have been pending for one year or more. Please indicate why these reviews have been delayed and describe your action plan to reduce the backlog.

No license renewals were delayed.

V. Technical Quality of Incident and Allegation Activities

23. For Agreement States, please provide a list of any reportable incidents not previously submitted to NRC (See Procedure SA-300, Reporting Material Events, for additional guidance, OMB clearance number 3150-0178). The list should be in the following format:

Licensee Name License # Date of Incident/Report Type of Incident UVMMC 44-10187-03 11/18/2019 Medical Event UVMMC 44-10187-03 11/27/2019 Lost seed Non-Licensee 2/27/2020 I-131 in waste

Non-Licensee 3/27/2020 I-131 in waste The Presidents 44-08056-03 5/10/2021 Leaking source and Fellows of Middlebury College

24. Identify any changes to your procedures for responding to incidents and allegations that occurred during the period of this review.

None for incidents and allegations.

C. NON-COMMON PERFORMANCE INDICATORS I. Compatibility Requirements

25. Please list all currently effective legislation that affects the radiation control program.

Denote any legislation that was enacted or amended during the review period.

None.

26. Are your regulations subject to a "Sunset" or equivalent law? If so, explain and include the next expiration date for your regulations.

No.

27. Please review and verify that the information in the enclosed State Regulation Status (SRS) sheet is correct. For those regulations that have not been adopted by the State, explain why they were not adopted, and discuss actions being taken to adopt them. If legally binding requirements were used in lieu of regulations and they have not been reviewed by NRC for compatibility, please describe their use.

For RATS ID 2018-1: Vermont incorporates Parts 30, 32, and 35 by reference in their final regulations which were effective March 1, 2019. Therefore, the regulations in this RATS ID have been incorporated by reference.

For RATS ID 2018-2: Vermont incorporates these regulations by reference in their final regulations which were effective March 1, 2019. Therefore, the regulations in this RATS ID have been incorporated by reference.

28. If you have not adopted all amendments within three years from the date of NRC rule promulgation, briefly describe your State's procedures for amending regulations in order to maintain compatibility with the NRC, showing the normal length of time anticipated to complete each step.

Not applicable.

II. Sealed Source and Device (SS&D) Evaluation Program Not Applicable in Vermont.

29. Prepare a table listing new and amended (including transfers to inactive status) SS&D registrations of sources and devices issued during the review period. The table heading

should be:

SS&D Manufacturer, Registry Distributor or Product Type Date Type of Number Custom User or Use Issued Action

30. Please include information on the following questions in Section A, as they apply to the SS&D Program:

Technical Staffing and Training - Questions 2-9 Technical Quality of Licensing Actions - Questions 18-22 Technical Quality of Incident and Allegation Activities - Questions 23-24 III. Low-level Radioactive Waste Disposal Program Not Applicable in Vermont.

31. Please include information on the following questions in Section A, as they apply to the Low-Level Radioactive Waste Disposal Program:

Technical Staffing and Training - Questions 2-9 Status of Materials Inspection Program - Questions 10-14 Technical Quality of Inspections - Questions 15-17 Technical Quality of Licensing Actions - Questions 18-22 Technical Quality of Incident and Allegation Activities - Questions 23-24 IV. Uranium Recovery Program Not Applicable in Vermont.

32. Please include information on the following questions in Section A, as they apply to the Uranium Recovery Program:

Technical Staffing and Training - Questions 2-9 Status of Materials Inspection Program - Questions 10-14 Technical Quality of Inspections - Questions 15-17 Technical Quality of Licensing Actions - Questions 18-22 Technical Quality of Incident and Allegation Activities - Questions 23-24

MATERIALS REQUESTED TO BE AVAILABLE FOR THE ON-SITE PORTION OF AN IMPEP REVIEW Please have the following information available for use by the IMPEP review team when they arrive at your office:

• List of open license cases, with date of original request, and dates of follow-up actions

• List of licenses terminated during review period.

• Copy of current log or other document used to track licensing actions.

• List of all licensing actions completed during the review period (sorted by license reviewer, if possible).

• Copy of current log or other document used to track inspections.

• List of all inspections completed during the review period (sorted by inspector, if possible).

• List of inspection frequencies by license type.

• List of all allegations occurring during the review period. Show whether the allegation is open or closed and whether it was referred by NRC.

• List of all licenses that your agency has imposed additional security requirements upon.

ALSO, PLEASE HAVE THE FOLLOWING DOCUMENTS AVAILABLE:

• All State regulations

• Documented training plan, if applicable

• Statutes affecting the regulatory authority

• Records of results of supervisory of the State program accompaniments of inspectors

• Standard license conditions

• Emergency plan and communications list

• Technical procedures for licensing,

• Procedures for investigating allegations model licenses, review guides

• Procedures for investigating incidents

• SS&D review procedures, guides, and standards

• Enforcement procedures, including procedures for escalated enforcement,

• Instrument calibration records severity levels, civil penalties (as applicable)

• Inspection procedures and guides

• Job description

• Inspection report forms