ML21022A018

Nebraska Response to 2021 Impep Questionnaire

ML21022A018
Person / Time
Issue date:	01/20/2021
From:	Lizette Roldan-Otero NRC/NMSS/DMSST
To:
Roldan-Otero L
References
Download: ML21022A018 (16)

Text

From: Wisell, Becky To: Roldan-Otero, Lizette; Harisis, Becki; Miller, Bryan Cc: Wilson, Deb

Subject:

[External_Sender] RE: Query: IMPEP Questionnaire Date: Wednesday, January 20, 2021 12:13:21 PM Attachments: IMPEP Questionnaire 02-28-2023 Expiration Nebraska.pdf

Lizette, Attached is the questionnaire for Nebraska. Please let me know if anything further is needed. Thank you.

Becky Wisell l Interim Deputy Director DIVISION OF PUBLIC HEALTH; HEALTH LICENSURE AND ENVIRONMENTAL HEALTH Nebraska Department of Health and Human Services OFFICE: 402-471-0928 l CELL: 402-610-5122 l FAX: 402-471-3577 DHHS.ne.gov l Facebook l Twitter l LinkedIn From: Roldan-Otero, Lizette <Lizette.Roldan-Otero@nrc.gov>

Sent: Wednesday, January 20, 2021 11:02 AM To: Harisis, Becki <Becki.Harisis@nebraska.gov>; Miller, Bryan <Bryan.Miller@nebraska.gov>

Cc: Wilson, Deb <Deb.Wilson@nebraska.gov>; Wisell, Becky <Becky.Wisell@nebraska.gov>

Subject:

RE: Query: IMPEP Questionnaire Hi Becky -

I noticed that Deb already uploaded the questionnaire to the box. Thank you for that. I also need you to officially submit it to the NRC. Can you please send that to us as soon as possible? You can send it as an attachment in PDF format.

Thanks, Lisey Lizette Roldán-Otero, Ph.D.

Health Physicist NMSS/MSST/SALB Office: 817-200-1596 From: Roldan-Otero, Lizette Sent: Friday, January 15, 2021 9:28 AM To: Harisis, Becki <Becki.Harisis@nebraska.gov>; Miller, Bryan <Bryan.Miller@nebraska.gov>

Cc: Wilson, Deb <Deb.Wilson@nebraska.gov>; Wisell, Becky <Becky.Wisell@nebraska.gov>

Subject:

Query: IMPEP Questionnaire Hi Bryan and Becki -

I hope you are staying safe and warm. I looked at the weather and saw there was a

blizzard warning.

I wanted to see if you have a status for the questionnaire. It is due on Monday and wondering if it will be sent to us soon.

Thanks, Lisey Lizette Roldán-Otero, Ph.D.

Health Physicist NMSS/MSST/SALB Office: 817-200-1596

t Approved by OMB1 Control No.: 3150-0183 Expires: 02/28/2023 INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM QUESTIONNAIRE Nebraska Office of Radiological Health Reporting Period: January 16, 2016 - February 5, 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.

Previous IMPEP review discussed the need for a more timely process within the States rule development program. Only one significant legislative change occurred since the 2016 IMPEP review. That change was Executive Order 17-04, issued by the Governor on July 6, 2017 which in part, required all state agencies to immediately suspend all rulemaking and to review all current and pending regulations to determine if they are overly restrictive or are not cost vs benefit effective, and if so, to revise or repeal them. On August 31, 2017, the Department requested an exemption to Executive Order 17-04 to allow the Department to adopt pending regulations already in process. That exemption was granted allowing regulations to proceed to the Governors desk for signature.

At the time of the 2016 IMPEP review, a regulation package containing RATS ID:

2011-1, 2011-2, 2012-2, 2012-3, 2012-4, 2013-1 and 2013-2 was overdue for adoption. That regulation package was adopted on November 28, 2016. A second regulation package containing RATS ID: 2015-1, 2015-2, 2015-3, 2015-4 and 2015-5 was sent for signature on January 8, 2018 and was signed by the Governor on March 8, 2018 with an effective date of March 13, 2018. Currently the Program has no overdue regulations.

The current regulation package in process containing Nebraska chapters 3, 7, 13, and 24 incorporating RATS ID 2018-1 and 2018-2 was submitted for NRC review on November 5, 2019. Comments from the NRC were incorporated. Chapters 7 was amended 11/3/2020 and Chapter 24 was amended 11/25/2020. The revised versions of chapters 3 and 13 are awaiting final signature by the Governor.

Meeting the earliest RATS deadline of December, 21, 2021 is anticipated.

RATS 2018-3, 2019-1 & 2, and 2020-1-3 are currently in program review and will 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.

be submitted to our legal department by 1/22/2021.

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 RadHealth Org Chart.

(b) A chart showing positions of the radiation control program, including management; and See RadHealth Org Chart.

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

Not applicable.

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%

Bryan Miller HP Licensing/Compliance 95%

Emergency Response 5%

Becki Harisis HP Licensing/Compliance 95%

Emergency Response 5%

Travis Smith HP Licensing/Compliance 95%

Emergency Response 5%

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.

Becki Harisis started in the Radioactive Materials Program February 1, 2019. She has a Bachelor of Science in Radiation Science Technology and an Applied

Associates of Science Degree in Radiologic Technology. Becki had previously worked in the X-ray Program for 8 years and was a Nuclear Medicine Technologist for 12 years.

Travis Smith was hired June 29, 2020. He has a Masters in Nuclear Engineering and a Bachelor of Science in Nuclear Engineering.

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.

License reviewers and inspectors may take longer to become qualified due to out of state travel restrictions prohibiting attendance at training classes needed to complete qualification and inspections being delayed due to social distancing or other factors related to the COVID-19 PHE.

Becki Harisis:

Course Expected Completion Date G-205: Root Cause/Incident Applied 7/27/20 for 3/23/21 to 3/26/21 class (this Investigation Workshop class was rescheduled for 5/25/21 to 5/28/21, we have a graded exercise that week, Karen has moved my application to the 8/24/21 to 8/27/21 class)

H-305: Safety Aspects of Applied for 12/7/20 to 12/11/20 class - CX due to Industrial Radiography Covid Applied for 3/15/21 to 3/19/21 class H-122S: Fundamental Health Lab Activities Class - requested to take 6/10/19 Physics Self-Study LAB to 6/14/19 - not accepted into class Lab Activities Class - requested to take 6/8/20-6/12/20 CX due to Covid-19 Lab Activities Class - requested 7/27/20 to take 10/19/20 to 10/23/20 CX due to Covid-19 Lab Activities Class - requested 8/26/20 to take 6/14/21 to 6/18/21 G-109: Licensing Practices Applied for 9/28/20-10/2/20 CX due to Covid-19 and Procedures Applied 7/27/20 to take 10/5/20 to 10/9/20 CX due to Covid Applied 8/26/20 to take 4/26/21 to 4/29/21 A virtual class was created for 3/8/21 to 3/12/21, I have asked to be put in that class.

Travis Smith:

Course Expected Completion Date Licensing Practices and Requested to take 4/26/21-4/29/21 Procedures (G-109)

Root Cause/Incident Requested to take 3/23/21-3/26/21 (this class Investigation Workshop (G- was rescheduled for 5/25/21 to 5/28/21, we have 205) a graded exercise that week, Karen has moved my application to the 8/24/21 to 8/27/21 class)

Diagnostic and Therapeutic Requested to take 1/11/21-1/15/21(this class will Nuclear Medicine (H-304) be completed by IMPEP, but there will not be a

completion certificate yet)

Safety Aspects of Industrial Requested to take 3/15/21-3/19/21 Radiography (H-305)

Brachytherapy, Gamma Requested to take 1/18/21-1/22/21(this class will Knife, and Emerging be completed by IMPEP, but there will not be a Technologies Course (H-313) completion certificate yet)

NRC Materials Control & Requested to take 8/16/21-8/19/21 Security Systems &

Principles (S-201)

Advanced Health Physics (H- Requested to take 7/19/21-7/23/21 201)

Additional: Irradiator Requested to take 9/14/21-9/16/21 Technology (H-315)

Additional: Health Physics Requested to take 6/14/21-6/18/21 Lab (H-122)

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

The qualification and training procedure was not revised during the review period.

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

Larry Harisis left the program February 22, 2019.

Howard Shuman retired from the program April 17, 2020.

Julia Schmitt retired from the program December 1, 2020.

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.

PROGRAM MANAGER - Vacant 2 Months The Radiological Program Manager position has been vacant since December 1, 2020, when Julia Schmitt retired. The position has been approved to fill and will soon be advertised on the State Jobs website. I am working with Human Resources to select an interview panel with the technical expertise to select an appropriate candidate for the position.

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.

The Nebraska Board of Health reviews proposed rules and regulations for the use of radioactive material as part of their duties. Members are required to declare in writing any matter requiring action or decision that may cause a potential conflict.

A member abstains from activities in which the potential conflict exists.

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.

All licensee inspections are conducted at least as frequently as required by IMC 2800.

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.

Calendar Year Priority 1 Priority 2 Priority 3 Initial Jan. 16 - Dec. 31, 2016 4 13 13 2 2017 4 17 12 1 2018 4 16 13 2 2019 4 12 15 4 2020 3 9 6 2 Jan. 1 - Feb. 5, 2021 0 0 0 0

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.

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

(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 No inspections were performed overdue.

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.

No inspections 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.

Reciprocity inspections were not conducted in 2020 due to Covid-19 restrictions.

Candidates for reciprocity were chosen based upon:

Inspection priority; Scope of work to be performed; Focus on medical licensees and industrial radiography; and Duration (i.e., length of work/storage or number of visits in a calendar year).

Reciprocity Candidates for Reciprocity Calendar Year Inspections Inspections (Priority 1, 2, & 3)

Completed Jan 16 - Dec 31, 2016 18 4 2017 14 3 2018 15 4 2019 18 4 2020 14 0 Jan 1 - Feb 5, 2021 5 0 III. Technical Quality of Inspections

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

The inspection procedures were revised in the fall of 2019. Our inspection procedures reference the NRC inspection manual and procedures, those changes have been incorporated into our practices.

Radioactive Materials Program Procedures:

3.01 - Scheduling of Inspections 1.1.1: Added gives Licensees credit for good performance by extending the interval of the next inspection.

1.5: Updated definitions for reactive inspections, routine inspections and added the definition for risk significant radioactive material (RSRM);

2.3: Changed the individual to whom the program reports inspection and licensing statistics from the Unit Administrator to the Deputy Director.

3.3.1: Added that initial inspections will be announced and adjusted the time allowed to complete the inspections to within 12 months of the date the license issuance or 18 months of the date the license issuance if the licensee does not yet possess licensed materials or has not performed principal activities. Increased inspection date variance for Priority 1, 2 from +/- 25% to +/- 50%. Added inspection date variances for Priority 3 inspections be +/- 1 year.

3.4: Added the section Extension of Inspection Interval.

3.7, Item 2: Changed Reciprocity Inspections from a priority based to The Nebraska Radioactive Materials Program will attempt to conduct reciprocity inspections as time allows.

3.02 - Inspection Preparation 1.5.6: Updated the definition for reactive inspections.

3.2.2: Added item c) Regulatory Requirements.

3.03 - Performance Based Inspection 1.5.12: Updated the definition for reactive inspections.

2.3: Changed the individual to whom the program reports inspection statistics from the Unit Administrator to the Deputy Director.

3.1.1: Removed the last sentence of the first paragraph, The license shall be inspected within 6 months of the receipt of licensed material, within 6 months of beginning licensed activity, or within 1 year of license issuance, whichever is first. Removed the last sentence of the 3rd paragraph, For example, a priority 1 license with an inspection due date of 7/1/2010 shall be conducted any time during the period 4/1/2010 to 10/1/2010.

3.1.4: Added the section Extension of Inspection Interval.

3.3.2: Revised paragraph 4 changing from two or three to one to five and adding the measurement of at least 40% of the locations are to be inspected. If the license authorizes licensed activities to be conducted from 4-10 was changed to six to twenty and the measurable 30 % of locations are to be inspected was added. If the license authorizes licensed activities to be conducted from more than 10 permanent facilities was changed to 20 permanent facilities. Examples were removed from the paragraph.

3.3.3: Removed the last sentence in the 2nd paragraph, This will allow the licensee sufficient time to begin root cause analysis and possibly determine a corrective action prior to termination of the inspection.

3.4.1: Removed and to the formulation of corrective actions to prevent recurrence from the last sentence of the 2nd paragraph.

3.04 - Documentation of Inspection Results 1.5.13: Removed in accordance with 180 NAC Chapter 17.

3.05 - Enforcement, Escalated Enforcement and Administrative Actions 1.3.4: Added Office of Radiological Health Enforcement Manual 3.0: Changed 180 NAC 17 to the Office of Radiological Health Enforcement Manual Changed all instances of Unit Administrator to Deputy Director

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

Inspector Supervisor License Category Date Howard Shuman Julia Schmitt Nuclear Medicine 03/03/2016 Howard Shuman Julia Schmitt Industrial Gauge 05/12/2016 Larry Harisis Julia Schmitt Industrial Gauge 05/12/2016 Howard Shuman Julia Schmitt Nuclear Medicine 04/19/2017 Larry Harisis Julia Schmitt Nuclear Medicine 04/19/2017

Bryan Miller Julia Schmitt Industrial Radiography 04/26/2017 Bryan Miller Julia Schmitt Nuclear Medicine 06/14/2017 Larry Harisis Julia Schmitt Nuclear Medicine 06/14/2017 Bryan Miller Julia Schmitt Industrial Radiography 01/10/2018 Larry Harisis Julia Schmitt Industrial Radiography 01/10/2018 Howard Shuman Julia Schmitt Broad License - Ed. 02/14/2019 Larry Harisis Julia Schmitt Broad License - 02/14/2019 Educational Bryan Miller Julia Schmitt Irradiator, Unshielded 12/05/2019 During Irradiation Bryan Miller Julia Schmitt Educational 10/27/2020 (Instructional Only)

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?

See Instruments Available and calibrations Schedule in Technical Quality of Inspections Folder.

IV. Technical Quality of Licensing Actions

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

130

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.

None.

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

Due to COVID-19, inspections have been announced since spring of 2020.

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

Our procedures were updated in the fall of 2020.

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 renewal applications were pending for one year or more.

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 All reportable events have been reported.

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

No changes occurred during the reporting period.

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.

o Radiation Control Act 71-3501 to 71-3520 Amended 2017 o Transportation of High-level Radioactive Waste and Transuranic Waste 71-3523 to -3528 o Certified Registered Nurse Anesthetist Practice Act 38-701 to -711 o Advanced Practice Registered Nurse Practice Act 38-201 to -212 o Nebraska Emergency Management Act 81-829.37 to -829.75 Amended 2017 o Emergency, Governor, Civil Defense Assumption of Control of State Communication System 81-1120.25 o Administrative Procedures Act 84-901 to -920 Amended 2016 o Low-Level Radioactive Waste Act 81-1578 to -15,116

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

Our regulations are not subject to a Sunset or equivalent law.

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.

- Draft regulations for chapters 180 NAC 3, 7, 13, and 24 incorporating 2018-1 through 2018-2 have been approved by Department Legal Counsel and the Governors Policy Research Office. Public hearings were conducted and comments received have been addressed by staff. Draft regulations were submitted to NRC on November 5, 2019. Comments were received January 9, 2020 and incorporated into draft approved by the State of Nebraska Board of Health on March 16, 2020 and currently in queue to be signed by the governor.

After being signed by the Governor, the regulations will be promptly taken to the Secretary of States Office and placed on file. The regulations will go into effect five calendar days after being filed by with the Secretary of State, thus becoming law.

- 2018-3, 2019-1 through -2, and 2020-1 through -3 were published after the review deadline for current promulgation and are currently under program review to begin the legal process 1/22/2021.

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.

All amendments in the review period have been adopted within three years.

II. Sealed Source and Device (SS&D) Evaluation Program

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 Not applicable.

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 Not applicable.

III. Low-level Radioactive Waste Disposal Program

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 Not Applicable. There is currently no active Low Level Radioactive Waste Program in Nebraska Department of Health and Human Services or in Nebraska Department of Environmental Quality. Both agencies monitor the status of low level radioactive waste nationally and advise agency management and the Governor as appropriate.

IV. Uranium Recovery Program

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 Not applicable.

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 RAM Manual 4.01 RAM Manual 2.02-2.06 Procedures for investigating incidents SS&D review procedures, guides, and RAM Manual 4.02 standards - Not Applicable Enforcement procedures, including Instrument calibration records procedures for escalated enforcement, severity levels, civil penalties (as Inspection procedures and guides applicable)

RAM Manual 3.01-3.05 Job Descriptions Inspection report forms