August 22, 2013 

Terry Dwelle, M.D., M.P.H.T.M. 

State Health Officer 

North Dakota Department of Health 

State Capitol 

600 East Boulevard Avenue 

Bismarck, ND 58505-0200 

Dear Dr. Dwelle: 

On July 15, 2013, the Management Review Board (MRB) met to consider the proposed final 

Integrated Materials Performance Evaluation Program (IMPEP) report on North Dakota 

Agreement State Program for the followup review conducted in April 2013. The MRB found the 

North Dakota Agreement State Program adequate to protect public health and safety, but needs 

improvement, and compatible with the U.S. Nuclear Regulatory Commission’s program. The 

MRB agreed that the period of Heightened Oversight of the North Dakota Agreement State 

Program be discontinued and that a period of Monitoring be initiated to allow additional time for 

the Program to demonstrate a period of sustained performance, especially with the impending 

vacancy of the Program Manager position. 

Section 5.0, page 10, of the enclosed final report contains a summary of the IMPEP team’s 

findings and recommendations. The review team made one new recommendation regarding 

the full qualification of inspection staff and kept one recommendation open from the previous 

IMPEP regarding staff retention and depth. The review team recommended closing the 

remaining 10 recommendations from the 2011 IMPEP review. We request your evaluation and 

response to the one new recommendation in the report within 30 days from receipt of this letter. 

Based on the results of the current IMPEP review, the next full review of the North Dakota 

Agreement State Program will take place in approximately 2 years, with a periodic meeting 

tentatively scheduled for April 2014. 

 
T. Dwelle 2 

I appreciate the courtesy and cooperation extended to the IMPEP team during the review. 

I also wish to acknowledge your continued support for the Agreement State program. I look 

forward to our agencies continuing to work cooperatively in the future. 

 Sincerely, 

 /RA by Cathy Haney for/ 

 

 Michael F. Weber 

 Deputy Executive Director for Materials, Waste, 

 Research, State, Tribal and Compliance 

Programs 

 Office of the Executive Director for Operations 

Enclosure: 

North Dakota Final IMPEP Report 

cc w/encl: Cheryl Rogers, WI 

 Organization of Agreement States 

 Liaison to the MRB 
T. Dwelle 2 

I appreciate the courtesy and cooperation extended to the IMPEP team during the review. 

I also wish to acknowledge your continued support for the Agreement State program. I look 

forward to our agencies continuing to work cooperatively in the future. 

 Sincerely, 

 /RA by Cathy Haney for/ 

 Michael F. Weber 

 Deputy Executive Director for Materials, Waste, 

 Research, State, Tribal and Compliance Programs 

 Office of the Executive Director for Operations 

Enclosure: 

North Dakota Final IMPEP Report 

cc w/encl: Cheryl Rogers, WI 

 Organization of Agreement States 

 Liaison to the MRB 

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DATE 07/30/13 07/24/13 07/30/13 08/01/13 08/01/13 08/6/13 08/6/13 08/22/13 

OFFICIAL RECORD COPY
Enclosure 

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM 

REVIEW OF THE NORTH DAKOTA AGREEMENT STATE PROGRAM 

April 22-26, 2013 

FINAL REPORT
EXECUTIVE SUMMARY 

This report presents the results of the Integrated Materials Performance Evaluation Program 

(IMPEP) followup review of the North Dakota Agreement State Program. The review was 

conducted during the period of April 22-26, 2013, by a review team composed of technical staff 

members from the U.S. Nuclear Regulatory Commission (NRC) and the State of Washington.

Based on the results of this followup review, North Dakota’s performance was found satisfactory 

for the indicators Status of Materials Inspection Program, Technical Quality of Licensing 

Actions, and Technical Quality of Incidents and Allegations, and satisfactory, but needs 

improvement for the indicator Technical Quality of Inspections. The remaining indicators, 

Technical Staffing and Training, and Compatibility Requirements, were discussed with North 

Dakota as part of the Periodic Meeting conducted concurrently with the IMPEP followup review. 

The review team made one new recommendation regarding the full qualification of inspection 

staff and kept one recommendation open from the previous IMPEP regarding staff retention and 

depth. The remaining 10 recommendations from the 2011 IMPEP review, regarding policies 

and procedures, inspection scheduling, timeliness of inspection report issuance, inspection 

documentation, training, documentation of licensing actions, financial assurance matters, and 

evaluation of incidents and allegations, are closed. 

Accordingly, the review team recommended, and the Management Review Board (MRB) 

agreed, that the North Dakota Agreement State Program is adequate to protect public health 

and safety, but needs improvement, and is compatible with the NRC's program. The review 

team recommended, and the MRB agreed, that the period of Heightened Oversight of the North 

Dakota Agreement State Program be discontinued and that a period of Monitoring be initiated to 

allow additional time for the North Dakota Program to demonstrate a period of sustained 

performance, especially with the impending vacancy of the Program Manager position. The 

review team recommended, and the MRB agreed, that a Periodic Meeting be held in 

approximately one year and the next IMPEP review take place in approximately two years. 
North Dakota Final IMPEP Report Page 1 

1.0 INTRODUCTION 

This report presents the results of the followup Integrated Materials Performance Evaluation 

Program (IMPEP) review of the North Dakota Agreement State Program. The followup review 

was conducted during the period of April 22-26, 2013, by a review team composed of technical 

staff members from the U. S. Nuclear Regulatory Commission (NRC) and the State of 

Washington. Team members are identified in Appendix A. The followup review was conducted 

in accordance with the “Implementation of the Integrated Materials Performance Evaluation 

Program and Rescission of Final General Statement of Policy,” published in the Federal 

Register on October 16, 1997, and the NRC Management Directive 5.6, “Integrated Materials 

Performance Evaluation Program (IMPEP),” dated February 26, 2004. Preliminary results of the 

followup review, which covered the period of April 9, 2011 to April 26, 2013, were discussed 

with North Dakota managers on the last day of the review. 

A draft of this report was provided to North Dakota for factual comment on May 31, 2013. The 

State responded by letter dated June 24, 2013. A copy of the State’s response is included as 

an Attachment to this report. A Management Review Board (MRB) met on July 15, 2013, to 

consider the proposed final report. The MRB found the North Dakota Agreement State Program 

adequate to protect public health and safety, but needs improvement, and compatible with the 

NRC’s program. 

The North Dakota Agreement State Program is administered by the Radiation Control Program 

(the Program), in the Division of Air Quality (the Division). The Division is part of the 

Environmental Health Section under the North Dakota Department of Health. 

At the time of the review, the North Dakota Agreement State Program regulated 102 specific 

licenses authorizing byproduct, source, and certain special nuclear materials. The review 

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 State of North 

Dakota. 

As part of the Heightened Oversight process, the NRC conducted quarterly conference calls with 

the Program to discuss the State’s progress in implementing the Program Improvement Plan (the 

Plan). The State submitted the Plan on August 17, 2011, and the NRC approved the Plan on 

October 3, 2011. A Periodic Meeting was held with the Program on March 8, 2012. Quarterly 

conference calls to review progress on the Plan were held on November 17, 2011, June 6, 2012, 

September 13, 2012, December 6, 2012, and February 5, 2013. A listing of correspondence and 

summaries from the Periodic Meeting and the quarterly calls is included as Appendix C. The 

Program’s actions and its status, as documented in the Plan and subsequent status updates, 

were reviewed in preparation for this followup review. 

The followup review focused on the Program’s performance in regard to the common 

performance indicators: Status of Materials Inspection Program, Technical Quality of 

Inspections, Technical Quality of Licensing Actions, and Technical Quality of Incident and 

Allegation Activities. The followup review also included evaluation of the actions taken by the 

Program to address the recommendations made during the 2011 IMPEP review. Other aspects 

of the Program not fully evaluated as part of the followup review were discussed at a Periodic 
North Dakota Final IMPEP Report Page 2 

Meeting held in conjunction with the followup review. The Periodic Meeting summary is 

included as Appendix B. 

In preparation for the followup review, a questionnaire addressing the applicable performance 

indicators was sent to the Program on January 23, 2013. The Program provided its response to 

the questionnaire on April 6, 2013. A copy of the questionnaire response can be found in the 

NRC’s Agencywide Documents Access and Management System (ADAMS) using the 

Accession Number ML13105A022. 

The review team's general approach for conduct of this followup review consisted of 

(1) examination of the Program’s response to the questionnaire, (2) review of applicable North 

Dakota statutes and regulations, (3) analysis of quantitative information from the Program’s 

database, (4) technical review of selected regulatory actions, (5) field accompaniments of two 

inspectors, and (6) interviews with staff and managers. The review team evaluated the 

information gathered against the established criteria for each common and the applicable 

non-common performance indicator and made a preliminary assessment of the North Dakota 

Agreement State Program’s performance. 

Section 2.0 of this report covers the State’s actions in response to recommendations made during 

previous reviews. 

Results of the current review of the common performance indicators are presented in Section 3.0. 

Section 4.0 details the results of the review of the applicable non-common performance indicators, 

and Section 5.0 summarizes the review team's findings. 

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS 

During the previous IMPEP review, which concluded on April 8, 2011, the review team made 

11 recommendations regarding the North Dakota Agreement State Program’s performance. 

The status of each recommendation is as follows: 

1. “The review team recommends that the State (1) update its existing procedures and develop 

new procedures as necessary, to memorialize the policies and practices of the Agreement 

State program, to serve as a knowledge management tool, and (2) examine options to 

increase staff retention and/or develop sufficient depth in staffing to effectively implement 

the program. (Section 2.1 of 2011 IMPEP Report)” 

Status: The State has updated existing procedures and established new procedures to 

memorialize the policies and practices of the Program and serve as a knowledge 

management tool. The staff demonstrated familiarity with and use of these policies and 

procedures. Although staffing has stabilized since the last IMPEP review, and efforts have 

been made to increase depth in staffing by providing some cross training to X-ray 

inspectors, this recommendation remains open in order to monitor sustained performance 

by the Program in the area of staff training and qualifications. 

2. “The review team recommends that the State take measures to ensure that initial inspections 

are performed at the interval prescribed in Inspection Manual Chapter (IMC) 2800. (Section 

2.2 of 2011 IMPEP Report)” 
North Dakota Final IMPEP Report Page 3 

Status: The State has taken measures to ensure that initial inspections are performed in a 

timely manner. The State improved the tracking of initial inspections and enhanced the 

associated procedures. No initial inspections were performed beyond the interval 

prescribed in IMC 2800. This recommendation is closed. 

3. “The review team recommends that the State take measures to ensure that inspection 

findings are communicated to licensees within 30 days of the date of the inspection. 

(Section 2.2 of 2011 IMPEP Report)” 

Status: The State has taken measures to ensure that inspection findings are communicated 

in a timely manner. The State improved the tracking of inspection reports and related 

correspondence, and enhanced the associated procedures. For the inspection casework 

reviewed, all inspection findings were provided to licensees within 30 days. This 

recommendation is closed. 

4. “The review team recommends that the State (1) take measures to ensure that sufficient 

information pertaining to inspection observations and identified non-compliances is 

documented in inspection records and in letters to licensees and that these documents are 

appropriately reviewed by management, prior to issuance, for thoroughness and consistency, 

and (2) develop and implement a plan to address comments noted in Appendix C related to 

identified items of non-compliance that were not included in findings dispatched to licensees. 

(Section 2.3 of 2011 IMPEP Report)” 

Status: The State has taken measures to ensure that the identified findings are documented 

in letters issued to the licensee and appropriately reviewed by management. These 

measures included elements to ensure all items of non-compliance were included in findings 

to the licensees. This recommendation is closed. 

5. “The review team recommends that the State obtain additional training (formal and on-the-job, 

as appropriate) for the Program Manager and members of the technical staff to enhance 

inspection skills, particularly with regards to (1) radiation safety issues associated with 

cyclotron operations, and (2) proper operations and use of radiation survey and measurement 

instrumentation. (Section 2.3 of 2011 IMPEP Report)” 

Status: The Program staff has accompanied both NRC and Minnesota inspectors in the 

past and plan to continue to do so as schedules permit. In particular, the State also 

continues to work with the State of Minnesota to obtain training on cyclotron inspections. 

The training consisted of the Program staff observing cyclotron inspections in the State of 

Minnesota, and a Minnesota inspector accompanying the inspector performing the cyclotron 

inspection in North Dakota jurisdiction. The State plans to conduct cyclotron inspections 

either with a State qualified inspector or request the assistance of a qualified inspector from 

another agency such as another Agreement State or an NRC regional office. Regarding the 

use of instrumentation, staff from the NRC Technical Training Center (TTC) along with 

contracted personnel from Oak Ridge Institute for Science and Education (ORISE), provided 

specific instrumentation training to the technical staff members in North Dakota during the 

week of October 25-27, 2011. During the inspector accompaniments for the 2011 IMPEP, 

there were issues identified associated with the use of radiation survey and measurement 

instrumentation; however, accompaniments for the 2013 IMPEP revealed no similar issues 
North Dakota Final IMPEP Report Page 4 

regarding use of radiation survey and measurement instrumentation. This recommendation 

is closed. 

6. “The review team recommends that the State (1) take measures to ensure that the 

Program’s review of licensing actions are adequately documented and that licensing actions 

are thorough and consistent with the regulations and appropriate licensing guidance, and 

(2) take measures to address the licensing deficiencies that were identified in the comments 

in Appendix D of the 2011 IMPEP Report. (Section 2.4 of 2011 IMPEP Report)” 

Status: The State has taken measures to ensure that licensing actions are adequately 

reviewed and documented using appropriate guidance. These measures included elements 

to ensure previous deficiencies were addressed. For the licensing casework reviewed no 

issues with review or documentation of licensing actions were identified. This 

recommendation is closed. 

7. “The review team recommends that the State provide additional training to the Program 

Manager and technical staff members regarding technical review of licensing actions, 

including training to ensure that the staff acquires increased familiarity with (1) the 

regulations under North Dakota’s equivalent to 10 CFR Parts 30 through 39, and 

(2) applicable licensing guidance documents for use authorization and license conditions. 

(Section 2.4 of 2011 IMPEP Report)” 

Status: The State obtained additional training through NRC coursework. Also, the NRC 

Region IV staff provided specific licensing training to the State on March 5-7, 2012. This 

training included familiarization with regulations and applicable guidance documentation. 

License reviewers demonstrated enhanced knowledge and improved licensing performance. 

This recommendation is closed. 

8. “The review team recommends that the Program take measures to determine and document 

the basis of confidence, through consistent use of the pre-licensing checklist and guidance, 

that radioactive materials will be used as intended and as described in the application or 

amendment request, prior to authorizing the material on the license. (Section 2.4 of 2011 

IMPEP Report)” 

Status: The State obtained additional training through NRC coursework. Also, the NRC 

Region IV staff provided specific licensing training to the State on March 5-7, 2012. This 

training included familiarization with regulations and applicable guidance documentation. 

License reviewers demonstrated enhanced knowledge and improved licensing performance. 

This recommendation is closed. 

9. “Regarding financial assurance, the review team recommends that the State (1) develop a 

procedure or policy to assess financial assurance requirements as part of a significant 

licensing actions and during licensing renewals; (2) review all North Dakota licenses to 

determine whether licenses require financial assurance, and either request financial 

assurance for licenses that are authorized to process the applicable quantified or revise the 

license conditions to ensure clear quality limits that will not require provision of financial 

assurance; and (3) take measure to ensure that any financial assurance instruments received 
North Dakota Final IMPEP Report Page 5 

by the Program are maintained and stored in accordance with State requirements. (Section 

2.4 of 2011 IMPEP Report)” 

Status: The State has developed procedures to assess financial assurance requirements 

and has reviewed all North Dakota licenses for financial assurance with appropriate 

followup. The State has taken measures to ensure that financial instruments are properly 

maintained and stored. These measures, along with procedural enhancements and staff 

training, have improved the licensing of financial assurance-related actions. This 

recommendation is closed. 

10. “The review team recommends that the State strengthen its incident response program and 

take measures to ensure that (1) reported incidents are consistently evaluated to determine 

the appropriate type and level of Program response; (2) licensee event reports are reviewed 

by the Program for completeness and appropriate corrective actions; and (3) the Program’s 

evaluation of licensee events, whether based on a review of licensee reports, onsite reviews 

or inspection followup, is properly documented to facilitate future followup. (Section 2.5 of 

2011 IMPEP Report)” 

Status: The State has taken measures to strengthen its incident response program by 

establishing procedures to consistently evaluate incidents and appropriately respond. These 

procedures include evaluating corrective actions and documenting followup of events. 

These measures have improved the State’s response to events during the review period. 

This recommendation is closed. 

11. “The review team recommends that the State strengthen is allegation program and take 

measures to ensure that (1) allegations are promptly evaluated to determine the appropriate 

type and level of Program response; (2) the Program’s evaluation of allegation and any 

actions taken in response to allegations is properly documented to facilitate future followup; 

and (3) processes are in place to provide a response to allegers as appropriate. (Section 

2.5 of 2011 IMPEP Report)” 

Status: The State has taken measures to strengthen its allegation program by establishing 

procedures to consistently evaluate allegations and appropriately respond. These 

procedures include evaluating the circumstances and documenting followup, including 

responding to allegers as appropriate. These measures have improved the State’s 

response to allegations during the review period. This recommendation is closed. 

3.0 COMMON PERFORMANCE INDICATORS 

Five common performance indicators are used to review the NRC regional and Agreement 

State radioactive materials programs. 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. The 

indicator, Technical Staffing and Training, was found satisfactory in the 2011 IMPEP and 

therefore, not reviewed in this followup IMPEP. Technical staffing and training was discussed 

under the Periodic Meeting held concurrently (Appendix B). 
North Dakota Final IMPEP Report Page 6 

3.1 Status of Materials Inspection Program

The review team focused on five factors while reviewing this indicator: inspection frequency, 

overdue inspections, initial inspections of new licenses, timely dispatch of inspection findings to 

licensees, and performance of reciprocity inspections. The review team’s evaluation was based 

on the Program’s questionnaire response relative to this indicator, data gathered from the 

Program’s database, examination of completed inspection casework, and interviews with 

management and staff. 

The review team verified that North Dakota’s inspection frequencies for all types of radioactive 

material licenses are as frequent or in some cases (i.e. Type A broad scope, medical 

institution-no written directive required and well logging) more frequent as similar license types 

listed in IMC 2800, “Materials Inspection Program.” 

The Program conducted approximately 28 Priority 1, 2, and 3 inspections during the review 

period. None of these inspections were conducted overdue by more than 25 percent of the 

inspection frequency prescribed in IMC 2800. In addition, the Program performed five initial 

inspections during the review period, none of which was conducted overdue. Overall, the 

review team determined that the Program performed none of its inspections overdue during the 

review period. 

The review team evaluated the Program’s timeliness in providing inspection findings to 

licensees. A sampling of 10 inspection reports (see Appendix D) indicated that none of the 

inspection findings were communicated to the licensees beyond the Program’s goal of 30 days 

after the inspection. 

During the review period, the Program granted 18 reciprocity permits in calendar year (CY) 2011, 

15 of which were candidate licensees based upon the criteria in IMC 1220. The Program granted 

24 reciprocity permits in CY 2012, 23 of which were candidate licensees. The review team 

determined that the Program inspected 7 percent of the CY 2011 reciprocity candidates, and 

22 percent of the CY 2012 reciprocity candidates during the two years covered by the review 

period. The review team noted that the lower percentage of reciprocity inspections in 2011 was 

due in part to resource allocation and lacking inspector qualifications. 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that North Dakota’s performance with respect to the indicator, Status of Materials Inspection 

Program, be found satisfactory. 

3.2 Technical Quality of Inspections

The review team evaluated the inspection reports, enforcement documentation, inspection field 

notes, and interviewed inspectors for 10 of the 28 radioactive materials inspections and seven 

reciprocity inspections conducted during the review period. The casework reviewed included 

inspections conducted by two program inspectors and covered inspections of various license 

types, including: medical institutions-therapy, high dose rate remote afterloader, unsealed 

radioiodine therapy, permanent or temporary implant brachytherapy, medical-diagnostic, 

portable gauges, and industrial radiography. Appendix D lists the inspection casework files 

reviewed, as well as the results of the inspector accompaniments. 
North Dakota Final IMPEP Report Page 7 

Based on the evaluation of casework, the review team noted that inspections covered all 

aspects of the licensee’s radiation safety programs. The review team found that inspection 

reports were thorough, complete, and consistent, with sufficient documentation to ensure that a 

licensee’s performance with respect to health and safety was acceptable. The documentation 

supported violations, recommendations made to licensees, unresolved safety issues, the 

effectiveness of corrective actions taken to resolve previous violations and discussions held with 

licensees during exit interviews. 

The inspection procedures utilized by the Program are consistent with the inspection guidance 

outlined in IMC 2800. An inspection report is completed by the inspector which is then reviewed 

and signed by the accompanying inspector and the Radiation Control Program Manager. Per 

the North Dakota Radiation Control Program Administrative Policies and Procedures Manual 

issued April 15, 2013, supervisory accompaniments by the Radiation Control Program Manager 

or the Division Director are required for 10 percent of all inspections. Of the 28 inspections 

identified in the IMPEP questionnaire, the Radiation Control Program Manager accompanied 

the inspection team on four of those inspections (14 percent). The Radiation Control Program 

Manager also accompanied the inspection team on two of the seven reciprocity inspections 

conducted of the available candidates during the evaluation period (28 percent). 

The review team determined that the inspection findings were appropriate and prompt regulatory 

actions were taken, as necessary. Inspection findings were clearly stated and documented in 

the reports and sent to the licensees with the appropriate letter detailing the results of the 

inspection. The Program issues to the licensee, either a letter indicating a clear inspection or a 

Letter of Apparent Non-Compliance (LOAN), in letter format, which details the results of the 

inspection. When the Program issues a LOAN, the licensee is required to provide a written 

corrective action plan, based on the apparent non-compliances cited, within 30 days. All findings 

are reviewed by the Radiation Control Program Manager. 

The review team noted that the Program has an adequate supply of survey instruments to 

support its inspection program. Appropriate, calibrated survey instrumentation, such as GeigerMueller meters, scintillation detectors, ion chambers, micro-R meters, and neutron detectors, 

was observed to be available. Instruments are appropriately calibrated at least annually. 

Accompaniments of both program inspectors were conducted by one IMPEP team member during 

the week of March 19-22, 2013. The inspectors were accompanied during health and safety 

inspections of medical therapy including high dose rate remote afterloader/unsealed radioiodine 

therapy/permanent implant brachytherapy, medical diagnostic licenses, fixed and portable 

gauges. The accompaniments are identified in Appendix D. During the accompaniments, the 

inspectors demonstrated appropriate inspection techniques, knowledge of the regulations, and 

conducted performance-based inspections. The inspectors were trained, well-prepared for the 

inspection, and thorough in their audits of the licensees’ radiation safety programs. The 

inspectors conducted interviews with appropriate personnel, observed licensed operations, 

conducted confirmatory measurements, and utilized good health physics practices. The 

inspections were adequate to assess radiological health and safety and security at the licensed 

facilities. 

One weakness noted in the Program was that none of the technical staff are fully qualified to 

inspect all radioactive material program areas licensed by the State. This is partly due to the 
North Dakota Final IMPEP Report Page 8 

small number of staff and the significant staff turnover in years prior to this IMPEP followup 

review. This is also due to a relatively small number of licensees in the State which leads to 

fewer opportunities to gain experience in certain areas. For example, there are only two broad 

scope licensees and one cyclotron licensed in North Dakota. Therefore, it has been difficult for 

technical staff to gain inspection experience in these areas. Another area is well-logging which 

has recently become a potential area of growth in both numbers of licensees and reciprocity 

applicants due to the oil and gas industry boom. The review team recommends that the State 

develop and implement a plan to ensure that inspectors become qualified to conduct 

inspections in all radioactive material program areas licensed by the State. 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that North Dakota’s performance with respect to the indicator, Technical Quality of Inspections, be 

found satisfactory, but needs improvement. 

3.3 Technical Quality of Licensing Actions

The review team examined completed licensing casework and interviewed license reviewers for 

11 specific licensing actions. Licensing actions were reviewed for completeness, consistency, 

proper radioisotopes and quantities, qualifications of authorized users, adequacy of facilities and 

equipment, adherence to good health physics practices, financial assurance, operating and 

emergency procedures, appropriateness of license conditions, and overall technical quality. 

The casework was also reviewed for timeliness, use of appropriate deficiency letters and cover 

letters, reference to appropriate regulations, supporting documentation, consideration of 

enforcement history, pre-licensing visits, peer/supervisory review, and proper signatures. 

The licensing casework was selected to provide a representative sample of licensing actions 

completed during the review period. Licensing actions selected for evaluation included seven 

amendments, three new licenses, and one termination. Files reviewed included a cross-section 

of license types, including medical diagnostic and therapy including high dose rate remote 

afterloader, unsealed radioiodine therapy, industrial radiography, and portable and fixed 

gauges. The casework sample represented work from two license reviewers. A listing of the 

licensing casework evaluated is provided in Appendix E. 

Overall, the review team found that the licensing actions were thorough, complete, consistent, 

and of high quality with health, safety, and security issues properly addressed. License 

tie-down conditions were stated clearly and were supported by information contained in the file. 

Deficiency letters clearly stated regulatory positions, were used at the proper time, and identified 

substantive deficiencies in the licensees’ documents. Terminated licensing actions were well 

documented, showing appropriate transfer and survey records. License reviewers use the NRC 

NUREG-1556 series guidance documents or equivalent, policies, checklists, and standard 

license conditions specific to the type of licensing actions to ensure consistency in licenses. 

The Program Director performs a supervisory review on all licensing actions before issuance to 

the licensee. Licenses are issued for a 10 year period under a timely renewal system. 

Based on the casework evaluated, the review team concluded that the licensing actions were of 

high quality and consistent with the Program licensing procedures, the State’s regulations, and 
North Dakota Final IMPEP Report Page 9 

good health physics practices. The review team attributed the consistent use of templates and 

quality assurance reviews to the overall quality noted in the casework reviews. 

The Program performs pre-licensing checks of all new applicants. The Program’s pre-licensing 

review methods incorporate the essential elements of the NRC’s revised pre-licensing guidance 

to verify that the applicant will use requested radioactive materials as intended. All new 

licensees receive a pre-licensing site visit which includes an evaluation of the applicant’s 

radiation safety and security programs prior to receipt of the initial license. 

The review team examined the Program’s licensing practices regarding the Increased Controls 

and Fingerprinting Orders. The review team noted that the State uses legally binding license 

conditions that meet the criteria for implementing the Increased Controls Orders, including 

fingerprinting, as appropriate. The review team analyzed the Program’s methodology for 

identifying those licenses and found the rationale was thorough and accurate. The review team 

confirmed that license reviewers evaluated new license applications and license amendments 

using the same criteria. The Program requires full implementation of the Increased Controls 

prior to issuance of a new license or license amendment that meets the established criteria. 

The review team examined the Program’s procedure for the control of sensitive information. This 

procedure addresses the identification, marking, control, handling, preparation, transportation, 

transmission, and destruction of documents that contain sensitive information related to the 

Increased Controls. The review team noted that the Program maintains adequate controls to 

access its licensing and inspection files. Files that contained sensitive information were further 

secured in locked file cabinets. 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that North Dakota’s performance with respect to the indicator, Technical Quality of Licensing 

Actions, be found satisfactory. 

3.4 Technical Quality of Incident and Allegation Activities

In evaluating the effectiveness of the Program’s actions in responding to incidents and 

allegations, the review team examined the Program’s response to the questionnaire relative to 

this indicator, evaluated selected incidents reported for North Dakota in the Nuclear Material 

Events Database (NMED) against those contained in the Program’s files, and evaluated the 

casework for two radioactive materials incidents. A list of the incident casework examined may 

be found in Appendix E. The review team also evaluated the Program’s response to three 

allegations involving radioactive materials, including one allegation referred to the State by the 

NRC during the review period. 

The review team identified two radioactive material incidents in NMED for North Dakota during 

the review period. The review team reviewed both radioactive material incidents. The incidents 

involved an equipment failure that led to an inability to retract a radiography source, and a 

procedural failure that led to a radiography source disconnect. 

The review team determined that the Program’s response to incidents was complete and 

comprehensive. Initial responses were prompt and well-coordinated, and the level of effort was 

commensurate with the health and safety significance. Followup actions were taken and 
North Dakota Final IMPEP Report Page 10 

additional review of each event was made during the next inspections. If the incident met the 

reportability thresholds, as established in the Office of Federal and State Materials and 

Environmental Management Programs (FSME) Procedure SA-300 “Reporting Material Events,” 

the State notified the NRC Headquarters Operations Center and entered the information into 

NMED, in a prompt manner. As a policy, the State reports all incidents in NMED regardless of 

reportability. 

The review team examined the Program’s implementation of its incident and allegation processes, 

including written procedures for handling allegations and incident response, file documentation, 

notification of incidents to the NRC Headquarters Operations Center, and the use of NMED 

software. When notification of an incident or an allegation is received, the Program Manager, with 

staff input, determines the appropriate level of initial response. 

In evaluating the effectiveness of the Program’s response to allegations, the review team 

evaluated the completed casework for three allegations, including one that NRC referred to the 

State during the review period. The review team concluded that the Program took prompt and 

appropriate actions in response to concerns raised. The review team noted that the Program 

documented the investigations of concerns and retained all necessary documentation to 

appropriately close the allegations. When possible, the Program notified the concerned 

individuals of the conclusion of their investigations. The review team determined that the 

Program adequately protected the identity of concerned individuals. 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that North Dakota’s performance with respect to the indicator, Technical Quality of Incident and 

Allegation Activities, be found satisfactory. 

4.0 NON-COMMON PERFORMANCE INDICATORS 

Four non-common performance indicators are used to review Agreement State Programs: 

(1) Compatibility Requirements, (2) Sealed Source and Device Evaluation Program, (3) Low-Level 

Radioactive Waste Disposal Program, and (4) Uranium Recovery Program. The NRC’s 

Agreement with North Dakota does not relinquish regulatory authority for a sealed source and 

device evaluation, low level radioactive waste disposal, or uranium recovery program. Therefore, 

only the first non-common performance indicator for compatibility would apply. The indicator, 

Compatibility Requirements, was found satisfactory in the 2011 IMPEP and therefore, not 

reviewed in this followup IMPEP. Compatibility Requirements was discussed under the Periodic 

meeting held concurrently (Appendix B). 

5.0 SUMMARY 

As noted in Sections 3.0 and 4.0 above, North Dakota’s performance was found satisfactory for 

the indicators Status of Materials Inspection Program, Technical Quality of Licensing Actions, 

and Technical Quality of Incidents and Allegations, and satisfactory, but needs improvement for 

the indicator, Technical Quality of Inspections. The review team made one recommendation 

regarding qualification of staffing and kept one recommendation open from the 2011 IMPEP 

review. The review team determined the 10 other recommendations from the 2011 IMPEP 

review should be closed. 
North Dakota Final IMPEP Report Page 11 

The review team recommended, and the MRB agreed, that the North Dakota Agreement State 

Program is adequate to protect public health and safety, but needs improvement, and is 

compatible with the NRC's program. The review team recommended, and the MRB agreed, 

that the period of Heightened Oversight of the North Dakota Agreement State Program be 

discontinued and that a period of Monitoring be initiated to allow additional time for the Program 

to demonstrate a period of sustained performance, especially with the impending vacancy of the 

Program Manager position. The review team recommended, and the MRB agreed, that a 

Periodic Meeting be held in approximately one year and the next IMPEP review take place in 

approximately two years. 

Below are the review team’s recommendations, as mentioned in the report, for evaluation and 

implementation by the State: 

RECOMMENDATIONS 

1. The review team recommends that the State (1) update its existing procedures and develop 

new procedures as necessary, to memorialize the policies and practices of the Agreement 

State program, to serve as a knowledge management tool, and (2) examine options to 

increase staff retention and/or develop sufficient depth in staffing to effectively implement 

the program. (Section 2.1 of 2011 IMPEP Report) 

2. The review team recommends that the State develop and implement a plan to ensure that 

inspectors become qualified to conduct inspections in all radioactive material program 

areas licensed by the State. (Section 3.2)
LIST OF APPENDICES 

Appendix A IMPEP Review Team Members 

Appendix B Periodic Meeting Summary 

Appendix C Heightened Oversight Correspondence and Summaries 

Appendix D Inspection Casework Reviews 

Appendix E License Casework Reviews 

Appendix F Incident Casework Reviews 
APPENDIX A 

IMPEP REVIEW TEAM MEMBERS 

Name Area of Responsibility

Bryan Parker, Region III Team Leader 

 Technical Quality of Incident and Allegation 

 Activities 

 Status of Materials Inspection Program 

 Inspection Accompaniments 

Randy Erickson, Region IV Technical Quality of Inspections 

 Compatibility Requirements 

 Technical Staffing and Training 

 

Stephen Matthews, State of Washington Technical Quality of Licensing Actions 

Marti Poston-Brown, Region IV, supported the team with the review of Status of Materials 

Inspection Program and Technical Quality of Inspections 
APPENDIX B 

PERIODIC MEETING SUMMARY 

A Periodic Meeting was held with the Program Manager by Randy Erickson, Team Member and 

Regional State Agreements Officer, during the followup IMPEP review pursuant to the Office of 

Federal and State Materials and Environmental Management Programs (FSME) Procedure 

SA-116, “Periodic Meetings between IMPEP Reviews.” Topics normally documented during 

Periodic Meetings that were reviewed and documented as part of the followup IMPEP review 

are not discussed in this Appendix. The following topics were discussed: 

Status of Recommendations from Previous IMPEP Reviews 

See Section 2.0 for details on the status of recommendations identified during the previous 

IMPEP review. 

Program Strengths 

During the last IMPEP review period there were significant turnovers within the Radiation Control 

Program, which impacted the program and contributed to the number of recommendations 

identified by the IMPEP review team. Since the last IMPEP review, there has been stability in the 

staffing of the Radiation Control Program. The two technical staff members have completed most 

of the required training courses and some of the specialized training courses necessary to support 

the program. The Program Manager indicated that the staff has gained significant confidence in 

implementing program requirements. The Program Manager indicated that as the staff gains 

more experience and confidence it will only further enhance the program. The Program Manager 

stated that another major strength of the program is that they are well funded and that resources 

are sufficient to support the program. 

Program Weaknesses

The Radiation Control Program went through a cycle of significant turnover during the last 

IMPEP review period. The Radiation Control Program is fully staffed with two technical staff 

members and one supervisor to support a growing radiation control program. The Program 

Manager indicated that minimum staffing levels could potentially be a weakness in the event the 

program experiences any additional turnover. As a result, additional personnel in the Air Quality 

Division are being trained to support the Agreement State Program and provide the additional 

man-power support in areas such as medical inspections. 

Feedback on NRC’s Program 

The Program indicated that the IMPEP process was a very beneficial program and the review 

team provided good recommendations that focused the Radiation Control Program on areas 

that needed improvement. The IMPEP process guided the Radiation Control Program to 

develop policies and procedures to promote knowledge management transfer and minimize the 

impacts from any future, potential turnover in personnel. 
North Dakota Final IMPEP Report Page B.2 

Periodic Meeting Summary 

The Program also stated that they have had little trouble getting into NRC courses and that they 

appreciate NRC paying for their attendance at the training courses. 

Staffing and Training 

It was noted during the 2011 IMPEP review that several staff had left the Program for various 

reasons causing the Program to fall behind in many program areas. However, since that time 

the staff has remained stable. At the present time the Program is composed of a working 

supervisor and two technical staff members. The Program Manager and one of the technical 

staff members are considered qualified to perform most inspection types, and the second staff 

member is considered qualified to only perform fixed and portable gauge inspections at the 

present time. Additionally, staff from the X-ray program are being sent to NRC training courses 

as a means to develop depth in staffing to support the Radiation Control Program primarily with 

medical inspections of small facilities. 

Training and qualification requirements are found in the Administrative Procedures Manual. 

Training and documentation of inspector activities (observation of and participation in inspections) 

is recorded on a Training Regimen Checklist which is consistent with the requirements in the 

NRC/Organization of Agreement States Training Working Group Report and NRC’s Inspection 

Manual Chapter (IMC) 1246, “Formal Qualification Programs in the Nuclear Material Safety and 

Safeguards Program Area.” 

During the review, the Program Manager discussed with the review team the qualification 

process used in North Dakota. The Program Manager self-identified that he was not formally 

signed-off to perform inspections. Over the previous six years he attended NRC training 

courses, supported multiple inspection accompaniments with both NRC and Minnesota 

inspectors, and had performed inspections in the presence of Minnesota inspectors, but he did 

not receive any type of formal sign-off confirming he had the skills necessary to perform an 

inspection independently. In addition, he has been training the current inspection staff and 

confirming they had the skills necessary to perform certain inspections. 

The team discussed this situation with the Program Manager and then with North Dakota senior 

management. Collectively, it was determined that the Program Manager will document his 

classroom training in addition to his work history on the Training Regimen Checklist after which 

time the Division Director would sign off formally qualifying the Program Manager. Once this is 

completed, then the Program Manager can continue to qualify the staff. 

Program Reorganizations 

There has not been a program reorganization since the IMPEP review. 

Changes in Program Budget/Funding 

The Program has not been impacted by the recession or a reduction in revenue as a number of 

other state economies have experienced. The state is poised to continue to successfully meet 

their budget obligations based on the strong state economy as a result of the oil and gas 

industry and fiscally conservative agenda in the state programs. The Program evaluated their 
North Dakota Final IMPEP Report Page B.3 

Periodic Meeting Summary 

fee structure and set up a six-year program which automatically increased fees by fourteen 

percent annually. After the sixth year, the fee structure will be adjusted automatically based on 

the Consumer Price Index (CPI). When this fee increase is completed in 2016, the Program will 

be at 54.62 percent of 2011 NRC fees. They also have a small entity fee that will remain at 

60 percent of normal fee amounts. 

 

Status of the Materials Inspection Program 

See Sections 3.2 and 3.3 for details on the Materials Inspection Program. 

Materials Licensing Program 

See Section 3.4 for details on the Licensing Program. 

Regulations and Legislative Changes 

The Program has not had any legislation passed that affected the program. The following 

amendments will need to be addressed by the Radiation Control Program in future rulemakings 

or by adopting alternate generic legally binding requirements: 

• “Decommissioning Planning,” 10 CFR Parts 20, 30, 40, and 70 amendment (76 FR 35512) that 

is due for Agreement State adoption by December 17, 2015 

• "Licenses, Certifications, and Approvals for Materials Licensees," 10 CFR Parts 30, 36, 40, 70, 

and 150 (76 FR 56951) that is due for Agreement State adoption by November 14, 2014 

Response to Incidents and Allegations 

See Section 3.4 for details on the Incident and Allegations Program. 

Status of Allegations and Concerns Referred by the NRC for Action 

See Section 3.4 for details on the Incident and Allegations Program. 

Emerging Technologies 

None Reported 

Large, Complicated, or Unusual Authorizations for use of Radioactive Materials 

None Reported 

Current State Initiatives 

None Reported 
North Dakota Final IMPEP Report Page B.4 

Periodic Meeting Summary 

State’s Mechanisms to Evaluate Performance 

The Radiation Control Program uses management review of inspection reports and licensing 

actions to ensure the quality of regulatory products. The Radiation Control Program holds a 

meeting every two weeks to track metrics and ensure communications are sufficient for any 

large or complicated actions. The Radiation Control Program Supervisor performs 

accompaniments of the technical staff members during inspections. 

Current NRC Initiatives 

NRC staff discussed ongoing Office of Federal and State Materials and Environmental 

Management Programs (FSME) initiatives with the North Dakota representatives. This included 

a review of strategic FSME and RCPD letters, as well as proposed rulemaking and Regulatory 

Issues Summaries.
APPENDIX C 

HEIGHTENED OVERSIGHT PROGRAM CORRESPONDENCE 

Summaries of Quarterly Conference Calls: 

 

1. November 17, 2011 Summary (ML120900390) 

2. June 6, 2012 Summary (ML12192A689) 

3. September 13, 2012 Summary (ML12261A082) 

4. December 6, 2012 Summary (ML12348A065) 

5. February 5, 2013 Summary (ML13039A277) 

Letters from/to North Dakota: 

1. August 17, 2011 E-mail Letter to R. Browder, RASO, RIV from D. Harman – Submittal of 

Program Improvement Plan (ML112341233) 

 

2. October 3, 2011 Letter to T. O’Clair from J. Luehman, FSME – NRC Acceptance of 

Program Improvement Plan (ML112720330) 

3. April 6, 2012 Letter to T. O’Clair from R. Browder, RASO, RIV – Summary of Periodic 

Meeting Held on March 8, 2012 (ML12097A460) 
 

 APPENDIX D 

INSPECTION CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

Licensee: American Sugar Crystal Co – Hillsboro License No.: 33-05208-01 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 03/22/13 Inspectors: LV (lead) and DS 

File No.: 2 

Licensee: Sanford Medical Center License No.: 33-10227-02 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 03/20/13 Inspectors: DS (lead) and LV 

File No.: 3 

Licensee: Jamestown Regional Medical Center License No.: 33-05026-01 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 03/21/13 Inspectors: DS (lead) and LV 

File No.: 4 

Licensee: Bismarck Cancer Center License No.: 33-41919-01 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 04/02/12 Inspectors: DS (lead) and LV 

File No.: 5 

Licensee: Schlumberger License No.: 33-00090-01 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 02/02/13 Inspectors: DS (lead) and LV 

File No.: 6 

Licensee: St. Alexis Medical Center License No.: 33-11320-01 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 05/16-17 & 22/12 Inspectors: DS (lead) and LV 

File No.: 7 

Licensee: Team Industrial License No.: 33-48313-01 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 10/16 & 11/02/12 Inspectors: DS (lead) and LV 

File No.: 8 

Licensee: Steele Testing, Inc. License No.: 33-49619-01 

Inspection Type: Initial, Announced Priority: 1 

Inspection Date: 10/05/12 Inspectors: LV (lead) and DS 
North Dakota Final IMPEP Report Page D.2 

Inspection Casework Reviews 

File No.: 9 

Licensee: T&K Inspection, Inc. License No.: 33-22313-01 

Inspection Type: Routine, Announced Priority: 1 

Inspection Date: 04/28/11 Inspectors: DS (lead) and LV 

File No.: 10 

Licensee: Northern Technologies Inc. License No.: 33-32112-01 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 03/19/13 Inspectors: LV (lead) and DS 

INSPECTOR ACCOMPANIMENTS 

The following inspector accompaniments were performed prior to the on-site IMPEP review: 

Accompaniment No.: 1 

Licensee: Northern Technologies, Inc. License No.: 33-32112-01 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 03/19/13 Inspectors: LV (lead) and DS 

Accompaniment No.: 2 

Licensee: Sanford Medical Center License No.: 33-10227-02 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 03/20/13 Inspectors: DS (lead) and LV 

Accompaniment No.: 3 

Licensee: Jamestown Regional Medical Center License No.: 33-05026-01 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 03/21/13 Inspectors: DS (lead) and LV 

Accompaniment No.: 4 

Licensee: American Sugar Crystal Co – Hillsboro License No.: 33-05208-01 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 03/22/13 Inspectors: LV (lead) and DS 
 

APPENDIX E 

LICENSE CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

Licensee: Desert NDT, LLC License No.: 33-51220-01 

Type of Action: Amendment Amendment No.: 2 

Date Issued: 02/26/13 License Reviewer: LV 

File No.: 2 

Licensee: Northern Technologies License No: 33-32112-01 

Type of Action: Amendment Amendment No.: 7 & 8 

Date Issued: 03/28/13 License Reviewer: LV 

File No.: 3 

Licensee: Coca Cola Enterprises License No.: 33-48406-01 

Type of Action: New Amendment No.: N/A 

Date Issued: 04/08/10 License Reviewer: DS 

File No.: 4 

Licensee: Calfrac Well Services License No.: 33-48406-01 

Type of Action: Amendment Amendment No.: 2 

Date Issued: 04/12/12 License Reviewer: DS 

File No.: 5 

Licensee: T & K Inspection License No.: 33-22313-01 

Type of Action: Termination Amendment No.: 21 

Date Issued: 01/16/13 License Reviewer: DH 

File No.: 6 

Licensee: Sanford Medical Center License No.: 33-10227-02 

Type of Action: Amendment Amendment No.: 56 

Date Issued: 05/18/12 License Reviewer: DS 

File No.: 7 

Licensee: Tesoro Refining and Marketing Company License No.: 33-06568-03 

Type of Action: Amendment Amendment No.: 17 

Date Issued: 09/07/12 License Reviewer: DS 

File No.: 8 

Licensee: Bismarck Cancer Center License No.: 33-41919-01 

Type of Action: Amendment Amendment No.: 14 

Date Issued: 04/12/13 License Reviewer: DS 

 
North Dakota Final IMPEP Report E. 2 

License Casework Reviews 

File No.: 9 

Licensee: St. Alexius Medical Center License No.: 33-11320-01 

Type of Action: Amendment Amendment No.: 43 

Date Issued: 06/12/12 License Reviewer: DS 

File No.: 10 

Licensee: Estvold Oilfield Services, Inc. License No.: 33-51120-01 

Type of Action: New Amendment No.: N/A 

Date Issued: 08/27/12 License Reviewer: LV 

File No.: 11 

Licensee: Tops Well Services License No.: 33-51417-01 

Type of Action: New Amendment No.: N/A 

Date Issued: 12/12/12 License Reviewer: LV 
APPENDIX F 

INCIDENT CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

Licensee: Midwest Industrial X-Ray, Inc. License No.: 33-14907-01 

Date of Incident: 05/16/12 NMED No.: 120312 

Investigation Date: 05/18/12 Type of Incident: Equipment failure 

 

Type of Investigation: Office review initially with followup during next inspection performed on 

03/14/13 

File No.: 2 

Licensee: Braun Intertec License No.: 33-48303-01 

Date of Incident: 12/10/12 NMED No.: 120729 

Investigation Date: 12/12/12 Type of Incident: Procedure failure 

 

Type of Investigation: Office review initially with followup during next inspection performed on 

02/14/13
ATTACHMENT 

June 24, 2013 Letter from Terry O’Clair 

North Dakota’s Response to the Draft Report 

ADAMS Accession No.: ML13178A248