UNITED STATES

NUCLEAR REGULATORY COMMISSION 

WASHINGTON, D.C. 20555-0001 

October 20, 2015 

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 September 17, 2015, the Management Review Board (MRB) met to consider the proposed 

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

Agreement State Program. The MRB found the North Dakota program adequate to protect public 

health and safety, and compatible with the U.S. Nuclear Regulatory Commission’s program. 

Section 5.0, page 13, of the enclosed final report contains a summary of the IMPEP team’s 

findings. 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 4 years, with a periodic 

meeting tentatively scheduled for June 2017. 

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 Patricia Holahan Acting 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: Terry L. O’Clair, Director 

 Division of Air Quality 

 

 Dale Patrick, Manager 

 Radiation Control Program 

 Cindy Becker, FL 

 Organization of Agreement States 

 Liaison to the MRB 
October 20, 2015 

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 September 17, 2015, the Management Review Board (MRB) met to consider the proposed 

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

Agreement State Program. The MRB found the North Dakota program adequate to protect public 

health and safety, and compatible with the U.S. Nuclear Regulatory Commission’s program. 

Section 5.0, page 13, of the enclosed final report contains a summary of the IMPEP team’s 

findings. 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 4 years, with a periodic 

meeting tentatively scheduled for June 2017. 

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 Patricia Holahan Acting 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: Terry L. O’Clair, Director 

 Division of Air Quality 

 

 Dale Patrick, Manager 

 Radiation Control Program 

 Cindy Becker, FL 

 Organization of Agreement States 

DISTRIBUTION: SP05 

See next page 

ML15266A068 

OFC MSTR/ASPB MSTR/ASPB RI:TL NMSS/MSTR Tech Ed NMSS EDO 

NAME LDimmick 

(DWhite for) 

CEinberg 

(LDimmick for) 

OMasnyk-Bailey 

via e-mail JPiccone (CEinberg 

for) 

CPoland SMoore for 

CHaney 

MWeber: PH for 

DATE 9/25/15 9/28/15 9/24/15 10/6/15 10/7/15 10/13/15 10/20/15 

OFFICIAL RECORD COPY
Letter to Dr. Dwelle from M. Weber dated: October 20, 2015 

SUBJECT: North Dakota FY2015 FINAL IMPEP REPORT 

DISTRIBUTION: 

RidsEdoMailCenter 

JFoster, OEDO 

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OMasnyk-Bailey, RI 

BTharakan, RIV/RSAO 

RCraffey, RIII 

DShearer, PA 

JPiccone, NMSS 

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LHowell, RIV 

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OAS Board 

JWeil, OCA 
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM 

REVIEW OF THE NORTH DAKOTA AGREEMENT STATE PROGRAM 

June 22 – 25, 2015 

FINAL REPORT
EXECUTIVE SUMMARY 

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

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

during the period of June 22 – 25, 2015, by a review team composed of technical staff members 

from the U.S. Nuclear Regulatory Commission (NRC) and the Commonwealth of Pennsylvania. 

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

six of the indicators reviewed: Technical Staffing and Training, Status of Materials Inspection 

Program, Technical Quality of Inspections, Technical Quality of Licensing, Technical Quality of 

Incident and Allegation Activities, and Compatibility Requirements. 

The review team did not make any recommendations and determined that the two open 

recommendations regarding the staff retention and inspector qualifications should be 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 and is compatible with the NRC's program. The review team recommended, and the 

MRB agreed, that the next IMPEP review take place in approximately 4 years. The review team 

recommended, and MRB agreed, that the period of monitoring be discontinued. 
North Dakota Final IMPEP Report Page 1 

1.0 INTRODUCTION 

This report presents the results of the review of the North Dakota Agreement State 

Program radioactive materials safety program. The review was conducted during the 

period of June 22–25, 2015, by a review team composed of technical staff members 

from the U.S. Nuclear Regulatory Commission (NRC) and the Commonwealth of 

Pennsylvania. Team members are identified in Appendix A. The 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 NRC Management Directive 5.6 (MD 

5.6), “Integrated Materials Performance Evaluation Program (IMPEP),” dated February 

26, 2004. Preliminary results of the review, which covered the period of April 9, 2011, to 

June 25, 2015, for the performance indicators Technical Staffing and Training and 

Technical Quality of Incident and Allegation Activities, and April 27, 2013, until 

June 25, 2015, for the remainder of the indicators, were discussed with North Dakota 

managers on the last day of the review. 

In preparation for the review, a questionnaire addressing the common and applicable 

non-common performance indicators was sent to the North Dakota on February 9, 2015. 

North Dakota provided its response to the questionnaire on June 1, 2015. A copy of the 

questionnaire response can be found in the NRC’s Agencywide Documents Access and 

Management System (ADAMS) using using the Accession Number ML15167A136. 

A draft of this report was issued to North Dakota on July 24, 2015, for factual comment. 

North Dakota responded to the findings and conclusions of the review by electronic mail 

dated September 2, 2015. A copy of North Dakota’s response can be found in ADAMS 

using the Accession Number ML15251A086. The Management Review Board (MRB) 

met on September 17, 2015, to consider the proposed final report. The MRB found the 

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

and compatible with the NRC’s program. 

The North Dakota Agreement State Program (the Program) is administered by the 

Department of Health, Division of Air Quality (the Division), Radiation Control Program. 

Organization charts for North Dakota can be found in ADAMS using the Accession 

Number ML15167A131. 

At the time of the review, the Program regulated 98 specific licenses authorizing 

possession and use of radioactive 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. 

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. 
North Dakota Final IMPEP Report Page 2 

2.0 PREVIOUS IMPEP REVIEW AND STATUS OF RECOMMENDATIONS 

From the 2011 IMPEP review, North Dakota’s performance was found unsatisfactory for 

one performance indicator reviewed; satisfactory, but needs improvement for three 

performance indicators reviewed; and satisfactory for two performance indicators 

reviewed. The 2011 review team made 11 recommendations regarding the performance 

of the North Dakota Agreement State Program. These recommendations included areas 

for improvement to correct identified performance deficiencies and weaknesses in North 

Dakota’s Agreement State Program. The review team recommended that the State (1) 

update its procedures to memorialize the policies and practices of the Agreement State 

program and examine staffing options to effectively implement the program; (2) ensure 

that initial inspections are performed at the prescribed interval; (3) ensure that inspection 

findings are communicated to licensees in a timely manner; (4) ensure that sufficient 

information pertaining to inspections is appropriately documented and that items of noncompliance are appropriately communicated to licensees; (5) obtain additional training to 

enhance inspection skills; (6) ensure that licensing actions are adequately documented 

and consistent with the regulations and licensing guidance; (7) provide additional training 

regarding the technical review of licensing actions and correct deficiencies identified in 

the licensing casework review; (8) take measures to determine and document the basis 

of confidence that radioactive materials will be used as intended and as described in 

applications or amendment requests; (9) take measures to assure that financial 

assurance requirements are properly implemented; (10) take measures to strengthen its 

incident response program; and (11) take measures to strengthen its allegation program. 

In 2011, North Dakota was found adequate, to protect public health and safety, but 

needs improvement, and compatible with the NRC's program. The NRC initiated a 

period of heightened oversight for North Dakota. 

A follow-up IMPEP was conducted in 2013 to review the indicators found less than 

satisfactory in 2011. Based on the results of this follow-up 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. 

In 2013, the review team made one new recommendation regarding the full qualification 

of inspection staff and kept one recommendation open from the 2011 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, were closed in 2013. 
North Dakota Final IMPEP Report Page 3 

In 2013, North Dakota was found adequate to protect public health and safety, but needs 

improvement, and compatible with the NRC's program. The period of heightened 

oversight was discontinued and a period of monitoring was initiated to allow additional 

time for North Dakota to demonstrate a period of sustained performance. 

The final reports for the 2011 and 2013 reviews are available in ADAMS using the 

Accession Numbers ML111780525 and ML13204A355, respectively. The results of the 

2011 and 2013 reviews and the status of the open recommendations from the 2013 

review are as follows: 

Technical Staffing and Training: 

(1) 2011 Satisfactory; (2) 2013, Not evaluated, but discussed during the 2013 and 2014 

periodic meetings 

Open Recommendation: (2011) The review team recommends that the State 

(a) 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 (b) examine options to increase staff retention and/or 

develop sufficient depth in staffing to effectively implement the program. 

Status: (a) North Dakota 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. 

Status: (b) North Dakota elevated the promotion potential of inspector positions from 

Environmental Scientist two positions to Environmental Scientist three positions. The 

plan is to eventually have two Environmental Scientist three positions and three 

Environmental Scientist two positions. This will result in higher salary incentives for the 

newer staff. North Dakota also has the ability to provide “roll-up” dollars, which 

incrementally increases the staff’s pay when another staff person leaves with more 

seniority. North Dakota also increased staffing with the hiring of two additional 

inspectors, with one additional position posted. The two additional new hires and two 

X-ray inspectors have started training to become qualified materials inspectors. 

The review team recommended, and the MRB agreed, that both parts of this 

recommendation be closed. 

Status of Materials Inspection Program: 

(1) 2011 Satisfactory, but needs improvement; (2) 2013 Satisfactory 

 

Recommendation: (2013) None. 

Technical Quality of Inspections: 

(1) 2011 Unsatisfactory; (2) 2013 Satisfactory but needs improvement
North Dakota Final IMPEP Report Page 4 

Open Recommendation: (2013) 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. 

Status: North Dakota has developed and implemented a written training and 

qualification plan to ensure that inspectors become qualified to conduct inspections in all 

radioactive material program areas licensed by the State. One inspector is now fully 

qualified to conduct inspections in all program areas, and all other inspectors are making 

progress towards becoming fully qualified. To make progress in qualifications as quickly 

as the inspection schedule allows, the program sends multiple inspectors out on nearly 

all inspections. 

The review team recommended, and the MRB agreed, that this recommendation be 

closed. 

Technical Quality of Licensing Actions: 

(1) 2011 Satisfactory, but needs improvement; (2) 2013 Satisfactory 

Recommendation: (2013) None 

Technical Quality of Incident and Allegation Activities: (1) 2011 Satisfactory, but needs 

improvement; (2) 2013 Satisfactory 

Recommendation: (2013) None. 

Compatibility Requirements: (1) 2011 Satisfactory; (2) 2013, Not evaluated, but 

discussed during the 2013 and 2014 periodic meetings 

Recommendation: (2013) None 

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. 

3.1 Technical Staffing and Training

The ability to conduct effective licensing and inspection programs is largely dependent 

on having a sufficient number of experienced, knowledgeable, well-trained technical 

personnel. Under certain conditions, staff turnover could have an adverse effect on the 

implementation of these programs, and thus could affect public health and safety. 

Apparent trends in staffing must be explored. Review of staffing also requires a 

consideration and evaluation of the levels of training and qualification. The evaluation 

standard measures the overall quality of training available to, and taken by, materials 

program personnel. 
North Dakota Final IMPEP Report Page 5 

a. Scope

The review team used the guidance in State Agreements procedure SA-103, “Reviewing 

the Common Performance Indicator: Technical Staffing and Training,” and evaluated 

North Dakota’s performance with respect to the following performance indicator 

objectives: 

• A well-conceived and balanced staffing strategy has been implemented throughout 

the review period. 

• Agreement State training and qualification program is equivalent to the NRC 

Inspection Manual Chapter (IMC) 1248, “Formal Qualifications Program for Federal 

and State Material and Environmental Management Programs.” 

• Qualification criteria for new technical staff are established and are being followed or 

that qualification criteria will be established if new staff members are hired. 

• Any vacancies, especially senior-level positions, are filled in a timely manner. 

• There is a balance in staffing of the licensing and inspection programs. 

• Management is committed to training and staff qualification. 

• Individuals performing materials licensing and inspection activities are adequately 

qualified and trained to perform their duties. 

• License reviewers and inspectors are trained and qualified in a reasonable period of 

time. 

b. Discussion

The Program is composed of six staff members which equals five full-time equivalents 

for the radioactive materials program including any vacancies in the Program. Currently, 

there is one vacancy. Since the 2011 IMPEP, the Program’s staffing has increased by 

three positions. North Dakota has a training and qualification manual compatible with 

the NRC’s IMC 1248. During the review period, the radiation control program manager 

retired and was replaced. The previous and current manager’s time in the Program 

overlapped by 1 month which provided continuity in the Program. In addition, one staff 

member left the Program for the private industry, three staff members were hired, and 

one additional position had been posted at the time of the review. 

c. Evaluation

The team determined that during the review period the North Dakota program met the 

performance indicator objectives listed in Section 3.1.a. 

d. Results

Based on the IMPEP evaluation criteria in MD 5.6, the review team recommended, and 

the MRB agreed, that North Dakota’s performance with respect to the indicator, 

Technical Staffing and Training, be found satisfactory. 
North Dakota Final IMPEP Report Page 6 

3.2 Status of the Materials Inspection Program

Periodic inspections of licensed operations are essential to ensure that activities are 

being conducted in compliance with regulatory requirements and consistent with good 

safety practices. The frequency of inspections is specified in IMC 2800, “Materials 

Inspection Program,” and is dependent on the amount and kind of material, the type of 

operation licensed, and the results of previous inspections. There must be a capability 

for maintaining and retrieving statistical data on the status of the inspection program. 

a. Scope

The review team used the guidance in State Agreements procedure SA-101, “Reviewing 

the Common Performance Indicator: Status of the Materials Inspection Program,” and 

evaluated North Dakota’s performance with respect to the following performance 

indicator objectives: Initial inspections and inspections of Priority 1, 2, and 3, licensees 

are performed at the frequency prescribed in IMC 2800. 

• Candidate licensees working under reciprocity are inspected in accordance with the 

criteria prescribed in IMC 1220, “Processing of NRC Form 241, Report of Proposed 

Activities in Non-Agreement States, Areas of Exclusive Federal Jurisdiction, and 

Offshore Waters, and Inspection of Agreement State Licensees Operating Under 

10 CFR 150.20.” 

• Deviations from inspection schedules are normally coordinated between technical 

staff and management. 

• There is a plan to perform any overdue inspections and reschedule any missed or 

deferred inspections; or a basis has been established for not performing any overdue 

inspections or rescheduling any missed or deferred inspections. 

• Inspection findings are communicated to licensees in a timely manner (30 calendar 

days, or 45 days for a team inspection, as specified in IMC 0610, “Nuclear Material 

Safety and Safeguards Inspection Reports”). 

b. Discussion

The Program’s inspection frequency is the same for similar license types in IMC 2800. 

North Dakota performed 64 priority 1, 2, 3, and initial inspections during the review 

period. All inspections were conducted timely. 

Each year of the review period, North Dakota performed greater than 20 percent of 

candidate reciprocity inspections. 

c. Evaluation

The team determined that during the review period North Dakota met the performance 

indicator objectives listed in Section 3.2.a. 
North Dakota Final IMPEP Report Page 7 

d. Results

Based on the IMPEP evaluation criteria in MD 5.6, the review team recommended, and 

the MRB agreed, that North Dakota’s performance with respect to the indicator, Status of 

the Materials Inspection Program, be found satisfactory. 

3.3 Technical Quality of Inspections

Inspections, both routine and reactive, provide assurance that licensee activities are 

carried out in a safe and secure manner. Accompaniments of inspectors performing 

inspections, and the critical evaluation of inspection records are used to assess the 

technical quality of a program’s inspection capability. 

a. Scope

The review team used the guidance in State Agreements procedure SA-102, “Reviewing 

the Common Performance Indicator: Technical Quality of Inspections,” and evaluated 

North Dakota’s performance with respect to the following performance indicator 

objectives: 

• Inspections of licensed activities focus on health, safety, and security. 

• Inspection findings are well-founded and properly documented in reports. 

• Management promptly reviews inspection results. 

• Procedures are in place and used to help identify root causes and poor licensee 

performance. 

• Inspections address previously identified open items and violations. 

• Inspection findings lead to appropriate and prompt regulatory action. 

• Supervisors conduct annual accompaniments of each inspector to assess 

performance and assure consistent application of inspection policies. 

• For programs with separate licensing and inspection staffs, to verify that procedures 

are established and followed to provide feedback information to license reviewers. 

• For Agreement States, to determine if inspection guides are consistent with NRC 

guidance. 

• An adequate supply of calibrated survey instruments is available to support the 

inspection program. 

b. Discussion

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

interviewed inspectors for 20 materials inspections conducted during the review period. 

The team reviewed casework for inspections led by each of the program’s qualified 

inspectors, and covered inspections of medical, industrial, commercial, and academic 

licenses. 
North Dakota Final IMPEP Report Page 8 

A review team member accompanied the program’s two qualified inspectors on 

June 8-11, 2015. The inspector accompaniments are identified in Appendix B. 

The review team also evaluated the performance of supervisory accompaniments of the 

Program’s qualified inspectors. All qualified inspectors were accompanied at least 

annually. 

Within the scope of this indicator, the Program continued a trend of improved 

performance consistent with the 2013 follow-up IMPEP review. The review team found 

that the program’s inspectors were well-prepared, used appropriate and calibrated 

survey instruments effectively, and placed appropriate emphasis on the risk significance 

of observations and findings. All inspections were well documented, reviewed 

thoroughly by management, and resulted in appropriate and prompt regulatory action in 

response to non-compliances. 

c. Evaluation

The team determined that during the review period, North Dakota met the performance 

indicator objectives listed in Section 3.3.a. 

Results

Based on the IMPEP evaluation criteria in MD 5.6, 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. 

3.4 Technical Quality of Licensing Actions

The quality, thoroughness, and timeliness of licensing actions can have a direct bearing 

on public health and safety, and security. An assessment of licensing procedures, 

actual implementation of these procedures, and documentation of communications and 

associated actions between the North Dakota licensing staff and regulated community 

will be a significant indicator of the overall quality of the program. 

a. Scope

The review team used the guidance in State Agreements procedure SA-104, “Reviewing 

the Common Performance Indicator: Technical Quality of Licensing Actions,” and 

evaluated North Dakota’s performance with respect to the following performance 

indicator objectives: 

• Licensing action reviews are thorough, complete, consistent, and of acceptable 

technical quality with health, safety, and security issues properly addressed. 

• Essential elements of license applications have been submitted and elements meet 

current regulatory guidance (e.g. financial assurance, increased controls, 

pre-licensing guidance). 

• License reviewers, if applicable, have the proper signature authority for the cases 

they review independently.
North Dakota Final IMPEP Report Page 9 

• License conditions are stated clearly and are inspectable. 

• Deficiency letters clearly state regulatory positions and are used at the proper time. 

• Reviews of renewal applications demonstrate a thorough analysis of a licensee’s 

inspection and enforcement history. 

• Applicable guidance documents are available to reviewers and are followed (e.g., 

NUREG-1556 series, pre-licensing guidance, regulatory guides, etc.). 

• Licensing practices for risk significant radioactive materials are appropriately 

implemented including increased controls and fingerprinting orders (Part 37 

equivalent). 

• Documents containing sensitive security information are properly marked, handled, 

controlled and secured. 

b. Discussion

During the review period, North Dakota completed 309 radioactive materials licensing 

actions. The review team evaluated 17 radioactive materials licensing actions. The 

licensing actions selected for review included four new applications, nine amendments, 

one renewal, and three terminations. The review team evaluated casework which 

included the following license types and actions e.g., broad scope, medical diagnostic 

and therapy, accelerator, commercial manufacturing and distribution, industrial 

radiography, research and development, academic, nuclear pharmacy, gauges, 

panoramic and self-shielded irradiators, well-logging, service providers, waste brokers, 

financial assurance, and bankruptcies. The casework sample represented work from 

five license reviewers. 

c. Evaluation

The team determined that during the review period, North Dakota met the performance 

indicator objectives listed in Section 3.4.a. 

d. Results

Based on the IMPEP evaluation criteria in MD 5.6, 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. 

3.5 Technical Quality of Incident and Allegation Activities

The quality, thoroughness, and timeliness of response to incidents and allegations of 

safety concerns can have a direct bearing on public health and safety. An assessment 

of incident response and allegation investigation procedures, actual implementation of 

these procedures, internal and external coordination, and investigative and follow-up 

procedures and actions will be a significant indicator of the overall quality of the 

program.
North Dakota Final IMPEP Report Page 10 

a. Scope

The review team used the guidance in State Agreements procedure SA-105, “Reviewing 

the Common Performance Indicator: Technical Quality of Incident and Allegation 

Activities,” and evaluated North Dakota’s performance with respect to the following 

performance indicator objectives: 

• Incident response, investigation, and allegation procedures are in place and 

followed. 

• Response actions are appropriate, well-coordinated, and timely. 

• On-site responses are performed when incidents have potential health, safety or 

security significance. 

• Appropriate follow-up actions are taken to ensure prompt compliance by licensees. 

• Follow-up inspections are scheduled and completed, as necessary. 

• Notifications are made to the NRC Headquarters Operations Center for incidents 

requiring a 24-hour or immediate notification to the Agreement State or NRC. 

• Incidents are reported to the Nuclear Material Events Database. 

• Allegations are investigated in a prompt, appropriate manner. 

• Concerned individuals are notified of investigation conclusions. 

• Concerned individuals’ identities are protected, as allowed by law. 

b. Discussion

During the review period, seven radioactive materials incidents were reported to North 

Dakota. The review team evaluated all seven incidents, which included two damaged 

fixed and portable gauges, four defective radiography devices, and one abandoned well 

logging source. 

During the review period, nine allegations were received by North Dakota. The review 

team evaluated all nine allegations, including four allegations that the NRC referred to 

the State. 

c. Evaluation

The team determined that during the review period, North Dakota met the performance 

indicator objectives listed in Section 3.5.a. 

d. Results

Based on the IMPEP evaluation criteria in MD 5.6, 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 
North Dakota Final IMPEP Report Page 11 

Program, (3) Low-Level Radioactive Waste (LLRW) 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 Program or a Uranium 

Recovery Program. Additionally, in 1981, the NRC amended its Policy Statement, 

“Criteria for Guidance of States and NRC in Discontinuance of NRC Authority and 

Assumption thereof by States through Agreement,” to allow a State to seek an 

amendment for the regulation of LLRW as a separate category. Those States with 

existing Agreements prior to 1981 were determined to have continued LLRW disposal 

authority without the need for an amendment. 

Although North Dakota has such authority to regulate a LLRW disposal facility, the NRC 

has not required States to have a program for licensing a disposal facility until such time 

as the State has been designated as a host State for a LLRW disposal facility. When an 

Agreement State has been notified or becomes aware of the need to regulate a LLRW 

disposal facility, it is expected to put in place a regulatory program that will meet the 

criteria for an adequate and compatible LLRW program. Currently, there are no plans 

for a commercial LLRW disposal facility in North Dakota, so only the first non-common 

performance indicator applied to this review. 

4.1 Compatibility Requirements

State statutes should authorize the State to establish a program for the regulation of 

agreement material and provide authority for the assumption of regulatory responsibility 

under the agreement. The statutes must authorize the State to promulgate regulatory 

requirements necessary to provide reasonable assurance of protection of public health, 

safety, and security. The State must be authorized through its legal authority to license, 

inspect, and enforce legally binding requirements, such as regulations and licenses. 

NRC regulations that should be adopted by an Agreement State for purposes of 

compatibility or health and safety should be adopted in a time frame so that the effective 

date of the State requirement is not later than 3 years after the effective date of NRC's 

final rule. Other program elements, as defined in Appendix A of State Agreements 

procedure SA-200, “Compatibility Categories and Health and Safety Identification for 

NRC Regulations and Other Program Elements,” that have been designated as 

necessary for maintenance of an adequate and compatible program should be adopted 

and implemented by an Agreement State within 6 months following NRC designation. 

a. Scope

The review team used the guidance in State Agreements procedure SA-107, “Reviewing 

the Non-Common Performance Indicator: Compatibility Requirements,” and evaluated 

North Dakota’s performance with respect to the following performance indicator 

objectives. A complete list of regulation amendments can be found on the NRC Web 

site at the following address: https://scp.nrc.gov/rss_regamendents.html. 

• The Agreement State program does not create conflicts, duplications, gaps, or other 

conditions that jeopardize an orderly pattern in the regulation of radioactive materials 

under the Atomic Energy Act, as amended. 

• Regulations adopted by the Agreement State for purposes of compatibility or health 
North Dakota Final IMPEP Report Page 12 

and safety were adopted no later than 3 years after the effective date of the NRC 

regulation. 

• Other program elements, as defined in SA-200 that have been designated as 

necessary for maintenance of an adequate and compatible program have been 

adopted and implemented within 6 months of NRC designation. 

• The State statutes authorize the State to establish a program for the regulation of 

agreement material and provide authority for the assumption of regulatory 

responsibility under the agreement. 

• The State is authorized through its legal authority to license, inspect, and enforce 

legally binding requirements such as regulations and licenses. 

• Impact of sunset requirements, if any, on the State’s regulations. 

b. Discussion

North Dakota became an Agreement State on September 1, 1969. The North Dakota 

Agreement State Program‘s current effective statutory authority is contained in North 

Dakota Century Code Chapter 23-20. The North Dakota Century Code designates that 

the radiation control program is administered by the North Dakota Department of Health. 

The North Dakota Century Code is sufficiently broad to provide authority for the 

regulation of source, byproduct, special nuclear material, and other radioactive 

materials. No legislation affecting the Program was passed during the review period. 

The State’s administrative rulemaking process takes approximately 6 months from 

drafting to finalizing a rule. The public, the NRC, other agencies, and potentially 

impacted licensees and registrants are offered an opportunity to comment during the 

process. Comments are considered and incorporated, as appropriate, before the 

regulations are finalized and approved by the Legislative Rules Committee. The review 

team noted that the State’s rules and regulations are not subject to “sunset” laws. 

At the time of this review, the following two amendments were overdue: 

• “Licenses, Certifications, and Approvals for Materials Licensees,” Parts 30, 36, 39, 

40, 70, and 150 (77 FR 56951), which was due for adoption by November 14, 2014. 

• “Change of Compatibility of 10 CFR 31.5 and 31.6 in the Withdrawal of Proposed 

Rule and Closure of Petition For Rulemaking” (77 FR 3640), which was due for 

adoption by January 25, 2015. 

At the time of the IMPEP review, North Dakota was in the process of addressing three 

NRC comments to the final regulations adopted for the “Requirements for Expanded 

Definition of Byproduct Material” Parts 20, 30, 31, 32, 33, 35, 61, 150 (72 FR 55864). 

Prior to the review period, in January 2011, North Dakota finalized regulations for 

10 CFR Part 36, “Licensing and Radiation Safety Requirements for Irradiators,” without 

submitting the final regulations to NRC for a compatibility review. Although North Dakota 

adopted the regulations, the Program has not had an application for a license that would 

be subject to 10 CFR Part 36 requirements.
North Dakota Final IMPEP Report Page 13 

North Dakota management committed to submitting a package addressing all of the 

above comments and amendments to the NRC for review prior to the Management 

Review Board meeting. Prior to the MRB, North Dakota did, in fact, follow through on 

this commitment and submited the regulations to the NRC for review on September 10, 

2015. 

c. Evaluation

The team determined that during the review period North Dakota met the performance 

indicator objectives listed in Section 3.4.1.a. 

d. Results

Based on the IMPEP evaluation criteria in MD 5.6, the review team recommended, and 

the MRB agreed, that North Dakota’s performance with respect to the indicator, 

Compatibility Requirements, be found satisfactory. 

5.0 SUMMARY 

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

satisfactory for all six performance indicators reviewed. The review team did not make 

any new recommendations regarding program performance by the State and determined 

that two recommendations from the 2011 and 2013 IMPEP reviews should be closed. 

Accordingly, the review team recommended, and the MRB agreed, that the 

North Dakota Agreement State Program be found adequate to protect public health and 

safety and compatible with the NRC's program. Based on the results of the current 

IMPEP review, the review team recommended, and the MRB agreed, that the period of 

monitoring be discontinued and that the next full IMPEP review take place in 

approximately 4 years. 
LIST OF APPENDICES 

Appendix A IMPEP Review Team Members 

Appendix B Inspection Accompaniments 
APPENDIX A 

IMPEP REVIEW TEAM MEMBERS 

Name Area of Responsibility

Orysia Masnyk Bailey Team Lead 

Region I Technical Staffing and Training 

 Technical Quality of Incidents and Allegations 

Ryan Craffey Technical Quality of Inspections 

Region III Inspector Accompaniments 

Dwight Shearer Technical Quality of Licensing Actions 

Commonwealth of Pennsylvania 

Binesh Tharakan Status of Materials Inspection Program 

Region IV Compatibility Requirements 
 

APPENDIX B 

INSPECTION ACCOMPANIMENTS 

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

Accompaniment No.: 1 License No.: 33-52122-01

License Type: Industrial Radiography – Temporary Job Sites Priority: 1 

Inspection Date: 06/08/2015 Inspector: KD 

Accompaniment No.: 2 License No.: 33-32706-01 

License Type: Measuring Systems – Portable Gauges Priority: 5 

Inspection Date: 06/09/2015 Inspector: KD 

Accompaniment No.: 3 License No.: 33-43520-01 

License Type: Medical Institution – Written Directive 

Required, including High Dose Rate Remote Afterloader 

Priority: 2 

Inspection Date: 06/10/2015 Inspector: DS 

Accompaniment No.: 4 License No.: 33-48922-01 

License Type: Radionuclide Production Using an Accelerator Priority: 2 

Inspection Date: 06/11/2015 Inspector: DS