August 1, 2007

Terry Dwelle, M.D.

State Health Officer

North Dakota Department of Health

State Capitol

600 East Boulevard Avenue

Bismarck, ND 58505-0200

Dear Dr. Dwelle:

On June 25, 2007, 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 Agreement State Program

adequate to protect public health and safety and compatible with the U.S. Nuclear Regulatory

Commission’s (NRC) program.

As noted in the enclosed final IMPEP report and as discussed during the MRB meeting, the

North Dakota Radiation and Indoor Air Branch (the Branch) completed a number of overdue

inspections during the review period. The root causes of overdue inspections are the loss of an

experienced inspector and the subsequent training of a new inspector. Experience from IMPEP

reviews of other Agreement State programs demonstrates that the loss of key personnel,

especially in smaller programs, can have a detrimental effect on a program. However, North

Dakota was able to fill the vacancy in an expedient manner and minimize the impact to the

Branch. The MRB commended the Branch for its efforts to maintain stability during the

transition between inspectors. The MRB also voiced concerns about the continued stability of

the Branch, given its small size.

Since the time of the review, the MRB was notified of the departure of the Branch Manager. 

The Branch Manager position is currently the only vacancy in the Branch, but it is a very critical

vacancy. The former Branch Manager was instrumental in balancing the Branch’s workload

after the departure of the experienced inspector to minimize the overall impact to the Branch. 

Any further attrition, especially while the Branch Manager position remains vacant, could be

detrimental to overall performance by the Branch. The MRB concerns are lessened knowing

that the State is already undertaking efforts to fill the Branch Manager position and has a

contingency plan in place in the interim.

The Branch’s actions in other areas of the Agreement State program were noted by the MRB. 

The State should take pride in the high level of technical quality of inspections, licensing

actions, and response to incidents and allegations exhibited by the Branch during the review

period. The Branch was able to maintain this level of technical quality even during the staff

transition period. A high level of technical quality, especially in the area of response to

incidents involving radioactive material, can instill a high level of public confidence in an

Agreement State program.
T. Dwelle, M.D. -2-

To maintain a high level of technical competency, it is imperative to recruit and retain an

adequate number of qualified and motivated individuals. In the NRC’s experience of reviewing 

Agreement State programs, the ability to recruit qualified applicants and maintain a stable

staffing level can be inhibited by low salaries and/or limited potential for career growth.

Section 5.0, page 10, of the enclosed final report contains a summary of the IMPEP review

team’s findings. The review team made no recommendations in regard to program

performance for the North Dakota Agreement State Program.

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 April 2008. Typically, periodic meetings take place approximately

2 years after an IMPEP review, but because of the relatively short amount of time that has

elapsed since the Branch was able to catch up on its inspections and the management

transition, the MRB directed that a periodic meeting be held sooner.

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/

Martin J. Virgilio

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: Arvy Smith, Deputy State Health Officer

 North Dakota Department of Health

 David Glatt, Chief

 North Dakota Environmental Health Section

 Terry O’Clair, Director

 North Dakota Division of Air Quality

 Gary Robertson, Washington

 Organization of Agreement States 

 Liaison to the MRB
T. Dwelle, M.D. -2-

To maintain a high level of technical competency, it is imperative to recruit and retain an

adequate number of qualified and motivated individuals. In the NRC’s experience of reviewing 

Agreement State programs, the ability to recruit qualified applicants and maintain a stable

staffing level can be inhibited by low salaries and/or limited potential for career growth.

Section 5.0, page 10, of the enclosed final report contains a summary of the IMPEP review

team’s findings. The review team made no recommendations in regard to program

performance for the North Dakota Agreement State Program.

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 April 2008. Typically, periodic meetings take place approximately

2 years after an IMPEP review, but because of the relatively short amount of time that has

elapsed since the Branch was able to catch up on its inspections and the management

transition, the MRB directed that a periodic meeting be held sooner.

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/

Martin J. Virgilio

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: Arvy Smith, Deputy State Health Officer

 North Dakota Department of Health

 David Glatt, Chief

 North Dakota Environmental Health Section

 Terry O’Clair, Director

 North Dakota Division of Air Quality

 Gary Robertson, Washington

 Organization of Agreement States 

 Liaison to the MRB

DISTRIBUTION: See next page.

ML071880008/FSME-2007-0014

OFFICE FSME/DMSSA FSME/DMSSA FSME/DMSSA Tech. Ed.

NAME ATMcCraw:kk ADWhite JRSchlueter CPoland

DATE 07/09/07 07/10/07 07/11/07 7/16/07

OFFICE FSME DEDMRT

NAME CLMiller (GPangburn for) MJVirgilio

DATE 07/27/07 08/01/07

OFFICIAL RECORD COPY
LETTER TO T. DWELLE, M.D., FROM M. J. VIRGILIO DATED: August 1, 2007

SUBJECT: NORTH DAKOTA FINAL IMPEP REPORT

Distribution: DCD (SP01)

DMSSA RF Chairman Klein

EDO RF Commissioner McGaffigan

KKarcagi, FSME/DMSSA Commissioner Jaczko

KSchneider, FSME/DMSSA Commissioner Lyons

RErickson, RIV/RSAO

BTaylor, TX

MKunowski, OEDO

TCombs (2 copies)

KCyr, OGC

FCameron, OGC

SCollins, Region I

SMoore, DMSSA

DSollenberger, DMSSA

WRautzen, DMSSA
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM

REVIEW OF NORTH DAKOTA AGREEMENT STATE PROGRAM

April 17 - 19, 2007

FINAL REPORT

U.S. Nuclear Regulatory Commission

ENCLOSURE
North Dakota Final Report Page 1

1.0 INTRODUCTION

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

The review was conducted during the period of April 17-19, 2007, by a review team consisting

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

Agreement State of Texas. 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 the February 26, 2004, NRC Management Directive

5.6, "Integrated Materials Performance Evaluation Program (IMPEP)." Preliminary results of

the review, which covered the period of April 25, 2003, to April 19, 2007, were discussed with

North Dakota management on the last day of the review.

A draft of this report was issued to North Dakota for factual comment on May 15, 2007. The

State responded by e-mail on May 31, 2007, from Kenneth W. Wangler, Manager, Radiation

and Indoor Air Branch (the Branch). The Management Review Board (MRB) met on June 25,

2007, 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 NRC's program.

The North Dakota Agreement State program is administered by the Branch, Division of Air

Quality (the Division), Environmental Health Section (the Section), North Dakota Department of

Health (the Department). Organization charts for the Department and the Division are included

as Appendix B.

At the time of the review, the North Dakota Agreement State Program regulated 67 specific

licenses authorizing Agreement 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.

In preparation for the review, a questionnaire addressing the common and non-common

performance indicators was sent to the Branch on December 20, 2006. The Branch provided a

response to the questionnaire on April 5, 2007. A copy of the questionnaire response may be

found in the NRC’s Agencywide Document Access and Management System using Accession

Number ML071230758. 

The review team's general approach for conduct of this review consisted of: (1) examination of

the Branch’s response to the questionnaire; (2) review of applicable North Dakota statutes and

regulations; (3) analysis of quantitative information from the Branch’s licensing and inspection

database; (4) technical review of selected regulatory actions; (5) field accompaniments of one

Branch inspector; and (6) interviews with staff and management to answer questions or clarify

issues. The review team evaluated the information gathered against the established criteria for

each common and applicable non-common performance indicator and made a preliminary

assessment of the Agreement State program’s performance.

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

following the previous IMPEP review. Results of the current review of the common

performance indicators are presented in Section 3.0. Section 4.0 discusses the results of the
North Dakota Final Report Page 2

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 25, 2003, no recommendations

were made by the review team.

3.0 COMMON PERFORMANCE INDICATORS

IMPEP identifies five common performance indicators to be used in reviewing 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

Issues central to the evaluation of this indicator include the Branch’s staffing level and staff

turnover, as well as the technical qualifications and training histories of the staff. To evaluate

these issues, the review team examined the Branch’s questionnaire response relative to this

indicator, interviewed Branch management and staff, and reviewed training plans and records. 

The review team also considered any possible workload backlogs in evaluating this indicator.

The Branch consists of three technical positions: the Branch Manager, a fully qualified

Environmental Scientist III, and an Environmental Scientist II in training. The Branch Manager

and staff are responsible for all radioactive materials licensing, inspection, and emergency

response activities.

In August 2005, the Branch lost an experienced staff member to a higher paying position with

the Federal government. The vacated position was open until December 2005, when it was

filled by an employee from within the Division. Between December 2005 and June 2006, the

new staff member was not able to fully devote his time to the Branch. Vacancies within the

Division caused the individual to be shared between his former program and the Branch. Since

June 2006, the new staff member has been fully dedicated to the Branch. The Branch was fully

staffed at the time of the review.

Training and qualification requirements for Branch staff are established in a Training Regimen

Checklist which sets forth essentially the same training and qualification recommendations

detailed in the NRC’s Inspection Manual Chapter (IMC) 1246, as well as indication of ability to

perform specific inspections independently. As of April 2007, the new staff member had

completed five of nine NRC courses required by the Branch and several supplemental training

courses. The other technical staff member and Branch Manager have taken the NRC courses

deemed appropriate for their tasks. The Branch Manager is committed to continuing training

for the staff, as appropriate.

The Branch Manager has accompanied the new staff member during inspections, reviews all

licensing actions performed by the new staff member, and will determine when the individual is
North Dakota Final Report Page 3

proficient enough to work independently. The new staff member is expected to be fully trained

to perform industrial type licensing actions and inspections within the year. The review team

concluded that the Branch has a well balanced staff, and a sufficient number of personnel to

carry out regulatory duties, when the new staff member is fully trained and proficient to work

independently.

Approximately 75 percent of the radioactive materials program’s operations are funded through

fees. The review team noted that the Branch had stable funding throughout the review period

due to the dedicated revenue from licensee fees; however, this funding is dedicated to

equipment, training, and travel and is not available for salary increases. The review team

believes the Branch may face staffing challenges in the future if their salaries do not become

comparable to other State and Federal salaries.

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 Staffing and Training,

was satisfactory.

3.2 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 Branch’s questionnaire response relative to this indicator, data gathered from the

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

managers and staff.

The review team verified that the Branch’s inspection priorities for various types of licenses are

at least as frequent as similar license types listed in IMC 2800. The Branch previously had a

procedure for extending inspection frequencies for good performance, but changed the

procedure when IMC 2800 was revised to exclude this activity. The Branch retained the ability

to reduce inspection frequency for poor performance. The review team noted that one licensee

was currently on a reduced inspection interval.

The Branch uses a Microsoft Access database to track all inspection data. A report, identifying

inspections coming due, is periodically generated and is used to assign inspectors and

tentatively schedule the inspections. Management and staff have been able to effectively track

the timeliness of individual inspections using this tool.

At the time of the review, there was one overdue Priority 2 inspection. The review team

examined the Branch’s inspection tracking information and identified a total of 33 Priority 1, 2,

and 3 inspections, including three initial inspections that were due during the review period. 

Nine Priority 1, 2, and 3 inspections were either conducted overdue or were overdue at the

time of the review. The review team calculated that 27 percent of the Priority 1, 2, and 3 and

initial inspections were conducted or will be conducted at intervals that exceed NRC

frequencies.

Timeliness in issuing inspection findings was evaluated by reviewing inspection casework and

inspection data maintained in the database. The Branch requires that all inspection
North Dakota Final Report Page 4

correspondence be issued to licensees within 30 days of the inspection date. For the 32

inspection files examined that required correspondence to the licensee, only four inspection

findings were sent to the licensee beyond the 30-day requirement. The review team noted that

these four cases occurred in 2005 after the departure of an experienced staff member.

During the review period, the Branch granted 21 reciprocity permits, of which, 16 permits were

candidate licensees based on criteria in IMC 1220. The review team determined that the

Branch inspected at least 20 percent of the candidate licensees operating under reciprocity

during the review period.

The review team determined that with respect to Commission Staff Requirements

Memorandum (SRM) for COMSECY-05-0028, on Increased Controls, the Branch planned for

the initial set of inspections of licensees subject to the Increased Controls in accordance with

the SRM. The review team evaluated the Branch's prioritization methodology and found it

acceptable. The Branch identified eight licensees subject to Increased Controls, with six

Increased Controls inspections scheduled for completion within the first year. Four Increased

Controls inspections had been conducted by the Branch at the time of the review. For three of

the four, one is completed and closed out and two are under Branch review. The fourth

inspection was of a new licensee subject to Increased Controls. The other two inspections

scheduled for completion within the first year are tentatively scheduled for completion by June

2007.

Based on the IMPEP evaluation criteria, the review team initially recommended that North

Dakota’s performance with respect to the indicator, Status of Materials Inspection Program, be

found unsatisfactory; however, based on the State’s efforts to eliminate the backlog of

inspections and their commitments to maintaining a current inspection program, the MRB

determined that the State’s performance with respect to this indicator was satisfactory, but

needs improvement.

3.3 Technical Quality of Inspections

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

field notes and interviewed inspectors for 13 radioactive materials inspections conducted during

the review period. The casework review included inspections conducted by both of the

Branch’s fully-trained radioactive materials inspectors (one current and one former inspector),

as well as inspections in which the Branch Manager participated. The casework review covered

inspections of a variety of licensed activities, including: industrial radiography, academic broad

scope, research and development, well logging, self-shielded irradiators, large source service

providers, Increased Controls, and reciprocity. Appendix C lists the inspection casework files

reviewed, as well as the results of the inspector accompaniments.

Based on the evaluation of casework, the review team determined that routine inspections

covered all aspects of the licensees’ radiation protection programs. The inspection reports

were thorough, complete, consistent, and of high quality, with sufficient documentation to

demonstrate that licensees’ performances with respect to health and safety were acceptable. 

Inspection documentation frequently included photographs, illustrating licensee facilities and

documenting the actual conduct of licensed activities. The documentation adequately
North Dakota Final Report Page 5

supported any cited violations. Exit interviews were held with appropriate licensee personnel.

Team inspections were performed when appropriate and for training purposes.

For any violations identified, a written analysis of the licensee’s response along with any

needed follow-up actions was prepared by the inspector. These documents provided a clear,

easy-to-follow record of decision making regarding the enforcement action. All violations to be

issued are reviewed by the Branch Manager who determines whether or not they should be

referred to the Attorney General’s Office for potential escalated enforcement action. Available

escalated enforcement options include the formal Notices of Violation issued by the Attorney

General and the imposition of monetary civil penalties.

The Branch Manager attempts to conduct supervisory accompaniments of radioactive material

inspectors on at least 10 percent of all inspections. The review team found that the Branch

Manager performed an accompaniment of each inspector annually during the review period,

with the exception of 2006. The Branch Manager did not conduct accompaniments in 2006 due

to the loss of the experienced staff member in the Branch and two staff members from other

programs within the Branch. At the time of the review, accompaniments for 2007 had been

conducted.

The Branch has an adequate supply of survey instruments to support their inspection program,

as well as for responding to incidents and emergency conditions. The Branch has contractors

who calibrate their survey instruments on an annual basis. Appropriate documentation for

calibrated survey instruments was available. Radioactive contamination samples can be

evaluated at the Department’s Chemistry Division’s counting laboratory using a liquid

scintillation counting system.

The review team accompanied the qualified radioactive materials inspector during the week of

March 26, 2007, during inspections of one industrial radiography licensee and a self-shielded

irradiator licensee. Both health and safety and Increased Controls inspections were conducted

at both facilities. The accompaniments are identified in Appendix C. Inspections are generally

unannounced; however, the inspector indicated that he may contact the licensee either the day

before or the morning of an inspection to ensure that appropriate licensee personnel are

available prior to his arriving at the facility. During the accompaniments, the inspector

conducted interviews with appropriate personnel, observed licensed operations, documented

the inspection with digital photographs, conducted confirmatory measurements, and utilized

good health physics practices. The inspections were adequate to assess radiological health

and safety and Increased Controls at the licensed facilities.

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,

was satisfactory.

3.4 Technical Quality of Licensing Actions

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

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

radioisotopes and quantities, qualifications of authorized users, adequate facilities and

equipment, adherence to good health physics practices, financial assurance, operating and
North Dakota Final Report Page 6

emergency procedures, appropriateness of license conditions, Increased Controls, and overall

technical quality. The casework was evaluated for timeliness, use of appropriate

correspondence, reference to appropriate regulations, documentation of safety evaluation

reports, consideration of compliance history, use of a pre-licensing checklist, peer or

supervisory review as necessary, and proper signature authority. The casework was also

checked for retention of necessary documents and supporting data.

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

completed during the review period. The sampling included the following types of licenses: 

medical, high dose-rate remote afterloader, mobile nuclear medicine, broad scope university,

self-shielded irradiator, portable and fixed gauges, industrial radiography, and well logging. 

Licensing actions selected for evaluation included one new license, five renewals, four

amendments, and one termination. A listing of the licensing casework evaluated may be found

in Appendix D.

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

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

Documentation of each review was thorough and complete. License tie-down conditions were

stated clearly, backed by information contained in the file, and were auditable.

Deficiencies are addressed via telephone, by electronic mail, or by letter depending on the level

of detail of the additional information required. The deficiency notices contained appropriate

regulatory language and were well-documented in the license file. There were no licensing

backlogs identified during the review period. The licensee’s compliance history was taken into

account when reviewing renewal applications and amendments. The license reviewers

appropriately used the Branch’s licensing guides and policies and standard licensing conditions. 

All licensing information is available at the State’s website, including the Branch’s licensing

guides and NRC licensing guides.

Based on the type of action, licensing actions are assigned to the qualified license reviewer or

the license reviewer-in-training. The license reviewer conducts a technical review of each

licensing action, prepares the appropriate licensing documents, and then enters the information

into the Branch database, where the status of licensing actions is tracked. The Branch

Manager performs technical and supervisory reviews on all licensing actions, and the Division

Director performs a supervisory review before a license is issued under his signature. The

Branch’s licensing procedure sets a 45-day guideline for the completion of routine renewals and

new applications, including minor amendments without significant changes. The majority of

licensing actions meet this guideline and currently the Branch does not have a backlog of

licensing actions. Licenses are issued for a 5-year period.

The review team evaluated financial assurance and decommissioning activities conducted by

the Branch. The review team concluded that the Branch handles financial assurance

appropriately. The review team identified no performance issues with the handling of financial

assurance or decommissioning by the Branch. The review team found that terminated licensing

actions were well-documented and that the files included the appropriate transfer and survey

records. Confirmatory surveys for license terminations were conducted when appropriate.

The Branch administers a radiographer certification program as a certifying entity. The Branch,
North Dakota Final Report Page 7

in coordination with the Conference of Radiation Control Program Directors, Inc., and the State

of Texas, proctors the Texas examination. The Branch certified approximately 60

radiographers during the review period.

The review team examined the list of licensees that the Branch determined to meet the criteria

for the Increased Controls, per COMSECY-05-0028. The review team determined that the

Branch correctly identified the licensees that require the Increased Controls, based on the

criteria. The Branch will continue to issue Increased Controls to any additional licensees, as

appropriate. Each licensee was issued a license amendment, requiring the Increased Controls,

in accordance with the time lines established by the Commission in the SRM for 

COMSECY-05-0028.

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, was satisfactory.

3.5 Technical Quality of Incident and Allegation Activities

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

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

this indicator, reviewed the incident reports for North Dakota in the Nuclear Material Events

Database (NMED) against those contained in the Branch’s files, and evaluated reports and

supporting documentation for seven radioactive material incidents. A listing of the incident

casework examined may be found in Appendix E. The review team also reviewed the Branch’s

response to five allegations involving radioactive material.

The incidents selected for review included the following event categories: transportation,

potential overexposure, lost and recovered gauge, medical event, and faulty equipment. The

review team determined that the Branch’s responses to incidents were, in general, complete

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

was commensurate with the health and safety significance. The Branch dispatched inspectors

for on-site investigations when appropriate and took suitable followup actions. Incident reports

were thorough, well-documented and were generally timely.

The responsibility for initial response and followup actions to radioactive materials incidents

may be assigned to one of the staff or the Branch Manager. Upon receipt, staff reviews the

report, decides on the appropriate response, and enters the information into a database. 

Documentation related to an incident is placed in the appropriate license file, an incident file,

and/or a separate confidential file depending on the subject matter.

As identified as a good practice during the 2003 IMPEP, North Dakota's incident response

procedure includes a list of trained personnel in the State who are willing to respond to a

radiation incident, such as a transportation incident, and would provide initial assessment of the

incident or assist during the incident until State radiological emergency response personnel can

arrive. The list includes the names of volunteers, their location within the State, the types of

safety equipment they have available, and their contact numbers.

The Branch’s incident procedure references the NRC’s “Handbook on Nuclear Material Event
North Dakota Final Report Page 8

Reporting in the Agreement States.” The Branch responded to a total of 20 incidents involving

radioactive materials during the review period. The review team identified six incidents in

NMED for North Dakota during the review period. One event not meeting the reporting criteria

in the handbook was entered into the NMED database for tracking purposes. The review team

noted that all events requiring 24-hour notification and routine and/or event updates, requiring

30-day notification, were reported to the NRC for inclusion in NMED. All NMED records were

complete and closed.
North Dakota Final Report Page 9

The review team evaluated the casework for five allegations. The Branch evaluates each

allegation and determines the proper level of response. The review of the casework indicated

that the Branch took prompt and appropriate action in response to the concerns raised. Each

of the allegations reviewed was closed, and the allegers were informed of the results, when

possible. The review team identified no performance issues from the allegation casework

review.

The review team noted that Section GII.B. of North Dakota's procedures states protection of

witnesses is provided for in Rule 509, North Dakota Rules of Evidence. The procedures further

state that it is the responsibility of the Branch Manager to handle requests for information. The

State makes every effort to protect an alleger’s identity, but it cannot be guaranteed. The

review team found this practice acceptable.

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, was satisfactory.

4.0 NON-COMMON PERFORMANCE INDICATORS

IMPEP identifies four non-common performance indicators to be used in reviewing 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. North Dakota's Agreement does not cover a sealed source and device evaluation

program or a uranium recovery program, so only the first and third non-common performance

indicators were applicable to this review.

4.1 Compatibility Requirements

4.1.1 Legislation

North Dakota became an Agreement State on September 1, 1969. Legislative authority to

create an agency and enter into an Agreement with the NRC is granted in the North Dakota

Century Code Chapter 23-20. The Department is designated as the State's radiation control

agency. The review team noted that no legislation affecting the radiation control program was

passed during the review period.

4.1.2 Program Elements Required for Compatibility

The North Dakota Revised Radiological Health Rules, found in North Dakota Administrative

Code Chapters 33-10-01 through 33-10-14, apply to all ionizing radiation, whether emitted from

radionuclides or devices. North Dakota requires a license for possession and use of all

radioactive material including naturally-occurring radioactive materials, such as radium, and

accelerator-produced radionuclides.

The review team examined the State's rulemaking process and found that the process takes

approximately 9 months after preparation of a draft rule. Proposed rules are submitted to the

State Health Council for consideration and approval to proceed with public comment. Public

notice of proposed rule revisions is made and a 60-day public comment period, including a
North Dakota Final Report Page 10

public hearing is conducted. Proposed rules are sent to NRC for a compatibility review. After

resolution of comments and the Attorney General’s approval, final draft rules are sent to the

State Health Council for final review and adoption. Final rules are sent to the NRC and to

licensees. The State has the authority to issue legally binding requirements (e.g., license

conditions) in lieu of regulations until compatible regulations become effective.

The review team evaluated the Branch’s response to the questionnaire relative to this indicator,

reviewed the status of regulations required to be adopted by the State under the Commission’s

adequacy and compatibility policy, and verified the adoption of regulations with data obtained

from the Office of Federal and State Materials and Environmental Management Programs’s

(FSME) State Regulation Status Sheet.

Current NRC policy requires that Agreement States adopt certain equivalent regulations or

legally binding requirements no later than three years after they are effective. The following two

NRC amendments are overdue; however, the State does not have any facilities subject to either

provision and, until they receive a license application for a facility that would be subject to these

provisions, do not need to adopt these amendments:

• "Financial Assurance for Materials Licensees," 10 CFR Part 30, 40, and 70 amendments

(68 FR 57327) that became effective on December 3, 2003, and was due for Agreement

State adoption by December 3, 2006.

• “National Source Tracking System - Serialization Requirements,” 10 CFR Part 32

amendment (with reference to Part 20 Appendix E) (71 FR 65685) that became effective

February 6, 2007, and was due for Agreement State adoption by February 6, 2007.

The review team identified the following four NRC amendments that will be needed in the

future:

• "Compatibility with IAEA Transportation Safety Standards and Other Transportation

Safety Amendments," 10 CFR Part 71 amendment (69 FR 3697) that became effective

on October 1, 2004, and is due for Agreement State adoption by October 1, 2007.

• "Security Requirements for Portable Gauges Containing Byproduct Material," 10 CFR

Part 30 amendment (70 CFR 2001) that became effective on July 11, 2005, and is due

for Agreement State adoption by July 11, 2008.

• "Medical Use of Byproduct Materials - Recognition of Specialty Boards," 10 CFR Part 35

amendment (70 FR 16336, 71 FR 1926) that became effective on April 29, 2005, and is

due for Agreement State adoption by April 29, 2008.

• “Minor Amendments,” 10 CFR Part 20, 30, 32, 35, 40 and 70 amendments (71 FR

15005) that became effective March 27, 2006, and is due for Agreement State adoption

by March 27, 2009.

The Branch Manager indicated that all of the above regulations would be addressed in an

upcoming rulemaking or by issuance of alternate legally binding requirements. He expects the
North Dakota Final Report Page 11

draft rulemaking package to be completed by October 2007 for comments with an anticipated

final publication in June 2008.

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

that North Dakota’s performance with respect to the indicator, Compatibility Requirements, was

satisfactory.

4.2 Low-Level Radioactive Waste (LLRW) Disposal Program

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 of an amendment. Although North Dakota has such

disposal authority, 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, they are expected to put in place a regulatory program which will meet

the criteria for an adequate and compatible LLRW disposal program. There are no plans for a

LLRW disposal facility in North Dakota. Accordingly, the review team did not evaluate this

indicator.

5.0 SUMMARY

As noted in Sections 3.0 and 4.0, North Dakota’s performance was found to be satisfactory, but

needs improvement, for the indicator, Status of Materials Inspection Program, and satisfactory

for all remaining performance indicators reviewed. The review team made no

recommendations regarding the performance of the North Dakota Agreement State Program. 

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 NRC's program. Based on the results of the current IMPEP review, the review

team recommended, and the MRB agreed, that a periodic meeting should be held in 1 year and

that the next full IMPEP review should take place in approximately 4 years.
LIST OF APPENDIXES AND ATTACHMENT

Appendix A IMPEP Review Team Members

Appendix B North Dakota Organization Charts

Appendix C Inspection Casework Reviews

Appendix D License Casework Reviews

Appendix E Incident Casework Reviews

Attachment May 31, 2007, E-mail from Kenneth W. Wangler

North Dakota’s Response to Draft IMPEP Report
APPENDIX A

IMPEP REVIEW TEAM MEMBERS

Name Area of Responsibility

Kathleen Schneider, FSME Team Leader

Technical Quality of Incident and Allegation

 Activities

Compatibility Requirements

Randy Erickson, RIV Status of Materials Inspection Program

Technical Quality of Inspections

Inspector Accompaniments

Barbara Taylor, TX Technical Staffing and Training

Technical Quality of Licensing Actions
APPENDIX B

NORTH DAKOTA ORGANIZATION CHARTS

ADAMS ACCESSION NO.: ML071230758

PAGES 16-17
APPENDIX C

INSPECTION CASEWORK REVIEWS

NOTE: CASEWORK LISTED WITHOUT COMMENT ARE INCLUDED FOR COMPLETENESS

ONLY.

File No.: 1

Licensee: Ewer Testing & Inspection License No.: 33-32610-01

Inspection Type: Field, Announced Priority: 1

Inspection Date: 2/7/06 Inspectors: JK, CS

File No.: 2

Licensee: Ewer Testing & Inspection License No.: 33-32610-01

Inspection Type: Routine & Increased Controls, Announced Priority: 1

Inspection Dates: 3/28-29/07 Inspectors: JK, CS

File No.: 3

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

Inspection Type: Routine, Announced Priority: 3

Inspection Date: 9/13/06 Inspectors: JK, CS

File No.: 4

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

Inspection Type: Routine, Unannounced Priority: 1

Inspection Date: 7/12/05 Inspector: KW

File No.: 5

Licensee: United Blood Services License No.: 33-05427-02

Inspection Type: Routine & Increased Controls, Announced Priority: 5

Inspection Date: 3/14/07 Inspectors: KW, JK, CS

File No.: 6

Licensee: United Blood Services License No.: 33-05427-02

Inspection Type: Routine & Increased Controls, Announced Priority: 5

Inspection Date: 3/28/07 Inspectors: JK, CS

File No.: 7

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

Inspection Type: Routine & Increased Controls, Announced Priority: 1

Inspection Date: 9/11/06 Inspectors: JK, CS

File No.: 8

Licensee: University of North Dakota License No.: 33-12827-01

Inspection Type: Routine, Announced Priority: 3

Inspection Dates: 4/25-27/05 Inspectors: KW, JG
North Dakota Final Report Page C.2

Inspection Casework Reviews

File No.: 9

Licensee: North Dakota State University License No.: 33-06769-06

Inspection Type: Routine, Announced Priority: 3

Inspection Dates: 3/2-4/05 Inspectors: KW, JG

File No.: 10

Licensee: Braun Intertec Corporation License No.: N/A

Inspection Type: Reciprocity, Announced Priority: 1

Inspection Date: 9/8/05 Inspectors: JK, CS

File No.: 11

Licensee: USA Environment, L.P. License No.: N/A

Inspection Type: Reciprocity, Announced Priority: 3

Inspection Dates: 10/25-27/04 Inspector: JK

File No.: 12

Licensee: Shaw Pipeline Services, Inc. License No.: N/A

Inspection Type: Reciprocity, Unannounced Priority: 1

Inspection Date: 9/25/03 Inspectors: KW, JG

File No.: 13

Licensee: J.L. Shepherd & Associates License No.: N/A

Inspection Type: Reciprocity, Unannounced Priority: 2

Inspection Date: 10/7/04 Inspectors: KW, JG

INSPECTOR ACCOMPANIMENTS

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

Accompaniment No.: 1

Licensee: United Blood Services License No.: 33-05427-02

Inspection Type: Announced, Routine & Increased Controls Priority: 5

Inspection Date: 3/28/07 Inspectors: JK, CS

Accompaniment No.: 2

Licensee: Ewer Testing & Inspection License No.: 33-32610-01

Inspection Type: Announced, Routine & Increased Controls Priority: N/A

Inspection Dates: 3/28-29/07 Inspectors: JK, CS
APPENDIX D

LICENSE CASEWORK REVIEWS

NOTE: CASEWORK LISTED WITHOUT COMMENT ARE INCLUDED FOR COMPLETENESS

ONLY.

File No.: 1

Licensee: St. Joseph’s Hospital and Health Center License No.: 33-01901-01

Type of Action: Renewal Amendment No.: 28

Date Issued: 9/30/04 License Reviewer: JK

File No.: 2

Licensee: Varco, L.P. License No.: 33-13562-01

Type of Action: Renewal Amendment No.: 20

Date Issued: 9/6/06 License Reviewer: CS

File No.: 3

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

Type of Action: Amendment Amendment No.: 43

Date Issued: 10/13/06 License Reviewer: CS

File No.: 4

Licensee: United Blood Services License No.: 33-05427-02

Type of Action: Amendment Amendment No.: 10

Date Issued: 7/27/06 License Reviewer: JK

File No.: 5

Licensee: United Blood Services License No.: 33-05427-02

Type of Action: Amendment Amendment No.: 10

Date Issued: 7/27/06 License Reviewer: JK

File No.: 6

Licensee: United Blood Services License No.: 33-05427-02

Type of Action: Renewal Amendment No.: 7

Date Issued: 2/3/05 License Reviewer: JG

File No.: 7

Licensee: The Kidney and Hypertension Center License No.: 33-44302-01

Type of Action: New Amendment No.: 1

Date Issued: 11/2/06 License Reviewers: CS, JK

File No.: 8

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

Type of Action: Renewal Amendment No.: 14

Date Issued: 11/14/03 License Reviewer: JG
North Dakota Final Report Page D.2

License Casework Reviews

File No.: 9

Licensee: MeritCare Health System License No.: 33-10227-02

Type of Action: Amendment Amendment No.: 45

Date Issued: 1/10/06 License Reviewer: JK

File No.: 10

Licensee: University of North Dakota License No.: 33-12827-01

Type of Action: Renewal Amendment No.: 25

Date Issued: 8/4/05 License Reviewer: JK

File No.: 11

Licensee: Interstate Testing Services, Inc. License No.: 33-29016-01

Type of Action: Termination Amendment No.: 2

Date Issued: 6/1/06 License Reviewer: JK
APPENDIX E

INCIDENT CASEWORK REVIEWS

NOTE: CASEWORK LISTED WITHOUT COMMENT ARE INCLUDED FOR COMPLETENESS

ONLY.

File No.: 1

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

Date of Incident: 10/17/03 Incident Log No.: NMED 030910

Investigation Date: 10/17/03 Type of Incident: Damage to Equipment

Type of Investigation: Phone

File No.: 2

Licensee: Trinity Medical Center License No.: ND 33-04608-01

Date of Incident: 1/3/03 Incident Log No.: NMED 030911

Investigation Date: 10/23/03 Type of Incident: Medical Event

Type of Investigation: Inspection

File No.: 3

Licensee: Motor Coach Industry License No.: General license

Date of Incident: 7/18/03 Incident Log No.: NMED 030988

Investigation Date: 9/4/03 Type of Incident: Lost Radioactive Material

Type of Investigation: Phone

File No.: 4

Licensee: M Bar D Facility License No.: N/A

Date of Incident: N/A Incident Log No.: N/A

Investigation Date: 6/5/06 Type of Incident: Landfill survey

Type of Investigation: Investigation

File No.: 5

Licensee: Heart of America Medical Center License No.: N/A

Date of Incident: 7/23/03 Incident Log No.: NMED 030672

Investigation Date: 7/23/03 Type of Incident: Medical Event

Type of Investigation: Phone

File No.: 6

Licensee: ALTRU Hospital License No.: ND 33-01599-03

Date of Incident: 1/28/04 Incident Log No.: NMED 040150

Investigation Date: 3/10/04 Type of Incident: Medical Event

Type of Investigation: Inspection

File No.: 7

Licensee: Llyod Richmond & Associates License No.: ND 33-20305-01

Date of Incident: 7/22/04 Incident Log No.: NMED 010820

Investigation Date: 7/26/04 Type of Incident: Recovered Radioactive Material

Type of Investigation: Inspection
ATTACHMENT

May 31, 2007, E-mail from Kenneth W. Wangler

North Dakota’s Response to Draft IMPEP Report

ADAMS: ML071630461