DATED: JUNE 11, 1996 SIGNED BY: HUGH L. THOMPSON, JR.

 

Jon R. Rice, M.D.

State Health Officer

State Department of Health

Capitol Building

600 East Blvd.

Bismark, North Dakota 58505-200

Dear Dr. Rice:

On May 14, 1996, 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 review team found the

State's performance with respect to four of the five common performance

indicators to be fully satisfactory. On the Status of Materials Inspection

Program indicator, the review team found the State's performance to be

satisfactory with recommendations for improvement. The review team found the

State's performance on the only applicable non-common performance indicator to

be satisfactory. The MRB considered and concurred with the review team's

recommendation that the North Dakota program be found adequate to protect

public health and safety and compatible with NRC's regulatory program. Based

on the results of the current IMPEP review, the next review will be scheduled

in two to three years, unless program concerns develop that require an earlier

evaluation.

Section 5 (page 18) of the enclosed final report presents the IMPEP team's

recommendations. We request your evaluation and response to those

recommendations within 30 days from receipt of this letter.

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

the review.

Sincerely,/RA/

Hugh L. Thompson, Jr. 

Deputy Executive Director for

 Nuclear Materials Safety, Safeguards,

 and Operations Support

Enclosure: 

As stated

cc: Dana Mount, Director

 Division of Environmental Engineering

 North Dakota Department of Health
Jon R. Rice, M.D.

State Health Officer

State Department of Health

Capitol Building

600 East Blvd.

Bismark, North Dakota 58505-200

Dear Dr. Rice:

On May 14, 1996, 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 review team found the

State's performance with respect to four of the five common performance

indicators to be fully satisfactory. On the Status of Materials Inspection

Program indicator, the review team found the State's performance to be

satisfactory with recommendations for improvement. The review team found the

State's performance on the only applicable non-common performance indicator to

be satisfactory. The MRB considered and concurred with the review team's

recommendation that the North Dakota program be found adequate to protect

public health and safety and compatible with NRC's regulatory program. Based

on the results of the current IMPEP review, the next review will be scheduled

in two to three years, unless program concerns develop that require an earlier

evaluation.

Section 5 (page 18) of the enclosed final report presents the IMPEP team's

recommendations. We request your evaluation and response to those

recommendations within 30 days from receipt of this letter.

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

the review.

Sincerely,

Hugh L. Thompson, Jr. 

Deputy Executive Director for

 Nuclear Materials Safety, Safeguards,

 and Operations Support

Enclosure: 

As stated

cc: Dana Mount, Director

 Division of Environmental Engineering

 North Dakota Department of Health

BCC: See next page Distribution: See next page

DOCUMENT NAME: G:\KXS\96FINLTR.ND, G:\KXS\NDIMPEP.FIN

*See previous concurrence.

To receive a copy of this document, indicate in the box: "C" = Copy without attachment/enclosure "E" = Copy with attachment/enclosure "N" = No copy

OFFICE IMNS* E OSP* E OSP:DD* OSP:D DEDS

NAME SMoore KSchneider:vb PLohaus RLBangart HLThompson

DATE 05/24/96 05/24/96 06/03/96 06/ /96 06/ /96

 OSP FILE CODE: SP-AG-22
bcc: Chairman Jackson

Commissioner Rogers

Commissioner Dicus

 

Distribution: 

DIR RF

EDO RF

HLThompson, DEDS

DCD (SP01)

RLBangart

PLohaus

SDroggitis

KSchneider

CPaperiello, NMSS

ELJordan, AEOD

KCyr, OGC

SMoore, NMSS

CMattson, Colorado

JLynch, RIII

JHornor, RIV/WC

CHackney, RII

DCool, NMSS

JPiccone, NMSS

GPangburn, NMSS

FCameron, OGC

HNewsome, OGC

TCombs, OCA
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM

REVIEW OF NORTH DAKOTA AGREEMENT STATE PROGRAM

February 6 - 9, 1996

FINAL REPORT

Office of State Programs

U.S. Nuclear Regulatory Commission
North Dakota Final Report Page 1

1.0 INTRODUCTION

This report presents the results of the review of the North Dakota radiation

control program. The review was conducted during the period February 6 - 9,

1996, by a review team comprised of technical staff members from the Nuclear

Regulatory Commission (NRC) and the Agreement State of Colorado. Team members

are identified in Appendix A. The review was conducted in accordance with the

"Interim Implementation of the Integrated Materials Performance Evaluation

Program Pending Final Commission Approval of the Statement of Principles and

Policy for the Agreement State Program and the Policy Statement on Adequacy

and Compatibility of Agreement State Programs," published in the Federal

Register on October 25, 1995, and the September 12, 1995, NRC Management

Directive 5.6, "Integrated Materials Performance Evaluation Program (IMPEP)." 

Preliminary results of the review, which covered the period July 1993 to

January 1996, were discussed with North Dakota management on February 9, 1996. 

A draft of this report was issued to North Dakota for factual comment on

March 18, 1996. The State of North Dakota responded in a letter dated

April 11, 1996 (Attachment 1) and the comments were incorporated into the

proposed final report. The Management Review Board (MRB) met on May 14, 1996,

to consider the proposed final report. The review team found the State's

performance with respect to four of the five common performance indicators to

be fully satisfactory. On the Status of Materials Inspection Program

indicator, the review team found the State's performance to be satisfactory

with recommendations for improvement. The review team found the State's

performance on the only applicable non-common performance indicator to be

satisfactory. The MRB concurred in the team's individual and overall

recommendations and found that the North Dakota program was adequate to

protect public health and safety and was compatible with NRC's regulatory

program.

The North Dakota Department of Health (NDDH) is the agency within North Dakota

State government that regulates, among other public health issues,

environmental health. The State Health Officer, who heads NDDH, is appointed

by, and reports directly to, the Governor. Within NDDH, the North Dakota

radiation control program is administered by the Environmental Health Section,

Division of Environmental Engineering. The Department of Health and Division

of Environmental Engineering organization charts are included as Appendix B. 

The North Dakota program regulated 69 specific licensees at the time of the

review. In addition to radioactive materials, the Division of Environmental

Engineering is responsible for regulating air quality permitting, compliance,

impact, and monitoring; asbestos control; machine-produced radiation; and

radon control. The review focused on the 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 noncommon indicators was sent to the State on December 5, 1995. North Dakota

provided its response to the questionnaire on January 17, 1996. A copy of

that response is included as Appendix C to this report. 

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

(1) examination of North Dakota's response to the questionnaire; (2) review of

applicable North Dakota statutes and regulations; (3) analysis of quantitative

information from the radiation control program licensing and inspection data

base; (4) technical review of selected files; (5) field accompaniments of the

two North Dakota inspectors in January 1996; and (6) interviews with staff and

management to answer questions or clarify issues. The team evaluated the

information that it gathered against the IMPEP performance criteria for each
North Dakota Final Report Page 2

common and non-common indicator and made a preliminary assessment of the

radiation control program's performance. 

Section 2 below discusses the State's actions in response to recommendations

made following the previous review. Results of the current review for the

IMPEP common performance indicators are presented in Section 3. Section 4

discusses results of the applicable non-common indicators, and Section 5

summarizes the review team's findings and recommendations.

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS

The previous routine review concluded on June 25, 1993, and the results were

transmitted to John R. Rice, M.D., State Health Officer, North Dakota State

Department of Health and Consolidated Laboratories, on October 29, 1993. NRC

visited the program again in October 1994 to evaluate the status of open

issues identified in the 1993 review. The results of this visit were

transmitted to Dr. Rice on July 14, 1995.

2.1 Status of Items Identified During the June 1993 Routine Review

A number of recommendations were identified as part of the June 1993 review. 

Some of the recommendations were closed at the time of the October 1994 visit. 

The review team looked at each remaining item to determine whether or not the

North Dakota program had taken additional actions to close open

recommendations. The team's review of recommendations open after the

October 1994 visit are summarized below:

(1) The 1993 reviewer recommended that the State utilize technical 

assistance findings by NRC to reevaluate the tritium and carbon-14

disposal authorizations given to two broad-scope academic licensees. 

The 1994 status was that the North Dakota program had proposed

amendments to the two licensees and was awaiting responses from the

licensees. Also, the North Dakota program had sent a memorandum on the

subject of waste disposal to all medical licensees.

Current Status: The North Dakota program had received NRC's response to

the technical assistance requests. However, program personnel reported

that the waste disposal authorizations in question for the two licensees

had expired, and that the licensees were not pursuing renewing the

authorizations. Because the authorizations had expired and the academic

licensees were not continuing disposal in this manner, the

recommendation is closed.

(2) The 1993 reviewer recommended that the State update the

Administrative Procedures Manual so that it contains only current

information and that it be made available for all staff members. 

The 1994 status was that the draft revised manual was under review

by the North Dakota staff. The 1994 visit also recommended that

the North Dakota program consider use of the procedures developed

by the Conference of Radiation Control Program Directors (CRCPD) as

guides to facilitate the manual development.

Current Status: The North Dakota program has updated the Administrative

Procedures Manual and issued it in final form in June 1995. All North

Dakota staff in the program were aware of the Administrative Procedures

Manual and had access to the manual. The recommendation is closed. 
North Dakota Final Report Page 3

2.2 Status of Items Identified During the October 1994 NRC Review Visit

Several recommendations were also identified as part of the October 1994 NRC

visit to the State. The review team looked at each item to determine whether

or not the North Dakota program had taken actions to close the recommendation. 

The recommendations opened during the October 1994 visit are summarized below:

(1) The NRC reviewer recommended that the State continue to apply

regulatory attention to a licensee that had repeatedly been cited

for violations in 1990, 1991, and 1994, until it was demonstrated

that the licensee's problems are resolved. NRC also recommended in

the 1994 review visit that the State should consider that further

escalated enforcement may be required for this licensee.

Current Status: The State has not inspected the licensee, Trinity

Medical Center (ND 33-04608-01), since the October 1994 review. The

last inspection was conducted in February 1994, before the review visit,

and the State did not take escalated enforcement following that

inspection. Inspection frequency for this licensee is every three

years. The State should increase regulatory attention to this licensee,

until the State determines that the licensee's problems are resolved. 

The State has scheduled this licensee's inspection for the Spring 1996. 

This recommendation is closed.

(2) NRC recommended that the State should consistently use checklists

and notes to document licensing decisions, and that supervisory

reviewers should always sign-off on the checklists.

Current Status: Since this IMPEP review was performance-based and no

significant licensing concerns were noted, no further follow-up of this

issue is needed. The recommendation is closed.

(3) NRC recommended that the State should follow its commitment for

staff training. Specifically, the NRC reviewer noted that the

State program manager and one staff member needed to complete the

series of NRC core training courses.

Current Status: The program manager and staff member have not yet taken

the NRC core training courses identified in the [now-suspended] May 28,

1992, Policy Statement (57 FR 22495). Although the Policy Statement is

no longer in effect, the review team continues to recommend that both

individuals complete the licensing course. The staff member performs

license reviews for roughly half of the State's licensees. The program

manager serves as the sole reviewer. In the longer term, the program

manager should also attend the inspection procedures course, but that

need is not as immediate. The review team examined this recommendation

as part of the Technical Staffing and Training common performance

indicator (see Section 3.2). This recommendation is considered closed

and will be tracked as a new recommendation (see Section 5.0).

3.0 COMMON PERFORMANCE INDICATORS

IMPEP identifies five common performance indicators to be used in reviewing

both NRC Regional and Agreement State programs. These indicators are:

(1) Status of Materials Inspection Program; (2) Technical Staffing and

Training; (3) Technical Quality of Licensing Actions; (4) Technical Quality of

Inspections; and (5) Response to Incidents and Allegations. 
North Dakota Final Report Page 4

3.1 Status of Materials Inspection Program

The team focused on four factors in reviewing this indicator: inspection

frequency, overdue inspections, initial inspection of new licenses, and timely

dispatch of inspection findings to licensees. 

Review of the State's inspection priorities showed that the State's inspection

frequencies for various types or groups of licenses are at least as frequent

as similar license types or groups listed in the frequency schedule in the NRC

Inspection Manual Chapter 2800 (IMC 2800). Inspection frequencies under the

State's system range from 1-year to 5-year intervals. The State requires more

frequent inspections in some license categories as follows: moisture/density

gauges and portable gauges are inspected on a 4-year frequency compared with

an NRC 5-year frequency; self-shielded irradiators are inspected on a 3-year

frequency compared with an NRC 5-year frequency; laboratory facilities are

inspected on a 4-year frequency compared with an NRC 5-year frequency; and

testing and calibration licensees are inspected on a 3-year frequency compared

with an NRC 5-year frequency. The inspection frequencies of licenses selected

for inspection file reviews were compared with the frequencies listed in the

State's data system and were verified to be consistent with the State's system

and as frequent as similar license types under the IMC 2800 system.

In its response to the questionnaire, North Dakota indicated that as of

January 17, 1996, only one licensee identified for a core inspection in

IMC 2800 was overdue by more than 25 percent of the NRC frequency. This

number is well within the 10 percent criterion for overdue inspections of

Management Directive 5.6. By the time of the on-site review, on February 6-9,

1996, this well-logger licensee had received its initial inspection, about

three and one-half months past the inspection overdue date.

The IMPEP review team also looked at the State's experience with overdue

inspections during the entire review period. In practice during IMPEP

reviews, the 10 percent criterion for overdue inspections is applied at the

time of the review, but North Dakota had a recommendation in the June 1993

review regarding overdue inspections that were closed during the October 1994

review visit, and a cursory review of the inspection dates led the review team

to examine this issue more closely. The review team identified 8 inspections

of core licensees out of approximately 27 routine (non-initial) core

inspections conducted during the review period that were overdue by more than

25 percent of the NRC frequency. These core inspections ranged from a few

weeks to over seven months beyond the 25 percent window. In discussions with

the program manager and staff, the State personnel had been aware of these

cases during the review period. The program manager had, during the review

period, developed and implemented a plan to complete overdue inspections, and

by December 1995 the program had completed all of its overdue core

inspections. Because the State recognized the problem with overdue

inspections, developed a management plan to address overdues, and implemented

effective measures to eliminate overdues, the review team concluded that the

State has successfully addressed its earlier problem with overdue core

inspections.

With respect to initial inspections of new licensees, the team reviewed the

inspection tracking data system and verified that the initial inspections had

been entered into the tracking system. The State identified six new licenses

that were issued during the review period. At the time of the review, five of

the new licensees had been inspected and the sixth was still within the 

6-month time frame for inspection. The review team looked further to

determine whether the State inspected the new licensees within six months of

license issuance, or within the provisions of IMC 2800. The team found that
North Dakota Final Report Page 5

during the review period four of the initial inspections had been conducted

late. The program manager was aware that during the review period the State

had a problem in conducting initial inspections within the established

criteria, but that the problem had since been resolved. Of the four initial

inspections that were late, they ranged from about seven weeks past the due

date (for a moisture/density gauge licensee) to over a year past the due date

(for a mobile nuclear medicine licensee). Three of the four overdue initial

inspections were inspected in January 1996, the month before the IMPEP review. 

In discussions with the program manager and staff, it was evident that the

State was aware of their overdue initial inspections and had successfully

addressed the problem by completing the overdue initial inspections. In

addition, the program manager showed the IMPEP reviewer a management database

system that he had recently implemented to track assignments of the two staff

members. Although the review team concluded that the State had trouble

conducting initial inspections within the prescribed time frame in IMC 2800,

at the time of the review the State had conducted all overdue initial

inspections. It is too early to determine whether the new management tracking

system will be effective in preventing future initial inspections from

becoming overdue, because the system has not been in use long and because most

of the overdues were inspected in the final month before the IMPEP review.

The timeliness of the issuance of inspection findings was also evaluated

during the inspection file review. Out of eight inspection files examined in

depth, five had inspection correspondence sent to the licensee within 30 days

after completion of the inspection. Of the remaining 3 inspections, 2 took

10 months to issue the reports. The third was inspected two months before the

IMPEP review and findings had not yet been sent at the time of the review. In

addition, State personnel informed the review team of two other inspections

where inspection findings were not yet communicated to the licensee. One of

these two cases was a level gauge licensee that had been inspected in January

1995. In this particular case, it took so long to issue the inspection

findings that Division managers decided to re-inspect, rather than to issue

inspection findings almost a year old. This caused the review team to look

further into the timeliness of issuance of inspection findings.

The IMPEP reviewers selected another 13 files for inspections conducted during

1994 and 1995, by both program staff members. These 13 were not selected at

random; the review team had indications that some were issued late. Of those

13, seven had inspection findings communicated to the licensee in excess of

30 days after completion of the inspection. The times ranged from one week to

14 months beyond the 30-day criteria, but six of the seven were over six

months late. The IMPEP reviewer discussed this issue with the program manager

and staff. They attributed the cause of the late inspection reports to a lack

of punctuality by an inspector coupled with, until recently, the lack of close

management oversight. The program manager told the reviewer that the

recently-instituted management tracking system will address the timeliness

issue and give the manager information to track when reports are due. The

IMPEP reviewer observed that several factors caused the reports to be issued

late: (1) until recently, no formal tracking system, (2) lack of availability

of staff and management (staff effort on promulgation of regulations during

Summer 1996 and significant leave during early Fall 1996), (3) lack of staff

and management attention to the problem, and (4) no formal policy on

timeliness of issuing inspection results.

The State's difficulty in issuing inspection findings to the licensee in a

timely manner is significant. Delays in issuing inspection reports impairs

the effectiveness of getting prompt corrective action by the licensee to any

violations. Some of the findings on the overdue reports had safety
North Dakota Final Report Page 6

significance, both individually and as a group. Late reports make it

difficult for the program to require a prompt response from the licensee. 

Finally, late reports open the program to criticism by licensees, as was seen

in one licensee's response to the inspection findings.

The State reported in its response to the questionnaire that 30 requests for

reciprocity were received during the review period, of which 14 were from

industrial radiographers, well-loggers, and mobile nuclear medicine licensees,

and 16 were from portable gauge users and other licensees with an inspection

frequency of more than 3 years. The State did not conduct any inspections of

reciprocity licensees during the review period. The staff and program manager

said that the short lead time on reciprocity requests and the distance

involved in travel to the site usually prohibit inspections of reciprocity

licensees.

In its response to the questionnaire, the State reported conducting one field

inspection on a non-reciprocity industrial radiography licensee, and State

staff told the IMPEP reviewer that they may have also conducted another

radiography field inspection not identified in the questionnaire. The staff

also reported efforts to conduct another field inspection of a radiographer

that was cancelled because of poor weather. For comparison, the State listed

four industrial radiography companies in its list of licensees, one of which

is a new licensee. When possible, the State attempts to conduct field

inspections of radiographers, but has had limited success in doing so.

In summary on this indicator, the State program had inspection frequencies at,

or more frequent than, NRC's inspection frequencies. During the review

period, the North Dakota program experienced a problem with overdue core

inspections, but the program had corrected that problem by the time of the

review. Similarly, the program had conducted a number of initial inspections

late during the review period, but the overdue initial inspections had been

completed by the time of the review. Finally, the State experienced serious

delays in issuing inspection findings to licensees. 

Based on the IMPEP evaluation criteria, the review team recommends that North

Dakota's performance with respect to the indicator, Status of Materials

Inspection Program, be found satisfactory with recommendations for

improvement.

Recommendations:

- The review team recommends that the State adopt a written timeliness

goal for issuance of inspection findings to the licensee.

- The review team recommends that State management and staff devote

increased attention to issuing inspection results or notice in a timely

manner (30 days).

- The review team recommends that the State monitor the timeliness of

issuing inspection findings to licensees, as experience is gained with

the new management tracking system. Within the next year, the State

should perform a systematic assessment of use of the tracking system,

and decide whether it is effective in tracking assignments and prompting

staff and management to issue inspection findings.

- The review team recommends that, over the next year, the State assess

whether initial inspections have been performed within 6-months of

license issuance or within the provisions of IMC 2800, and whether the

State's method for scheduling initial inspections has worked adequately.
North Dakota Final Report Page 7

3.2 Technical Staffing and Training

Issues central to the evaluation of this indicator include the radioactive

materials program staffing level, technical qualifications of the staff,

training, and staff turnover. To evaluate these issues, the review team

examined the State's questionnaire responses regarding this indicator,

interviewed NDDH management and staff, and considered any possible workload

backlogs.

The Division of Environmental Engineering organization chart shows that the

Radiation and Asbestos Control program was staffed with one program manager

and seven staff at the time of the review. Within that group, an

environmental scientist and an environmental engineer comprise the radioactive

materials control program staff. The other staff positions cover radon,

machine-produced radiation, and asbestos control. The two radiation control

program staff members are full-time positions, with few outside (non-program)

duties. In response to the questionnaire, the State reported that the

radiation control program manager spends about 57 percent of his effort on

radiation-specific tasks, including machine-produced radiation tasks (the

other 43 percent of his effort being spent on special projects and asbestos). 

Upper division management spends between 5 and 10 percent of their time on

supervision of the program. In response to the questionnaire, the State

reported that 2.6 FTEs were assigned to the radioactive materials control

program. None of the three positions (one manager and two staff) directly

involved with the radiation control program was vacant at any time during the

review period, nor were vacancies forecasted in any of the three positions in

the near future. The State budgets in 2-year cycles. The current staffing

level will remain in effect through July 1, 1997, according to the program

manager. The program manager also told the review team that he does not know

of any plans to reduce the staffing level for the radioactive materials

control program in the next budget cycle, after July 1997.

The licensing and inspection functions of the program are integrated, and

therefore, both radiation control program staff members perform duties in

licensing, inspection, and event response. Balance between the licensing and

inspection functions is achieved by basing staff assignments on program needs. 

The 69 specific licensees are assigned, by licensee, to one of the two

radioactive material staff. In discussions with the staff during inspection

accompaniments, the IMPEP reviewer was told that the State does not have

specific plans, at this time, to switch licenses between the two radioactive

materials control program staff. While not a formal review team

recommendation, the State should consider switching licensees between the two

staff members, at some point in the future. Benefits of assigning particular

licensees to a particular staff member, especially for inspections, may be

outweighed by the benefits that result from inspection by a person who has no

pre-conceived views about licensees' programs based on prior inspections. At

this time, over-familiarity is not a problem.

The program manager explained that, when vacancies occur, the positions

require Bachelor's degrees in a science or engineering field. The review team

reviewed the qualifications of the technical staff and concluded that the

State has been able to retain well-qualified individuals. The program manager

and both radioactive materials control program staff have at least a

Bachelor's degree in science or engineering. 

The review team reviewed the training of all three personnel involved with the

radioactive materials control program. According to information provided in

the questionnaire, one staff member has attended all of the core training

courses outlined in the [now-suspended] May 28, 1992, Policy Statement
North Dakota Final Report Page 8

(57 FR 22495). That is, he has attended the licensing, inspection procedures,

industrial radiography, and medical courses. He has also attended the 5-week

Health Physics and Radiation Protection course. The other staff member has

attended all of the core training courses except for the licensing course. 

The program manager has attended the radiography and medical courses, but has

not attended the inspection procedures or licensing courses. The program

manager has also attended the 5-week Health Physics and Radiation Protection

course. In addition to these courses, the program manager and staff have

completed numerous other training courses and have attended job-specific

technical conferences and meetings. Examples of training the program manager

or staff attended during the review period include: Radionuclide NESHAPS,

OSHA refresher, All Agreement States Meeting, CRCPD Annual Meeting, Health

Physics Engineering, Nuclear Materials Events Database Event Reporting, and

Health Physics Technology.

The program manager provided the review team an internal memorandum dated

February 1, 1996, that he had written to the Division Director regarding the

training schedule for program personnel. The State plans for one radioactive

materials staff member to attend the licensing course in September, which will

complete his core courses. In addition, the State plans for both staff

members to complete an additional technical training course during the

upcoming year involving teletherapy and brachytherapy. The plan also notes

that the program manager's "long range training plans" include eventual

attendance at the licensing class and inspection class, among others.

Because of the program manager's plans to attend technical meetings in the

coming year and because of his plans to prioritize more technical health

physics training for himself, the review team concludes that it is unlikely

that he will be able to attend the licensing and inspection courses this year.

The review team suggests that the State follow-through on its plan to have the

radioactive materials control program staff member complete the licensing

course. The review team also suggests that the program manager attend the

licensing course as soon as practical, because the program manager serves as

the secondary reviewer for all licensing actions. The program manager should

eventually complete the inspection procedures course, and the State plans

include this. These training issues were also identified on the October 1994

visit (see Section 2.2).

The IMPEP reviewer discussed training with the program manager and both staff

members. The program manager was knowledgeable and had good documentation of

the training that each individual has completed. Based on the training that

program personnel have taken during the review period, the State appears

supportive of continued staff training, and management demonstrated a

commitment to staff training during the review. However, the review team

learned that approval for out-of-State travel can be an impediment to

training, and limits the amount of training that can be taken. The 

February 1, 1996, training memorandum also implies that out-of-State travel

should be minimized. The review team notes that because of the highlyspecialized nature of training involving health physics and regulation of

radioactive materials, out-of-State travel is unavoidable. The review team

suggests that out-of-State travel considerations should not curtail necessary

training for program personnel.

Based on the IMPEP evaluation criteria, the review team recommends that North

Dakota's performance with respect to the indicator, Technical Staffing, and

Training be found satisfactory.
North Dakota Final Report Page 9

3.3 Technical Quality of Licensing Actions

The review team examined casework for 11 licenses and interviewed the two

radioactive materials control program staff. Licensing actions were reviewed

for completeness, consistency, proper isotopes and quantities used,

qualifications of authorized users, adequate facilities and equipment, and

operating and emergency procedures sufficient to establish the basis for

licensing actions. Casework was reviewed for timeliness, adherence to good

health physics practices, reference to appropriate regulations, documentation

of safety evaluation reports, product certification or other supporting

documents, consideration of safety evaluation reports, product certification

or other supporting documents, consideration of enforcement history on

renewals, pre-licensing visits, peer or supervisory review, and proper

signature authorities. Licenses were reviewed for accuracy, appropriateness

of the license and its conditions and tie-down conditions, and overall

technical quality. The files were checked for retention of necessary

documents and supporting data.

The cases were selected to provide a representative sample of licensing

actions which had been completed in the review period and to include work by

both license reviewers. The cross-section sampling included 11 licenses and

included the following types: academic broad scope, medical-institution and

medical-mobile, industrial radiography, well-logging sources and well-logging

tracers, research and development, and portable gauges. Licensing actions

included two new licenses, two terminations, and 16 amendments. A list of

these licenses with case-specific comments is included in Appendix D.

The review team found that the licensing actions were generally thorough,

complete, consistent, and of acceptable quality with health and safety issues

properly addressed. Special license tie-down conditions were stated clearly,

backed by information contained in the file, and able to be inspected. The

licensees' compliance histories were taken into account when reviewing renewal

applications. The State's licensing guides were based upon NRC Regulatory

Guides, but had been revised and updated for use by North Dakota licensees. 

The administrative policies had been rewritten during the review period. 

Reviewers were observed to be skilled with the use of these and other

licensing documents. Reviewers used licensing guides appropriately and

generally used check lists in reviewing applications. The Division Director,

or alternatively the Assistant Division Director, reviews and signs all

licenses. No potentially-significant health and safety issues were

identified.

Based on the IMPEP evaluation criteria, the review team recommends that North

Dakota's performance with respect to the indicator, Technical Quality of

Licensing Actions, be found satisfactory. 

3.4 Technical Quality of Inspections

The team reviewed the inspection reports, enforcement documentation, and the

data base information for 8 materials inspections conducted during the review

period. The casework included both of the State's materials inspectors and

covered a sampling of different license types as follows: industrial

radiography, broad scope university, nuclear medicine, laboratory use, well

logging, portable gauge, and level gauge licensees. Appendix E provides a

list of the inspection cases reviewed in depth with case-specific comments.

The review team noted several strengths in the North Dakota program on this

indicator. For instance, the IMPEP reviewer saw examples where inspectors

included photographs of licensee operations in the inspection files. This
North Dakota Final Report Page 10

practice is not widely used by NRC Regions and other Agreement States. The

photographs help supervisors and future inspectors have a visual indication of

licensee facilities, equipment, and operations. This novel inspection

practice is to be commended. Likewise, the State has inspection field notes

available on computer, which helps with inspection documentation. Another

strength is that the program manager conducted numerous inspection

accompaniments during the review period, more than the minimum annual standard

in the IMPEP evaluation criteria. This gives program management a better

understanding of both inspectors' abilities and on-site licensee conditions. 

Finally, the State was able to conduct a number of joint inspections, where

the two staff members (sometimes joined by the program manager) conducted

inspections together. Having two different inspectors review a particular

licensees' operations may lead to more thorough inspections.

The team reviewed the inspection reports and found them to be comparable with

the types of information and data collected under NRC Inspection Procedure

(IP) 87100. The inspection field notes provided documentation of inspection

findings in a consistent manner. The State uses separate inspection field

notes for various classes of licensees, such as nuclear medicine, portable

gauges, and broad scope academic. The inspection field notes provide

documentation of scope of the licensee's program; unusual occurrences;

postings; storage and use of radioactive material; receipt, transfer, and

disposal of radioactive material; inventory; leak tests; radiation protection

program; personnel monitoring; training; independent measurements; and

inspection findings.

In general, the inspection reports demonstrated that the State inspectors were

examining appropriate radiation health and safety issues at licensees'

facilities. Inspectors performed independent measurements on seven of the

eight cases reviewed. Inspectors' written comments in the field notes

indicate that they discussed safety issues with licensee personnel. Some of

the field notes indicate that licensee operations were observed, when licensed

operations were being conducted by the licensee, and interviews with the State

inspectors support that they routinely tour licensee areas such as

laboratories, other locations of use, and storage areas. One inspector said

that he sometimes asks the licensee to demonstrate licensed activities, which

is a good inspection technique. The inspectors consistently examined and,

when appropriate, closed-out previous violations. Also, because the

radioactive materials control program staff serve as both inspectors and

license reviewers for the same licensees, there was evidence that licensing

issues were considered in the inspection process. 

While reviewing the eight inspection cases, the IMPEP reviewer found a number

of minor issues, that were discussed directly with the State staff. Examples

included: no independent measurements in one case, frequent absence of

interviews with licensee ancillary personnel, in one case not conducting the

exit meeting with high-level licensee managers, lack of closure documented in

the field notes on safety-significant inspection issues, and general

documentation concerns. Most of these issues were resolved by asking the

State inspectors to explain their comments on the inspection field notes, or

to provide more details. On items that were not resolved, individual

recommendations were made to the inspectors by the review team. However, none

of the issues indicated a systemic problem in the technical quality of

inspections.

Three inspector accompaniments were performed by a review team member during

the period of January 10-11, 1996. Both of the North Dakota inspectors were

accompanied during the inspection of a hospital nuclear medicine/therapy

program. One of the inspectors was also accompanied on a portable moisture
North Dakota Final Report Page 11

density gauge inspection and the other inspector was accompanied to an

industrial radiography facility. During the accompaniments, the North Dakota

inspectors demonstrated appropriate inspection techniques and knowledge of the

regulations and licenses. The inspectors were well-prepared and thorough in

their reviews of the licensees' radiation safety programs. Overall, the

technical performance of the inspectors was satisfactory, and their

inspections were adequate to assess radiological health and safety at the

licensed facilities.

In response to the questionnaire, the State reported that both staff members

(i.e., inspectors/license reviewers) were accompanied by the program manager

during the review period. The questionnaire and interviews with the staff

indicate that the program manager conducted accompaniments with staff to 13

separate licensees between September 1993 and December 1995. The program

manager had accompanied one particular inspector individually on four

inspections, and he had accompanied both inspectors together on nine

inspections. The inspectors reported receiving feedback from the supervisor

on their performance during the accompaniments. In response to the

questionnaire, the State reported that "supervisory accompaniments take place

approximately every six months." The review team saw evidence that the State

was exceeding the IMPEP criteria in NRC Management Directive 5.6 for annual

accompaniments.

It was noted that the State has a variety of portable instruments for routine

confirmatory surveys and use during incidents and emergency conditions. The

instruments were a mix of low range GM tubes and pancake probes, micro R

meters, higher-range instruments, instrumentation for alpha detection, pocket

dosimeters, an audible dosimeter, and a multichannel analyzer. The portable

instruments used during the inspector accompaniments were observed to be

operational and calibrated. The portable instruments maintained in the office

were also observed to be calibrated. Program staff explained that instruments

are calibrated at least on an annual basis. 

The review team found that the State is performing both announced and

unannounced routine inspections of materials licensees. Of the eight

inspection cases reviewed by the review team, five were announced to the

licensee before the inspection. Several of the announced inspections had notes

indicating that they were announced either one or two days in advance of the

inspection. State staff reported that they announce about half of the

inspections in advance to the licensees, sometimes on the day of, or the

afternoon before, the inspections. The staff indicated that this is done for

efficiency, to make sure that licensee personnel are present. One of the

eight cases reviewed was a special inspection, to examine a medical licensee's

problem involving no permanent Radiation Safety Officer or authorized user. 

That special inspection was not announced.

The review team examined whether inspection field notes were being signed by

the inspectors, and reviewed and signed by the program manager. Of 20

inspection reports selected for detailed review or spot-check by the review

team, 3 had not been signed by the inspector. In those cases, either the

inspector signature line was blank, or the computer-generated field notes did

not include a line for the inspector's signature. This is not indicative of a

serious problem, but the review team suggests that inspectors sign all final

versions of the inspection field notes or that management adopt a policy that

inspectors need not sign the field notes. 

Of the same 20 inspection reports, 9 had not been signed by the program

manager as being reviewed. In response to the questionnaire, the State said,

"All inspection reports are reviewed and signed by the manager of the
North Dakota Final Report Page 12

Radiation Control Program." In discussions with the program manager, he was

not aware of the cases where there was no supervisory signature on the field

notes. In discussions with the inspectors, they were also not aware that the

field notes had not been signed by the supervisor. In many cases, the

inspectors could recall discussing specifics of the field notes with the

program manager, indicating that they had been reviewed. Also, all

enforcement letters (including letters with minor violations) are signed-out

to the licensee at the Division Director level, so they pass through two more

levels of management review. The Division Director was a past manager of the

radiation control program, so he performs a detailed review, according to the

current program manager. The multiple levels of management review mitigate

the issue of supervisory signatures on the field notes, but the review team

suggests that this is an area needing more attention by the State. The review

team suggests that the State devote more attention to supervisory sign-off on

inspection field notes, to indicate supervisory review. The program manager

should sign all final field notes or the State should adopt a policy that the

Division Director's signature on the letter to the licensee constitutes

supervisory approval.

Based on the IMPEP evaluation criteria, the review team recommends that North

Dakota's performance with respect to the indicator, Technical Quality of

Inspections, be found satisfactory.

3.5 Response to Incidents and Allegations

In evaluating the effectiveness of the State's actions in responding to

incidents and allegations, the review team examined the State's response to

the questionnaire regarding this indicator and reviewed the casework, and

license files as appropriate, of five incidents and two allegations. In

addition, the review team interviewed the radioactive materials supervisor and

the health physicists assigned to each response.

Responsibility for initial response and follow-up actions to materials

incidents and allegations rests with the radioactive materials section. 

Written procedures require the prompt response by the section staff to each

incident or allegation, with no additional specific guidance provided by the

procedures. Because of the size of the program, each incoming notification is

discussed with both health physicists and the supervisor. If the response

included an on-site inspection, this was usually completed by two, or

sometimes all three, staff. When a follow-up was completed via telephone or

correspondence, it was assigned to the individual staff member responsible for

that institution's routine licensing and compliance. Review of the files

indicated that this approach provided effective response actions and an

appropriate response time. 

The review team examined the State's response to the four events that were

identified as most significant in the IMPEP questionnaire, the State's

incident and allegation file, and the appropriate license files. Events

reviewed included two lost well-logging sources and a lost generally-licensed

static meter. The incident file included three annual overexposures at two

institutions which were determined to have been caused primarily by medical

fluoroscopy. A list of the incident casework with comments is included in

Appendix F.

In the cases reviewed in depth, the review team found that the State's

responses were well within the performance criteria. Responses were prompt

and well-coordinated, and the level of effort was commensurate with health and

safety significance. Radioactive materials control program staff were

dispatched to the sites when appropriate. The State took suitable corrective
North Dakota Final Report Page 13

and enforcement actions and followed the progress of the investigation through

close-out. 

Allegations were responded to promptly with appropriate investigations and

follow-up actions. In one allegation the identity of the alleger was

inadvertently released to the licensee. Although the individual expressed

concern, the individual did not wish to proceed with additional action

regarding this issue. The State told the review team that they do not have

written procedures regarding protecting allegers' identities, except for cases

that go the State's Attorney General.

 

Based on the IMPEP evaluation criteria, the review team recommends that North

Dakota's performance with respect to the indicator, Response to Incidents and

Allegations, be found satisfactory. 

4.0 NON-COMMON PERFORMANCE INDICATORS

IMPEP identifies four non-common performance indicators to be used in

reviewing Agreement State programs: (1) Legislation and Regulations, 

(2) Sealed Source and Device Evaluation Program, (3) Low-Level Radioactive

Waste Disposal Program, and (4) Uranium Recovery. North Dakota has no

agreement to regulate uranium recovery operations, so only the first three

non-common performance indicators were applicable to this review.

4.1 Legislation and Regulations

4.1.1 Legislative and Legal Authority

Given the State's response to the questionnaire that there had been no change

to the State legislation, the review team did not review the legislation but

relied on previous reviews where State legislation was determined to be

adequate. Although the State indicated in the response to the questionnaire

that there were no changes to legislation that affect the radiation control

program, the review team discussed both the radiation control act and the

administrative act with the staff. The Department of Health is designated as

the State radiation protection agency in the North Dakota Century Code,

Chapter 23-20. The Code grants the Department of Health the authority to

promulgate rules and regulations to be followed in the administration of a

radiation protection program.

4.1.2 Status and Compatibility of Regulations

North Dakota's final equivalent rules and amendments to the following rules

became effective in July 1995: "Licensing and Radiation Safety Requirement

for Irradiators," 10 CFR Part 36; "Decommissioning Recordkeeping and License

Termination: Documentation Additions," 10 CFR Parts 30, 40, 70, and 72; 

"Self-Guarantee as an Additional Financial Mechanism," 10 CFR Parts 30, 40,

and 70; and "Timeliness in Decommissioning of Materials Facilities," 10 CFR

Parts 30, 40, and 70. These regulations were promulgated within the three

year period. NRC staff has reviewed the amended regulations and has found

these regulations are compatible with equivalent NRC regulations. 

According to information provided in the questionnaire, the State does not

regulate uranium recovery operations or a low-level radioactive waste disposal

facility; it does not have a rule equivalent to NRC's 10 CFR Part 61 and NRC's

regulations applicable to uranium recovery contained in 10 CFR Part 40. 

Therefore, it will not adopt the regulations equivalent to the following NRC

rules:
North Dakota Final Report Page 14

• "Definition of Land Disposal and Waste Site QA Program," 10 CFR Part 61

amendments (58 FR 33886) that became effective on July 22, 1993.

• "Uranium Mill Tailings Regulations: Conforming NRC Requirements to EPA

Standards," 10 CFR Part 40 amendments (59 FR 28220) that became

effective on July 1, 1994, and will need to be adopted by July 1, 1997.

The State has not begun the process of promulgation of the following rules

necessary for a compatible program:

• "Preparation, Transfer for Commercial Distribution and Use of Byproduct

Material for Medical Use," 10 CFR Parts 30, 32, and 35 amendments

(59 FR 61767, 59 FR 65243, 60 FR 322) that became effective on

January 1, 1995.

• "Frequency of Medical Examinations for Use of Respiratory Protection

Equipment," 10 CFR Part 20 amendments (60 FR 7900) that became effective

on March 13, 1995. Note, this rule is designated as a Division 2 matter

of compatibility. Division 2 compatibility allows the Agreement States

flexibility to be more stringent (i.e., the State could choose to

continue to require annual medical examinations). 

• "Low-Level Waste Shipment Manifest Information and Reporting," 10 CFR

Parts 20 and 61 amendments (60 FR 15649, 60 FR 25983) that will become

effective March 1, 1998. North Dakota and other Agreement States are

expected to have that equivalent rule effective on the same date.

• "Performance Requirements for Radiography Equipment," 10 CFR Part 34

amendments (60 FR 28323) that became effective June 30, 1995.

• "Radiation Protection Requirements: Amended Definitions and Criteria,"

10 CFR Parts 19 and 20 amendments (60 FR 36038) that became effective

August 14, 1995.

• "Medical Administration of Radiation and Radioactive Materials," 10 CFR

Part 20 and 35 amendments (60 FR 50248) that became effective 

October 20, 1995.

• "Clarification of Decommissioning Funding Requirements," 10 CFR Parts

30, 40, and 70 amendments (60 FR 38235) that became effective

November 24, 1995.

• "Compatibility with the International Atomic Energy Agency," 10 CFR Part

71 amendment (60 FR 50248) that will become effective April 1, 1996.

The review team examined the procedures used in the State's regulation

promulgation process and found that the public is offered the opportunity to

comment on proposed regulations during two different 30-day comment periods

and in a public hearing. According to program management, the NRC is provided

with drafts for comment on the proposed regulations early in the promulgation

process. A copy of the final regulation is submitted to NRC.

The State's regulations were compatible with those of the NRC at the time of

the review, including all regulations necessary for a compatible program that

are due by December 1997. During discussions with the review team, program

management explained that they would begin the process of preparing draft

revisions to the regulations in late 1996 for new regulations due in 1998. 

The State's formal regulation promulgation process takes approximately 
North Dakota Final Report Page 15

9-10 months. The State is aware of the importance of maintaining compatible

regulations and the State plans to make every effort to maintain

compatibility. 

Based on the IMPEP evaluation criteria, the review team recommends that North

Dakota's performance with respect to the indicator, Legislation and

Regulations, be found satisfactory.

4.2 Sealed Source and Device Evaluation Program

The review team did not review the State's sealed source and device (SS&D)

evaluation program because of the request from North Dakota Governor

Edward T. Schafer to Richard L. Bangart, Director, Office of State Programs,

on September 25, 1995, to relinquish its SS&D authority. The State did not

perform SS&D evaluations in the past, except for two customized evaluations in

1983, and believes it is not likely that any devices containing radioactive

material will be manufactured in the near future. In addition, such

evaluations require large personnel resource requirements that are not within

the scope of the North Dakota program. Based on the Governor's request, NRC

assumed SS&D authority on June 1, 1996. The State has not performed any

evaluations during the period covered by this review.

4.3 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 low-level radioactive waste as a separate category. Those

States with existing agreements prior to 1981 were determined to have

continued low-level radioactive waste disposal authority without the need of

an amendment. Although North Dakota has low-level radioactive waste disposal

authority, NRC has not required the State to have a program for licensing a

low-level radioactive waste disposal facility until such time as the State has

been designated as a host State for a low-level radioactive waste disposal

facility. When an Agreement State has been notified or becomes aware of the

need to regulate a low-level radioactive waste disposal facility, it is

expected to put in place a regulatory program which will meet the criteria for

an adequate and compatible low-level radioactive waste disposal program. 

There are no plans for a low-level radioactive waste disposal facility in

North Dakota. Accordingly, the review team did not review this indicator.
North Dakota Final Report Page 16

5.0 SUMMARY

As noted in Section 3 above, the review team found the State's performance

with respect to four of the five common performance indicators to be fully

satisfactory. On the Status of Materials Inspection Program indicator, the

review team found the State's performance to be satisfactory with

recommendations for improvement. As noted in Section 4 above, the review team

found the State's performance on the only applicable non-common performance

indicator to be satisfactory. The MRB concurred in the team's individual and

overall recommendations and found that the North Dakota program was adequate

to protect public health and safety and was compatible with NRC's regulatory

program.

Below is a summary list of recommendations, as mentioned in earlier sections

of the report, for consideration by the State. 

1. The review team recommends that the State adopt a written timeliness

goal for issuance of inspection findings to the licensee. (Section 3.1)

2. The review team recommends that State management and staff devote

increased attention to issuing inspection results in a timely manner

(30 days). (Section 3.1)

3. The review team recommends that the State monitor the timeliness of

issuing inspection findings to licensees, as experience is gained with

the new management tracking system. Within the next year, the State

should perform a systematic assessment of the tracking system, and

decide whether it is effective in tracking assignments and prompting

staff and management to issue inspection findings. (Section 3.1)

4. The review team recommends that, over the next year, the State should

assess whether initial inspections have been performed within 6 months

of license issuance or within the provisions of IMC 2800, and whether

the State's method for scheduling initial inspections has worked

adequately. (Section 3.1)

5. The review team suggests that the State follow-through on its plan to

have the radioactive material control program staff member complete the

licensing course. (Section 3.2) 

6. The review team suggests that the program manager attend the licensing

course as soon as practical. The program manager should also eventually

complete the inspection procedures course. (Section 3.2)

7. The review team suggests that out-of-State travel considerations should

not curtail necessary training for program personnel. (Section 3.2)

8. The review team suggests that inspectors sign all final versions of the

inspection field notes or that management adopt a policy that inspectors

need not sign the field notes. (Section 3.4)

9. The review team suggests that the State devote more attention to

supervisory sign-off on inspection field notes, to indicate supervisory

review. The program manager should sign all final field notes or the

State should adopt a policy that the Division Director's signature on

the letter to the licensee constitutes supervisory approval. 

(Section 3.4)
LIST OF APPENDICES AND ATTACHMENTS

Appendix A IMPEP Review Team Members

Appendix B North Dakota Department of Health, Division of Environmental

Engineering Organization Charts

Appendix C North Dakota's Questionnaire Response

Appendix D License File Reviews

Appendix E Inspection File Reviews

Appendix F Incident File Reviews

Attachment 1 North Dakota's Response to Review Findings
APPENDIX A

IMPEP REVIEW TEAM MEMBERS

Name Area of Responsibility

Scott Moore, NMSS/IMNS On-Site Team Leader

Status of Materials Inspection Program

Technical Staffing and Training

Technical Quality of Inspections

Charles Mattson, Colorado Technical Quality of Licensing Actions

Response to Incidents and Allegations

James Lynch, RIII Advance Team Leader

Inspection Accompaniments

Kathleen Schneider, OSP Legislation and Regulations (from NRC

Headquarters)
APPENDIX B

NORTH DAKOTA DEPARTMENT OF HEALTH

AND

DIVISION OF ENVIRONMENTAL ENGINEERING

ORGANIZATION CHARTS
APPENDIX C

INTEGRATED MATERIALS PERFORMANCE EVALUATION

PROGRAM QUESTIONNAIRE
ATTACHMENT 1

NORTH DAKOTA'S RESPONSE TO REVIEW FINDINGS