February 29, 2012 

Aggie Leitheiser, Assistant Commissioner 

Health Protection Bureau 

Minnesota Department of Health 

P. O. Box 64975 

St. Paul, MN 55164-0975 

 

Dear Ms. Leitheiser: 

On February 14, 2012, the Management Review Board (MRB) met to consider the proposed 

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

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

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

Section 4.0, page 9, of the enclosed final report contains a summary of the IMPEP team’s 

findings. The review team made no recommendations in regard to program performance by the 

Minnesota Agreement State Program during this review. Based on the results of the current 

IMPEP review, the next full review of the Minnesota Agreement State Program will take place in 

approximately five years from the date of the current review, with a periodic meeting tentatively 

scheduled for May 2014. The Minnesota Agreement State Program received an extension of 

1 year for the next IMPEP review based on two consecutive IMPEP reviews with satisfactory 

findings for all the performance indicators reviewed. 

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/ 

 Michael F. Weber

 Deputy Executive Director for Materials, Waste, 

 Research, State, Tribal and Compliance Programs 

 Office of the Executive Director for Operations 

Enclosure: 

Minnesota Final IMPEP Report 

cc w/ encl: Dale Dorschner, Environmental Health Manager 

 Indoor Environments and Radiation Section 

 Sherrie Flaherty, Supervisor 

 Radioactive Materials Unit
Aggie Leitheiser, Assistant Commissioner 

Health Protection Bureau 

Minnesota Department of Health 

P. O. Box 64975 

St. Paul, MN 55164-0975 

 

Dear Ms. Leitheiser: 

On February 14, 2012, the Management Review Board (MRB) met to consider the proposed 

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

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

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

Section 4.0, page 9, of the enclosed final report contains a summary of the IMPEP team’s 

findings. The review team made no recommendations in regard to program performance by the 

Minnesota Agreement State Program during this review. Based on the results of the current 

IMPEP review, the next full review of the Minnesota Agreement State Program will take place in 

approximately 5 years from the date of the current review, with a periodic meeting tentatively 

scheduled for May 2014. The Minnesota Agreement State Program received an extension of 

1 year for the next IMPEP review based on two consecutive IMPEP reviews with satisfactory 

findings for all the performance indicators reviewed. 

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/ 

 Michael F. Weber

 Deputy Executive Director for Materials, Waste, 

 Research, State, Tribal and Compliance Programs 

 Office of the Executive Director for Operations 

Enclosure: 

Minnesota Final IMPEP Report 

cc w/ encl: Dale Dorschner, Environmental Health Manager 

 Indoor Environments and Radiation Section 

 Sherrie Flaherty, Supervisor 

 Radioactive Materials Unit 

DISTRIBUTION: EDATS: FSME-2012-0008 

See next page 

ADAMS Accession Number: ML120520266 

OFFICE FSME/MSSA FSME/MSSA FSME/MSSA FSME/MSSA 

NAME LDimmick LCD DWhite ADW PHenderson PH BMcDermott PH for

DATE 02/ 23 /12 02/ 23 /12 02/ 24 /12 02/ 24 /12 

OFFICE Tech Editor FSME DEDMRT 

NAME CPoland PNT for MSatorius CC for MWeber 

DATE 02/ 27 /12 02/ 27 /12 02/29/12 

OFFICIAL RECORD COPY
Letter to A. Leitheiser from Michael F. Weber dated: February 29, 2012 

SUBJECT: Minnesota 2012 FINAL IMPEP REPORT 

DISTRIBUTION: EDATS: FSME-2012-0008 

MSSA_Technical_Asst_Resource DCD (SP01) 

RidsEdoMailCenter 

RidsFsmeOd 

RidsOgcMailCenter 

RidsFsmeDmssaResource 

RidsSecyCorrespondenceMailCenter Chairman Jaczko 

DJanda, RI/RSAO Commissioner Svinicki 

JLynch, RIII/RSAO Commissioner Apostolakis 

MMcKinley, KY Commissioner Magwood 

JOpila, CO Commissioner Ostendorff 

AHowell, RIV SECY 

RidsRgn3MailCenter 

MBeardsley, FSME 

DMerzke, OEDO 

JWeil, OCA (2 copies) 
Enclosure 

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM 

REVIEW OF THE MINNESOTA AGREEMENT STATE PROGRAM 

NOVEMBER 14 – 18, 2011 

FINAL REPORT
EXECUTIVE SUMMARY 

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

(IMPEP) review of the Minnesota Agreement State Program. The review was conducted during 

the period of November 14-18, 2011, by a review team composed of technical staff members 

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

Based on the results of this review, the review team recommended, and the Management 

Review Board (MRB) agreed, that Minnesota’s performance be found satisfactory for the six 

performance indicators reviewed. The review team did not make any recommendations 

regarding program performance by the State. Accordingly, the review team recommended, and 

the MRB agreed, that the Minnesota Agreement State Program be found adequate to protect 

public health and safety and compatible with the NRC's program. 

Based on the results of the current IMPEP review, and in accordance with the criteria in NRC 

Management Directive 5.6, the review team recommended, and the MRB agreed, that the next 

IMPEP review take place in approximately five years (receiving a one year extension for good 

performance.) 
Minnesota Final IMPEP Report Page 1

1.0 INTRODUCTION 

This report presents the results of the review of the Minnesota Agreement State Program. 

The review was conducted during the period of November 14-18, 2011, by a review team 

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

the Commonwealth of Kentucky. Team members are identified in Appendix A. The review was 

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

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

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

Materials Performance Evaluation Program (IMPEP),” dated February 26, 2004. Preliminary 

results of the review, which covered the period of October 20, 2007, to November 18, 2011, 

were discussed with Minnesota managers on the last day of the review. 

A draft of this report was provided to Minnesota for factual comment on December 12, 2011. 

The State responded by letter dated January 17, 2012. A copy of the State’s response is 

included as an Attachment to this report. A Management Review Board (MRB) met on February 

14, 2012, to consider the proposed final report. The MRB found the Minnesota Agreement 

State Program adequate to protect public health and safety, and compatible with NRC’s 

program. 

The Minnesota Department of Health (the Department) is designated as the State’s radiation 

control agency. The Agreement State Program is administered by the Radioactive Materials 

Unit (the Unit), which is located within the Indoor Environments and Radiation Section (the 

Section) of the Division of Environmental Health (the Division). The Division is part of the 

Health Protection Bureau (the Bureau), which is one of four bureaus in the Department. The 

Unit Supervisor reports to the Section Environmental Health Manager. Organization charts for 

the Department and the Section are included as Appendix B. 

At the time of the review, the Minnesota Agreement State Program (the Program) regulated 178 

specific licenses authorizing possession and use of radioactive materials. The review focused 

on the radioactive materials program as it is carried out under the Section 274b. (of the Atomic 

Energy Act of 1954, as amended) Agreement between NRC and the State of Minnesota. 

In preparation for the review, a questionnaire addressing the common and applicable noncommon performance indicators was sent to the Section on September 19, 2011. The Section 

provided its response to the questionnaire on October 25, 2011. A copy of the questionnaire 

response can be found in NRC’s Agencywide Documents Access and Management System 

(ADAMS) using the Accession Number ML113110142. 

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

the Section’s response to the questionnaire; (2) review of applicable Minnesota statutes and 

regulations; (3) analysis of quantitative information from the Unit’s database; (4) technical 

review of selected regulatory actions; (5) field accompaniments of three inspectors; and 

(6) interviews with staff and managers. The review team evaluated the information gathered 

against the established criteria for each common performance indicator and the applicable noncommon performance indicator and made a preliminary assessment of the Minnesota 

Agreement State Program’s performance. 
Minnesota Final IMPEP Report Page 2

There were no recommendations made to the State during the previous IMPEP review, which 

concluded on October 19, 2007. Section 2.0 of this report covers the current review of the 

common performance indicators. Section 3.0 details the results of the review of the applicable 

non-common performance indicators, and Section 4.0 summarizes the review team's findings. 

2.0 COMMON PERFORMANCE INDICATORS 

Five common performance indicators are used to review 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. 

2.1 Technical Staffing and Training

Issues central to the evaluation of this indicator include the Unit’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 Section’s questionnaire response relative to this 

indicator; interviewed managers and staff, reviewed job descriptions and training records, and 

considered any workload backlogs. 

The Minnesota Agreement State Program is composed of the Unit Supervisor (Supervisor), four 

technical staff, and one administrative assistant. The Supervisor is responsible for coordinating 

materials inspections, licensing and compliance activities. Technical staff perform both 

licensing and inspection duties and respond to incidents and allegations. The Supervisor and 

technical staff also perform emergency response duties. Based on information provided by the 

Unit, the review team estimated that the Unit routinely expends approximately 4.8 full-time 

equivalents (FTE) to administer the Agreement State program, including administrative duties. 

In September 2010, the former Supervisor retired and a technical staff member was 

subsequently promoted to the Supervisor position. In addition, during the review period, two 

technical staff members left the Unit and three technical staff members were hired into the Unit. 

There are no open positions currently. 

Due to a State budget impasse, Minnesota state government services were shut down from 

July 1, 2011, until July 20, 2011. During this period, the Department retained two staff members 

for the Agreement State program and all other staff members were laid off. On June 30, 2011, 

the Department submitted a contingency plan to NRC which described the Department’s plans 

for continuity of operations during the State government shutdown. On July, 1, 2011, the NRC 

responded to the Department’s letter and found that the contingency plan was acceptable for 

the short term and provided adequate assurance that the Program would continue to respond to 

emergencies and protect public health and safety in case of a radioactive material event during 

the temporary government shutdown. 

The review team noted that the Program experienced stable funding during the review period. 

The Government shutdown did not affect overall funding of the Program. The Program is totally 

funded through licensee fees which have not been increased since the 2007 IMPEP review. 
Minnesota Final IMPEP Report Page 3

The Unit has a documented training plan that is consistent with the guidance in the NRC’s 

Inspection Manual Chapter 1246, “Formal Qualification Programs in the Nuclear Materials 

Safety and Safeguards Program Area.” All technical staff members have a Bachelor’s degree in 

a science discipline. Technical staff members attend NRC courses, or equivalent, as part of 

their inspection and license reviewer qualification process. In addition the staff has on-the-job 

training to supplement formal course work. Under the direction of the Supervisor, technical staff 

members are assigned increasingly complex licensing actions and accompany more 

experienced inspectors on complex inspections. Inspectors are assigned independent 

inspections after demonstrating competence during accompaniment evaluations by the 

Supervisor. The review team confirmed the qualifications of all technical staff through review of 

qualification journals, training records, and documentation of supervisory accompaniments. The 

review team concluded that management is supportive of staff training opportunities. 

The Supervisor and one senior technical staff member are fully qualified to perform both 

licensing and inspection activities and have completed the required training in each of these 

areas. The two technical staff members who were hired in late 2010 are currently in the 

qualification process and can independently perform inspections of lower priority (i.e., priority 5) 

licensees. The Supervisor anticipates both staff members being fully qualified by the end of 

calendar year 2012. The review team concluded that the Unit has a well-balanced staff and an 

adequate number of trained personnel to carry out its regulatory responsibilities. 

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

that Minnesota’s performance with respect to the indicator, Technical Staffing and Training, be 

found satisfactory. 

2.2 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 Unit’s questionnaire response relative to this indicator, data gathered from the Unit’s 

database, examination of completed inspection casework, and interviews with managers and 

staff members. 

The Unit tracks all inspection activities in a computer database. The review team observed that 

the database could easily be queried by managers and staff to determine the inspection status 

for any licensed facility. In addition, the notification of licensees working under reciprocity in the 

state was also easily accessible from the database. 

The review team verified that the Unit’s inspection frequencies for all types of radioactive 

materials licenses are at least the same frequency as those listed in NRC’s IMC 2800, 

“Materials Inspection Program.” The review team confirmed the Unit is conducting Increased 

Controls inspections in conjunction with the routine health and safety inspections. 

The Unit conducted 135 Priority 1, 2, and 3 inspections during the review period. The Unit 

indicated in its response to the questionnaire that no inspections were conducted overdue by 

more than 25 percent of the inspection frequency prescribed by IMC 2800. The review team 

verified that no Priority 1, 2, or 3 inspections were conducted overdue during the review period 
Minnesota Final IMPEP Report Page 4

or found overdue at the time of the review. 

The review team evaluated the Unit’s timeliness for conducting initial inspections. The review 

team noted that the Unit issued 11 new licenses during the review period and conducted all 

initial inspections within 12 months after license issuance as prescribed by IMC 2800. 

The review team evaluated the Unit’s timeliness for issuance of inspection reports. The Unit 

has a policy of issuing the inspection findings to licensees within 30 days from the date of the 

inspection. All inspection reports are submitted for both a peer and supervisory review. Based 

on a review of 48 inspection reports, the review team identified two of the inspection reports 

were provided to the licensees beyond the Unit’s 30-day goal. 

During the review period, the Unit granted 97 reciprocity permits, 39 of which were candidate 

licensees based upon the criteria in IMC 1220 “Processing of NRC Form 241 and Inspection of 

Agreement State Licensees Operating Under 10 CFR 150.20.” The review team determined 

that the Unit exceeded the NRC’s criteria of inspecting 20 percent of candidate licensees 

operating under reciprocity in each of the four years covered by the review period. 

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

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

Program, be found satisfactory. 

2.3 Technical Quality of Inspections

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

notes and interviewed the responsible inspector for 28 radioactive materials inspections 

conducted during the review period. The casework examined included a cross-section of 

inspections conducted by eight current and former inspectors and covered a wide variety of 

inspection types. These included radiation therapy, mobile nuclear medicine, veterinarian 

nuclear medicine, industrial radiography, portable gauges, gamma knife, nuclear pharmacy, 

Positron Emission Tomography production, well logging, and research. The casework included 

initial, routine, reciprocity, and Increased Controls inspections. Appendix C lists the inspection 

casework files reviewed. 

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

aspects of the licensees’ radiation safety and security programs. The review team noted that 

the inspections covered the Increased Controls, fingerprinting, and the National Source 

Tracking System when appropriate. The review team found that inspection reports were very 

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

licensees’ performances with respect to health, safety, and security were acceptable. 

Inspection report documentation supported violations, recommendations made to licensees, and 

unresolved safety issues. All inspection reports are peer-reviewed by a qualified inspector and 

are approved by the Unit Supervisor. 

While on site, the review team evaluated the Unit’s handling and storing of sensitive documents. 

The team noted that inspection reports were appropriately marked as containing sensitive 

information. Inspection files containing Increased Controls documents were protected in locked 

cabinets in a limited access room. 
Minnesota Final IMPEP Report Page 5

The Unit has a policy to accompany all staff performing radioactive materials inspections on an 

annual basis. All inspector accompaniments were performed annually during the review period 

except for one missed accompaniment in 2010 due to a managerial transition. The 

accompaniment reports contained sufficient details to document the areas covered during the 

accompaniments. 

The review team noted that the Unit has an adequate supply of survey instruments to support its 

inspection program, as well as to respond to incidents and emergency conditions. Appropriate, 

calibrated survey instruments, such as Geiger-Mueller (GM) meters, scintillation detectors, ion 

chambers, micro-R meters, and neutron detectors, were observed to be available. The Unit 

also has portable multi-channel analyzers for field identification of radioisotopes. Instruments 

are calibrated at least annually, or as needed, with sources that were traceable to the National 

Institute of Standards and Technology. The Unit uses a database to track each instrument, its 

current location, and its calibration due date. In addition, the Unit supplies calibrated radiation 

detection equipment to the Minnesota Department of Transportation’s Hazardous Materials 

Inspectors, and the Minnesota Highway Patrol. The Unit receives laboratory and sample 

analysis support from the Public Health Laboratory Division within the Department. 

A review team member accompanied three of the Unit’s inspectors during the period of October 

17-19, 2011. The inspectors conducted inspections at a medical licensee, an industrial 

radiography licensee, and a portable gauge licensee. The inspector accompaniments are listed 

in Appendix C. The inspectors demonstrated performance-based inspection techniques and 

knowledge of the regulations. The inspectors were well trained, prepared for the inspections, 

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

inspectors conducted interviews with appropriate personnel, observed licensed operations, 

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

inspectors held entrance and exit meetings with the appropriate level of licensee management. 

The review team determined that the inspections were adequate to assess radiological health, 

safety, and security at the licensed facilities. 

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

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

found satisfactory. 

2.4 Technical Quality of Licensing Actions

The review team examined completed casework and interviewed license reviewers for 18 

licensing actions covering 17 specific licenses. Licensing actions were reviewed for 

completeness, consistency, proper radioisotopes and quantities, qualifications of authorized 

users, adequacy of facilities and equipment, adherence to good health physics practices, 

financial assurance, security requirements, operating and emergency procedures, 

appropriateness of license conditions, and overall technical quality. The casework was also 

reviewed for timeliness, use of appropriate correspondence, reference to appropriate 

regulations, supporting documentation, consideration of enforcement history, pre-licensing 

visits, peer and supervisory review, and proper signatures. 

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

completed during the review period. Licensing actions selected for evaluation included two new 
Minnesota Final IMPEP Report Page 6

licenses, five renewals, nine amendments, and two license terminations. Casework reviewed 

included a cross-section of license types, including: industrial radiography, broad scope - 

medical and academic, nuclear medicine - diagnostic and therapeutic, research and 

development, portable gauge, fixed gauge, nuclear pharmacy, and veterinary. A listing of the 

licensing casework reviewed can be found in Appendix D. 

The review team found that the licensing actions were thorough, complete, consistent, and of 

high quality with health, safety, and security issues properly addressed. License tie-down 

conditions were stated clearly, backed by information contained in the file and enforceable. The 

review team found that actions terminating licenses were well documented, included the 

appropriate material survey records, and contained documentation of proper disposal or transfer 

of radioactive material, as appropriate. 

The Unit has two fully qualified license reviewers including the supervisor, and two partially 

qualified license reviewers. License reviewers use the Unit’s licensing guidance which is 

compatible with NRC’s NUREG-1556 series. Licenses are created and tracked using a local 

database. Licensing actions are tracked on a master list which is accessible to all license 

reviewers but not linked directly to the database. Once completed all licensing actions are peer 

reviewed by another qualified license reviewer, and then reviewed and signed by the Unit 

Supervisor. The Unit identified six licensees requiring financial assurance; all licensees had 

financial assurance in place prior to the review period. 

The review team verified that the Unit uses legally binding license conditions that meet the 

criteria for implementing the Increased Controls Orders, including fingerprinting, as appropriate. 

There are currently 24 licenses that are required to meet these requirements. Files containing 

Increased Control licenses are kept in a locked file room. The review team determined that 

these licenses and corresponding cover letters were marked as containing sensitive information 

as required. In addition, the review team verified that the Unit is identifying and marking 

sensitive security-related information appropriately in accordance with their policy. 

The review team assessed the Unit’s implementation of the pre-licensing guidance. The Unit 

has implemented the essential elements of NRC’s pre-licensing guidance issued on September 

22, 2008, and transmitted to the Agreement States via Office of Federal and State Materials and 

Environmental Management Programs (FSME) Letter RCPD-08-020, “Requesting 

Implementation of the Checklist to Provide a Basis for Confidence That Radioactive Material 

Will Be Used as Specified on a License and the Checklist for Risk-significant Radioactive 

Material.” The Unit has incorporated a basic pre-licensing checklist into the licensing process. 

The Unit completes pre-licensing visits as required. New licensees that fall under the Increased 

Controls also have a full security inspection performed prior to issuing the license. 

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

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

Actions, be found satisfactory. 

2.5 Technical Quality of Incident and Allegation Activities 

In evaluating the effectiveness of the Unit=s actions in responding to incidents and allegations, 

the review team examined the Unit=s response to the questionnaire relative to this indicator, 
Minnesota Final IMPEP Report Page 7

evaluated selected incidents reported for Minnesota in the Nuclear Material Events Database 

(NMED) against those contained in the Unit=s files, and evaluated the casework for 13 

radioactive materials incidents. A listing of the incident casework examined, with case-specific 

comments, may be found in Appendix E. The review team also evaluated the Unit=s response 

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

by the NRC during the review period. 

The incidents selected for review included the following categories: medical events, lost 

material, damaged equipment, leaking sources, and equipment failure. The review team 

determined that the Unit=s response to incidents was complete and comprehensive. Initial 

responses were prompt and well-coordinated, and the level of effort was commensurate with the 

health and safety significance. The Unit dispatched inspectors for on-site investigations, as 

appropriate, in all of the cases reviewed and took suitable enforcement and follow-up actions. If 

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

Materials and Environmental Management Programs (FSME) Procedure SA-300 “Reporting 

Material Events,” the State notified the NRC Headquarters Operations Center and entered the 

information into NMED, in a prompt manner. As additional incident details were learned, the 

NMED records were updated, using the NMED software. 

The review team noted that at the conclusion of investigations, inspectors generated reports 

that thoroughly documented their findings; however, two of the incident reports could not be 

located during the review. The Unit Supervisor stated that all incident investigation reports 

would be tracked in the future. 

In evaluating the effectiveness of Minnesota's actions responding to allegations, the review 

team evaluated the casework for three allegations, one of which was referred to the State by the 

NRC. The Unit evaluated each allegation and determined the proper level of response. The 

review team determined that the Unit took prompt and appropriate action in response to all 

concerns raised. All of the allegations reviewed were appropriately closed, appropriate parties 

were notified of the actions taken, and allegers’ identities were protected. The review team 

identified no performance issues from the evaluation of the allegation casework. 

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

that Minnesota=s performance with respect to the indicator, Technical Quality of Incident and 

Allegation Activities, be found satisfactory.

3.0 NON-COMMON PERFORMANCE INDICATORS 

3.1 Compatibility Requirements

3.1.1 Legislation

Minnesota became the 34th Agreement State on March 31, 2006. The current effective statutory 

authority is contained in the Minnesota Statutes, Sections 144.12 through 144.1205. Section 

144.1202 authorized the Governor to enter into the Agreement with the Commission and 

contains provisions for the orderly transfer of regulatory authority over affected licenses from 

NRC to the State. This Section identifies the Minnesota Department of Health as the lead 

agency for the Agreement State program. 
Minnesota Final IMPEP Report Page 8

3.1.2 Program Elements Required for Compatibility

Minnesota’s regulations for the control of radiation are located in the Minnesota Rules Chapters 

4731 and 4732. Minnesota requires a license for possession and use of all radioactive 

materials, including naturally occurring radioactive materials, such as radium, and acceleratorproduced radionuclides. 

The review team examined the State’s administrative rulemaking process and found that the 

process typically takes approximately one year after drafting before a rule becomes effective. 

Draft rules are developed by Unit staff and then sent to the Office of the Revisor of Statutes. 

Proposed rules are then published for comment in a Notice of Intent to Adopt Rules in the 

Minnesota Register. A hearing opportunity is offered upon publication of the notice. An 

Administrative Law Judge approves final rules prior to submission to the Secretary of State for 

final approval. At the conclusion of the rulemaking process, a Notice of Adoption is published in 

the Minnesota Register. The Governor’s office is informed of proposed rules at each step in the 

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

conditions) in lieu of regulations until compatible regulations become effective. Minnesota’s 

regulations are not subject to any sunset provisions. 

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

reviewed the status of regulations required to be adopted, and verified the final adoption of 

regulations with data obtained from the State Regulation Status Sheet maintained by FSME. 

Since the previous IMPEP review, the Department has completed and adopted twelve 

amendments. During the onsite review, the Unit submitted the following final amendment due 

for adoption by September 28, 2012. 

• “Medical Use of Byproduct Material –Authorized User Clarification,” Part 35 (74 FR 

33901). 

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

legally binding requirements no later than three years after they become effective. There were 

no amendments overdue at the time of the review. 

The State will need to address the following amendments in upcoming rulemakings or by 

adopting alternate legally binding requirements: 

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

effective on December 17, 2011, and is due for Agreement State adoption by December 

17, 2015. 

• “Licenses, Certifications, and Approvals for Materials Licensees,” Parts 30, 36, 39, 70, 

and 150 (76 FR 56951) that became effective on November 14, 2011, and is due for 

Agreement State adoption by November 14, 2014. 

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

Minnesota’s performance with respect to the indicator, Compatibility Requirements, be found 

satisfactory. 
Minnesota Final IMPEP Report Page 9

4.0 SUMMARY 

As noted in Sections 2.0 and 3.0 above, Minnesota’s performance was found satisfactory for all 

six performance indicators reviewed. The review team made no recommendations regarding 

the performance of the Minnesota Agreement State Program. Accordingly, the review team 

recommended, and the MRB agreed, that the Minnesota Agreement State Program be found 

adequate to protect public health and safety, and compatible with the NRC's program. 

Based on the results of the current IMPEP review, the review team recommended, and the MRB 

agreed, that the next full IMPEP review take place in approximately five years (receiving a one 

year extension based on good performance.)
LIST OF APPENDICES 

Appendix A IMPEP Review Team Members 

Appendix B Minnesota Organization Charts 

Appendix C Inspection Casework Reviews 

Appendix D License Casework Reviews 

Appendix E Incident Casework Reviews 
APPENDIX A 

IMPEP REVIEW TEAM MEMBERS 

Name Area of Responsibility

Donna Janda, Region I Team Leader 

 Technical Staffing and Training 

 Inspector Accompaniments 

 

Lisa Dimmick, FSME Status of Materials Inspection Program 

 Compatibility Requirements 

Jim Lynch, Region III Technical Quality of Inspections 

 Technical Quality of Incident and Allegation 

 Activities 

 

Matthew McKinley, Kentucky Technical Quality of Licensing Actions
APPENDIX B 

MINNESOTA ORGANIZATION CHARTS 

ADAMS ACCESSION NO.: ML113110139
APPENDIX C 

INSPECTION CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

Licensee: IESCO License No.: 1181 

Inspection Type: Special, Unannounced Priority: 2 

Inspection Dates: 1/22-23/09 Inspector: BJ 

File No.: 2 

Licensee: Midwest Industrial X-ray, Inc. License No.: 1186 

Inspection Type: Special, Unannounced Priority: 1 

Inspection Dates: 4/21-29/11 Inspectors: BA, LD, BJ 

File No.: 3 

Licensee: Braun Intertec Corporation License No.: 1082 

Inspection Type: Special, Unannounced Priority: 1 

Inspection Date: 9/9/08 Inspector: SF 

File No.: 4 

Licensee: Chart Industries License No.: 1075 

Inspection Type: Special, Unannounced Priority: 1 

Inspection Date: 10/14/09 Inspectors: BA, BJ 

File No.: 5 

Licensee: Medtronic, Inc. License No.: 1171 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 9/16/09 Inspector: SF 

File No.: 6 

Licensee: Abbott Northwestern Hospital License No.: 1007 

Inspection Type: Routine, Announced Priority: 2 

Inspection Dates: 2/18-23/09 Inspectors: BJ, CV 

File No.: 7 

Licensee: Animal Emergency Clinic License No.: 1215 

Inspection Type: Initial, Unannounced Priority: 5 

Inspection Dates: 2/10/11 & 3/6/11 Inspector: BA 

File No.: 8 

Licensee: Metropolitan Cardiology Consultants License No.: 1208 

Inspection Type: Initial, Unannounced Priority: 3 

Inspection Dates: 11/12-13/09 Inspectors: BJ, BA 

 
Minnesota Final IMPEP Report Page C. 2 

Inspection Casework Reviews 

 

File No.: 9 

Licensee: Stork Twin City Testing License No.: 1069 

Inspection Type: Special, Unannounced Priority: 1 

Inspection Date: 5/13/10 Inspector: BA 

File No.: 10 

Licensee: DiaSorin, Inc. License No.: 1159 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Dates: 1/27-28/10 Inspector: BJ 

File No.: 11 

Licensee: St. Mary’s Hospital License No.: 1077 

Inspection Type: Special, Unannounced Priority: 2 

Inspection Date: 12/3/09 Inspectors: GJ, BA 

File No.: 12 

Licensee: General Dynamics License No.: 1086 

Inspection Type: Special, Unannounced Priority: 2 

Inspection Date: 5/12/11 Inspectors: SF, TP 

File No.: 13 

Licensee: Lakeview Hospital License No.: 1051 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 4/12/10 Inspector: GJ 

File No.: 14 

Licensee: Macalester College License No.: 1175 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 12/11/07 Inspector: CV 

File No.: 15 

Licensee: Southdale Medical Diagnostics, LLC License No.: 1204 

Inspection Type: Initial, Unannounced Priority: 5 

Inspection Date: 6/4/09 Inspectors: SM, BJ 

File No.: 16 

Licensee: RRHS University Medical Center - Mesabi License No.: 1139 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 9/14/11 Inspector: TP 

File No.: 17 

Licensee: Midwest Asphalt Corporation License No.: 1013 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 10/12/11 Inspectors: LD, BJ 

 
Minnesota Final IMPEP Report Page C. 3 

Inspection Casework Reviews 

 

File No.: 18 

Licensee: Southern Minnesota Construction License No.: 1073 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 8/31/11 Inspector: TP 

File No.: 19 

Licensee: St. Luke’s Hospital License No.: 1137 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 1/18/11 Inspectors: SF, TP, LD 

File No.: 20 

Licensee: PETNET Solutions, Inc. License No.: 1017 

Inspection Type: Routine, Announced Priority: 2 

Inspection Dates: 10/25/07 & 11/13/07 Inspectors: SM, SF 

File No.: 21 

Licensee: Mayo Clinic License No.: 1047 

Inspection Type: Initial, Unannounced Priority: 2 

Inspection Dates: 2/11-14/08 Inspectors: SF, GJ, BJ, CV 

File No.: 22 

Licensee: Mobile Imaging Services License No.: 1009 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 6/10/09 Inspector: CV 

File No.: 23 

Licensee: Fairview Southdale Hospital License No.: 1039 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 7/9/08 Inspectors: BJ, CV 

File No.: 24 

Licensee: Baker Hughes Oilfield Operations, Inc. License No.: 9057 

Inspection Type: Reciprocity, Announced Priority: 3 

Inspection Date: 11/12/10 Inspector: BJ 

File No.: 25 

Licensee: MIKON Corporation License No.: 9059 

Inspection Type: Reciprocity, Unannounced Priority: 5 

Inspection Date: 4/13/10 Inspector: BJ 

File No.: 26 

Licensee: Lifescan Minnesota License No.: 1024 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 10/17/11 Inspector: TP 

 
Minnesota Final IMPEP Report Page C. 4 

Inspection Casework Reviews 

 

File No.: 27 

Licensee: Braun Intertec Corporation License No.: 1082 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 11/18/11 Inspector: BJ 

File No.: 28 

Licensee: City of Minneapolis License No.: 9059 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 11/19/11 Inspector: LD 

INSPECTOR ACCOMPANIMENTS 

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

Accompaniment No.: 1 

Licensee: Lifescan Minnesota License No.: 1024 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 10/17/11 Inspector: TP 

Accompaniment No.: 2 

Licensee: Braun Intertec Corporation License No.: 1082 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 10/18/11 Inspector: BJ 

Accompaniment No.: 3 

Licensee: City of Minneapolis License No.: 1015 

Inspection Type: Routine, Unannounced Priority: 5 

Inspection Date: 10/19/11 Inspector: LD
APPENDIX D 

LICENSE CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

Licensee: Animal Emergency Clinic License No.: 1215 

Type of Action: New Amendment No.: 100 

Date Issued: 09/07/10 License Reviewer: BA 

File No.: 2 

Licensee: 3M License No.: 1066 

Type of Action: Renewal Amendment No.: 200 

Dates Issued: 11/07/07 License Reviewer: SF 

File No.: 3 

Licensee: Metropolitan Cardiology Consultants License No.: 1208 

Type of Action: Amendment Amendment No.: 102 

Dates Issued: 10/28/10 License Reviewer: SF 

File No.: 4 

Licensee: Mayo Clinic License No.: 1047 

Type of Action: Amendment Amendment No.: 206 

Date Issued: 05/25/10 License Reviewer: BJ 

File No.: 5 

Licensee: US Steel Corporation License No.: 1081 

Type of Action: Amendment Amendment No.: 105 

Date Issued: 01/26/09 License Reviewer: GJ 

File No.: 6 

Licensee: Twin Ports Testing License No.: 1211 

Type of Action: New Amendment No.: 100 

Date Issued: 01/05/10 License Reviewer: SF 

File No.: 7 

Licensee: IESCO License No.: 1181 

Type of Action: Amendment Amendment No.: 201 

Date Issued: 08/03/11 License Reviewer: BJ 

Comment: 

MDH did not perform a site visit/inspection to ensure compliance with security requirements for 

vehicles prior to amending the license to allow an existing fixed site radiographer to conduct 

licensed operations at temporary job sites. The basis for this decision was that the licensee was 

known to be compliant and they made specific commitments to maintain compliance. Also, the 

licensee was due for inspection within the year. 
Minnesota Final IMPEP Report Page D. 2 

License Casework Reviews 

 

File No.: 8 

Licensee: Fairview Maple Grove Medical Center License No.: 1202 

Type of Action: Amendment Amendment No.: 101 

Date Issued: 04/22/08 License Reviewer: BJ 

File No.: 9 

Licensee: PETNET Solutions License No.: 1017 

Type of Action: Amendment Amendment No.: 108 

Date Issued: 09/28/10 License Reviewer: BJ 

File No.: 10 

Licensee: Xcel Energy License No.: 1072 

Type of Action: Renewal Amendment No.: 200 

Date Issued: 06/14/11 License Reviewer: LD 

File No.: 11 

Licensee: Xerium Technologies License No.: 1183 

Types of Action: Renewal Amendment No.: 200 

Dates Issued: 08/10/11 License Reviewer: TP 

File No.: 12 

Licensee: Bemidji State University License No.: 1144 

Types of Action: Termination Amendment No.: 103 

Dates Issued: 10/24/11 License Reviewer: TP 

File No.: 13 

Licensee: Beckman Coulter License No.: 1148 

Type of Action: Termination Amendment No.: 101 

Date Issued: 02/21/08 License Reviewer: CV 

File No.: 14 

Licensee: Ulland Brothers License No.: 1199 

Type of Action: Amendment Amendment No.: 103 

Date Issued: 04/26/11 License Reviewer: TP 

File No.: 15 

Licensee: NewPage Corporation Duluth Mills License No.: 1193 

Type of Action: Renewal Amendment No.: 200 

Date Issued: 04/11/11 License Reviewer: TP 

File No.: 16 

Licensee: North Country Health Services License No.: 1059 

Type of Action: Amendment Amendment No.: 205 

Date Issued: 03/01/11 License Reviewer: LD 
Minnesota Final IMPEP Report Page D. 3 

License Casework Reviews 

 

File No.: 17 

Licensee: Sanford Medical Center License No.: 1059 

Type of Action: Amendment Amendment No.: 206 

Date Issued: 03/14/11 License Reviewer: BA 

File No.: 18 

Licensee: Norbord Minnesota License No.: 1111 

Type of Action: Renewal Amendment No.: 200 

Date Issued: 02/28/11 License Reviewer: LD 
APPENDIX E 

INCIDENT CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS. 

File No.: 1 

Licensee: Braun Intertec Corporation License No.: 1082 

Date of Incident: 8/21/08 NMED Log No.: 080494 

Investigation Date: 8/22/08 Type of Incident: Equipment Failure 

 Type of Investigation: Site 

File No.: 2 

Licensee: Braun Intertec Corporation License No.: 1082 

Date of Incident: 6/18/09 NMED Log No.: 090591 

Investigation Date: 7/13/09 Type of Incident: Damaged Equipment 

 Type of Investigation: Telephone 

File No.: 3 

Licensee: Metropolitan Cardiology Consultants License No.: 1208 

Date of Incident: 10/6/11 NMED Log No.: 110602 

Investigation Date: 10/7/11 Type of Incident: Lost Source 

 Type of Investigation: Telephone 

File No.: 4 

Licensee: Abbott Northwestern Hospital License No.: 1007 

Date of Incident: 11/13/08 NMED Log No.: 090020 

Investigation Date: 11/14/08 Type of Incident: Lost Source 

 Type of Investigation: Telephone 

File No.: 5 

Licensee: Abbott Northwestern Hospital License No.: 1007 

Date of Incident: 3/17/11 NMED Log No.: 10144 

Investigation Date: 4/5/11 Type of Incident: Medical Event 

 Type of Investigation: Site 

File No.: 6 

Licensee: See Company License No.: 1161 

Date of Incident: 11/5/08 NMED Log No.: 090365 

Investigation Date: 12/29/08 Type of Incident: Leaking Source 

 Type of Investigation: Telephone 

File No.: 7 

Licensee: See Company License No.: 1161 

Date of Incident: 9/30/11 NMED Log No.: 110544 

Investigation Date: 10/4/11 Type of Incident: Leaking Source 

 Type of Investigation: Telephone 

 
Minnesota Final IMPEP Report Page E. 2 

Incident Casework Reviews 

 

File No.: 8 

Licensee: American Engineering and Testing License No.: 1089 

Date of Incident: 5/20/09 NMED Log No.: 090506 

Investigation Date: 5/21/09 Type of Incident: Damaged Equipment 

 Type of Investigation: Telephone 

Comment: 

The incident investigation report was not in the license file. 

File No.: 9 

Licensee: Stork Twin City Testing License No.: 1069 

Date of Incident: 10/5/09 NMED Log No.: 090766 

Investigation Date: 10/5/09 Type of Incident: Damaged Equipment 

 Type of Investigation: Site 

Comment: 

The incident investigation report was not in the license file. 

File No.: 10 

Licensee: University of Minnesota License No.: 1049 

Date of Incident: 10/30/09 NMED Log No.: 090822 

Investigation Date: 11/2/09 Type of Incident: Equipment Failure 

 Type of Investigation: Telephone 

File No.: 11 

Licensee: University of Minnesota License No.: 1049 

Date of Incident: 6/15/10 NMED Log No.: 100313 

Investigation Date: 6/18/10 Type of Incident: Medical Event 

 Type of Investigation: Site 

File No.: 12 

Licensee: Mayo Clinic License No.: 1047 

Date of Incident: 3/23/10 NMED Log No.: 100148 

Investigation Date: 4/6/10 Type of Incident: Medical Event 

 Type of Investigation: Site 

File No.: 13 

Licensee: Mayo Clinic License No.: 1047 

Date of Incident: 11/9/10 NMED Log No.: 100563 

Investigation Date: 11/15/10 Type of Incident: Medical Event 

 Type of Investigation: Site 
ATTACHMENT(S) 

January 17, 2012 Letter from Dale Dorschner 

Minnesota’s Response to the Draft Report 

ADAMS Accession No.: ML120240123