November 7, 2003

Mary Mincer Hansen, RN, Ph.D.

Director

Iowa Department of Public Health

Lucas State Office Building

321 East 12th Street

Des Moines, IA 50319

Dear Dr. Hansen: 

On September 30, 2003, the Management Review Board (MRB) met to consider the proposed

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

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

and safety and compatible with the Nuclear Regulatory Commission’s program. 

Based on the results of the current IMPEP review, the next full review will be in approximately

four years.

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

also wish to acknowledge your continued support for the Radiation Control Program and the

excellence in program administration demonstrated by your staff as reflected in the team’s

findings. I look forward to our agencies continuing to work cooperatively in the future.

Sincerely,

/RA/

Carl J. Paperiello 

Deputy Executive Director 

 for Materials, Research and State Programs

Enclosure:

As stated

cc: Tom Newton, Director

Division of Health Protection and Environmental Health

Donald A. Flater, Chief

Bureau of Radiological Health

Daniel K. McGhee, State Liaison Officer

Bureau of Radiological Health

Pearce O’Kelley, SC

OAS Liaison to the MRB
November 7, 2003

Mary Mincer Hansen, RN, Ph.D.

Director

Iowa Department of Public Health

Lucas State Office Building

321 East 12th Street

Des Moines, IA 50319

Dear Dr. Hansen: 

On September 30, 2003, the Management Review Board (MRB) met to consider the proposed

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

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

and safety and compatible with the Nuclear Regulatory Commission’s program. 

Based on the results of the current IMPEP review, the next full review will be in approximately

four years.

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

also wish to acknowledge your continued support for the Radiation Control Program and the

excellence in program administration demonstrated by your staff as reflected in the team’s

findings. I look forward to our agencies continuing to work cooperatively in the future.

Sincerely,

/RA/

Carl J. Paperiello 

Deputy Executive Director 

 for Materials, Research and State Programs

Enclosure:

As stated

cc: Tom Newton, Director, Division of Health Protection and Environmental Health 

Donald A. Flater, Chief, Bureau of Radiological Health

 Daniel K. McGhee, State Liaison Officer, Bureau of Radiological Health 

Pearce O’Kelley, SC, OAS Liaison to the MRB

bcc: Chairman Diaz

Commissioner McGaffigan

Commissioner Merrifield

Distribution: DCD (SP01) PDR (YES)

DIR RF LRakovan, STP AMcCraw, STP KSchneider, STP

LBolling, STP/ASPO KCyr, OGC ISchoenfeld, OEDO MVirgilio, NMSS

CMiller, NMSS/IMNS FCameron, OGC RStuckmeyer, NMSS/IMNS TCombs, OCA (2 copies)

JLynch, RIII JMullauer, RIII GBaker, NY STreby, OGC

JLieberman, OGC

Iowa File *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 STP STP:DD STP:D DEDMRS

NAME KPHsueh:gd JMPiccone

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PHLohaus

(CHMaupin for)

CJPaperiello

DATE 10/23/03* 10/24/03* 10/24/03* 11/07/03*

ML032970346 (Package) OFFICIAL RECORD COPY
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM

REVIEW OF IOWA AGREEMENT STATE PROGRAM

July 29 - August 1, 2003

FINAL REPORT

U.S. Nuclear Regulatory Commission
Iowa Final Report Page 2

1.0 INTRODUCTION

This report presents the results of the review of the Iowa Agreement State program. The

review was conducted during the period of July 29 - August 1, 2003, by a review team

consisting of technical staff members from the Nuclear Regulatory Commission (NRC) and the

Agreement State of New York. 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 a Final General Statement of Policy," published in the

Federal Register on October 16, 1997, and the November 5, 1999, NRC Management Directive

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

the review, which covered the period of August 21, 1999 to August 1, 2003, were discussed

with Iowa management on August 1, 2003.

A draft of this report was issued to Iowa for factual comment on August 29, 2003. The State

responded by letter dated September 9, 2004 (sic). The Management Review Board (MRB)

met on September 30, 2003 to consider the proposed final report. The MRB found the Iowa

radiation control program adequate to protect public health and safety and compatible with

NRC’s program. In addition, in a letter dated October 1, 2003, the State provided clarifying

information to its September 9, 2004 (sic) letter involving Nuclear Materials Events Database

(NMED) reporting.

The Iowa Agreement State program is administered by Iowa Department of Public Health (the

Department). The Department Director is appointed by and reports directly to the Governor. 

Within the Department, the Iowa radiation control program is administered by the Bureau of

Radiological Health (the Bureau), Division of Health Protection and Environmental Health. 

Organization charts for the Department are included as Appendix B. At the time of the review,

the Iowa program regulated 182 specific licenses authorizing Agreement materials. 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 Iowa.

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

performance indicators was sent to the Bureau on, April 16, 2003. The Bureau provided a

response to the questionnaire on June 25, 2003. A copy of the questionnaire response can be

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

Number ML032380269.

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

Iowa's responses to the questionnaire; (2) review of applicable Iowa statutes and regulations;

(3) analysis of quantitative information from the Bureau licensing and inspection data base; 

(4) technical review of selected licensing and inspection actions; (5) field accompaniments of

two Iowa inspectors; and (6) interviews with Bureau staff and management to answer questions

or clarify issues. The review team evaluated the information that it gathered against the IMPEP

performance criteria for each common and applicable non-common indicator and made a

preliminary assessment of the Iowa Agreement State program's performance.

Section 2 below discusses the State’s actions in response to recommendations made following

the previous IMPEP review and the team’s conclusions regarding close-out of the

recommendations. Results of the current review for the IMPEP common performance
Iowa Final Report Page 3

indicators are presented in Section 3. Section 4 discusses results of the applicable noncommon performance indicators, and Section 5 summarizes the review team’s findings. 

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS

During the previous IMPEP review, which concluded on August 20, 1999, one recommendation

was made and transmitted to Stephen C. Gleason, D.O., Director, Iowa Department of Public

Health, on November 23, 1999. The team’s review of the current status of the recommendation

is as follows:

1. The review team recommends that staff who conduct independent inspections and/or

license reviews of teletherapy and brachytherapy licenses complete a teletherapy and

brachytherapy course. (Section 3.3)

Current Status: Staff performing independent inspections and/or license reviews of

teletherapy and brachytherapy licenses have completed the NRC-sponsored

Teletherapy and Brachytherapy course. This recommendation is closed.

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) Technical Staffing and

Training; (2) Status of Materials Inspection Program; (3) Technical Quality of Inspections; 

(4) Technical Quality of Licensing Actions; and (5) Response to Incidents and Allegations. 

3.1 Technical Staffing and Training 

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

indicator, interviewed Bureau management and staff, reviewed job descriptions and training

records, and considered any possible workload backlogs.

Prior to a reorganization that occurred in early July 2003, the Bureau was structured with a

Bureau Chief, three Program Coordinators and ten staff members under the three programs. 

The radioactive materials program included one Program Coordinator, two health physicists,

and one clerical staff member. One Program Coordinator devoted his time to training and

emergency response, and the third Program Coordinator was responsible for radiation

machines. The Bureau Chief spent about 30 percent of his time in administration of radioactive

materials program activities. Note that Appendix B contains two Bureau’s organization charts:

one is prior to the reorganization and the other is current.

The Bureau completed the reorganization several weeks prior to the on-site review. As noted in

Appendix B, the Bureau is currently structured with a Bureau Chief, two Program Coordinators,

and 10 staff members under the two programs. The Radioactive Materials, Transportation and

Environmental Program includes one Program Coordinator, three health physicists, and one

clerical staff member. Consistent with the State’s past practices, all of the technical staff

members perform duties in licensing, inspection, and incident response. The second Program

Coordinator is responsible for radiation machine certification. 
Iowa Final Report Page 4

During 2001, the two health physicists left the radioactive materials program. The Bureau had

significant staffing challenges that year. In spite of the staff shortages at that time, the Bureau

took actions to alleviate the losses and remained viable. The actions taken included hiring two

new health physicists; one began work in September 2001 and the other in October 2002. One

other action taken noted by the review team is that since the Bureau was short-staffed at that

time, two inspectors from the Wisconsin Department of Health were requested to participate in

a team inspection of a broad scope licensee. The assistance from Wisconsin allowed the team

inspection to be performed in a timely and thorough manner. It also provided Wisconsin

valuable experience in support of their effort to become an Agreement State in 2003. In

addition, in April 2003, the Program Coordinator of the radioactive materials program left the

Iowa program.

The Bureau currently has one health physicist position vacant under the Radioactive Materials,

Transportation and Environmental Program. The new Program Coordinator for that program

was the Program Coordinator of the Training, Emergency Response and Environmental Issues

Program which existed prior to the reorganization. 

The review team noted that the Bureau had stable funding during the review period from a

general fund. In addition to the general fund, the Department implemented a fee for

transportation of radioactive waste shipments in 2002. The fee was established to fund training

for personnel who might respond to transportation accidents involving radioactive materials.

Training and qualification requirements for Bureau staff are established in a procedure which

sets forth essentially the same recommendations detailed in NRC Inspection Manual Chapter

(IMC) 1246. The review team noted that a qualification journal is used for each technical staff

member. Technical staff members have at least a Bachelor’s degree or equivalent training and

experience. Overall, the staff is well trained and qualified from an education and experience

standpoint. 

All technical staff members have taken the NRC courses deemed appropriate for their tasks.

The training records demonstrate that Bureau management is committed to a high degree of

training for the staff. The review team noted that one new staff member attended 11 NRC

courses within 18 months, and the other new staff member is scheduled to complete nine NRC

courses within a year. Bureau management indicated that upper level management has been

very supportive of training opportunities. Based on the lack of backlogs and the quality of the

licensing actions and inspections, the review team concluded that the Bureau has a wellbalanced staff, and a sufficient number of trained personnel to carry out regulatory duties. 

Before performing an inspection independently, inspectors accompany qualified inspectors to

licensee sites to observe inspections. Next they assist in an inspection with a qualified

inspector, and finally perform as a lead inspector with an accompanying qualified inspector. 

During the review period, two self-assessments were conducted. One reviewed radioactive

materials program activities in 2001 and the other one reviewed all the Bureau’s programs in

2002. The self-assessments covered a variety of areas including training and staffing levels,

licensing and inspection status and discussion of incidents. The review team noted that one of

the strengths of the Iowa program is the annual self-assessment program. 
Iowa Final Report Page 5

The review team noted the apparent benefits to the Bureau from staff participation on IMPEP

reviews. The Program Coordinator who left the Bureau in April 2003 participated on two IMPEP

review teams during the review period. The review team noted that the knowledge and

experience gained from participation of IMPEP activities have been reflected back to the

Bureau. 

During the on-site review, Bureau management expressed concerns about the effect of an

aging workforce and the Bureau’s ability to maintain continuity of experience. The review team

noted that one of the Department’s challenges is to effectively deal with the potential loss of an

experienced workforce because of the possible retirement of senior Bureau staff and managers

in the near future.

The State Board of Health is the policy making body for the Department. Their duties include

the adoption and promulgation of rules. The Board is composed of five members experienced

in health-related disciplines and four members representing the general public. The

Department Director serves as secretary of the Board. As stated in the Iowa Code, Chapter

68B, Government Ethics and Lobbying, any person who serves or is employed by the State or a

political subdivision of the State shall not engage in any outside employment or activity which is

in conflict with the person’s official duties and responsibilities.

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

that Iowa’s performance with respect to the indicator, Technical Staffing and Training, was

satisfactory.

3.2 Status of Materials Inspection Program 

The review team focused on five factors in reviewing the status of the material inspection

program: inspection frequency, overdue inspections, initial inspections of new licensees, timely

dispatch of inspection findings to licensees, and the performance of reciprocity inspections. 

The review team’s evaluation is based on the Bureau’s questionnaire response relative to this

indicator, data gathered independently from the Bureau’s licensing and inspection data tracking

system, the examination of complete licensing and inspection casework, and interviews with

Bureau staff and management.

Evaluation of Iowa’s inspection priorities for the materials program indicated that the maximum

period for an inspection interval is seven years. The Bureau has adopted inspection categories

and inspection frequencies consistent with those in NRC IMC 2800.

The Bureau conducted a total of 113 core and 69 non-core routine inspections during the

review period. There were no overdue core inspections and no overdue inspections of noncore licenses. 

With respect to initial inspections, the Bureau assigns the inspection due date six months from

the issuance of a new license. This information is entered into the Bureau’s database. In

practice, the Bureau conducts initial inspections six months from receipt of radioactive materials

or commencement of licensed activities. The review team noted that all new licenses are

inspected within one year of license issuance regardless of licensed activities.
Iowa Final Report Page 6

With respect to reciprocity, the Bureau recognizes licensees for 180 days from the date of their

initial request to enter the State. The review team found that the Bureau’s reciprocity program

was similar to NRC IMC 1220. The Bureau’s database indicated that 13 core reciprocity

inspections were conducted during the review period. Overall it appears that 25 percent of the

core reciprocity licensees entering the State on an annual basis during the review period were

inspected. 

The review team noted that the information regarding reciprocity inspections provided in the

Bureau's response to the questionnaire was not accurate due to a database error. Bureau

management indicated that they have been trying to upgrade their database system for years. 

Due to fiscal constraints beyond the Bureau's control, the system has not been upgraded. 

Bureau management indicated that they will continue their effort to resolve this issue and have

the database system upgraded. As a result, the review team's statistical analysis was based on

the reciprocity inspection information obtained during the on-site review.

The timeliness of the issuance of inspection findings was also evaluated. The Bureau has an

effective and efficient process which ensures that inspection findings are communicated to

licensees in a timely manner. The Bureau’s goal is to complete each inspection report and

deliver the notice of violation, as appropriate, to the licensee within 30 days. Of the 12 core

licensee files reviewed, no inspection reports exceeded the 30 day goal. A review of the

Bureau’s database also supported this finding and did not reveal any inspections issued over 30

days past the inspection date.

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

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

Program, was satisfactory.

3.3 Technical Quality of Inspections 

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

field notes and interviewed inspectors for 12 materials inspections conducted during the review

period. The casework included all of the Bureau’s materials inspectors, and covered

inspections of various types including both fixed facilities and temporary job sites of industrial

radiography; medical institutions including group and private practices; academic broad scope;

nuclear pharmacy; and nuclear medical vans. Appendix C lists the inspection casework files

reviewed for completeness and adequacy with case-specific comments. 

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

the licensees’ radiation safety programs. The review team found that inspection reports were

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

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

documentation supported violations, recommendations made to the licensee, unresolved safety

issues, and discussions held with the licensee during exit interviews. Team inspections were

performed when appropriate and for training purposes. 

The review team found that routine inspections include a written summary of the scope of the

licensed activities and categorize violations into severity levels which can later be used for

escalated enforcement, if necessary. Iowa Administrative Code 641, Chapter 38 provides for
Iowa Final Report Page 7

the initiation of enforcement actions and civil penalties. The review team noted that

enforcement actions have been taken for facilities when appropriate. 

The review team noted that a practice, which allowed two broad scope licensees to evaluate the

inspection report prior to issuance, had been implemented. This resulted in revisions to the

final inspection report, including items that had indicated a violation involving testing of a high

dose rate afterloader (HDR). The review team discussed this issue with Bureau management

since the practice of sharing draft inspection reports with broad scope licensees and revising

inspection findings based on the licensees’ comments is not a common practice. The Bureau

Chief noted the issue raised by the review team and indicated that he will consider changing the

practice. In the State's response to the draft IMPEP report dated September 9, 2004 (sic), it

was indicated that the Bureau has modified the practice and will no longer send draft inspection

reports to the broad scope licensees for review and comment.

The Program Coordinator conducts supervisory accompaniments of material inspectors at least

once a year. In addition, the Bureau Chief periodically accompanies inspectors on inspections. 

The results of the annual supervisory accompaniments were reviewed and signed by the

inspector and supervisor, and were documented as part of the inspector’s qualification journal.

During the week of June 16, 2003, a review team member performed accompaniments of two

of the Bureau inspectors. The inspections included a HDR and an institutional nuclear

medicine facility. These accompaniments are identified in Appendix C. During the

accompaniments, the Iowa inspectors conducted performance-based inspections and

demonstrated thorough knowledge of the regulations. The inspectors were well prepared and

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

performance of the inspectors was good, and their inspections were adequate to assess

radiological health and safety at the licensed facilities.

The Bureau has adequate numbers and types of survey meters to support the current

inspection program, as well as for responding to incidents and emergency conditions. The

Bureau uses the State Calibration Shop operated by the Homeland Security and Emergency

Management Division of the Iowa Department of Public Defense for calibration of their survey

instruments on a biannual basis. Appropriate documentation of calibrated survey instruments

such as Geiger Mueller meters, scintillation detectors, and ion chambers was provided. Air

monitoring equipment as well as prepared emergency field kits are also available for

emergency use. Contamination wipes are primarily evaluated at the State Hygienic Laboratory

which is located in Iowa City and is designated as the State Public Health Laboratory by Iowa

Code. 

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

that Iowa’s performance with respect to the indicator, Technical Quality of Inspections, was

satisfactory.

3.4 Technical Quality of Licensing Actions 

The review team interviewed license reviewers, evaluated the licensing process, and examined

licensing casework for 15 specific licenses. Licensing actions were reviewed for completeness,

consistency, proper radioisotopes and quantities, qualifications of authorized users, adequate

facilities and equipment, adherence to good health physics practices, financial assurance,
Iowa Final Report Page 8

operating and emergency procedures, appropriateness of the license conditions, and overall

technical quality. The casework files were also reviewed for timeliness, use of appropriate

deficiency letters and cover letters, reference to appropriate regulations, product certifications,

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

supervisory review as indicated, and proper signatures. The files were checked for retention of

necessary documents and supporting data.

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

which were completed during the review period. The cross-section sampling focused on the

new licenses, amendments, renewals, and licenses terminated during the review period. The

sampling included the following types: broad scope research and development, medical

institution - written directive required, private practice, research and development, nuclear

pharmacy, industrial radiography, and portable gauge. Licensing actions reviewed included two

new, three renewals, three amendments and seven termination files. A listing of the casework

licenses evaluated with case specific comments can be found in Appendix D.

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

quality, with health and safety issues properly addressed. Tie-down conditions were backed by

information contained in the file, and inspectable. Deficiency letters clearly stated regulatory

positions, were used at the proper time, and identified deficiencies in the licensees’ documents. 

License files were complete and well organized. The Bureau used a combination of NRC and

State regulatory guides, and State regulations. In addition, licensing checklists were used and

designed for each category of license. These documents were complete, well organized,

available to reviewers, and were followed by reviewers. Based on the files reviewed, actions

were completed in a timely manner. 

Terminated licensing actions were well-documented, showing appropriate transfer and survey

records with one exception. During review of terminated portable gauge licenses, it was noted

that records of final radiological status of portable gauges were not included in the file. After

discussing the issue with Bureau staff, the review team noted that information concerning the

final radiological status of portable gauges was not required by the Bureau staff for license

termination. 

Bureau staff indicated that due to the integrity of sealed sources used in portable gauges and

the good track record of portable gauges in general, verification that there is no source leakage

from these gauges is not conducted in all cases during the license termination process. The

review team believes that the radiological hazard of typical portable gauge sources pose

external and internal hazards to the general public if leakage occurs. The review team

discussed this issue with Bureau management and staff, and initially made a recommendation

that the Bureau take appropriate action to verify that there is no source leakage for each

portable gauge possessed under a license prior to termination of the license.

In the State’s response to the draft IMPEP report dated September 9, 2004 (sic), it was

indicated that the Bureau took action to address this issue. Specifically, Bureau staff has been

advised that in order to terminate a gauge license, verification that a leak test of the source was

performed and no leakage of radioactive material was present must be received. During the

September 30, 2003 MRB meeting, this issue was discussed and the recommendation was

removed from the report.
Iowa Final Report Page 9

The review team noted that the Bureau identified a potential problem associated with model

number designations involving Troxler 3400 Series and other Troxler Model 34XX portable

gauges. Specifically, the Bureau recognized that the Troxler 3400 Series listing in the Sealed

Source and Device (SS&D) Registry Sheet consists of only four model numbers, i.e., 3430,

3430B, 3440 and 3440B, and that other Troxler model numbers such as 3450 and 3451 do not

fall within the Troxler 3400 Series. The review team further noted that other model numbers

such as 3401 and 3411 can be considered as part of the Troxler 3400 Series based on

additional information contained in the Troxler 3400 Series SS&D Registry Sheet. This can be

misleading and confusing for both the licensee and the license reviewer. To avoid the potential

problem, the Bureau revised all portable gauge licenses that authorized Troxler 3400 Series by

removing the 3400 Series authorization and specifying each portable gauge in the Series by its

own model number. It should be further noted that the Bureau shared this problem and remedy

with other Agreement States, as other programs may face similar situations. The review team

recommended that the Bureau’s revision of all Troxler portable gauge licenses to specifically list

each gauge model number be found a good licensing practice, and the MRB agreed. 

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

that Iowa's performance with respect to the indicator, Technical Quality of Licensing Actions,

was satisfactory.

3.5 Response to Incidents and Allegations 

In evaluating the effectiveness of the Bureau’s actions in responding to incidents, the review

team examined the Bureau’s response to the questionnaire regarding this indicator, evaluated

selected incidents reported for Iowa in NMED against those contained in the Iowa files, and

evaluated the casework and supporting documentation for ten material incidents. A list of

incident files examined along with case specific comments is contained in Appendix E. The

review team also reviewed the Bureau’s response to three allegations, including one allegation

referred to the State by NRC, during the review period.

The review team interviewed program management and staff to discuss the Bureau’s incident

and allegation process, file documentation, the State’s equivalent to the Freedom of Information

Act, NMED, and notification of incidents to the NRC. The ten incidents selected for review

included the following event categories: medical event, radiation overexposure, contamination

event, leaking sealed sources, damaged radiography equipment and lost sources.

Radiological incidents can be reported 24 hours a day through the State’s Radiological

Response Team emergency telephone line. When notification of an incident or an allegation is

received, the Bureau Chief and staff meet to discuss the safety significance, initial response,

and need for an on-site investigation. The small size of the Iowa program allows for the prompt

dissemination of information regarding the event to all personnel in the program. 

The review team found that the Bureau’s responses to incidents and allegations were complete

and comprehensive. Initial responses were prompt and well coordinated. The level of effort

was commensurate with the health and safety significance. Inspectors were dispatched for onsite investigations when appropriate and the Bureau took suitable enforcement action.

The review team found the documentation of the incidents to be consistently of high quality,

with one exception. One incident was not discussed with a licensee during the next inspection
Iowa Final Report Page 10

of the license after the incident, as required by Bureau procedures. Corrective actions

promised by the licensee in response to the incident were therefore not confirmed by the

inspector. The Program Coordinator stated that the incident follow-up would be reviewed

during a planned inspection of the licensee later this year. Staff will be reminded by the

Program Coordinator of the need to review any incidents and/or corrective actions which

occurred since the previous inspection.

Reportable incidents are promptly communicated to the NRC Operations Center and are

reported to NMED. One incident, which occurred in 2000, was not reported to NMED. This

was apparently an oversight and the Program Coordinator stated that he would update NMED

to include the incident. The staff was familiar with the guidance contained in the Office of State

and Tribal Programs Procedure SA-300, Reporting Material Events. 

During the review period, one allegation was referred to the State by the NRC and two

allegations were reported directly to the Bureau. The evaluation of the Bureau’s allegation files

indicated that the Bureau took prompt and appropriate action in response to the concerns

raised. The review team noted that all documentation related to the investigation of allegations

was maintained in the allegation file. Allegers were properly notified of investigation results. 

There were no performance issues identified from the review of the casework documentation.

The Bureau has complete written guidance for handling incidents and allegations in their

inspection procedures. The review team noted that Iowa’s Freedom of Access law requires that

all public documents be made available for inspection and copying. The State makes every

effort to protect an alleger’s identity, but it cannot be guaranteed.

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

that Iowa's performance with respect to the indicator, Response to Incidents and Allegations,

was 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 Program Elements Required for Compatibility; (2) Sealed

Source and Device (SS&D) Evaluation Program; (3) Low-Level Radioactive Waste Disposal

Program; and (4) Uranium Recovery Program. Iowa’s Agreement does not authorize low-level

radioactive waste disposal or uranium recovery activities, and the SS&D Evaluation Program

was returned to NRC on June 1, 1996. Accordingly, only the first non-common performance

indicator was applicable to this review. 

4.1 Legislation and Program Elements Required for Compatibility 

4.1.1 Legislation

Iowa became an Agreement State in 1986. Along with their response to the questionnaire, the

Bureau provided the review team with the opportunity to review copies of legislation that affects

the radiation control program. The current effective statutory authority for the radiation control

program is contained in the Iowa Code, Chapter 136C. The Department is designated as the

State's radiation control agency. The review team noted that one legislation change affecting

the program was passed during the review period. As a result of the change, persons
Iowa Final Report Page 11

convicted of violation of the Iowa Code, Chapter 136C are guilty of a serious misdemeanor

instead of a simple misdemeanor. For a serious misdemeanor, a convicted person may be

fined up to one thousand five hundred dollars. In addition, the person may be imprisoned for up

to one year. 

4.1.2 Program Elements Required for Compatibility 

The Iowa Regulations for Control of Radiation, found in the Iowa Administrative Code, Section

641, Chapters 38-45, apply to all ionizing radiation, whether emitted from radionuclides or

devices. Iowa requires a license for possession and use of all radioactive material including

naturally occurring materials, such as radium, and accelerator-produced radionuclides.

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

process takes approximately five months after filing the draft administrative rule with the State

Rules Coordinator. Draft rules are published in the State Administrative Bulletin and a public

hearing is scheduled. Rules are presented to the Board of Health prior to being adopted. The

State has Emergency Rule capability, if public health and safety is at risk. It was noted that the

State’s rules and regulations are not subject to “sunset” laws.

Proposed rules are sent to all potentially impacted licensees for comment. The Bureau also

sends proposed rules to NRC for review. Comments are considered and incorporated, as

appropriate, before rules are finalized. The State has the authority to issue legally binding

requirements (e.g., license conditions) in lieu of rule adoption until equivalent State rules

become effective.

The review team reviewed the status of regulations required to be adopted by the State under

the Commission’s adequacy and compatibility policy and verified the adoption of regulationswith

data obtained from the Office of State and Tribal Programs’ State Regulation Status Data

Sheet. Since the previous IMPEP review, the Department has adopted 26 regulation

amendments. Current NRC policy requires that Agreement States adopt certain equivalent

regulations or legally binding requirements no later than three years after they become

effective. The review team found that the State currently has no overdue NRC amendments. 

The State has adopted all the regulation amendments that are due up to the year of 2005.

The review team noted that NRC reviewed the Iowa proposed rules and requested that the

State provide a copy of the final published rules for review. It was noted that some final rules

have not been submitted to NRC for review as requested. The review team discussed this

issue with the Bureau Chief and staff. During the on-site review, the Bureau contacted NRC on

submitting the final rules. Subsequently, the Bureau submitted the final rules for NRC review

shortly after the on-site review.

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

Iowa’s performance with respect to the indicator, Legislation and Program Elements Required

for Compatibility, was satisfactory.

5.0 SUMMARY

As noted in Sections 3 and 4 above, the review team and the MRB found Iowa’s performance to

be satisfactory for all performance indicators. Accordingly, the review team recommended and
Iowa Final Report Page 12

the MRB concurred in finding the Iowa Agreement State program adequate to protect public

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

IMPEP review, it was agreed that the next full review should be in approximately four years. No

recommendations were made for the State. The good practice recommended by the review

team and approved by the MRB is also given.

GOOD PRACTICE

The Bureau identified a potential problem associated with model number designations involving

Troxler 3400 Series and other Troxler Model 34XX portable gauges. To avoid the potential

problem, the Bureau revised all portable gauge licenses that authorized Troxler 3400 Series by

removing the 3400 series authorization and specifying each portable gauge in the Series by its

own model number. Other programs may face similar situations and may be able to apply this

practice. The Bureau’s revision of all Troxler portable gauge licenses to specifically list each

gauge model number was found a good practice. (Section 3.4)
LIST OF APPENDICES AND ATTACHMENTS

Appendix A IMPEP Review Team Members

Appendix B Iowa Organization Charts

Appendix C Inspection Casework Reviews

Appendix D License Casework Reviews

Appendix E Incident Casework Reviews

Attachment September 9, 2004 (sic), Letter from Donald A. Flater, Chief, 

Bureau of Radiological Health
APPENDIX A

IMPEP REVIEW TEAM MEMBERS

Name Area of Responsibility

Kevin Hsueh, STP Team Leader

Technical Staffing and Training

Legislation and Program Elements Required for

Compatibility

James Lynch, Region III Response to Incidents and Allegations

Inspector Accompaniments

James Mullauer, Region III Technical Quality of Licensing Actions

Gary Baker, New York Status of Materials Inspection Program

Technical Quality of Inspections
APPENDIX B

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ATTACHMENT

Letter from Donald A. Flater, dated September 9, 2004 (sic)

Iowa’s Response to Draft IMPEP Report

ML032541016
Fields of Opportunities STATE OF IOWA

THOMAS J. VILSACK DEPARTMENT OF PUBLIC HEALTH

GOVERNOR MARY MINCER HANSEN, RN, PhD

DIRECTOR

SALLY J. PEDERSON

LT. GOVERNOR

September 9, 2004

Kevin Hsueh, Ph.D.

State & Tribal Programs

U.S. Nuclear Regulatory Commission

One White Flint North - 3fd Floor

11555 Rockville Pike

Rockville, MD 20852

RE: Iowa's LMPEP DRAFT Report 2003

Dear Dr. Hsueh:

Your letter to Tom Newton, Director, Division of Health Protection and Environmental Health

dated August 29, 2003 and received in this office on September 3, 2003 has been referred to me

for response. The draft document entitled "Integrated Materials Performance Evaluation

Program - Review of Iowa Agreement State Program" was attached. The comments provided

are directed toward that document.

In your letter you indicated that the preliminary schedule is that Iowa's Management Review

Board (MRB) meeting should occur during the week of October 6, 2003. Because of our

promptness in reviewing and submitting comments on your DRAFT Report, it is hoped that

schedules would allow an MRB meeting prior to the current tentative schedule date. Please

accept this letter as our formal request that our presence at the meeting is through the

telecommunications process rather than a personal appearance.

DRAFT REPORT COMMENTS

1. 1.0 INTRODUCTION

a. Page #1, paragraph #2. The second sentence of this paragraph states that the Iowa

Department of Public Health is the agency within state government which among

other things regulates "radiation hazards". Our reading of this sentence is that the

only items we address are those that deal with "radiation hazards". We believe

that this terminology is too restrictive regarding what is accomplished by the

Radioactive Materials Program in Iowa. Our duties include licensing,

inspections, education, investigation, etc. and addressing radiation hazards.

Please reword the sentence so that what we do is truly reflected.

LUCAS STATE OFFICE BUILDING / 321 E. 12TH ST. / DES MOINES, IOWA 50319-0075

DEAF RELAY (HEARING OR SPEECH IMPAIRED) 1-800-735-2942 1 INTERNET: HTTP://WWW.IDPH.STATE.IA.US/

R05-s SNPal
Kevin Hsueh, Ph.D.

September 9, 2003

Page 2

b. The first sentence on page 2 requests a response to recommendations being made.

There is only one recommendation in the report and it will be addressed in our

last comment.

2. 2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS In the first sentence

you refer to our previous Department Director as Dr. Gleason. I would suggest, for

posterity purposes, that you use his full name and professional credentials, which is

Stephen C. Gleason, DO.

3. 3.1 Technical Staffing and Training

a. Page #4, the second full paragraph. We are uncomfortable with the wording of

this paragraph. We suggest the following paragraph.

"During the on-site review, Bureau management expressed concerns about

the effect of any aging workforce and the Bureau's ability to maintain

continuity of experience. The review team noted that one of the

department's challenges is to effectively deal with potential loss of an

experienced workforce because of the possible retirement of senior bureau

staff and managers in the near future."

b. Page #4, third full paragraph, second sentence. At the end of this sentence

reference is made to "promulgation of rules and regulations". Please be advised

that Iowa only promulgates rules. Please put a period after "rules" and delete

"and regulations".

4. 3.2 Status of Materials Inspection Program

a. Page #4, the last paragraph on the page.

The inspection this paragraph refers to was a special nuclear material license,

which was one of two licenses, that NRC last inspected in 1998 (previous to

transferring the license to Iowa in 2000)-a fact noted in the file. However, in

preparing to conduct the inspection of both licenses, we found that the NRC had

documented both inspections on one form. This form was not in the special

nuclear materials license. This form indicated that the inspection interval had

been increased by two years. This made the due date 2003. The inspection is not

significantly overdue and we erred in reporting this to the review team.

b. Page #5, the fourth full paragraph addressing the Bureau's long term efforts to

establish an accurate data system. In the past we have had difficulty providing

information in the format requested for tracking licensing actions and inspections.

This issue has been discussed with Mr. Newton and he has indicated that the Iowa

Department of Public Health Executive Team has identified the need for a
Kevin Hsueh, Ph.D.

September 9, 2003

Page 3

consolidated database for tracking programs in the Bureau. He further indicates

that the Team has placed our needs for a system on the Bureau of Information

Management's priority list and the Team is in the process of identifying funding

for the project. It is estimated that system development should be in full swing in

fiscal year 2004.

5. 3.3 Technical Ouality of Inspection

a. Page #6, third paragraph. We have discussed our practice and have modified it.

We will no longer send "draft" inspection reports to the broad-scope licensees for

review and comment.

b. Page #6, sixth paragraph. The reference to Iowa Government is not correct. We

suggest that paragraph read as follows:

"The Bureau has adequate numbers and types of survey meters to support the

current inspection program, as well as for responding to incidents and emergency

conditions. The Bureau uses the State Calibration Shop operated by the

Homeland Security and Emergency Management Division of the Iowa

Department of Public Defense for calibration of their survey instruments on a

biannual basis. Appropriate documentation of calibrated survey instruments such

as Geiger Mueller meters, scintillation detectors, and ion chambers was provided.

Air monitoring equipment as well as prepared emergency field kits are also

available for emergency use. Contamination wipes are primarily evaluated at the

State Hygienic Laboratory which is located in Iowa City and is designated as the

State Public Health Laboratory by Iowa Code."

6. 3.5 Response to Incidents and Allegations Page #9, second paragraph, first sentence.

The fourth word in the sentence indicates that we "usually" promptly report incidents and

allegations to NRC Operation Center and NMED. Our policy is to "always" report. We

have reviewed our records and the results of the review indicate that we have met our

policy. The one incident on NMED was reported but it appears to us that the NRC

contractor or did not correctly enter the data. We would suggest that the word "usually"

be removed.

7. 4.0 NON-COMMON PERFORMANCE INDICATORS First paragraph, last sentence

indicates that Iowa's Agreement does not authorize SS&D evaluations. In fact in early

years, former staff member Bruce Hokel worked with Lloyd Bolling to get a Radium

device in the SS&D system. It was never accomplished because Iowa never held the

status of a CRCPD :Licensing State". We do not have SS&D authority by virtue of the

fact that in the 1990's I sent a letter to the NRC turning back our authority to perform

SS&D evaluation. I would suggest that the paragraph be reworded to reflect what

actually occurred.
I , i ... w '

Kevin Hsueh, Ph.D.

September 9, 2003

Page 4

8. 4.1 Program Elements Required for Compatibility Page #10, paragraph's 3,4,&5 contain

numerous references to "regulation". The Iowa Administrative Code is rules not

regulations. Please replace all reference to regulation in these paragraphs with rule or

rules, whichever is appropriate.

9. RECOMMENDATION Page 10. As a result of the recommendation being made by the

IMPEP team, the following action was taken prior to the team completing their exit

interviews.

We determined that in some cases we had paper work verifying the performance of a

source leakage test prior to license termination. It was further determined that this type

of over-sight was easily corrected by an educational process. Therefore, the Program

Coordinator spoke with all RAM program staff and advised them that in order to

terminate a gauge license the record must contain verification that a leak test of the

source was performed and no leakage of RAM was present. Also, as part of the desk

performance record for the individual who does the final overview of the termination of a

license, words have been added to assure the above.

Reference is made to page #2 first sentence of the DRAFT Report which indicates that a

response to nay recommendation is provided. Please accept the above as the requested

response.

Thank you for the opportunity to review the Team's Draft Report. We hope that the information

provided above will be of assistance to you. We look forward to the date of our conference call

meeting with the MRB. If you have questions regarding the above, please do not hesitate to

contact me. Again, thanks to everyone for all the help why in making the Iowa Radioactive

Materials Program a success.

Sincerely,

Donald A. Flater, Chief

Bureau of Radiological Health

515-281-3478

515-725-0318 - FAX

dflateraiidph.state.ia.us

DAF/rk

cc: Tom Newton