March 21, 2002

Donald A. Flater, Chief

Bureau of Radiological Health

Iowa Department of Public Health

401 SW 7th St., Suite D

Des Moines, IA 50309

Dear Mr. Flater:

A periodic meeting with Iowa was held on March 13, 2002. The purpose of this meeting was to

review and discuss the status of Iowaís Agreement State program. The NRC was represented

by Lloyd Bolling from the NRC's Office of State and Tribal Programs, Cindy Pederson from the

NRC Region III office, and me. Specific topics and issues of importance discussed at the

meeting included: IDPH staffing, regulation development, and your recent program self

assessment.

I have completed and enclosed a general meeting summary, including any specific actions that

will be taken as a result of the meeting.

If you feel that our conclusions do not accurately summarize the meeting discussion, or if you

have any additional remarks about the meeting in general, please contact me at (630) 829-

9661, or e-mail to JLL2@NRC.GOV to discuss your comments. 

Sincerely,

/RA/

James L. Lynch

State Agreements Officer

Enclosure: As stated

cc w/encl.: S. Quirk, Director, Environmental Health

D. McGhee, Iowa State Liaison Officer

D. Cool, NMSS

L. Bolling, STP

K. Schneider, STP

C. Pederson, RIII
March 21, 2002

Donald A. Flater, Chief

Bureau of Radiological Health

Iowa Department of Public Health

401 SW 7th St., Suite D

Des Moines, IA 50309

Dear Mr. Flater:

A periodic meeting with Iowa was held on March 13, 2002. The purpose of this meeting was to

review and discuss the status of Iowaís Agreement State program. The NRC was represented

by Lloyd Bolling from the NRC's Office of State and Tribal Programs, Cindy Pederson from the

NRC Region III office, and me. Specific topics and issues of importance discussed at the

meeting included: IDPH staffing, regulation development, and your recent program self

assessment.

I have completed and enclosed a general meeting summary, including any specific actions that

will be taken as a result of the meeting.

If you feel that our conclusions do not accurately summarize the meeting discussion, or if you

have any additional remarks about the meeting in general, please contact me at (630) 829-

9661, or e-mail to JLL2@NRC.GOV to discuss your comments. 

Sincerely,

/RA/

James L. Lynch

State Agreements Officer

Enclosure: As stated

cc w/encl.: S. Quirk, Director, Environmental Health

D. McGhee, Iowa State Liaison Officer

D. Cool, NMSS

L. Bolling, STP

K. Schneider, STP

C. Pederson, RIII

DOCUMENT NAME:C:\Program Files\Adobe\Acrobat 4.0\PDF Output\Iowa 03__02.wpd

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OFFICE RIII RIII by email

NAME Lynch:jb Lynch for Bolling

DATE 03/19/02 03/19/02

OFFICIAL RECORD COPY
1

AGREEMENT STATE ANNUAL MEETING SUMMARY FOR IOWA

DATE OF MEETING: MARCH 13, 2002

ATTENDEES: NRC STATE

James Lynch Stephen Quirk

Lloyd Bolling Donald Flater

Cynthia Pederson George Johns

Daniel McGhee

Nancy Farrington

Charlene Craig

Ramona Ubaldo-Mealey

DISCUSSION:

The following is a summary of the meeting held in Des Moines on March 13, 2002, between

representatives of the NRC and the State of Iowa.

Previous IMPEP Review Findings

The previous Integrated Materials Performance Evaluation Program (IMPEP) review was

conducted during the period August 17-20, 1999, with the findings discussed in a meeting

between the State and the IMPEP Management Review Board (MRB) on November 9, 1999. 

The results were issued in a final report dated November 23, 1999. The MRB found that the

Iowa radiation control program was adequate to protect public health and safety and compatible

with NRCís program.

Radiation Control Program Staffing and Training

The Iowa Department of Public Health (IDPH) radiation control program experienced the loss of

two health physics staff, recently. Mark Flickinger left State employment for a job in the private

sector and, sadly, Joyce Spencer passed away.

The loss of two health physics staff in a small program such as Iowaís is a serious challenge to

maintaining an adequate and compatible radiation control program. Nancy Farrington, an

experienced nuclear medicine technologist was hired in September 2001, to fill Mr. Flickingerís

position. Nancy is in the process of attending the required core training courses. To date, she

completed the Licensing Practices and the Inspection Procedures courses. She is enrolled in

the Inspecting For Performance (G-304), Industrial Radiography (H-305), and Transportation of

Radioactive Materials (H-308) courses in March-April 2002.

The remaining position is currently being reviewed, at a Division level, to determine the

possibility of funding the position during the current State monetary shortfall. Stephen Quirk

asked what the acceptable level of staffing was for a program like Iowaís and whether the level

is a function of the number of State licensees. The NRC no longer uses the 1 to 1.5 FTE per
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100 licensees criteria as an adequate staffing level. Rather the IMPEP review criteria requires

the State to assess its staffing level based on the routine work, possible emergencies, and the

number and complexity of its license base. 

With the staff shortage, inspection and licensing activities were affected as described below.

In 2001, the Radioactive Materials Coordinator participated as a team member on the Nevada

IMPEP team. His support to the team was notable.

Inspection Program

The materials program staff completed 44 inspections in 2001. Included was an inspection of

the University of Iowa. Since the program was short-staffed, two inspectors from the Wisconsin

Department of Health were requested to participate in the inspection. 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.

The Radioactive Materials Coordinator indicated that no specific license inspections are

overdue, at this time.

Scoping surveys at the Iowa Army Ammunition Plant identified minor uranium-238

contamination, historical in nature, in some of the buildings. Historical records indicate that

other radionuclides were also used at the site. Iowa requested that the Army perform a full site

evaluation to determine the extent of contamination. The U. S. Congress, in the Energy and

Water Appropriations Bill, directed the Army Corps of Engineers to report, in consultation with

the State of Iowa, its recommendations for conducting a site-wide radiological survey of the

Army Ammunition Plant. The State provided information to the Army Corps of Engineers and is

awaiting further developments.

Fansteel/Wellman Dynamics Corporation, Creston, Iowa, researched its buried thorium waste

legacy, and is evaluating monitoring data to determine the appropriate course of action. The

waste is in an old 10 CFR 20.304 (before Iowa became an Agreement State) thorium slag burial

site. A bankruptcy filing by the company in January 2002 apparently slowed progress in the

area. The State is monitoring the licenseeís actions.

Licensing Program

A total of 110 licensing actions were completed in 2001. The Radioactive Materials Coordinator

stated that the program does not have a licensing backlog.

The loss of staff members resulted in a less extensive peer review process for licensing

actions. In any case, all licensing actions are signed by the Bureau Chief before issuance.

IDPH identified what they call an anomaly in the NRC guidance regarding the Novoste

Corporation Intravascular Brachytherapy device. NRC guidance allows for the licensee to

deviate from the Food and Drug Administration (FDA) issued Pre-Market Approval while Iowa

licensees are required to follow the Pre-Market Approval unless granted a waiver by the FDA. 

This issue will be forwarded to the NRC NMSS medical staff.
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Some uncomplicated licensing actions are performed by the Radioactive Materials Section

secretary, under close supervision of the Radioactive Materials Coordinator.

General Licenses

Iowaís General License device registration and inspection program actively tracks 123 General

Licenses . Annual inventory forms are sent to general licensees with an annual fee of $150 per

type of device. Inspections are scheduled to be performed at three-year intervals, but due to

the staffing shortage, inspections of General Licenses have been severely curtailed. As

generally-licensed devices have safer designs, inspection of the devices is a lower priority. The

new employee will be assigned these inspections upon completion of appropriate training.

As discussed during the last Periodic Meeting in 2000, IDPH identified a generally-licensed

device distributed from the State of New York, which did not have a valid Sealed Source and

Device (SS&D) registry certificate. Discrepancies were noted with the manufacturerís name

and the activity of the radioactive source (900 vs. 50 microcuries) in the generally-licensed

device. Iowa requested that New York resolve the issue, but has not received cooperation in

the matter. NRC also requested that New York issue an updated registry certificate, but was

similarly unsuccessful.

New York State contended that generally-licensed devices are not required to have SS&D

certificates since the product evaluation is covered under the license to manufacture or

distribute. NRC will again raise the issue to New York during the upcoming IMPEP review since

the SS&D certificate documents the evaluation and provides valuable product information to

other licensing agencies and is the ìindustry standard.î Iowa management indicated that they

may submit, to the NRC, a ìpetition for rulemakingî to require that all generally-licensed devices

have SS&D certificates in the national registry.

Future Periodic Meetings

Don Flater again expressed that two single-day Periodic Meetings between IMPEP reviews are

not particularly useful either to the NRC or Iowa. Rather, a two - three day mini-review, with

some file evaluation and inspector accompaniments, midway between IMPEP reviews, would

be more informative and cost effective.

Jim Lynch commented that the IMPEP program working group studied the effectiveness of

Periodic Meetings and is making recommendations to NRC management to improve the

process. One of these recommendations will be that States perform self-assessments of their

radiation control programs prior to Periodic Meetings. Changes to the program are expected in

2002.

Self-Assessments

In early 2002, the Radioactive Materials Coordinator performed a self-assessment of the

radioactive materials program. The audit covered training and staffing levels, licensing and

inspection status (including accelerator and industrial x-ray unit inspection programs), policies

and procedures, the general licensing program, and the industrial radiography certification

testing program. The audit was shared with the NRC prior to this Periodic Meeting and proved

very useful in providing points of discussion. Lloyd Bolling was given permission by IDPH to
4

share the audit with other Agreement States wishing to perform self-assessments of their

programs.

Regulations

IDPH updates its regulations on an annual basis. Late in the calendar year, a package of

proposed regulation changes is sent to the NRC and the public for comment. The NRC

provided two comments on the proposed rule package submitted in December 2001. 

Comments were requested by February 26, 2002.

Preliminary comments were discussed with the Radioactive Materials Coordinator on 

January 28, 2002. Formal comments had not yet been received at the time of this Periodic

Meeting. The regulations were adopted, with the preliminary comments incorporated, on March

13, 2002, without formal NRC comment. Mr. Flater stated that NRC comments must be

received in the specified comment period to be considered. Jim Lynch said that NRC is

evaluating the regulation review process and the inherent delays in the process.

The regulation review program, described in the Office of State and Tribal Programs (STP)

procedure SA-201, ìReview of State Regulatory Requirements,î was discussed in detail. 

Agreement States were recently reminded to submit both draft and final regulations as specified

in the procedure to provide uniformity and help expedite the process. The ìState Regulation

Statusî form, found in this procedure, is maintained by NRC to track Agreement State

regulations.

George Johns asked whether a letter or an email message was acceptable to inform STP when

final regulations become effective. Lloyd Bolling will discuss the question with STP

management and inform IDPH if an email or a formal letter is acceptable provided that the

required information as detailed in STP Procedure SA-201 is included. This requires, among

other things, that the final amended rule be clearly identified and that any changes from the

proposed rule be highlighted.

It was noted that two regulations will be required for adoption prior to the next IMPEP review. 

The first is ìRespiratory Protection and Controls to Restrict Internal Exposure,î due in February

2003 and the other is ìEnergy Compensation Sources for Well Logging and Other Regulatory

Clarifications,î due in May 2003. If these two regulations are not adopted by their due dates,

legally binding requirements, such as license conditions or orders, may be used until

compatible rules are adopted.

Incidents and Allegations

No allegations were transferred to Iowa from the NRC since the last review.

Similarly, there were no reportable events involving radioactive materials in the State during the

same time period. IDPH did investigate several minor incidents and provided excellent support

to NRC on two investigations: an Internet auction of radioactive materials; and a temporary

loss of nuclear gauges in the transportation system.
5

Waste Disposal

Iowa regulations were modified on March 13, 2002, incorporating a provision for charging fees

for radioactive waste shipments, both high and low-level, within the State. The regulations

become effective in May 2002 and fee collection will begin in July 2002. Fees received

pursuant to the rule are to be used for purposes related to transporting hazardous material,

including an emergency response program.

CONCLUSIONS:

The Iowa Radiation Control Program has had significant staffing challenges over the past year. 

In spite of the staff shortage, the program has remained viable and is taking actions to alleviate

the losses. The inspection and licensing programs appear to be meeting program goals, with

the exception of the lower-priority General License inspection program.

The new hire, Nancy Farrington, is in an aggressive training program, scheduled for five core

training courses in the first eight months of her employment.

The intravascular brachytherapy device Pre-market Approval issue will be forwarded to NRC

NMSS medical staff.

NRC will again raise the generally-licensed device SS&D issue to the State of New York.

NRC will continue to review means for improving the timeliness of regulation reviews.

At the 1999 Management Review Board meeting, It was recommended that the next Iowa

IMPEP review be scheduled in four years. Those present at this meeting agreed to schedule

the review as planned, approximately August 2003.