DATED: AUGUST 28, 1996 SIGNED BY: HUGH L. THOMPSON, JR.

Mr. Christopher Atchison, Director

Iowa Department of Public Health

Lucas State Office Building

Des Moines, IA 50319

Dear Mr. Atchison:

On August 7, 1996, 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 considered and concurred

with the review team's recommendation that the Iowa program be found adequate

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

Regulatory Commission's (NRC) regulatory program. The next IMPEP review will

be scheduled in three years, unless program concerns develop that require an

earlier evaluation. However, based on the continuing good performance of the

State, the review schedule may be extended to four years.

NRC recognizes the efforts of Iowa and the other Agreement States to maintain

an adequate and compatible program. During the MRB meeting, the potential

impact of NRC's new policy on funding Agreement State travel and training was

discussed. Although the Iowa staff is stable at the moment, the State should

consider developing plans for staff training in light of NRC's policy, which

will end funding by NRC for Agreement State travel and require tuition for

attendance at certain NRC training courses.

Section 5 page 16 of the enclosed final report presents the IMPEP team's

recommendations. We have received your letter dated August 1, 1996, and

appreciate the positive actions that you and your staff have taken and are

continuing to implement with regard to our comments. No response to this

letter is necessary. 

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

the review and your support of the Radiation Control Program. I look forward

to working with you in the future.

Sincerely,/RA/

Hugh L. Thompson, Jr. 

Deputy Executive Director for

 Nuclear Materials Safety, Safeguards,

 and Operations Support

Enclosure: 

As stated

cc: Donald A. Flater, Bureau 

 of Radiological Health

S. Parveen Baig, State Liaison Officer
Mr. Christopher Atchison, Director

Iowa Department of Public Health

Lucas State Office Building

Des Moines, IA 50319

Dear Mr. Atchison:

On August 7, 1996, 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 considered and concurred

with the review team's recommendation that the Iowa program be found adequate

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

Regulatory Commission's (NRC) regulatory program. The next IMPEP review will

be scheduled in three years, unless program concerns develop that require an

earlier evaluation. However, based on the continuing good performance of the

State, the review schedule may be extended to four years.

NRC recognizes the efforts of Iowa and the other Agreement States to maintain

an adequate and compatible program. During the MRB meeting, the potential

impact of NRC's new policy on funding Agreement State travel and training was

discussed. Although the Iowa staff is stable at the moment, the State should

consider developing plans for staff training in light of NRC's policy, which

will end funding by NRC for Agreement State travel and require tuition for

attendance at certain NRC training courses.

Section 5 page 16 of the enclosed final report presents the IMPEP team's

recommendations. We have received your letter dated August 1, 1996, and

appreciate the positive actions that you and your staff have taken and are

continuing to implement with regard to our comments. No response to this

letter is necessary. 

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

the review and your support of the Radiation Control Program. I look forward

to working with you in the future.

Sincerely,

Hugh L. Thompson, Jr. 

Deputy Executive Director for

 Nuclear Materials Safety, Safeguards,

 and Operations Support

Enclosure: 

As stated

cc: Donald A. Flater, Bureau 

 of Radiological Health

S. Parveen Baig, State Liaison Officer

bcc: Chairman Jackson

Commissioner Rogers

Commissioner Dicus

Commissioner Diaz

Commissioner McGaffigan

 *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 OSP OSP:DD OSP:D DEDS

NAME KSchneider:gd PHLohaus RLBangart HLThompson

DATE 08/14/96* 08/19/96* 08/24/96* 08/ /96

 OSP FILE CODES: SP-AG-9
Distribution: 

DIR RF EDO RF HLThompson, DEDS

DCD (SP01) RLBangart PLohaus

SDroggitis KSchneider CPaperiello, NMSS

ELJordan, AEOD KCyr, OGC DWhite, RI

RWoodruff, RII JLynch, RIII JErickson, WA

JPiccone, NMSS CHaney, NMSS DCool, NMSS

GPangburn, RIV FCameron, OGC HNewsome, OGC

TCombs, OCA GDeegan, NMSS

Iowa File

 
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM

REVIEW OF IOWA AGREEMENT STATE PROGRAM

April 1 - 4, 1996

FINAL REPORT

U.S. Nuclear Regulatory Commission

Iowa Final Report Page 1

1.0 INTRODUCTION

This report presents the results of the review of the Iowa radiation control

program. The review was conducted during the period April 1 - 4, 1996, by a

review team comprised of technical staff members from the Nuclear Regulatory

Commission (NRC) and the Agreement State of Washington. Team members are

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

"Interim Implementation of the Integrated Materials Performance Evaluation

Program Pending Final Commission Approval of the Statement of Principles and

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

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

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

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

Preliminary results of the review, which covered the period December 15, 1993,

to March 31, 1996, were discussed with Iowa management on April 4, 1996. 

A draft of this report was issued to Iowa for factual comment on May 8, 1996. 

The State of Iowa responded in a letter dated May 22, 1996 (Attachment 1), and

the comments were incorporated into the proposed final report. The State of

Iowa responded to the recommendations in the proposed final report in a letter

dated August 1, 1996. The Management Review Board (MRB) met on August 7,

1996, to consider the proposed final report. The MRB concurred in the teams's

overall recommendations and found that the Iowa radiation control program was

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

regulatory program.

The Iowa Department of Public Health (IDPH) is the agency within Iowa State

government that regulates, among other public health issues, radiation

hazards. The Director, IDPH, is appointed by, and reports directly to, the

Governor. Within IDPH, the Iowa radiation control program is administered by

the Bureau of Radiological Health (BRH), Division of Health Protection. The

Division of Health Protection organization chart is included as Appendix B. 

The Iowa program regulated 215 specific licenses at the time of the review. 

In addition to radioactive materials, the BRH is responsible for superfund

risk assessment, control of machine-produced radiation, and radon control. 

The review focused on the materials program as it is carried out under the

Section 274b. (of the Atomic Energy Act of 1954, as amended) Agreement between

the NRC and the State of Iowa.

In preparation for the review, a questionnaire addressing the common and noncommon indicators was sent to the State on January 31, 1996. Iowa provided

its response to the questionnaire on February 29, 1996. A copy of that

response is included as Appendix C to this report. 

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

(1) examination of Iowa's response to the questionnaire, (2) review of

applicable Iowa statutes and regulations, (3) analysis of quantitative

information from the radiation control program licensing and inspection data

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

three Iowa inspectors, and (6) interviews with staff and management to answer

questions or clarify issues. The team evaluated the information that it

gathered against the IMPEP performance criteria for each common and non-common

indicator and made a preliminary assessment of the radiation control program's

performance. 
North Carolina Draft IMPEP Report Page 2

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

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

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

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

summarizes the review team's findings and recommendations.

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS

The previous routine review concluded on December 14, 1993, and the results

were transmitted to Mr. Christopher G. Atchison, Director, Iowa Department of

Public Health, on April 11, 1994. NRC visited the program again in December

1994 to evaluate the status of open issues identified in the 1993 review. The

results of this visit were transmitted to Mr. Donald A. Flater, Chief, Bureau

of Radiological Health, on February 13, 1995.

2.1 Status of Items Identified During the December 1993 Routine Review

A number of recommendations were identified as part of the December 1993

review. Some of the recommendations were closed at the time of the December

1994 visit. The review team looked at each remaining item to determine

whether or not the Iowa program had taken additional actions to close open

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

1994 visit are summarized below:

(1) The 1993 reviewer recommended the computer tracking system be 

updated to track licensee responses.

Current Status: The computer tracking system has been updated to track

licensee responses to inspection letters. The program secretary gives

the Program Coordinator a monthly printout. This previous

recommendation is closed.

(2) The 1993 reviewer recommended that the Program Coordinator attend

the licensing course and that the Environmental Specialist attend

the industrial radiography course. It was recommended that new

Environmental Specialists attend all of the NRC core training

courses.

Current Status: The Environmental Specialist has attended the

radiography course. The Bureau is committed to have all new

Environmental Specialists attend all NRC core courses. The Program

Coordinator was scheduled to attend the licensing course in 1995, but

was rescheduled and attended the course in June 1996. The attendance of

the Program Coordinator at the licensing course will be discussed in

Section 3.2. This previous recommendation is closed.

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

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

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

or not the Iowa program had taken actions to close the recommendation. The

recommendations opened during the December 1994 visit are summarized below:

(1) NRC recommended the expansion of audits of program areas such as

the computer tracking system, which was recently compromised due

to improper use, would benefit the program.

Current Status: The Program Coordinator had been identifying problems

with the computer tracking system and coordinating with the computer
North Carolina Draft IMPEP Report Page 3

support staff within the State to rectify errors. The tracking system

was examined in relationship to the common performance indicators, and a

discussion on its performance is found in Section 3.1. This previous

recommendation is closed.

(2) NRC recommended that the State require from its two major broad

scope academic licensees a statement of intent containing a cost

estimate for decommissioning and an indication that funding will

be obtained when necessary. 

Current Status: The Program Coordinator recalled conversing with the

appropriate individuals at the licensees in question and believed that

the required documentation had already been received. However, no

record could be found in the files. The Program Coordinator will be

contacting the licensees and will obtain the required documentation. 

This previous recommendation is closed.

(3) NRC recommended that the qualification journals be kept up to

date.

Current Status: The supervisor sign off sheet for courses completed by

the staff was not kept up to date for two environmental specialists. 

All other portions of the qualification journals were complete. 

However, these two environmental specialists had copies of the

certification of completion for the NRC courses in the Journal. This

previous recommendation is closed.

(4) NRC recommended that the State continue to address the need to

have additional qualified personnel capable of inspecting complex

licensee programs. At the time of the review visit, only one

inspector was qualified to evaluate health and safety issues at

complex licensee programs such as nuclear pharmacies and broad

scope universities.

Current Status: The inspection staff is qualified to perform complex

inspections. Two additional inspectors are qualified to inspect nuclear

pharmacies now. The Program Coordinator is qualified and has been the

team leader for the broad scope universities, and one inspector has the

qualifications and experience to team lead broad scope universities and

other complex inspections as backup to the Program Coordinator. The

remaining inspection staff is continuing to work towards their

qualifications in this area. 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) Status of Materials Inspection Program, (2) Technical Staffing and

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

Inspections, and (5) Response to Incidents and Allegations. 

3.1 Status of Materials Inspection Program

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

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

dispatch of inspection findings to licensees. 
North Carolina Draft IMPEP Report Page 4

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

frequencies for various types or groups of licenses are, with few exceptions,

at least as frequent as similar license types or groups listed in the

frequency schedule in the NRC Inspection Manual Chapter (IMC) 2800. Although

the State had not incorporated some of the April 1995 revisions to IMC 2800,

with the exception of the three instances noted below, the State is conducting

inspections at the same frequency or more frequent than NRC currently

requires. Those categories for which NRC revisions to IMC 2800 were more

conservative than the Iowa frequencies are: (1) medical private practice

license inspections conducted as a Priority 4 in Iowa v. NRC's change to

Priority 3; (2) nuclear laundry licenses, which Iowa considers as a

Priority 3, but treated by NRC as a Priority 2; and (3) possession

only/storage licenses, which Iowa codes as a Priority 7, and NRC considers as

a Priority 3. In discussions with the Program Coordinator, these three

categories were overlooked in the State's review of the changes to IMC 2800. 

It is the State's intention to have inspection frequencies at least as

frequent as those of NRC. When these preliminary findings were raised with

the Iowa staff, the State revised the inspection frequency on April 1, 1996,

to reflect the April 1995 revisions to IMC 2800. The inspection frequencies

of licenses selected for inspection file reviews were compared with the

frequencies listed in the State's data system and were verified to be

consistent with the State's system and as frequent as similar license types

under the IMC 2800 system.

In its response to the questionnaire and additional correspondence with staff,

Iowa indicated that as of March 1996 no licensee identified as a core

inspection in IMC 2800 was overdue by more than 25 percent of the NRC

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

overdue inspections during the entire review period. As a result, two

licenses were identified by the State during the IMPEP review as exceeding the

inspection frequency (These were inspected the week of April 22, 1996). In

discussions with the Program Coordinator, BRH employed a secretary in 1995 who

did not enter all data in the computer tracking system on the licensees

inspections. During 1995, the Program Coordinator and staff reviewed the

information in each file against the data in the tracking system in an attempt

to identify and correct all instances of missing information to the tracking

system used by BRH. However, during the review of the data and the files, BRH

staff have found that copies of correspondence had been lost also. The two

licenses had been overlooked in the State's audit.

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

computer tracking data system and license files. The State identified 21 new

licenses that were issued during the review period, 15 agreement material

licenses and 6 non-agreement material licenses. At the time of the review,

two new licenses issued since November 1995 were not due for inspection, two

licenses were overdue and two licenses had been inspected at intervals of

13 months and 14 months in 1994. All other new licenses had been inspected

within six months of license issuance. The team found that the two licenses

that were inspected late occurred following the last review, when the State

was training staff and management had approved the delay. The two new

licenses that had not been inspected, an in-vitro testing lab and a portable

gauge, are overdue by nine months and seven months, respectively, beyond the

six month due date. These two licenses had not been entered into the computer

tracking system and had not been identified in the audit conducted by BRH. 

The review team recommends that the two new licenses that have not been

inspected, be scheduled for inspection and that the State continue to follow

the IMC 2800 provisions for new licenses. 
North Carolina Draft IMPEP Report Page 5

The timeliness of the issuance of inspection findings was also evaluated

during the inspection file review. Out of 23 compliance files examined both

in detail for quality of the inspection program and for issuance of inspection

findings, 11 had inspection correspondence sent to the licensee within 30 days

after completion of the inspection. On closer examination, 16 out of 23 were

issued within five weeks of the inspection. Six inspection findings were

issued within the time range of 8 to 16 weeks. The remaining case had taken

six months, however, it was a team inspection of Iowa State University's

licenses with significant findings. Management was aware of this delay due to

the complexity of the Iowa State University's report. Delays in issuing

inspection reports impairs the effectiveness of getting prompt corrective

action by the licensee to any violations. Late reports make it difficult for

the program to require a prompt response from the licensee. Finally, late

reports open the program to criticism by licensees. The review team suggested

that State management and staff continue to devote increased attention to

issuing inspection results in a timely manner (30 days).

On examination of the root case for both the timeliness of new license

inspections and the timely issuance of inspection findings, it was noted that

the computer tracking system contributed to some problems experienced by BRH. 

The computer tracking system generates reports based on the date of the cover

letter to the notice of violation. There is a time lag as much as three weeks

between the cover letter and the date the notice of violation is signed. The

reports used by management to track the 30-day response are in some cases

based on artificially generated information, such as the 30 days from the

inspection and not the actual date the notices of violation are signed. The

review team recommends that management information systems, e.g., the computer

tracking system, be reviewed with the appropriate management and support staff

to ensure that the BRH is receiving the information to manage the program. 

The review team suggests that the data in the computer tracking system be

reviewed to ensure the information is complete and correct.

The State reported in its response to the questionnaire that 70 requests for

reciprocity were received during the review period; 18 from industrial

radiographers, 1 well-logger, and 51 portable gauge users and other licensees

with an inspection frequency of more than three years. The State conducted

13 inspections of reciprocity licensees during the review period. The State

requires radiographers to be certified and conducts an aggressive program on

verifying radiographers conduct their licensed activities in accordance with

Iowa regulations. In its response to the questionnaire, the State reported

conducting three field inspections on a non-reciprocity industrial radiography

licensee. 

Based on the IMPEP evaluation criteria, the review team recommends that Iowa's

performance with respect to the indicator, Status of Materials Inspection

Program, be found satisfactory.

3.2 Technical Staffing and Training

Issues central to the evaluation of this indicator include the radioactive

materials program staffing level, technical qualifications of the staff,

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

examined the State's questionnaire responses relative to this indicator,

interviewed IDPH management and staff, and considered any possible workload

backlogs.

IDPH organization chart shows that BRH was staffed with 1 program supervisor

and 14 staff at the time of the review. The staff positions cover radioactive

material, radon, machine-produced radiation, and superfund risk assessment. 
North Carolina Draft IMPEP Report Page 6

Within that group, five technical staff comprise the radioactive materials

control program. Mr. Dan McGhee is the Program Coordinator for the

radioactive materials control program. The three environmental

specialist/engineers (including the Program Coordinator) in the radioactive

materials control program are full-time positions, with few outside (nonprogram) duties. One environmental specialist spends 40 percent of her time

in licensing and the other environmental specialist has begun her training in

the inspection program at a 10 percent effort at this time. In response to

the questionnaire, the State reported that the Bureau Chief spends about

33 percent of his effort on the radioactive material program. In response to

the questionnaire, the State reported that 3.8 FTEs were assigned to the

radioactive materials control program. In addition, BRH retains the services

of a consultant (former NRC employee) at .33 FTE level per year. One position

was filled during the review period. No vacancies were forecast in any of the

radioactive materials positions in the near future. If the funding for the

radon program is reduced, any radon program excess FTE will be placed in the

radioactive material inspection program. The Bureau Chief also told the

review team that he does not know of any plans to reduce the staffing level

for the radioactive materials control program. 

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

therefore, both full time environmental specialists and Program Coordinator

perform duties in licensing, inspection, and event response. Balance between

the licensing and inspection functions is achieved by basing staff assignments

on program needs. 

The Bureau Chief explained that, when vacancies occur, the positions require

bachelor's degrees in a science/engineering field or a technologist degree

with at least three years experience. The review team reviewed the

qualifications of the technical staff and concluded that the State has been

able to retain well-qualified individuals. The Program Coordinator and both

environmental specialists have at least a bachelor's degree in science or

engineering or technologist degree with at least three years experience. 

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

radioactive materials control program. The Program Coordinator provided the

review team Iowa's "Inspector Qualification Journal" and the "Supervisor's

Manual" as developed for the program by their consultant. The inspector

qualification involves completing a series of written examinations and

participating in accompanied inspections, until the Program Coordinator

evaluates their performance as acceptable to perform independent inspections. 

Each inspector had their journal up to date except for the sign off sheet for

completed course work. However, two of the staff had copies of the

certification of completion for the NRC courses in the Journal. 

The documentation of licensing qualifications is not as structured as the

inspection journals. License reviewer candidates are assigned case work in a

given program area after an orientation with a qualified license reviewer. 

The Program Coordinator evaluates these reviews and makes the decision as to

whether the candidate is able to conduct independent reviews. Although

courses are not considered as an actual part of the qualification process, BRH

attempts to schedule new staff for the licensing and inspection courses within

the first nine months of employment. The Program Coordinator had not

completed the licensing course at the time of the review. However, he

received on the job training from Region III staff and the Regional State

Agreements Officer and no licensing performance weakness was identified

because of the lack of this training course. The Program Coordinator was

scheduled for the 1995 course, but was rescheduled and attended the June 1996

course. 
North Carolina Draft IMPEP Report Page 7

The IMPEP reviewer discussed training with the Bureau Chief and Program

Coordinator. Based on the training that program personnel have taken during

the review period, the State appears supportive of continued staff training,

and management demonstrated a commitment to staff training during the review. 

However, the State has concerns as to the impact of NRC's change in policy for

funding State training will have on their program. It was also noted that the

Bureau Chief had requested specialized training for BRH staff on investigation

techniques from the State Highway Patrol for this summer.

Based on the IMPEP evaluation criteria, the review team recommends that Iowa's

performance with respect to the indicator, Technical Staffing and Training, be

found satisfactory.

3.3 Technical Quality of Licensing Actions

The review team examined casework and interviewed the four reviewers for

14 licenses. Licensing actions were reviewed for completeness, consistency,

proper isotopes and quantities used, qualifications of authorized users,

adequate facilities and equipment, and operating and emergency procedures

sufficient to establish the basis for licensing actions. Casework was

reviewed for timeliness, adherence to good health physics practices, reference

to appropriate regulations, documentation and consideration of safety

evaluation reports, product certification or other supporting documents,

consideration of enforcement history on renewals, pre-licensing visits, peer

or supervisory review, and proper signature authorities. Licenses were

reviewed for accuracy, appropriateness of the license and its conditions and

tie-down conditions, and overall technical quality. The files were checked

for retention of necessary documents and supporting data.

The cases were selected to provide a representative sample of licensing

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

all license reviewers. The cross-section sampling included 14 licenses and

included the following types: medical-institution and medical-mobile,

industrial radiography, research and development, fixed and portable gauges,

an in vitro laboratory, and a nuclear laundry. Licensing actions included two

new licenses, five renewals, four amendments and three terminations. A list

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

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

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

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

backed by information contained in the file, and were inspectable. The

licensees' compliance histories were taken into account when reviewing renewal

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

Guides and several were in the process of being revised and updated for use by

Iowa licensees. Reviewers were observed to be skilled with the use of these

and other licensing documents. Reviewers used licensing guides appropriately

and generally used check lists in reviewing applications, although these were

not retained for the files. There was no apparent procedure for terminating

licenses which may have contributed to some inconsistencies in closing files,

particularly with respect to unsealed materials. The Bureau Chief, unless

absent for a prolonged period, reviews and signs all licenses following both a

peer review and a supervisory review by the Program Coordinator. No

potentially-significant health and safety issues were identified. 

Based on the IMPEP evaluation criteria, the review team recommends that Iowa's

performance with respect to the indicator, Technical Quality of Licensing

Actions, be found satisfactory. 
North Carolina Draft IMPEP Report Page 8

3.4 Technical Quality of Inspections

The team reviewed the inspection reports, enforcement documentation, and

inspection field notes for 17 materials inspections conducted during the

review period. The casework included all three of the State's materials

inspectors and covered a sampling of different license types as follows: 

industrial radiography, broad scope university, broad scope research and

development, broad scope medical, teletherapy, nuclear medicine, large

hospital, nuclear pharmacy, laboratory use, portable gauge, and fixed gauge

licensees. Appendix E provides a list of the inspection cases reviewed in

depth with case-specific comments.

The review team noted several strengths in the Iowa program on this indicator. 

For instance, the IMPEP reviewer noted that the routine inspections covered

all aspects of the licensee's radiation program and often included a written

summary of the root cause if a deficiency or violation was noted. The IMPEP

reviewer also noted that the inspectors observed licensed operations whenever

possible. The observation of licensed activities provides the inspectors with

an indication of the effectiveness of the licensee's radiation protection

program. Another strength noted was the numerous inspection accompaniments

conducted during the review period by the Program Coordinator or the Bureau

Chief, more than the minimum annual standard in the IMPEP evaluation criteria. 

This gives program management a better understanding of both inspectors'

abilities and on-site conditions. Finally, the State conducted team

inspections of larger licensees, where the Program Coordinator was joined by

one or both of the environmental specialists along with one or both

individuals who supported the radioactive materials program part time. Having

multiple inspectors review a particular licensees' operations may lead to more

thorough inspections and provide the opportunity for less experienced

inspectors to observe experienced inspectors as an effective training

technique.

The review team reviewed the inspection reports and found them to be

comparable with the types of information and data collected under NRC

Inspection Procedure (IP) 87100. The inspection field notes provided

documentation of inspection findings in a consistent manner. The State uses

separate inspection field notes for various classes of licensees, such as

nuclear medicine, portable gauges, radiography, and industrial/academic. The

inspection field notes provide documentation of the scope of the licensee's

program including: unusual occurrences; postings; storage and use of

radioactive material; receipt, transfer, and disposal of radioactive material;

inventory; leak tests; radiation protection program; personnel monitoring;

training; independent measurements; and inspection findings. The IMPEP

reviewer noted that the State had specific field notes for radiography field

sites that include documentation for security of radioactive material,

security and posting of radiation areas, personnel monitoring, radiation

surveys and instruments, training, operating and emergency procedures, records

and confirmatory measurements. The reviewer concluded that separate field

notes specific for field radiography were a good addition to the State program

to provide inspectors with an effective means to document the use of large

activity sources in the public domain.

During the review of the inspection files, the IMPEP reviewer noted that one

of the medical licensees possesses and uses a high dose rate afterloader

(HDR). Although the inspection documentation for this licensee was in the

form of a written report, the State does not have field notes specific for the

inspection of a HDR. The review team suggests that the State have field notes

specific to HDRs in order to document the proper use and compliance with the

regulations and license conditions for this medical device.
North Carolina Draft IMPEP Report Page 9

The IMPEP reviewer noted that the field notes did not include documentation

for the evaluation of dose to members of the public or instruction on dose

limits to embryo/fetus and declared pregnant women. Although the dose to

members of public was evaluated for nuclear pharmacy and one of the large

broad scope inspection reports reviewed by the team, there are other

facilities where such an evaluation is appropriate. The reviewer also noted

that the State had Quality Management Program (QMP) requirements in the State

Code, but the State's field notes or inspection reports did not address this

area of a medical licensee's program. In discussions with one of the

inspectors, the reviewer was informed that the inspector did look at the

licensee's QMP activities and compared their implementation to the

regulations, but the observations were not documented. In addition, the

reviewer noted that level of documentation for a particular section of one

class of field notes was different from another. For example, the radiation

protection section in the academic/industrial field notes has an additional

item for review compared to the State's medical and teletherapy field notes.

The review team suggests that the State revise their field notes to

incorporate dose to members of the public and instruction on dose limits to

embryo/fetus and declared pregnant women for all field notes and to revise the

medical and teletherapy field notes to incorporate the State's QMP

requirements. In addition, the review team suggests that the State review

their field notes to incorporate consistent content of sections in all classes

of field notes.

The inspection reports and field notes demonstrated that the State inspectors

were examining appropriate radiation health and safety issues at licensees'

facilities. Two environmental specialists told the reviewer that they are

required to review all aspects of the licensee's radiation safety program and

document that review in the field notes. Inspectors routinely performed

independent measurements at the licensee facility. The performance of such

measurements by the State inspectors in one case resulted in the

identification of a significant safety problem, inadequate survey of a patient

room after a therapeutic treatment. Inspectors' written comments in the field

notes indicate that they discussed safety issues with licensee personnel. The

field notes or reports indicate that licensee operations were observed when

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

the State inspectors support that they routinely tour licensee areas such as

laboratories, other locations of use, and storage areas. Both environmental

specialists told the IMPEP reviewer that they emphasize the observation of

licensed activities to determine the effectiveness of the licensee's radiation

safety program and compliance to the requirements, a critically important

inspection technique. The field notes indicate that the inspectors

consistently examined and, when appropriate, closed-out previous violations. 

Also, because the environmental specialists serve as both inspectors and

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

issues were considered in the inspection process.

While reviewing the 17 inspection cases, the IMPEP reviewer found a number of

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

none of the issues indicated a systemic problem in the technical quality of

inspections.

Three inspector accompaniments were performed by a review team member during

the period of March 4-7, 1996. All three of the Iowa inspectors were

accompanied during the period. One of the environmental specialists was

accompanied during the inspections of a mobile nuclear medicine program and a

fixed gauge program. The second environmental specialist and the Program

Coordinator were accompanied during the inspection of a nuclear pharmacy. On
North Carolina Draft IMPEP Report Page 10

April 3, 1996, the environmental specialist who participated at the nuclear

pharmacy inspection was accompanied by a review team member during the

inspection of a diagnostic nuclear medicine licensee. During the

accompaniments, the Iowa inspectors demonstrated appropriate inspection

techniques and knowledge of the regulations and licenses. The reviewer

particularly noted that all three inspectors emphasized observation of

licensed activities and interview of personnel to assess the effectiveness of

licensee's radiation safety program. The inspectors were well-prepared and

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

Overall, the technical performance of the inspectors was satisfactory, and

their inspections were adequate to assess radiological health and safety at

the licensed facilities.

In response to the questionnaire, the State reported that the two staff

members were accompanied by the Program Coordinator during the review period. 

In addition, two individuals who did not inspect independently during the

review period were also accompanied by the Program Coordinator. The

questionnaire indicates that the Program Coordinator conducted accompaniments

with each staff inspector twice during 1995. Based on interviews with the

State staff, the number of accompaniments was actually higher than the number

in the questionnaire. The questionnaire did not include the accompaniments by

the Bureau Chief or the Program Coordinator. The Program Coordinator also

observed staff during team inspections that were conducted. The inspectors

reported receiving feedback from the supervisor on their performance during

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

supervisory accompaniment procedures were not fully developed since only one

inspector (Program Coordinator) could independently inspect all areas. The

State noted, however, by the end of 1996, the goal was to accompany each

inspector twice a year. The review team found that the State was exceeding

the IMPEP criteria in NRC Management Directive 5.6 for annual accompaniments.

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

confirmatory surveys and use during incidents and emergency conditions. The

instruments were a mix of low and high range Geiger-Mueller (GM) detectors and

pancake probes, micro R meters, higher-range instruments, instrumentation for

alpha detection, pocket dosimeters, and audible dosimeters. The portable

instruments used during the inspector accompaniments were observed to be

operational and calibrated. The portable instruments maintained in the office

were also observed to be calibrated. The reviewer noted that instruments are

calibrated at least on a quarterly basis.

The IMPEP reviewer noted that all of the beta/gamma detection instrumentation

was calibrated in units of exposure rate without a detector efficiency. 

Without an efficiency, the State inspectors would not be able to evaluate a

licensee's compliance with contamination release limits. The State's

instruments are calibrated by another State agency: Iowa Department of Public

Defense, Disaster Services Division located at Camp Dodge in Johnson, Iowa. 

The IMPEP reviewer toured the facility and spoke to the individual responsible

for the calibration of the State's radiological survey instrumentation. The

calibration facility had National Institute of Science and Technology

traceable sealed sources to determine the efficiency of beta/gamma

instrumentation. The determination of the instrument efficiency will enable

the inspector to convert counts per minute (cpm) to disintegration per minute

(dpm) in order to determine the licensee's compliance with surface

contamination release criteria. The review team suggests that some of the

State's instrumentation be calibrated with the efficiency to convert cpm to

dpm.
North Carolina Draft IMPEP Report Page 11

Based on the IMPEP evaluation criteria, the review team recommends that Iowa's

performance with respect to the indicator, Technical Quality of Inspections,

be found satisfactory.

3.5 Response to Incidents and Allegations

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

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

the questionnaire relative to this indicator, reviewed the incidents reported

for Iowa in the "Nuclear Material Events Database" (NMED) against those

identified by Iowa, and reviewed the casework and license files, as

appropriate, of six incidents. There were no allegations during the time

period covered by the review. In addition, the review team interviewed the

staff assigned to each response.

Responsibility for initial response and follow-up actions to materials

incidents and allegations rests with BRH. Written procedures require the

prompt response by BRH to each incident or allegation, with no specific

instruction. In the response to the questionnaire, Iowa noted that their

policy was to inform the Region III Regional State Agreements Officer within

24 hours of any unusual occurrence or incident. The review team suggested

that the procedures for notifying NRC of incidents be revised to reflect the

current guidance to Agreement States to notify the NRC headquarters operations

office of events requiring immediate or 24-hour reporting by the licensee.

Because of the size of the program, each incoming notification is discussed

with staff and management, as appropriate. If the response included an onsite inspection, this was completed by the assigned staff. The review team

examined the State's response to all the events including three events that

were identified by the State (two contamination events and a lost gauge) as

most significant in the IMPEP questionnaire, the State's incident and

allegation process, and the appropriate license files. The information in

NMED agreed with the information in the Iowa files. The incident files

reviewed included a lost generally-licensed gauge, fire at a nuclear laundry,

damage to a specific gauge, and three contamination incidents. A list of the

incident casework with comments is included in Appendix F.

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

responses were well within the performance criteria. Responses were prompt

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

safety significance. The IMPEP reviewer noted that most incident reports

included a written summary of the root cause if a deficiency or violation was

noted. BRH staff were dispatched to the sites when appropriate. The State

took suitable enforcement actions, required the licensee to implement

corrective actions, and completed all steps of the investigation through

close-out. 

Although there were no allegations received by the State during the time

period covered by the review, the State told the review team that they do

protect allegers' identities, and notify allegers of the results of the

State's investigation.

 

Based on the IMPEP evaluation criteria, the review team recommends that Iowa's

performance with respect to the indicator, Response to Incidents and

Allegations, be found satisfactory. 
North Carolina Draft IMPEP Report Page 12

4.0 NON-COMMON PERFORMANCE INDICATORS

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

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

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

Waste Disposal Program, and (4) Uranium Recovery. Iowa's Agreement does not

cover low-level radioactive waste disposal and uranium recovery operations, so

only the first two non-common performance indicators were applicable to this

review.

4.1 Legislation and Regulations

4.1.1 Legislative and Legal Authority

Along with their response to the questionnaire, the State provided the review

team with copies of legislation that affects the radiation control program. 

The Department of Public Health is designated as the State radiation

protection agency in the Iowa Code, Chapter 136C. With response to the

questionnaire that there had been no change to the State legislation, the

review team did not review the legislation but relied on previous reviews

where State legislation was determined to be adequate. Although the State

indicated there were no changes to Iowa Code in the questionnaire that affects

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

control act and the administrative act with the staff. The Iowa Code grants

the Department of Public Health the authority to promulgate rules and

regulations in accordance with the administrative act to be followed in the

administration of a radiation protection program.

4.1.2 Status and Compatibility of Regulations

Iowa's final equivalent rules and amendments to the following NRC rules became

effective September 7, 1994: "Quality Management Program and

Misadministrations" 10 CFR Part 35; "Decommissioning Recordkeeping and License

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

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

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

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

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

these regulations are compatible with equivalent NRC regulations. 

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

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

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

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

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

rules:

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

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

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

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

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

Given the absence of any interest in the use of irradiators in Iowa, the State

is postponing development and adoption of the "Licensing and Radiation Safety

Requirement for Irradiators," 10 CFR Part 36 equivalent rulemaking as stated

in their March 24, 1994, letter to NRC. In the August 31, 1994 response from

NRC, this action was deemed acceptable and would not affect the compatibility
North Carolina Draft IMPEP Report Page 13

determination for the Iowa program. However, Iowa committed in the March 24,

1994 letter, to take action to adopt the provisions of Part 36, if an

application for a large irradiator were to be received, and until such a rule

becomes effective, to incorporate the provisions of Part 36 through license

conditions. 

The State has begun the process of promulgation of the following rules

necessary for a compatible program:

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

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

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

January 1, 1995.

• "Frequency of Medical Examinations for Use of Respiratory Protection

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

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

of compatibility. Division 2 compatibility allows the Agreement States

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

continue to require annual medical examinations). 

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

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

effective March 1, 1998. Iowa and other Agreement States are expected

to have that equivalent rule effective on the same date.

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

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

August 14, 1995.

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

Parts 20 and 35 amendments (60 FR 48628) that became effective 

October 20, 1995.

• "Clarification of Decommissioning Funding Requirements," 10 CFR

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

November 24, 1995.

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

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

1996.

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

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

comment on proposed regulations during a 20-day comment period and in a public

hearing that follows the comment period. According to the Bureau Chief, NRC

is provided with drafts for comment on the proposed regulations early in the

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

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

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

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

Chief explained that they had begun the process of preparing draft revisions

to the regulations which they expect to promulgate in October 1996 for new

regulations due in 1998. The State's formal regulation promulgation process

takes approximately five months. The State is aware of the importance of

maintaining compatible regulations and the State plans to yearly update

regulations to maintain compatibility. 
North Carolina Draft IMPEP Report Page 14

Based on the IMPEP evaluation criteria, the review team recommends that Iowa's

performance with respect to the indicator, Legislation and Regulations, be

found satisfactory.

4.2 Sealed Source and Device Evaluation Program

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

evaluation program because of the request from Iowa Governor Terry E.

Branstaad to Richard L. Bangart, Director, Office of State Programs, on

January 22, 1996, to relinquish its SS&D authority. The State did not perform

SS&D evaluations in the past and believes it is not likely that any devices

containing radioactive material will be manufactured in the near future. In

addition, such evaluations require personnel resource commitments that the

Iowa program cannot justify. The Commission has agreed to these requests and

NRC reasserted authority in this area on June 1, 1996. 

5.0 SUMMARY

As noted in Sections 3 and 4 above, the review team found the State's

performance with respect to each of the performance indicators to be

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

recommendations and found that the Iowa program was adequate to protect public

health and safety and was compatible with NRC's regulatory program.

Below is a summary list of recommendations and suggestions, as mentioned in

earlier sections of the report, for consideration by the State. 

1. The review team recommends that the two new licenses that have not been

inspected, be scheduled for inspection and that the State continue to

follow the IMC 2800 provisions for new licenses. (Section 3.1)

2. The review team suggested that State management and staff continue to

devote increased attention to issuing inspection results in a timely

manner (30 days). (Section 3.1)

3. The review team recommends that management information systems, e.g., 

the computer tracking system be reviewed, with the appropriate

management and support staff to ensure that the BRH is receiving the

information to manage the program. (Section 3.1)

4. The review team suggests that the data in the computer tracking system

be reviewed to ensure the information is complete and correct. 

(Section 3.1)

5. The review team suggests that the State have field notes specific to

HDRs in order to document the proper use and compliance with the

regulations and license conditions for this medical device. 

(Section 3.4)

6. The review team suggests that the State revise their field notes to

incorporate dose to members of the public and instruction on dose limits

to embryo/fetus and declared pregnant women for all field notes and to

revise the medical and teletherapy field notes to incorporate the

State's QMP requirements. (Section 3.4)

7. The review team suggests that the State review their field notes to

incorporate consistent content of sections in all classes of field

notes. (Section 3.4)
North Carolina Draft IMPEP Report Page 15

8. The review team suggests that some of the State's instrumentation be

calibrated with the efficiency to convert cpm to dpm. (Section 3.4)

9. The review team suggests that the procedures for notifying NRC of

incidents be revised to reflect the current guidance to Agreement States

to notify the NRC Headquarter Operations Center. (Section 3.5)
LIST OF APPENDICES AND ATTACHMENTS

Appendix A IMPEP Review Team Members

Appendix B Iowa Department of Public Health, Division of Health

Protection Organization Chart

Appendix C Iowa's Questionnaire Response

Appendix D License File Reviews

Appendix E Inspection File Reviews

Appendix F Incident File Reviews

Attachment 1 Iowa's Response to Review Findings
APPENDIX A

IMPEP REVIEW TEAM MEMBERS

Name Area of Responsibility

Kathleen Schneider, OSP On-Site Team Leader

Status of Materials Inspection Program

Technical Staffing and Training

Response to Incidents and Allegations

Legislation and Regulations 

Terry Frazee, Washington Technical Quality of Licensing Actions

Duncan White, RI Technical Quality of Inspections
APPENDIX B

Iowa Department of Public Health

Division of Health Protection

ORGANIZATION CHART
APPENDIX C

Iowa's Questionnaire Response