ML20217L827

Proposed Final Rept, Integrated Materials Performance Evaluation Program Review of Iowa Agreement State Program, 990817-20

ML20217L827
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Issue date:	08/17/1999
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l lNTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW OF IOWA AGREEMENT STATE PROGRAM August 17-20,1999 PROPOSED FINAL REPORT l

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U.S. Nuclear Regulatory Commission l

l ATTACHMENT 1 9910270082 991015 PDR STPRO ESGIA l PDR

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~ lowa Proposed Final Report Page 1

1.0 INTRODUCTION

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This report presents the results of the review of the Iowa radiation control program. The review was conducted during the period August 17-20,1999, by a review team comprised of technical staff members from the Nuclear Regulatory Commission (NRC) and the Agreement State of North Carolina. . 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 Reaister on October 16,1997, and the November 25,1998, NRC Management Directive 5.6,

" Integrated Materials Performance Evaluation Program (IMPEP)." Preliminary results of the review, which covered the period April 4,1996 to August 20,1999 were discussed with lowa management on August 20,1999.

[A paragraph on the results of the MRB meeting will be included here in the final report.]

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

Department). The Department is the agency within Iowa State government that regulates, I among other public health issues, radiation hazards. 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 Administration and Regulatory Affairs. Organization charts for the Department are included as Appendix B. At the time of the review, the Iowa program regulated 220 specific licenses, including industrial radiography, academic, medical and research and development (both broad scope and specific) with broad scope activities including high dose rate (HDR)/ teletherapy, veterinary medicine, waste incineration, brachytherapy, nuclear pharmacy, research & development, and irradiator.

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 indicators was sent to the Bureau on May 19,1999. The Bureau provided a response to the questionnaire on June 10,1999. Copies of the questionnaire responses are included as Appendix F 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 Bureau licensing and inspection data base; (4) technical review of selected licensing and inspection actions; (5) field accompaniments of four lowa inspectors; and (0) 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 applicable non-common indicator and made a

- preliminary assessment of the radiation control program's performance.

Section 2 below discusses the Department'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

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- lowa Proposed Final Report Pare 2 non-common performance indicators, and Saction 5 summarizes the review team's findings, i recommendations. Recommendations made by the review team are comments that relate directly to program performance by the Department. A response is requested from the Department to all recommendations in the final report.

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- 2.0 - STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS During the previous routine review, which concluded on April 4,1996, two recommendations >

were made and the results of the review transmitted to Mr. Christopher Atchison, Director, Iowa Department of Public Health on August 28,1996. The team's review of the current status of these recommendations is as follows:

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.'

Current Status: These two licenses have been inspected. The tracking system used by the Bureau identifies new licenses and schedules initial inspections for six months after license issuance. The licensee is called at the six-month mark and an inspection is scheduled if licensed material has been received. If no material has been received, the inspection is delayed. The Bureau confirmed that all new licenses are inspected within one year of license issuance. A review of two new licenses issued during this IMPEP review period verified that both licensees were inspected within six months of the license-issuance. This recommendation is closed.'

2. The review team recommends that management information systems, e.g., the computer tracking system be reviewed, with tho' appropriate management and support staff to ensure that the Bureau is receiving the information to manage the program.

Current Status: The computer tracking system was evaluated and updated by the Bureau since the last review. The Bureau Chief stated that the tracking system provides accurate data for use in managing the radiation control program. During this IMPEP review the computer tracking system was examined and found to be providing accurate information. This recommendation is closed.

' During the 1996 review, seven suggestions were made concerning: (1) the timely issuance of inspection results; (2) the review of data in the computer tracking system; (3) the development of specific field notes for HDRs; (4) the revision of the field notes to include dose to the public, embryo / fetus, declared pregnant woman and quality managernent program requirements; (5) the review of Bureau's field notes for cons; stent content; (6) the calibration of some Bureau instrumentation with the efficiency to convert epm to dpm; and (7) the revision of incident procedures to include current guidance for notification of NRC Headquarters Operations Center.

The team determined that the State considered the suggestions and took appropriate actions.

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i lows r'roposed Final Report Page 3 l 3.0 COMMON PERFORMANCE INDICATORS i

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 Quality of Inspections; (3) Technical Staffing and Training; (4)

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

3.1 - Status of Materials Inspection Proaram 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. The review team's evaluation is based on the Iowa questionnaire responses relative to this indicator, data gathered independently from the Bureau's licensing and inspection data tracking system, the examination of completed licensing and inspection casework, and interviews with managers and staff.

Evaluation of Iowa's inspection priorities for the materials program indicated that the maximum period for an inspection interval is seven years. Five of the 36 licensee categories established by the Bureau have inspection frequencies greater than similar type categories listed in NRC Inspection Manual Chapter (IMC) 2800. None of the Bureau categories had a lower frequency of inspection. It was noted that the Bureau uses discretion to increase inspection frequency based on licensee history and performance.

in their response to the questionnaire, the Bureau indicated that they had no inspections ,

overdue by more than 25% of the NRC frequency. During the review, the team verified that there were no inspections that were overdue by these criteria.

With respect to initial inspections, the Bureau assigns the inspection due date six months from the issuance of a new license. This is automatically accomplished on the database. In practice, the Bureau conducts initialinspections six months from receipt of radioactive materials or commencement of licensed activities. As noted previously, all new licenses are inspected within one year of license issuance regardless of license activity, With respect to reciprocity, the Bureau recognizes licensees one year from the date of their initial request to enter the State. The review team found that the State's reciprocity program was in practice similar to NRC's IMC 1220. The one exception is that the Bureau has committed to ,

inspect 100% of the industrial radiography companies coming in under reciprocity. A review of l seven reciprocity inspections conducted during the review period verified this commitment.

Timeliness of inspection correspondence issuance was evaluated during the inspection casework review. Of 10 inspection reports reviewed by the team, eight were issued to the licensee within 30 days. Two were issued at 90 and 120 days,'respectively, however, the lateness of these inspection reports was due to the need for the inspector to take unplanned family leave.

u l lowa Proposed Final Report Page 4 Based Ja the IMPEP evaluation criteria, the review team recommends that lowa's performance with respect to the indicator, Status of the Materials Inspection Program, be found satisfactory.

3.2 - -Technical Quality of insoections

- The team evaluated the inspection reports, enforcement documentation, and inspection field nom cnd interviewed inspectors for 11 materials inspytions conducted during the review period. The casework included all of the Bureau's materials inspectors, and covered inspections of various types including industrial radiography fixed facilities and temporary job sites, medical institutions / group / private practice, academic broad scope, nuclear rd. rmacy, and nuclear medical vans.' Appendix C lists the inspation casework files reviewed for completeness and adequacy with case-specific comments.

Based on casework, the review team noted that the t outine inspections covered all aspects of the' licensees' radiation programs. The review team found that inspection reports were thorough, complete, consistent, and 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.

Field notes have been developed to cover most types of inspections that are conducted by the Bureau. These field notes provide documentation for the scope of the licensees' program and ,

cover all areas that need to be reviewed. The information contained in the field notes is comparable with NRC's inspection Procedure 87100.

During the week of July 20,1999, a review team member performed accompaniments with all four of the Bureau inspectors. The inspections included a nuclear pharmacy facility, one institutional nuclear medicine facility, one portable and one fixed nuclear gauge facilities. 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 tried a new approach to inspecting broad scope icensees during a routine team inspection at the University of Iowa. The new approach invoved a performance based-

- inspection utilizing a narrative report format that incorporated a collegial, cooperative approach

' to identifying inspection findings.

The inspection report for this inspection was issued approximately four months after the completion of the inspection. The report listed several"evaluative comments" regarding the inspection findings. The comments were not identified as violations. The Bureau inspection Procedure Manual described the narrative report format that was used for this new approach to broad scope inspections. The Management Discussion section of the procedure directed that, if

violations were identified and discussed with licensee management, and if the licensee 1

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proposed or' comrAttted to any corrective actions, the proposed corrective actions and licensee's proposed time of completion were to be described in the report. Since the report did not classify

' any of the inspection findings as violations, the licensee did not propose or commit to any I corrective actions.  !

The initial inspection report was followed by a revised inspection report five months later. The revised report was stated as being generated due to technical and clerical errors within the report. It was noted by the review team that some of the findings as stated in the first report had been revised. The State explained that the second report had been generated after a meeting was held between the licensee and lead inspector. The revised report also did not appear to n . have the supervitory review as did the first one.

The IMPEP review team discussed these issues with the Bureau staff. The staff committed to documenting a transition or bridge statement to be placed in the inspection file to further explain and document the: basis for the revised report. The review team found that at the time that the revised report was issued, the Bureau Chief had been out of the office and had not been available to sign the report to provide supervisory review. The Bureau Chief stated that he was aware of the revised report and had given his approval to the inspector to sign-out the report in his absence. He had not, however, authorized the meeting between the licensee and the -

inspector, although he was informed of the meeting after it occurred. The review team believes the Bureau's commitment to provide a transition or bridge statement in the inspection file is appropriate. Doing so, should not only provide the basis for but also alleviate any future possible questions on the Bureau's issuance of a revised inspection report.

Based on the IMPEP evaluation criteria, the review team recommends that lowa's performance w:th respect to the indicator, Technical Quality of Inspections, be fou'nd satisfactory. I

3.3 Technical Staffina and Trainino k

.lssues central to the evaluation of this indicator include the radioactive materials program

- staffing level and staff tumover, as well as the technical qualifications and training histories of the staff. To evaluate these issues, the review team examined the Bureau's questionnaire I responses relative to this indicator, interviewed program management and staff, and considered  !

- any possible workload backlogs.

) The Bureau is staffed with the Bureau Chief and three Program Coordinators, and nine staff members. The radioactive materials program includes the program coordinator, two health physicists, and one clerical staff member, All of the technical staff members perform duties in licensing, inspection, and event re'sponse. One program coordinator devotes his time to

. training, emergency response, and environmental issues, and the third program coordinator is responsible for radiation machines.

The W " ataffing level was stable over the review period. There are currently six people with

, various % ses of involvement with the Iowa radioactive materials program, equivalent to about j

' four FTEs devoted to the materials program. This staffing level does not include clerical support j staff. Of the six people in the program, two individuals are involved with licensing and j compliance approximately 80% of the time and one individual at 70%. The remaining three  !

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lowa Proposed Final Report Page 6 persons have responsibilities in administration, support, and environmental issues. All six staff members are involved in emergency response activities. The staff consists of experienced personnel. Among the materials program staff, there is one with an associate degree, with the i

. remainder having bachelor degrees I Based on the lack of backlogs and the quality of the licensing actions and inspection reports, the team concluded that the number and distribution of staff appear to be adequate to maintain the j program. '

Training for licensing and inspection staff is similar to the training program developed by the NRC. Because the staff have been with the Bureau for a number of years prior to the review period, training records reviewed showed extensive _ accumulation of both NRC, the Department, '

and other training courses.

The Bureau Chief stated that for the last three years, the Bureau has included requests for training funds in the budget, but that the requests have been denied each year. Nonetheless, the Bureau Chief stated that when someone needs training, the funds have been and will be made available as needed. During the review of the training records, the team noted that one staff member has not completed the teletherapy and brachytherapy core course. The team believes that all technical staff performing brachytherapy licensing or inspections would benefit from the teletherapy and brachytherapy course or equivalent training. 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. Prior to the end of the review, the Bureau Chief enrolled the staff member into NRC's March 2000, teletherapy and brachytherapy course.

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. Inspectors are accompanied at least once a year by a qualified inspector or the Bureau Chief, typically during te::m inspections. Inspector accompaniments have not been routinely documented; however, the

= Radioactive Materials Program Coordinator stated that they will be using an inspector evaluation form with each accompaniment.

Based on the IMPEP evaluation criteria, the review team recommends that lowa's performance with respect to this indicator, Technical Staffing and Training, be found satisfactory.

3.4 Technical Quality of Licensina Actions The review team examined completed licenses and casework for 10 licensing actions, representing the work of three license reviewers. The license reviewers were interviewed to supply additional information regarding licensing decisions or file contents. I Licensing actions were evaluated for completeness, consistency, proper isotopes and quantities i used, qualifications of authorized users, adequate facilities and equipment, and operating and emergency procedures sufficient to establish the basis for licensing actions. Licenses were reviewed for overall technical quality including accuracy, appropriateness of the license of its

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lowa Proposed Final Report Page 7 conditions, and tie-down conditions. The casework was evaluated for timeliness, adherence to

' good health physics practices, reference to appropriate regulations, documentation of safety

- evaluation reports, or other supporting documents, consideration of enforcement history on renewals, peer or supervisory review as indicated, and proper signature authority. The files were checked for retention of necessary documents and supporting data. In addition, the review team l noted the Bureau has been working on the tracking and registration of generally licensed devices since 1997 and have made significant progress in this endeavor.

The licensing actions reviewed included the following types of licenses: industrial radiography, academic, medical and research and development (both broad scope and specific) with broad scope activities including HDRheletherapy, veterinary medicine, waste incineration, ,

brachytherapy, nuclear pharmacy, research & development, and irradiators. Licensing actions included one new license, four amendments, four renewals, and one termination. A list of these licenses with case specific comments may be found in Appendix D. In discussions with Bureau management it was noted that there were no major decommissioning efforts underway with  ;

regard to agreement material in lowa.

The review team found that the licensing actions were thorough, complete, consistent, and of high quality, with health and safety issues properly addressed. Tie-down conditions are backed Dy information contained in the file, and are inspectable. Deficiency letters clearly state regulatory positions, are used at the proper time, and identify deficiencies in the licensees' documentsc Terminated licensing actions are well-documented, showing appropriate transfer and survey records. License files are complete and well organized. The Bureau uses a

. combination of NRC and State regulatory guides and State regulations. In addition, licensing checklists are used and designed for each category of license. These documents are complete, well organized, available to reviewers, and are followed by reviewers. Based on the files reviewed, actions were completed in a timely manner, j 4

'i The review team noted that during a visit in 1994, the NRC recommended that the Bureau require from its two major broad scope licensees a Statement of Intent containing a cost estimate for decommissioning and an indication that funding will be obtained when necessar) . This item 3 was closed in the last IMPEP report transmitW to the D3partment on August 26,1996, after the I Bureau agreed to obtain the required documeatation. However during the current IMPliP review, l the review team noted that only the University oi! cwa had a letter in the license file indicating that

they would be responsible for decommissioning costs, but did not contain a cost estimate for l decommissioning, as recommended by the NRC. (The other broad scope license, Iowa State j University, did not have a letter in the license file that addressed decommissioning.) Amendment I No. 01, of the Iowa State University license, authorized them to possess radionuclides with atomic numbers from 84 to 98, in any form, up to a maximum of 1 curie per radionuclide and up to 20 curies total quantity. These possession limits would require them to submit a Statement of Intent containing decommissioning cost estimates. The review team recommends that the State require both broad scope licensees to submit Statements of Intent containing cost estimates for  !

decommissioning indicating that funding will be obtained when necessary.

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Based on the IMPEP evaluation criteria, the review team recommends that lowa's performance  !

with respect to the indicator, Technical Quality of Licensing Actions, be found satisfactory. ,

c lowa Proposed Final Report Page 8 3.5 . Response to incidents and Alleoations 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 lowa in the " Nuclear Material Events Database" (NMED) against those contained in the Iowa files, and evaluated the casework and supporting documentation for three material incidents. These were the only reportable incidents during the review period. The team also reviewed the Bureau's response to four allegations, including three allegations referred to the State by NRC, during the review period. A list of incident files examined along with case specific comments is contained in Appendix E.

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 three incidents selected for review

= included a melted ga'uge, a lost source and an accidental release of radioactive material.

When notification of an incident or an allegation is received, the Bureau Chief and staff meet to discuss the initial response and the need for an on-site investigation. The safety significance of the incident / allegation is evaluated to determine the type of response that lowa will take. The small size of the Iowa program allows for the prompt dissemination of information regarding the

. event to all personnel in the program. Radiologicalincidents can be reported 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> a day

' through the State's Radiological Response Team emergency telephone line.

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 anti safety significance. Inspectors were dispatched for on-site investigations when appropriate end the Bureau took suitable enforcement action. The review

. team found the documentation of the incidents to be consistent and that incidents were followed up at the next inspection.

Incidents are promptly reported to the NRC via the Regional State Agreements Officer. The Bureau was reminded of the current guidance to Agreement States to report incidents to the ,

NRC Operations Center.

The staff was familiar with the guidance contained in the " Handbook on Nuclear Event Reporting in the Agreement States." The review team queried the incident information reported to the NMED system for lowa for the review period which identified the three incidents discussed

. above. As few incidents are required to be reported to NMED, the Bureau chooses to send information by hard copy to NRC for inclusion in the incident database, rather than training staff to input the information' electronically into the system. The Bureau constructed a template for the information required by the NMED database for completeness and ease of input by NRC.

During the review period, three allegations were referred to the State by the NRC and one allegation was reported directly to the program. The review of the Bureau's allegation files indicated that the Bureau took prompt and appropriate action in response to the concems raised.

The review team noted that all documentation related to the investigation of allegations was maintained in the incident file. Allegers were properly notified of investigation results.

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lowa Proposed Final Report Page 9 The Bureau has only very general written guidance for handling incidents and allegations in their inspection procedures. During the' review, the Agreement State review team member shared his L State's detailed incident procedures with the Iowa program. Bureau management indicated that they would modify the procedures to apply specifically to the Iowa incident and allegation response program.

Based on the IMPEP evaluation criteria, the review team recommends that lowa's performance with respect to the indicator, Response to incidents and Allegations, be found satisfactory.

4.0 ' NON-COMMON PERFORMANCE INDICATORS

'IMPEP identifies four non-common performance indicators to be used in reviewing Agreement State programs: '(1) Legislation and 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 cover the SS&D

program, low-level radioactive waste disposal program or uranium recovery program, so only the j first non-common performance indicator was applicable to this review.

-4.12 Leaislation and Proaram Elements Reauired for Comoatibility 4.1.1 ' Leaislation 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 currently effective statutory authority ter the radiation control 1 program is contained in the Iowa Code, Chapter 136. The Department is deCgnated as the i State's radiation control agency. The review team noted that no legislation affecting the program was passed during the review period.

4.1.2 Proaram Elements Reauired for Compatibility

- The lowa 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 lows 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.

. Proposed rules are sent to all potentially impacted licensees for comment. The Bureau's practice

- had been to also send the proposed rules to NRC for review. Comments are considered and incorporated as appropriate before the regulations are finalized. The State has the authority to issue legally binding requirements (e.g., license conditions) in lieu of regulations until equivalent State regulations become effective.

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lowa Proposed Final Report Page 10 in November 1997, a draft rule package was submitted to NRC for comment. The rule changes included several required regulations. NRC reviewed and commented on the rules and requested that lowa provide a copy of the fina1 published regulations for review. The final regulations, adopted in July 1998, were not submitted as requested, so the final review was not conducted. In late 1998, Iowa promulgated another rule package which was adopted in July 1999. This package was apparently not submitted to NRC for comment, in either draft or final form. The review team recommends that the State submit draft and final regulations to the NRC for review.

In their response to item 29 of the questionnaire, the Bureau submitted a table of regulation amendments adopted for compatibility purposes. The review team identified that several of the

. regulation adoption dates were incorrect in the response and that at least one regulation had been only partially adopted (radiography rule). Because of these inconsistencies, the review team and a Bureau representative elected to evaluate all of the regulations required for compatibility since the last IMPEP review. The review team intends, with the assistance of the i Bureau, to review the final rules from the 1997 and 1998 submissions, to ensure that compatibility concerns were addressed, prior to the Management Review Board meeting.

The State has not yet adopted the following regulations, which are not yet due, but intends to ,

address them in rulemakings or by adopting alternate generic legally binding requirements:

e " Compatibility with the International Atomic Energy Agency," 10 CFR Part 71 amendment (60 FR 50248) that became effective April 1,1996.

• " Recognition of Agreement State Licenses in Areas Under Exclusive Federal Jurisdiction Within an Agreement Stde," 10 CFR Part 150 amendment (62 FR 1662) that became effective February 27,1997.

• ' Licenses for Industrial Radiography and Radiation Safety - Requirements for industrial Radiography Operations," 10 CFR Parts 30,34,71, and 150 amendments (62 FR 28947) that became effective June 27,1997.

• " Licenses for Industrial Radiography and Radiation Safety Requirements for Industrial Radiographic Operations; Clarifying Amendments and Corrections," 10 CFR Part 34 amendments (63 FR 37059) that became effective July 9,1998.

• " Minor Corrections, Clarifying Changes, and a Minor Policy Change," 10 CFR Parts 20, 32 snd 39 amendments (63 FR 39477 and 45393) that became effective October 26, 1998.

• " Transfer for Disposal and Manifests; Minor Technical Conforming Amendment," 10 CFR Part 20 pmendment (63 FR 50127) that became effective November 20,1998.

Upon advice from the Iowa Assistant Attomey General, the Department can not adopt the following rule. Cases involving deliberate misconduct are reserved to the Office of the Attomey General. The review team plans on submitting this approach to NRC's Office of the General Counsel for review prior to the Management Review Board meeting.

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• " Deliberate Misconduct by Unlicensed Persons," 10 CFR Parts 30,40,61,70, and 150 amendments (63 FR 1890 and 13773) that became effective February 12,1998.

I It is noted that Management Directive 5.9, Handbook, Part V, (1)(C)(lli) provides that the above regulations should be adopted by the State as expeditiously as possible, but not later than three years after the September 3,1997 effective date of the Commission Policy Statement on Adequacy and Compatibility, i.e., September 3, 2000.

Based on the IMPEP evaluation criteria, the review team recommends that lowa's performance with respect to the indicator, Legislation and Program Elements Required for Compatibility, be found satisfactory.

5.0

SUMMARY

i As noted in Sections 3 and 4 above, the review team found that lowa's performance to be satisfactory for all six performance indicators. Accordingly, the review team recommends that the Management Review Board find the Iowa Agreement State Program to be adequate to protect public health and safety and compatihe with NRC's program.

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1 Below is a summary list of recommendations and suggestions, as mentioned in earlier sections of )

the report, for evaluation and implementation, as appropriate, by the State.

RECOMMENDATIONS:

- 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) 2 The review team recommands that the State require both broad scope licensees to submit Statements of Intent containing cost estimates for decommissioning indicating that funding will be obtained when necessary. (Section 3.4)

3. The review team recommends that the State submit draft and final regulations to the NRC for review. (Section 4.1.2.) .

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I LIST OF APPENDICES AND ATTACHMENTS I

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Appendix A IMPEP Review Team Members l . Appendix B ' lowa Organization Charts l - Appendix C.. Inspection Casework Reviews I.

' Appendix D License Casework Reviews Appendix E - Incident Casework Reviews Appendix F-- lowa's Questionnaire Response l

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APPENDIX A IMDEP REVIEW TEAM MEMBERS Name Area of Responsibility M. Linda McLean, Region IV Team Leader Technical Staffing and Training Lee Cox, State of North Carolina Status of Materials Inspection Program  ;

Technical Quality of Inspections Anthony S. Kirkwood, NMSS Technical Quality of Licensing Actions  !

James L. Lynch, Region lli Response to incidents and Allegations '

Legislation and Program Elements Required for Compatibility I

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l 1

, 1 APPENDIX C INSPECTION CASEWORK REVIEWS NOTE: ALL INSPECTIONS LISTED WITHOUT COMMENT ARE INCLUDED FOR COMPLETENESS ONLY; NO SIGNIFICANT COMMENTS WERE IDENTIFIED BY THE IMPEP i TEAM: l File No.: 1

, Licensee: Grinnell College License No.: 0119-1-79-RD2 l Location: Grinnell, IA - Inspection Type: Routine l t License Type:: Research & Development-Other Priority: 3 l l

Inspection Date: 12/11/98 Inspector: MLF l File No.: 2 Licensee: Nuclear Sonics Associated, Inc. License No.: 0004-1-77-NV Location: New Richmond, WI _

inspection Type: Routine l'

License Type: Nuclear Medical Van Priority: 2 Inspection Dates : 7/28- 30/98 Inspector: GFJ '

File No.: 3 i

, Licensee: Geodax Technology, Inc. d/b/a Hawkeye Diagnostics License No.: 0273-1-77-NP

l. Location: Des Moines, IA Inspection Type: Initial l l License Type: Nuclear. Pharmacy Priority: 1 l inspection Date: 7/9/98 inspector: MLF

! File No.: 4 Licensee : lowa Method:st Medical Center License No.: 0077-1-77-M1 Location: Des Moines, IA Inspection Type: Routine

License Type

- Medical Institution /Other-Group Priority: 3 l Inspection Dates: 3/10-11/98 Inspector: DKM Comment:

a) Enforcement letter issued three months after end of inspection. '

File No.i 5 l Licensee: Boone County Hospital License No.: 0081-1-08-M1 Location: Boone, IA Inspection Type: Reinspection License Type: Medical Institution /Other-Group Priority: 3

. Inspection Date: 8/1/97 Inspector: MLF-File No.: 6 Licensee: Northeast lowa Community College License No.: 0199-1-31-IR2/1 Location: Peosta, IA Inspection Type: Routine License Type: ' Industrial Radiography-Fixed FacilityTrem. Job Sites Priority: 1

. Inspection: Date: 4/2/98 Inspector: MLF

b:

'lowa Proposed Final Report Page C.2 Inspection Casework Reviews File No.: 7 Licensee: Wos Testing,Inc. License No.: 0253-1-57-IR1 Location: Cedar Rapids, IA . Inspection Type: Routine

' License Type: Industrial Radiography-Temp. Job Sites Priority: 1

' Inspection Date: 6/18/99 - Inspector:- GFJ

. File No.i 8 '

Licensee: Pitt-Des Moines, Inc. License No.: 0115-1-77-IR1

. Location: Clive, IA .

Inspection Type: Routine Licer,se Type: Industrial Radiography-Temp. Job Sites . Priority: 1 Inspection Date:' 6-22-99 Inspector: MLF File No.: 9 Licensee: lowa Methodist Medical Center License No.: 0077-2-77-HDR Location: Des Moines, lA Inspection Type: Routine

' License Type: High Dose Rate Afterloader Priority: 1 Inspection Date: 6/11/99 Inspector: MLF Comment:

a) No response has been received to the compliance report issued June 28,1999. The

. response was due July 28,1999.

File No.: 10 Licensee:' The University of Iowa License No.: 0037-1-52-AAB Location: lowa City, IA Inspection Type: Routine License Type: Academic Broad Scope-Type A Priority: 2 Inspection Date: .10/26/98 Inspectors: DKM, GFJ, JLS

- Comments: '

a) The inspection report was issued almost four months after the inspection had been completed.

INSPECTOR ACCOMPANIMENTS- l I

In addition, the following inspection accompaniments were performed as part of the on-site j

' IMPEP revew.

4 File No.: 1 l Licensee:: Geodax Technology, Inc. License No.: 0273-1-77-NP l Location: Des Moines, IA  !

~ License Type: Nuclear Pharmacy Priority: 1  ;

inspection Date: //17/99 Inspector: DKM  ;

i

i~

I' lowa Proposed Final Report Page C.3 Inspectiun Casework Reviews File No.: 2 l Licensee: Shoemaker and Haaland Professional Engineers License No.: 0107-1-52-PG Location: Coraville,IA License Type: Portable Gauge Priority: 5 Inspection Date: 7/18/99 Inspector: JLS File No.: 3 '-

Licensee: American Profol,Inc.

License No.: 0231-1-57-FG  !

Location: Cedar Rapids, IA -  !

License Type: Fixed Gauge Priority: 5  ;

inspection Date: 7/18/99 Inspector: JLS 1

File No.: 4 Licensee: St. Luke's Methodist Hospital License No.: 0018-1-57-Mi Location: Cedar Rapids, IA '

License Type: Nuclear Medicine Priority: 1 Inspection Date: 7/19/99 Inspectors: MLF, JLS, GFJ I

l 1

)

j APPENDIX D LICENSE CASEWORK REVIEWS NOTE: ALL LICENSES LISTED WITHOUT COMMENT ARE INCLUDED FOR COMPLETENESS ONLY; NO SIGNIFICANT COMMENTS WERE IDENTIFIED BY Ti>E IMPEP TEAM.

File No.: 1 l Licensee: lowa State University License No.: 0014-2-85-AAB l Location: Ames,IA Amendment No.: N/A License Type: Academic Broad A Type of Action: Renewal Date issued:. 8/5/97 License Reviewer: MLF ,

I Comments:

a) The license file was missing a Statement of Intent containing a cost estimate for decommissioning and an indication that funding will be obtained when necessary.

b) A portable gauge is authorized under license conditions 5.A. and B., any form. A separate line item already authorizes portable gauge possession and use.

File No.: 2 Licensee: lowa State University License No.: 0014-2-85-AAB Location: Ames,IA Amendment No.: 01 License Type: Academic Broad A Type of Action: Amendment Date issued: 10/6/97 License Reviewer: MLF Comment; a) Added authorization for any form, atomic numbers 84-98. This necessitated the need for decommissioning documentation (see recommendation in Section 3.4).

File No.: 3 Licensee: University of Iowa License No.: 0037-1-52-AAB Location: lowa City, IA Amendment No.: N/A License Type: Academic Broad A Type of Action: Renewal Date issued: 4/27/98 License Reviewer: DKM Comments:

a) The Statement of intent letter for decommissioning dated 4/15/96, signed by the University Science Department Chair and the University Business Manager did not contain a cost estimate.

b) Action levels for air sampling and for urine bioassays were listed in the application and accepted by license condition at 10,000 times the Annual Limit on Intake (All). These limits were based on the annual usage of radioactive material by workers. Nonetheless the approved limits are not conservative in that infrequent users of millicurie amounts of unsealed radioactive material may be excluded from needed air sampling or urine bioassays.

lowa Proposed Final Report l Page D.2

' License Casework Reviews File No.: 4-Licensee: Edwards Pipeline Service, LLC License No.: 0280-1-82-IR1 Location: Tulsa, OK Amendment No.: N/A License Type: Radiography < Type of Action: New

. Date issued: 11/10/98 License Reviewer: GFJ Comment:

(a): Maximum possession limits are not listed on the license and a financial assurance license L condition is not included on the license.

i

!~

File No.: 5 Licensee: Edwards Pipeline Service, LLC License No.: 0280-1-82-IR1 Location: Tulsa, OK Amendment No.: 01 License Typa: Radiography Type of Action: Amendment Date issued: 7/22/99 License Reviewer: MLF l . Comment:

I ~),

a Maximum possession limits are not listed on the license and a financial assurance license i

condition is not included on the license.

File No.: 6 Licensee: . Finley Hospital License No.: 0024-1-31-M1 Location: Dubuque, IA Amendment No.: N/A License Type: MedicalInstitution Other-Group Type of Action: Renewal j Date issued: 7/29/97 License Reviewer: MLF File No.:. 7 Licensee: Finley Hospital . License No.: 0024-1-31-M1 1 Location: Dubuque, IA . Amendment No.: 01 l License Type: MedicalInstitution Other-Group Type of Action: Amendment j Date lasued:. 3/8/99 License Reviewer: GFJ Comment:

a) The amendment added a new authorized user, new radiation safety officer and changed I the dosimetry to Optically Stimulated Luminescent Dosimetry (OSLD). As the State I indicated in their reply to NRC's IMPEP questionnaire, despite previous licensee '

commitments _to a monthly dosimetry exchange period, the State has allowed licensees to change to a two month exchange frequency, if individual total monthly readings have not exceeded 50 mrems. The State indicated that they have advised licensees to make ,

alternative provisions to continue monthly dosimetry exchange for programs using OSLD j dosimetry, in the case of Declared Pregnant Workers (DPW).

i I

L ,

1

i.

l lowa Proposed Final Report Page D.3 License Casework Reviews File No.: 8 Licensee: Allen Memorial Hospital License No.: 0117-1-07-M1 Location: Waterloo,IA Amendment No.: N/A License Type: MedicalInstitution Other-Group Type of Action: Renewal Date issued: 3/6/98 License Reviewer: GFJ File No.: 9 Licensee:. Allen Memorial Hospital License No.: 0117-1-07-M1 Location: Wateloo,IA Amendment No.: 01-License Type: Medical !nstitution Other-Group Type of Action: Amendment Date issued: 7/6/99 License Reviewer: GFJ File No.: 10 Licensee: Zeneca Ag Products License No.: 0276-1-65-RD2 Location: Richmond, CA Amendment No.: 01 License Type: Research & Development-Other Type of Action: Termination Date issued: 2/11/99 License Reviewer: DKM

l APPENDIX E INCIDENT CASEWORK REVIEWS NOTE: ALL INCIDENTS LISTED WITHOUT COMMENT ARE INCLUDED FOR COMPLETENESS ONLY; NO SIGNIFICANT COMMENTS WERE IDENTIFIED BY THE REVIEW Ti&M.

File No.: 1 Licensee: Nov.h Star Steel lowa incident ID No;; IA-99-01 Location: Wilten,IA. License No.: Exempt Date of incident: 3/22/99 Type of incident: Damaged Fixed Gauge Investigation Date: 3/26/99 Investigation Type: On-site Summary: A fixed nuclear gauge containing approximately 90 microcuries of cesium-137 in nine exempt sources was melted inside a caster mold by molten steel. The shielded device is in storage awaiting disposal at bivirocare of Utah.

File No.: 2 Licensee': Winnebago Industries incident ID No.: lA-98-01 1

- Location: Forest City, IA License No.: 3174-1-95-SEM l Date of Incident: 6/4/98 Type of incident: Lost Device {

investigation Dates: 6/11/98 Investigation Type: On-site !

Summary: A generally-licensed polonium-210 static eliminator was reported lost. It was later

{

found in the facility. During the IMPEP review, the State sent an update to NMED to reflect the recovered device.

File No.: 3 -

Licensee: University of Iowa incident ID No.: lA-98-02 Location: lowa City, IA License No.: 0037-1-52-AAB

, Date of incident: 9/21/98 Type of incident:l Radioactive Material Release Investigation Date: 9/21/98 investigation Type: On-site Summary: A break in the discharge line to the sanitary sewer system ruptured causing soil contamination with sulfur-35 and lodine-125. The State evaluated licensee decontamination and exposure control efforts.

j i

E' 1 i.:.

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i 1

)

1 1

APPENDIX F  ;

l l

STATE OF IOWA QUESTIONNAIRE RESPONSES i

l l

I I

l

1 4

Approved by OMBI l No. 3150-0183 i L Expires 5/31/2001 l --

l L ,,

lNTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM QQFSTIONNAIRE lOWA DEPARTMENT OF PUBIO HEALTH REPORTING PERIOD: APRIL 1996 - AUGUST 1999 i

. A. COMMON PERFORMANCE INDICATORS

1. Status of Materials insoection Proaram

1. Please prepare a table identifying the licenses with inspections that are overdue by more than 25% of the scheduled frequency set out in NRC Inspection Manual I

Chapter 2800.~ The list should include initial inspections that are overdue, tNone

2. D) yca currently have an action plan for completing overdue inspections? If so, please describe the plan or provide a written copy with your response to this i questionnaire.

N/A Estimated burden per response to comply with this voluntary collection request: 45 hours5.208333e-4 days <br />0.0125 hours <br />7.440476e-5 weeks <br />1.71225e-5 months <br />.

Forward comments regarding burden estimate to the Information and Records Management

. Branch (T-6 F33), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, and to the Paperwork Reduction Project (3150-0183), Office of Management and Budget, Washington, DC 20503. If an information collection does not display a currently valid OMB control number, NRC may not conduct or sponsor, and a person is not required to respond to, the information collection.

1

3. Please identify individual licensees or groups of licensees the State le inspecting more or less frequently than called for in NRC inspection Manual Chapter 2800 and state the reason for the change.

Inspection frequencies are the same as or more frequent than those of the NRC. The following frequencies are different from the NRC frequency:

a. Private practice medical facilities are currently assigned a four-year frequency. The NRC assigns a three-year frequency for private j

. facilities performing therapy and a five-year frequency for diagnostic procedures only. Currently, we do not have a private practice licensee that performs therapy. Therefore, we are more restrictive. This wil: be re examined when the need arises,

b. Veterinary Medicine inspection frequencies are more restrictive than l the NRC frequency. We separated this category. Diagnostic procedures are inspected at a five year frequency and therapeutic procedures are inspected at a two year frequency. Currently, we have I only one facility in lows that performs therapeutic lodination. Since this is a new facility, we do not have a " track record" to justify a less frequent inspection period.

4. Please complete the following table for licensees granted reciprocity during the reporting period.

See Attachment 1

5. Other than reciprocity licensees, how many field inspections of radiographers were performed?

We currently have four industrial radiography licensees. A fifth company terminated its license on December 23,1998. The following chart summarizes the number of field inspections.

scense No -

996 997 998 999 Total 4

~- '

0135-2-77-IR1p 1 +.1 = 1

[0186-j-82-IRjd3

?02531-57-IR14#

V 1

Di$

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1

- ~*

2 2

[0115-it7_7,-IRjf22 V gQ V 5 0 4175-1MIR1Es 1 scir Term iTernii 2 Taita E 4 6 5 N M 3 EDN 3 6@ 10 9 Office +.spection only.

• Licensee performs the majority of its operations inside its facility.

2

f

)

I

6. For NRC Regions, did you establish numerical goals for the number of inspections to be performed during this review period? If so, please describe your goals, the number of inspections actually performed, and the reasons for

' any differences between the goals and the actual number of inspections l performed.

l-N/A l

n

{

~

l 1

! l l

1 1

l l

l l

l. 3

11. Technical Quality of Inspections I 7. What, if any, changes were made to your written inspection procedures during the reporting period?

l There were no changes made to our inspection procedures during this reporting period.

8. Prepare a table showing the number and types of supervisory accompaniments made during the review period. Include:

nspector -- .

l Joyce Spencer George Johns, Jr. Fixed Gauge 9/4/96 Joyce Spencer Mark L. Flickinger l Portable Gauge 9/12/96 Joyce Spencer Mark L. Flickinger l Portable Gauge 9/13/96 Mark Flickinger, Donald Flater Academic 10/17/96 George Johns, Jr., Broadscope (ISU)

Daniel McGhee, and Joyce Spencer Mark Flickinger, Donald Flater Academic 11/4/96 George Johns, Jr., Broadscope (Ul)

Daniel McGhee, and Joyce Spencer i Joyce Spencer George Johns, Jr. I Fixed Gauge 3/18/97 l Joyce Spencer George Johns, Jr. l Fixed Gauge 3/20/97 l Joyce Spencer Daniel K. McGhee l Portable Gauge 6/17/97 Mark Flickinger, Donald Flater Academic 10/19/97 George Johns, Jr., Broadscope (ISU)

Daniel McGhee, and Joyce Spencer Mark Flickinger, Donald Flater Academic 11/3/97 George Johns, Jr., Broadscope (Ul)

Daniel McGhee, and Joyce Spencer Mark Flickinger, Donald Flater Academic 5/7/98 George Johns, Jr., Broadscope (ISU)

Daniel McGhee, and Joyce Spencer l George Johns, Jr., Donald Flater Academic 10/26/98 i

Daniel McGhee, and Broadscope (Ul)

Joyce Spencer 1

1 4

l

9. Describe intemal procedures for conducting supervisory accompaniments of inspectors in the field. If supervisory accompaniments were documented, please provide copies of the documentation for each accompaniment.

The procedure for the supervisory accompaniment is for the Radioactive Materials Program Coordinator or Bureau Chief to accompany each inspector twice per year. We also have the RSAO Region lli available for accompaniment of IDPH inspectors. Recently the IDPH developed an evaluation form to be used on these accompaniments. This program has not been completely implemented within this evaluation period.

See Attachment 2.

10. Describe or provide an update on your instrumentation and methods of calibration. Are allinstruments properly calibrated at the prese."t time?

2 Ludlum 14C Pancake GM probe, Open/ closed GM tube 1" Nal scintillation detector 2 l Victoreen Model 190 l Low range pancake probe l l l High range pancake probe l 1 FAG Kugelfischer Open window GM Closed window GM Pancake probe 1 l Victoreen Model 450P l lon Chamber l 1 l Ludlum Model 12 l Alpha detector l 3 Ludlum Model 2241-3 Alpha scintillation detector 1" Nal scintillation probe Open/ closed, energy compensated GM tube Pancake probe 1 l Ludlum Model 12-2 l Neutron Detector l 2 l Ludlum Model 9 l lon Chamber l 1 l Ludlum 14C l 1" Nal scintillation detector l 1 l Ludlum 14C l Open/ closed GM tube l The Iowa Emergency Management Division Radiological Repair Facility located at Camp Dodge calibrates all instruments on a six-month basis. The beta / gamma Instruments are calibrated using a J.L. Shepherd 28-5 calibrator.

Alpha detectors are electronically calibrated using a Ludlum model 500 pulser. The efficiency is determined using a NIST approved Americium 241 sealed source. All Instruments are calibrated except the neutron detector.

If we anticipate its use it will be sent to a calibration facility that is capable of calibration.

1

Ill. Technical Staffino and Trainino

11. Please provide a staffing plan, or complete a listing using the suggested format below, of the professional (technical) person-years of effort applied to the agreement or radioactive material program by individual. Include the name, position, and, for Agreement States, the fraction of time spent in the following areas: administration, materials licensing & compliance, emergency response, LLW, U mills, other. If these regulatory responsibilities are divided between l offices, the table should be consolidated to include all personnel contributing to the radioactive materials program. Include all vacancies and identify all senior personnel assigned to monitor work of junior personnel. If consultants were used to carry out the program's radioactive materials responsibilities, include their efforts. The table heading should be:

W ame

• Position -

re Donald A. Flater* Bureau Chief 46 17 17 20 l 0.3 l George F. Johns

• RAM Program Coordinator 15 70 10 5l 1.0 l Daniel K. McGhee* Training, Emergency 15 5 10 70 1.0 Pesponse &

Environmental Coordinator Mark L. Flickinger Health Physicist 10 80 5 5l 1.0 l Joyce L. Spencer Health Physicist 10 80 5 5l 0.5 l Charlene Craig Health Physicist 95 'a l 0.3 l Ramona Ulbaldo- RAM Secretary 100 l 0.5 l Mealey , I l j

• Individuals who rnonitor the work of others, i l

Legend for Area and % time.  ;

A= Administration l B= Licensing and Compliance C= Emergency Response D= EnvironmentalIssues i

12. Please provide a listing of all new professional personnel hired since the last l review, indicate the degree (s) they received, if applicable, and additional training and years of experience in health physics, or other disciplines, if appropriate. .

i None 1

1 1

6  !

l 4

, 13. Please list all professional staff who have not yet met the qualification requirements of license reviewer / materials inspection staff (for NRC, inspection Manual Chapters 1246; for Agreement States, please describe your qualifications requirements for materials license reviewers and inspectors). For each, list the courses or equivalent training / experience they need to attend and a tentative schedule for completion of these requirements.

All the technical staff has completed the core NRC courses except for the Well-logging course. The Bureau Chief and George F. Johns, Jr. have attended the formal course. George F. Johns, Jr., has trained Mark L.

Flickinger to perform well-logging inspections. Well-logging is accomplished under reciprocal recognition only and involves a maximum of two entries into towa per year.

As of June 17,1997, Joyce L Spencer has met the training requirements for '

performing nuclear gauge inspections and licensing. She also participates as a team member during broadscope inspections. Ms. Spencer is in the process of being trained to do inspections / licensing of industrial Radiography and Medical Facilities.

Inspector qualification involves the completion of a series of written examinations to test the candidate's knowledge of the rules. During this process the randidate accompanies a qualified inspector to observe inspection technique. The next step in the process is for the candidate to perform an inspection under the supervision of a qualified inspector. An i evaluation form is completed and the results are discussed with the RAM Program Coordinator and the Bureau Chief. If approved, the Program  ;

Coordinator or Bureau Chief accompanies the candidate on an inspection and approves or disapproves. This process takes place for every category (e.g.

nuclear gauges, industrial radiography, medical, etc.).

Licensing qualifications begin with the candidate observing a quallfled license reviewer as he/she reviews a license application. The Program Coordinator is apprised of the candidate's progress. The candidate is then assigned a number of reviews ofless complexity. The Program Coordinator, who makes the decision of whether the candidate is able to conduct reviews, independently evaluates the reviews. The candidate is assigned reviews of more complexity in this continual process until all license types are covered.

14. Please identify the technical staff who left the RCP/ Regional DNMS program during this period.

N/A 7

/

15. List the vacant positions in each program, the length of time each position has been vacant, and a brief summary of efforts to fill the vacancy.

N/A IV. Technical Quality of Licensina Actions

16. Please identify any major, unusual, or complex licenses which were issued, received a major amendment, were terminated, decommissioned, submitted a  !

bankruptcy notification or renewed in this period. Also identify any new or amended licenses that now require emergency plans.  !

i Both the University of Iowa and lowa State University broadscope licenses were renewed in 1998 and 1999. Daniel K. McGhee renewed the University of Iowa and Mark L. Flickinger renewed lows State University.

l

17. Discuss any variances in licensing policies and procedures or exemptions from the regulations granted duing the review period.

None

18. What, if any, changes were made in your written licensing procedures (new procedures, updates, policy memoranda, etc.) during the reporting period?

Regulatory Guides have been updated to reflect new regulations. Inspection issues that are perceived as a trend are more clearly defined in revisions to l the regulatory guides. For example, medical licensees were receiving similar  !

citations pertaining to their radiopharmaceutical therapy room preparation procedures. Once identified, these procedures were more clearly defined in our Medical Regulatory Guide.

l Licensing checklists are updated as a result of any changes in the Regulatory l Guides. l Recently, we issued a policy concoming the exchange frequency of personnel dosimetry. Questions arose concerning the- use of Landauer Luxel@ .

personnel Dosimeters. Landauer suggests a two-month exchange frequency. l A new policy was issued requiring that any individual that does not exceed 50 mrom in any one month can exchange their Luxel@ dosimetry with a two

. or three month exchange frequency. All others must remain on a monthly  ;

l exchange frequency. It is anticipated that this will be incorporated into our rules.

Electronic copies are being provided. Printed copies will be available at j the IMPEP.

8

19. For NRC Regions, identify by licensee name, license number and type, any renewal applications that have been pending for one year or more.

N/A V. Responses to incidents and Alleastions

20. Please provide a list of the reportable incidents (i.e., medical misadministration, ,

overexposures, lost and abandoned sources, incidents requiring 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> or less  !

notification, etc. See Handbook on Nuclear Material Event Reporting in Agreement States for additional guidance.) that occurred in the Region / State ,

during the review period. For Agreement States, information included in previous  !

submittals to NRC need not be repeated (i.e., those submitted under OMB l clearance number 3150-0178, Nuclear Material Events Database). The list j 1

should be in the following format:

Licensee / Facility License Number Date Type of incident Winnebago General Licensee June 4,1998 Lost static Industries eliminator Forest City, Iowa - containing Po-210 North Star Steel Exempt source March 22,1999 Degradation of a Wilton, lows bundle flow gauge containing a total of 90 microcuries of Cesium 137

21. During this review period, did any incidents occur that involved equipment or source failure or approved operating procedures that were deficient? If so, how and when were other State /NRC licensees who might be affected notified? For States, was timely notification made to NRC7 For Regions, was an appropriate and timely PN generated?

The incident at Winnebago industries that involved the loss of control of a static eliminator. The device was ultimately found in a locker that belonged to a former employes.

22. For incidents involving failure of equipment or sources, was information on the incident provided to the agency responsible for evaluation of the device for an i' assessment of possible generic design deficiency? Please provide details for each case.

This incident was not reportable to the NRC. NRC regulations did not i prohibit exempt bundles at the time of the investigation. As of June 1998, the Iowa Department of Public Health prohibits distribution of gauges of this type without being evaluated and licensed. Since this violated our rules we did report it to the NRC. According to NRC Information notice l

9 l

99-01 dated May 3,1999, the NRC fell in line with the Iowa Department of Public Health.

See Attachment 3 for the investigation Report.

23. In the period covered by this review, were there any cases involving possible wrongdoing that were reviewed or are presently undergoing review? If so, please describe the circumstances for each case.

University of Iowa 0037-1-52-AAB Allegations were made by union workers involving improper procedures at the University Hospital and Waste Disposal Facility. The report is being finalized.

24. Identify any changes to your procedures for handling allegations that occurred during the period of this review.

None

a. For Agreement States, please identify any allegations referred to your program by the NRC that have not been closed.

censee Name , .

Novastar Corp. 0208-1-51-lG Allegation that the company was distributing irradiated gemstones containing trace amounts of Radioactive  !

Materials without a NRC class G license. )

i VI. General ,

25. Please prepare a summary of the status of the State's or Region's actions taken l

in response to the comments and recommendations following the last review. j Enclosed is a copy of the letter dated August 1,1996, transmitting our responses to the recommendations made on the April 1- 4,1996 IMPEP j review. The following is a summary of the status of our responses. The items 1 are numbered as they appear in our response. l 1

1. No further response necessary.  !

2. No further response necessary. Inspection reports are flied and open for review.  ;

10

3. We currently meet the 30-day turn-around for licensing and inspection actions. Most are done before 30 days.

4. This review is performed on Monday mornings during staff meetings.

5. This is reviewed during Monday morning staff meetings.

6. The current staff, with the exception of one member, is fully qualified license reviewers and inspectors. The manual is updated as necessary.

7. No further action necessary.

8. The HDR field notes are kept up-to-date and have been used on inspections.

9. No further response necessary.

10. No further response necessary.

11. No further response necessary.

12. The one reportable incident was reported to the NRC operational headquarters. Copies of the submitted reports are available for review.

26. Provide a brief description of your program's strengths and weaknesses. These strengths and weaknesses should be supported by examples of successes, problems or difficulties that occurred during this review period.

The main strength of the program is the stable, well-trained staff with a variety of radiological experience. The program continues to evolve to meet the needs of the licensees and the public. Because inspections and licensing actions are current, this al!cws special projects to be initiated. These include maintaining current regulatory guides that reflect the istest rule revisions, making IDPH current rules and regulatory guides available via the IDPH website, improving the licensing process, etc.

Additionally, IDPH has completed extensive research into the general licensed radioactive material and is designing a program to address use of radioactive material by general licensees. This is a progressing project. Currently, staff has updated facility status that includes developing an accurate database, designing a registration system, and conducting pre-registration inspections.

One of the program weaknesses is the supervisory audit program. This program is developed, but has not been fully implemented. These audits have 11

k

~

taken place Informally when one inspector accompanies another on an inspection. If one inspector notices a weakness, it is discussed and resolved.

With such a small program this has been adequate in the past. However, it is recognized that there should be a formal Quality Assurance Program. Our plans include a formal audit program.

- B. NON-COMMON PERFORMANCE INDICATORS

1. Leoislation and Proaram Elements Reauired for Comoatibility

27. Please list all currently effective legislation that affects the radiation control program (RCP).

Iowa Code Chapters 17A,136B,136C and 136D.

- 28. Are your regulations subject to a " Sunset" or equivalent law? If so, explain and include the next expiration date for your regulations. j There is no " sunset" provision.

29. Please complete the enclosed table based on NRC chronology of amendments.

Identify those that have not been adopted by the State, explain why they were not adopted, and discuss any actions being taken to adopt them. Identify the regulations that the State has adopted through legally binding requirements other than regulations.

30. If you have not adopted all amendments within three years from the date of NRC rule promulgation, briefly describe your State's procedures for amending {

- regulations in order to maintain compatibility with the NRC, showing the normal '

length of time anticipated to complete each step.

1 Items B.ll, Ill, IV, and V are not applicable based on the Agreement Letter signed by former Governor Terry Branstad. In the letter, IDPH relinquished the SSD program to the NRC. The agreement does not include the authority to regulate Low-Level Waste disposal sites or Uranium Mills. l l

12

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THOMAS J. VILSACK DEPARTMENT OF PUBLIC HE ALTH to tam a $7EPHE N C. CLE A80N, 0.0 . oingCYom LY.oovannom September 24,1999 j e i e

c:3 Paul H. Lohus, Director Q Office of State Programs J. o ,

US Nuclear Regulatory Commission cn l Mail Stop 3-D-23 $T Washington, D.C. 20555 cp

Dear Mr. Lohaus:

N Your letter to Dr. Gleason, Director of the IDPH dated September 17,1999 has been referred to this office for response. That letter transmitted a draft report of our IMPEP review in August. You requested our comments about the draft report at our earliest convenience.

We have reviewed the draft report and have the following remarks:

o Page 10 contains part of the discussion of the compatibility of our administrative rules.

Paragraph three states,"The State has not yet adopted the following regulations, but intends to address them in rulemakings or by adopting ahernate generic legally binding requirements: [a list of regulations follows]." We recommend modifying that statement to read, "...the following regulations, which are not yet due, but intends..." On the other hand, including the change we recommended, the draft report lays out for pubic scrutiny, something-adoption of NRC regulations-not yet due, but that Iowa "has not yet" done. This same statement is true of the j

approximately 225 inspections that are due in the next review period, yet there is no statement in i the draft report that Iowa "has not yet" done these inspections. Therefore, the question of whether to include similar statements about other program areas, such as inspections or to remove this one arises.

o Pages 10-11, the last paragraph on the former and the first two lines on the latter, discuss our intended non adoption of the regulation entitled " Deliberate Misconduct by Unlicensed Persons."

The discussion implies that we will not adopt that regulation "upon advice" by our Attomey General. _ The situation is stronger than stated. In this state, the activities covered by that reguls tion are reserved to the Office of the Attomey General. We cannot adopt that regulation regardless of compatibility requirements.

o Page C.2 delineate., some of the inspection casework that the team reviewed. The comment about File No.: 9,"lDPH does not have a tracking system for overdue (30 days) responses to noncompliance items," is incorrect. We recommend that the statement be deleted because Iowa does have tracking system and has for 8 + years, s

j VQ- LUC AS STATE OFFICE BUILDING / 321 E.12TH 87. I DES MOINES. lOWA 50319 0075 DE AF REL AY (usamino on spascM surainso) 1 800 736 2042 / INTERNET: uttp://sopw.st Ats. A.us/

FAasity C HsAttn AommistmAt Rao toav AnAIR$ $VD$tANCE St HEAltM PROWoYlON EIRC TAFP DIREC P Ct FAA/515 2424344 pax /515 2814958 P Ax/515-2814535 P Ax/515-281 4958 ' Ax/510281 4958

. 3 G.

Paul H. Lohus

October 1,1999 Page 2 I would like to take this opportunity to request a video conference link for our participation in the NRC Management Review Board when it occurs. We feel that this method allows full participation l by our staff and also is a much more efficient use of funds and time. The contact point for this link is l- Dan McGhee at 515-281-7007. .

If you have any questions or comments, please contact me.

Sincerely, 1 Donald A. Flater, Chief

! . Bureau of Radiologi cal Heal th q 515-281-3478.

515-242-6284 - FAX l dilater@ideh. state.ia.us

. DAF/rk i

Fax: Linda McLean, Regional State Agreemehts Officer l- Jim Lynch, Regional State Agreements Officer l ,

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'h Aaenda for Manaaement Review Board Meeting Tuesday. November 9.1999 - OWFN 8.4

1. Convention. MRB Chair Convenes Meeting

2. New Business - Consideration of Iowa IMPEP Report A. Introduction of lowa IMPEP Team Members (L. McLean)

. B. Introduction of Iowa representatives and other State representatives participating through videoconference or teleconference. i C. Findings regarding towa Program (IMPEP Team)

Status of Materials inspection Program Technical Quality of Inspections Technical Staffing and Training l

Technical Quality of Licensing Actions l

Response to incidents and Allegations Legislation and Program Elements Required for Compatibility D. Questions (MRB. Members)

E. Comments from State of Iowa F. MRB Consultation / Comments on Issuance of Report I - Recommendation for next IMPEP review  !

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3. Status of Upcoming Reviews l

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- North Dakota follow-up

4. Approval of the South Carolina MRB minutes

5. Adjournment

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Attendees: Carl Paperiello, MRB Member, DEDMRS Paul Lohaus, MRB Member, OSP Karen Cyr, MRB Member, OGC William Kane, MRB Member, NMSS OAS Liaison to the MRB, Donald Flater, IA Linda McLean, IMPEP, Team Leader, RIV James Lynch, IMPEP Team Member, Rlll ,

Anthony Kirwood, IMPEP Team Member, NMSS l Lee Cox, IMPEP Team Member, NC Kathleen Schneider, OSP Lance Rakovan, OSP ATTACHMENT 2

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