ML20141B211

Notifies of Implementation,On Interim Basis,Integrated Matls Performance Evaluation Program for Use in Evaluation of Agreement States Programs.Forwards Draft Integrated Matls Performance Evaluation Program Rept

ML20141B211
Person / Time
Issue date:	04/25/1997
From:	Bangart R NRC OFFICE OF STATE PROGRAMS (OSP)
To:	Ortciger T ILLINOIS, STATE OF
References
NUDOCS 9705150182
Download: ML20141B211 (70)

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j UNITED STATES s

• NUCLEAR REGULATORY COMMISSION

• WASHINGTON, D.C. 2006Ho01

%***** April 25, 1997 l i

Mr. Thomas W. Ortciger, Director i Illinois Department of Nuclear Safety  !

1035 Outer Park Drive '

Springfield, IL 62704

Dear Mr. Ortciger:

The Nuclear Regulatory Commission (NRC) is implementing, on an interim basis, the l integrated Materials Performance Evaluation Program (IMPEP) for use in the evaluation l of Agreement State programs. Enclosed for your review is the draft IMPEP report which documents the results of the Agreement State review held in your offices on March 24-28, 1997. Richard Woodruff, Regional State Agreements Officer, from Region ll, Atlanta, )

j Georgia, was the team leader for the Illinois review. The review team's recommendations were discussed with you and your staff on March 28,1997.

NRC has significantly changed the manner in which periodic reviews are conducted for Agreement State programs to assure that public health and safety are adequately  ;

protected from the hazards associated with the use of radioactive materials and that i Agreement State programs are compatible with NRC's program. The new process, titled IMPEP, employs a team of NRC and Agreement State staff to assess both Agreement State and NRC Regional Office radioactive materials licensing and inspection programs. All reviews use common criteria in the assessment and place primary emphasis on i performance. Four additional areas have been identified as non-common indicators and are also addressed in the assessment. The final determination of adequacy and compatibility j of each Agreement State program, based on the review team's report, will be made by a  !

Management Review Board (MRB) composed of NRC managers and an Agreement State

. program manager who serves as a liaison to the MRB.

i In accordance with procedures for implementation of IMPEP, we are providing you with a j copy of the draft team report for review prior to submitting the report to the MRB. Your 2

review of the draft report should focus on factual correctness of information reported by the team. I am asking that you provide your response to me as soon as possible, but no later than four weeks from receipt of this letter.

The team will review the response, make any necessary changes to the report and issue it to the MRB as a proposed final report. We will coordinate with you to establish the date i

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( .. 8 Thomas W. Ortciger 2 APR 2 51997 for the MRB review of the Illinois report and will provide invitational travel for you or your de"gnee to attend. If you have any questions regarding the enclosed report, please contact me at (301) 415-3340 or Richard Woodruff at (404) 562-4704.

Sincerely, 4(

Richard L. Bangart, Director vhdt"l Office of State Programs

Enclosure:

As stated cc: Gordon Appel, Deputy Director, IDNS Paul Eastvold, Manager, Office of Radiation Safety, IDNS

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)' APR 2 51997 Thomas W. Ortciger 2 l 2

l for the MRB review of the Illinois report and will provide invitational travel for you or your  !

designee to attend. If you have any questions regarding the enclosed report, please 1 contact me at (301) 415-3340 or Richard Woodruff at (404) 562-4704.  !

Sincerely, j j  :

i %Siped By RICHARD L BANGART

! Richard L. Bangart, Director j

j. Office of State Prograrns l 1 >

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Enclosure:

l As stated l l

cc: Gordon Appel, Deputy Director, IDNS  ;

Paul Eastvold, Manager, Office of Radiation Safety, IDNS  ;

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Distribution:

DIR RF DCD (SP01) e SDroggitis PDR'(YESf NO,J KSchneider JLynch, Rlli SMoore, NMSS JJohnson, KS MBurgess, NMSS RWoodruff, Ril GDeegan, NMSS DSollenberger, OSP FCameron, OGC lilinois File HNewsome, OGC DOCUMENT NAME: G:\KXS\97LTR.lL G:\KXS\lLIMP97.DFT in meive e copy of this document,inacate in the boa: c = copy without attachmeg/ enclosure 'E" = Copy with attachment / enclosure *N" = No copy OFFICE Region 11 lE OSP:DD l OSP:D M y l l NAME RWoodruff:kk PHLohaus44 RLBangart ( * ' V DATE- 04M/9746 04hy/97/tr 04/fy97 yyKu# (N OSP FILE CODE: . SP-AG-8

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l INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM I

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REVIEW OF ILLINOIS AGREEMENT STATE PROGRAM I

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MARCH 24-28,1997 j

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1.0 INTRODUCTION

This report presents the results of the review of the lilinois radiation control program. The

. review was conducted during the period March 24-28,1997, by a review team comprised i

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

. Agreement State of Kansas. Team members are identified in Appendix A. The review was l 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 i Adequacy and Compatibility of Agreement State Programs," published in the Federal

Reaister on October 25,1995, and the September 12,1995, NRC Management Directive j 5.6, " Integrated Materials Performance Evaluation Program (IMPEP)." Preliminary results of

! the review, which covered the period July 23,1994 to March 28,1997, were discussed i

! with Illinois management on March 28,1997, t.

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

The lilinois Department of Nuclear Safety (IDNS) is a cabinet level agency within Illinois I

State Government. The Director is appointed by and reports directly to the Governor. The i

Office of Radiation Safety (ORS), which includes the Division of Radioactive Materials i (DRM), and the Office of Environmental Safety (OES), report directly to the Department Director. The IDNS organization charts are included as Appendix B. The 'ORM program 3 regulates approximately 857 materials licenses, has an 11e(2) uranium (thorium) recovery j' ' program for the decommissioning of the Kerr-McGee West Chicago site, and is the host ,

l State for the Central Midwest Low-Level Radioactive Waste Compact. In addition to the i radioactive materials program, the IDNS administers programs for inspections at nuclear

j. power plants and emergency response under the Office of Nuclear Facility Safety, and an environmental monitoring and laboratory under the Office of Environmental Safety. The i review focused on the materials program as it is carried out under the Section 274b. (of 1 the Atomic Energy Act of 1954, as amended) Agreement between the NRC and the State  ;

of Illinois.

l in preparation for the review, a questionnaire addressing the common and non-common j indicators was sent to ORS on January 10,1997. Illinois provided its response to the questionnaire on February 24,1997. A copy of that response, as updated during the review, is included as Appendix C to this report, i e

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

l (1) examination of Illinois' response to the questionnaire, (2) review of applicable Illinois i statutes and regulations, (3) analysis of quantitative information from the DRM licensing and inspection data base, (4) technical review of selected files, (5) field accompaniments of three Illinois materials inspectors, (6) the on site visit at the Kerr-McGee West Chicago i site that is undergoing decommissioning, and (7) interviews with staff and management to

, answer questions or clarify !ssues. The team evaluated the information that it gathered i against the IMPEP performance criteria for each common and non-common indicator and j made a preliminary assessment of the radiation control programs's performance.

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

'following the previous review. Results of the current review for the IMPEP common l performance indicators are presented in Section 3. Section 4 discusses results of the j applicable non-common indicators, and Section 5 summarizes the review team's findings and recommendations.

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVJEWS The previous routine review concluded on July 22,1994. It should be noted that Illinois participated in the IMPEP pilot program concurrent with the 1994 review. The final results of the review were transmitted to the Director, IDNS on December 28,1994.

The July 1994 review findings resulted in recommendations in eight program indicators:

(1) Status and Compatibility of Regulations; (2) Legal Assistance; (3) Administrative -

Procedures; (4) Status of the Inspection Program; (5) Enforcement Procedures; (6)

Inspection Procedures; (7) Inspection Reports; and (8) Confirmatory Measurements. The -

State responded by letter dated February 24,1995. On March 9,1995, the Office of State Programs (OSP) met with State staff to discuss unresolved issues concerning the Status and Compatibility of Regulations. Following this meeting, OSP documented NRC's positions regarding the compatibility issues in a letter dated September 7,1995, and closed out the other recommendations (2) through (8) based upon the meeting discussions, and the State's letter of February 24,1995. The State's corrective actions were also evaluated during a review visit by the Region til State Agreements Officer (RSAO) during the period of July 26 - August 2,1995, and the results of this visit were provided to the State on September 14,1995.

The recommendations regarding the Status and Compatibility of Regulations indicator remain open, and are discussed in detail under Section 4.1.

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 include: (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 insoection Proaram i l

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 team evaluation is based on the lilinois questionnaire re'sponse relative to this indicator, data gathered independently from the State's licensing and  ;

inspection data tracking system, the examination of licensing and inspection casework I files, and interviews with managers and staff.

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i The team's review of the State's inspection priorities verified that the State's inspection  ;

a frequencies for various types or groups of licenses are at least as frequent as similar license types -or groups listed in the frequency schedule in the NRC Inspection Manual Chapter (IMC) 2800. The State requires more frequent inspections in some license categories as follows: wireline services were verified to be inspected on a two year

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4 frequency as compared to the NRC three year frequency; all type A broad scope licenses are inspected on a one year frequency compared with the NRC two ya, frequency for type A broad industrial and academic, and a one year frequency of type A broad medical; type B and C broad scope licenses are inspected on a two and three year frequency, respectively, compared to the NRC frequencies of three and five years; and general license (GL) distribution type licenses are on a four year frequency compared to NRC's five year i frequency.

l l The inspection frequencies of licenses selected for inspection file review were compared with the frequencies listed in the State's data system and verified to be consistent with the State's system and as frequent as similar license types under the IMC 2800 system.

! In their response to the questionnaire, Illinois indicated that there were no inspections

[ overdue by more than 25 percent of the NRC frequency. This information was verified

! during the inspection casework reviews, and the review of the monthly generated

" inspections due" listing provided to the team.

1 5 With respect to initial inspections of new licensees, the team reviewed the inspection tracking data system and verified that the initialinspections had been entered into the tracking system. Discussions with staff members were conducted to determine how initial

, inspections are assigned and how data are entered into the system. The inspection data i system is updated as inspection reports are developedrand the " inspections due" listing is 4

updated on a monthly basis, and provided to the inspectors. The initial inspections are assigned a three month inspection due date with a 25 percent window, which allows the

{- inspections to be conducted well within the six month interval after issuance.

, The timeliness of the issuance of inspection findings was also evaluated during the inspection file review. Out of 19 inspection files examined, eight of the inspection findings

! sent to the licensees exceeded the 30 day guidance in IMC 2800 for notification to the licensee following completion of the inspection. Of these late notifications, two were clear i inspections, and the other six required frorn 50 to 84 days for the findings to be dispatched to the licensee. The DRM policy requires the findings to be dispatched within 30 days following the inspection, same as NRC policy. The team suggests that the State 4

examine their procedures for preparing inspection reports and correspondence, and make modifications needed to assure timely issuance of inspection findings.

The State reported in their response to the questionnaire that 77 licensees had submitted 1,276 requests for reciprocity during the review period, of which 42 were from licensees

with inspection intervals of three years or less. The State reported that seven reciprocity l licenses were inspected, which represents about 17 percent of the reciprocity licenses av'ailable for inspection. Four of the inspections were industrial radiography, two were

{ source exchanges, and one was a welllogger. In addition, the State conducted seven i

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additional non-reciprocity inspections of industrial radiography field sites. The team t considered that the State had expended considerable resources since the last review to  !

[ overcome the previous inspection backlog, and that in this instance, the numbers of '

i reciprocity type inspections were adequate. Representatives from the State of lilinois

stated that it was not necessary to inspect 50 percent of the reciprocity licensees to 4 - ensure safe licensee operations. However, now that the inspection backlog has been ,

overcome, the team suggests that the State should reconsider the IMC 1220 guidance for j

conducting reciprocity inspections, and increase the reciprocity inspections to meet the -

guidance.

i Based on the IMPEP evaluation criteria, the review team recommends that the State's I performance with respect to the indicator, Status of Materials inspection Program, be found satisfactory. l I

! 3.2 Technical Staffino and Trainina in reviewing this indicator, the review team considered the radioactive materials program l' staffing level, technical qualifications of the staff, training, and staff turnover. To evaluate l these issues, the review team examined the State's questionnaire responses relative to this l indicator, interviewed IDNS management and staff, reviewed training records, and j considered any possible workload backlogs.

! The IDNS organization chart shows that the Department consists of the Office of Legal j Counsel, the Office of Nuclear Facility Safety, the OES, the Office of Administrative

! Services, and the ORS.

F ORS is made up of the Division of Electronics, and DRM. DRM has two Sections,

} Licensing, and Inspection and Enforcement. The Licensing'Section has four positions for materials licensing, and five persons for low-level radioactive waste licensing. The

inspection and Enforcement Section has one inspector located in Springfield and five

- inspectors in the Glen Ellyn Regional Office. The Glen Ellyn office also provides support for I. the Mill Program which will be discussed under the appropriate non-common indicator j (Section 4.4). The Section managers and the DRM Director are technical managers. i

1 l lDNS has established qualifications for all of the technical positions. Applicants at the e

entry level are required to have a baccalaureate degree and are assigned duties in the j J program based upon their experience and training. The experience and training of each  ;

{ person is evaluated and additional training is given based upon the specific needs of the 4

position. Several of the personnel have advanced degrees in Health Physics, two persons j are certified health physicists, and two low-level radioactive waste persons have degrees in j Engineering, both are professional engineers, and one with an advanced degree in Geology.

i Alllicense reviewers have had the basic health physics courses and the Licensing course.

l Allinspectors have had the basic health physics training and the Inspection Procedures .

course. -Other specialized training is given depending upon the needs of the position. Staff I j are assigned increasingly' complex licensing duties under the direction of senior staff, and

accompany experienced inspectors during increasingly complex compliance inspections.

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Staff are required to demonstrate competence as determined during accompaniments by I their supervisors. This information was verified through discussions with managers and I staff, review of the questionnaire response, and review of the position descriptions. The team determined that all staff utilized for the agreement matericte program were technically qualified by evidence of their training and experience.

DRM reported that the program had experienced only two turnovers since the previous review. One person left for additional schooling and the other person accepted a position l with a licensee. The vacancies were filled within a matter of months and the program manager related that DRM had not experienced any problems in replacing personnel in vacated positions. I Although DRM has not participated in NRC training courses this fiscal year, a review of the training records, and statements made by managers, confirmed that DRM is committed to continued staff training as needed to allow the staff to carry out the duties and functions of the radiation control program. The DRM manager related that special training could be provided as needed through contracts.

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

i 3.3 Technical Quality of Licensina Actions I The review team examined casework and interviewed the reviewers for 20 specific  !

licenses. Licensing actions were reviewed for completeness, consistency, proper isotopes I 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 of safety evaluation reports, ,

product certifications or other supporting documents, consideration of enforcement history on renewals, pre-licensing visits, peer or supervisory review as indicated, and proper signature authorities. Licenses were reviewed for accuracy, appropriateness of the license and of 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 reviewers. The cross-section sampling included the following types of licenses: large irradiator, medical, academic, nuclear pharmacy, research and development, veterinary nuclear medicine, service, industrial radiography, portable gauges and devices, wireline services and in-vitro general license. Licensing actions included two new licenses, five renewals, nine amendments, and four terminations. A list of these licenses with case-specific comments may be found 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.

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License tie-down conditions were almost always stated clearly, backed by information  !

contained in the file, and inspectable. The licensee's compliance history was taken into

' account when reviewing renewal applications. Good communication was identified i

between licensing and inspection staff via " green sheets" placed in license files.

Reviewers appropriately used the State's licensing guides, license templates, standard  ;

_ conditions and checklists. The licensing supervisor reviews and signs alllicensing actions,

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. No potentially significant health and safety issues were identified.

One file review of a nuclear gauge distribution and installation license identified a contradiction between a leak test license condition and the sealed source and device 4

(SS&D) registry sheet for a gauge. The review team suggests that license reviewers check

, SS&D registry sheets prior to authorizing license modifications which result in a change in the handling of a sealed source or device. l l lDNS maintains an aggressive program in the decommissioning area. In addition, since i j 1993, NRC Region 111 has sent copies of 54 terminated NRC license files, authorizing use of i i radioactive material at facilities in Illinois, to IDNS for review and c ose-out. These license i

files were identified during a contractor review of terminated license files which had  ;

insufficient documentation to assure that radioactive material had been properly disposed )

of and/or remediated when the licenses were terminated. IDNS performed historical I research and performed surveys at the formerly-licensed sites. All but one of the sites, which is in remediation, have been closed out. An NRC health physicist assisted the State )

on one of the facility surveys. Records of the close-out measures were provided to NRC l for inclusion in the terminated license files. This effort was an excellent independent and cooperative effort by IDNS.

' Based on the IMPEP evaluation criteria, the review team recommends that lilinois' performance with respect to the indicator, Technical Quality of Licensing Actions, be found satisfactory.

3.4 Technical Quality of insoections The team reviewed the inspection reports, enforcement documentation, and inspection field notes for 24 materials inspections conducted during the review period. The casework included all six of the State's materials inspectors and covered a sampling of different license types as follows: industrial radiography, wireline services, broad scope university, j broad scope research and development, broad scope medical, veterinary medicine, ]

teletherapy, brachytherapy, manufacturing and distribution, nuclear laundry, nuclear <

medicine, large hospital, nuclear pharmacy, laboratory use, waste packaging, large j irradiator, portable gauge, and fixed gauge licensees. Appendix E lists the inspection cases l reviewed in depth with case specific comments. J l

The team reviewed the inspection reports and found them to be comparable with the types j of information and data collected under NRC Inspection Procedure (IP) 87100. The I inspection procedures and techniques utilized by the State were reviewed and determined to be consistent with the inspection guidance provided in NRC IMC 2800.

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- in addition, several spot checks were performed on the files to verify that enforcement 4

correspondence was being maintained in a consistent manner and to verify the I

implementation of the proper inspection frequency. In all cases, license files selected from l

}. the data base for the spot checks were determined to have the proper inspection frequency

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.and current inspection findings and correspondence. Some of the inspection files were also reviewed during the license file review, thus providing further insight on how the State l considers inspection findings when completing a licensing action.

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. The review team noted that routine inspections adequately cover the licensee's radiation

program and include a written summary of the scope of the licensed activities and a root j cause if a noncompliance was identified. The review team 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, inspection accompaniments were conducted by the ORS Manager, the i DRM Director, the inspection and Enforcement Head, as well as the Glen Ellyn office i supervisor, Accompaniments give the IDNS program management a better understanding

. of both the inspectors' abilities and competence to perform license inspections and provide i

[ a better insight into licensee programs. l 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, l

} such as industrial radiography, wireline services, broad scope university, broad scope l research and development, broad scope medical, teletherapy, manufacturing and l distribution, nuclear medicine, pool irradiators, portable gauge, and fixed gauge licensees.

! The inspection field notes provide documentation of the scope of the licensee's program l including: unusual occurrences; postings; storage and use of radioactive material; receipt,

! transfer, and disposal of radioactive material; inventory; leak tests; radiation protection l program; personnel monitoring; training; independent measurements; and inspection l compliance and noncompliance findings. The review team also noted that the DRM had l specific field notes for radiography field sites and follow-up forms for documenting 1- follow-up inspections to ensure previously cited violations have been corrected, i

l' The inspection reports and field notes demonstrated that DRM inspectors were examining appropriate radiation health and safety issues at licensees' facilities. From the review of 2 case work, the review team found a number of minor issues (i.e., timeliness of letters to licensee, announced inspections, supervisory oversight) that were discussed directly with l the Head, inspection and Enforcement Section. However, none of the issues indicated a

. systemic problem in the technical quality of inspections. The review team found that the i- inspection reports contained only minor discrepancies, when compared to DRM internal guidance or standard practices.

All of the inspection results and reports, correspondence and enforcement letters were j verified as having been reviewed and signed off by the Head, inspection and Enforcement i Section, before issuing the results to licensees. The review team concluded that this supervisory review enhanced the quality of the inspection and enforcement documents, a

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The appropriateness of announcing routine materials inspe'ctions was discussed with DRM

, managers during this review. As iterated during the previous review, IDNS' philosophy. ,

j with regard to the announcing of inspections considers less than 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> notification to a l ' licensee to be an " unannounced" inspection. DRM staff members stated that if a licensee, 2

upon notification of an inspection the next day, indicated that the Radiation Safety Officer i- (RSO) would not be available for the inspection, the inspe'c tion would likely be deferred. ,

, The review team suggests that, even if the RSO indicates a scheduling conflict, the  ;

inspection be conducted if license activities are continuing in the RSO's absence.

1 3- Three inspector accompaniments were performed by a review team member during the i- period of March 11-14,1997 tOne inspector was accompanied during the inspection of a l~ nuclear medicine program, and the other two inspectors were accompanied on portable l gauge inspections. These accompaniments are identified in Appendix E. The three other l DRM inspectors have been accompanied during previous reviews. On the

! accompaniments, the DRM inspectors demonstrated appropriate inspection techniques and .

! knowledge of the regulations. The inspectors were wel.1 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 i

health and safety at the licensed facilities.

The State calibrates their own survey instruments at their CRCPD-certified Regional Calibration Facility. The review team interviewed the individual responsible for the calibration of the State's radiological survey instrumentation. The calibration facility has National Institute of S::ience and Technology traceable scaled sources to determine the efficiency of beta / gamma instrumentation.

i 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 good  :

mix of low range GM tubes and pancake probes, micro R meters, high range instruments, instrumentation with calibration standards for alpha detection, a neutron rem ball, a portable multichannel analyzer, and the Environmental Laboratory maintains a mobile  ;

laboratory van for use in emergencies and emergency exercises. Air monitoring equipment .

is also available. The portable instruments used during the inspector accompaniments i were observed to be operational and calibrated. The portable instruments maintained in the DRM office were also observed to be' calibrated. DRM staff explained that instruments are calibrated at least on an annual basis, and staggered so as to always have instruments calibrated within the calendar quarter for use during industrial radiography inspections.

Based on the IMPEP evaluation criteria, the review team recommends that Illinois' performance with respect to the indicator, Technical Quality of Inspections, be found satisfactory.

3.5 Resoonse to incidents and Alleaations 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 regarding this indicator, reviewed the incidents reported for Illinois' " Nuclear Material Events t

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u 4 Database" (NMED) against those contained in the Illinois' files, reviewed in general all 1996 and 1997 incident files, and reviewed in detail the casework of 17 incident files and

five allegation files, in addition, the review team interviewed the DRM Director, the Head,

, inspection and Enforcement Section, and the Freedom of Information Act (FOIA) Officer.

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Responsibility for initial response and follow up actions to materials incidents and allegations rests with the inspection and Enforcement Section. IDNS procedures require

! the prompt response to each significant incident or allegation. Each incoming notification

! is discussed with management and staff as appropriate and the response is coordinated l with the appropriate field staff including an on site inspection as appropriate. The managers related that allincidents, complaints, and allegations are evaluated by l management, followed up with an inspection when necessary, and recorded and tracked in the computerized tracking system. The State does not utilize the NMED system for reporting significant events, but the event information is provided on printed copy to the l

Office of State Programs (OSP) for entry into the NMED system, initial notification is made through the RSAO, Region Ill.

3 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 Headquarters Operations Center of events requiring immediate or 24-hour reporting by the licensee.

t l The review team examined in detail the State's response and documentation of the 17 l events listed in Appendix F and verbally discussed several other events with the Head, inspection and Enforcement Section. This effort incluoeo the State's incident and allegation process, tracking system, file documentation, open records laws and policies, j and notification of events to other Federal and State agencies.

l i- The review team found that the State's responses generally were well within the

performance criteria. Responses were prompt and well-coordinated, and the level of effort .

i was commensurate with health and safety significance. Inspectors were dispatched to the site when appropriate. In general, the State took suitable corrective and enforcement actions, notified the NRC, other States, and other agencies as appropriate, and followed j the progress of the investigation through until close out.

j As noted above, Illinois does not participate in the NMED program offered by NRC. The i State has their own tracking system and data / report entry system, and all events and i allegations are tracked chronologically by date. Significant events are reported to the j RSAO, Region ill, and printed copies of the event reports are submitted to OSP for entry

into the NMED system. The team discussed the merits of participating in the NMED system, including quality control, and queries available for generating various reports that

, would be of value to license reviewers and inspectors, and program managers. The DRM l Director related that the State's system was easier to use than the NRC system; however, the State is considering converting their software to Microsoft Access. The review team j suggests that the State reconsider the benefits of participating in the NMED system.

1 l All five allegation files reviewed were referred to the State from Region 111, and all were j closed out with Region Ill. Region lil repoited that there were no outstanding l'

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allegations that had beu. referred to the State of Illinois. Allegations were responded to

, promptly with appropriate investigations and follow-up actions. The identity of a e

Concerned Individual (Cl) can be protected under the State's open record law. IDNS

j. management related that all confidential information is approved and processed by the 1 FOlA Officer. The CI's identity can be protected as needed, and the managers related that '

notification to the Cl concerning the results of investigations are provided as needed. This

close out action was confirmed by the reviewer, in general, the State's response was

determined by the review team to meet the indicator guidance.

The review team also found good correlation of the State's response to the questionnaire, the incident information in the files, and the event information reported on the NMED system printout for Illinois.

Based on the IMPEP evaluation criteria, the review team recommends that the State's performance with respect to the indicator, Response to Incidents and Allegations, be found

satisfactory.

1 1 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 program. Illinois is the host State for the Central Midwest Low-Level Radioactive

- Waste Compact, and received an amended Ac:eement in 1990 to include authority for 11e(2) byproduct material; therefore, all of tF,e four non-common performance indicators were applicable to this review.

4.1 Leaislation and Reaulations 4.1.1 Leoislative and Leoal Authority The State provided, in their response to the questionnaire, a listing of legislation that affects the radiation control program. IDNS is designated as the State radiation protection agency under the provisions of the ' Radiation Protection Act of 1990, as amended

[420 ILCS 40/1-40/45]. The Act grants the Department the authority to promulgate rules and regulations to be followed in the administration of the radiation protection program.

Other statutes, the Radioactive Waste Storage Act (420 ILCS 35/0.01-35/6], the Illinois Low-Level Radioactive Waste Management Act (420 ILCS 20/1-20/24] and the Uranium and Thorium Mill Tailings Control Act [420 ILCS 42], provide authority for the low-level radioactive waste disposal and uranium'reccvery programs.

The Radiation Protection Act has a sunset date of December 31,2000. The legislature M have to pass another Act to reauthorize the State's program. The other aforemet.Jow d statutes do not have sunset provisions.

f lilinois Draft Report Page 12 s

, 4.1.2 Status and Comoatibility of Reaulations in a December 19,1994, letter from NRC to IDNS, a number of unresolved compatibility issues from the 1992 program review and from the State's 1994 implementation of 10 CFR Part 20-equivalent regulations were identified. A series of discussions and meetings resolved some of the compatibility issues as reflected in the September 7,1995, letter to the State. That letter discussed the implementation deferral for the " Policy Statement on Adequacy and Compatibility of Agreement State Programs. This po!!cy has not yet been implemented. The review team proposes that NRC continue deferral on these unresolved compatibility issues until the NRC's final adoption of a new Adequacy and Compatibility Policy Statsment.

The unresolved compatibility issues remaining are as follows:

Financial assurance for decommissionina. 330.250 " General Reauirements for the issuance of Soecific Licenses" The State's " decommissioning" rule exempts all educational institutions, nuclear pharmacies and medicalinstitutions. This regulation does not meet Division 2 compatibility standards.

Discussions with staff during the review indicated that modifications were planned for this rule in the new Part 326, currently in process, which would align it more closely with 10 CFR 30.35.

• " Quality Manaaement Procram and Misadministrations." 10 CFR Part 35 The State adopted misadministration requirements on May.2,1994 in Part 335.1080 " Notifications, Reports and Records of Reportable Events." The State requires licensees to notify the patient of the reportable event within 15 days after the licensee ascertains and confirms that a reportable event has occurred instead of within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> as required by NRC regulations. This regulation does not meet Division 2 compatibility standards.

IDNS has not adopted the Quality Management Program, pending the outcome of the NRC's rebaselining initiative and the NRC/ Agreement State Working Group's recommendations on medical rules. As .itated in the September 7,1995, letter to IDNS, the NRC is evaluating methods by which Agreement States can be provided increased flexibility in the adoption of compatible Quality Management rules. NRC is cuc<ni:V deferring compatibility findings for Agreement States that have not yet adopted a compatible Quality Management rule, pending resolution of the issue of Agreement State compatibility.

• 10 CFR Part 20-eauivalent rules in lil, Adm. Code 310.20 " Definitions" Declared pregnant woman - This definition deletes the requirement for a woman to provide the estimated date of conception along with her declaration of pregnancy.

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Illinois Draft Report Page 13

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This issue relates to Section 340.280 " Dose to an Embryo / Fetus" (also Division 1 2

compatibility). Section 340.280 adds a clause for a situation in which a declared pregnant woman does not wish to disclose the estimated date of conception. If an estimated date of conception is not disclosed, the dose is limited to 50 millirem (0.5 l

.nSv) per month. This definition does not meet Division 1 compatibility standards, l

, The State believes that this definition protects a woman's right to privacy with l respect to the date of conception.

Two additional regulations roquired for co'mpatibility have not been adopted but the State imposed the requirements by legally binding requirements, license conditions. The State has met compatibility requirements through this action, i

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• " Emergency Planning Rule," 10 CFR Parts 30,40 and 70 (54 FR 14051) which was l i- due April 7,1993.  ;

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j Radiological contingency plans are required by license condition for all affected licensees. The State has verified by inspection that the three licensees requiring contingency plans have them implemented. This regulation is planned to be adopted with the re9ision of Part 330, currently in process.

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• " Licensing and Radiation Safety Requirements for Irradiators," 10 CFR Part 36 amendments (58 FR 7715) which was due July 1,1996.

The State reported that allirradiator licenses issued implernent the rule through license cono;tions. This regulation is planned to be adopted with the issuance of Part 336, projected for late 1997.

Since the last review, the State adopted regulations to satisfy compatibility for the following:

• "Notificatton of incidents," 10 CFR Parts 20, 30, 31, 34, 39, 40 and 70 (56 FR 64980) which was due on 10/15/94 and adopted on 6/12/95.

• " Licensing Requirements for Land Disposal of Radioactive Waste," 10 CFR Part 61 amendment (58 FR 33886) that was due on July 22,1996, and was adopted on May 1,1996.

Current NRC policy on compatibility requires that Agreement States adopt certain equivalent regulations or legally binding r'aquirements no later than three years after they are effective. As of the date of the rewsw, two regulations are overdue for edoption.

• " Decommissioning Recordkeeping, and License Termination: Documentation Additions," 10 CFR Parts 30,40,70, and 72 amendments (58 FR 39628) which was due on October 25,1996. IDNS drafted regulations for compatibility with this regulation in their proposed restructuring of Part 330. Adoption of this section is

lllinois Draft Report Page 14 ,

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projected for Summer / Fall 1997. The review team recommends that IDNS expedite promulgation of Part 330 at the first opportunity.

"Self-Guarantee as an Additional Financial Mechanism," 10 CFR Parts 30,40, and 70 amendments (50 FR 68726) which was due on January 28,1997. Note, this 1 rule is designated as a Division 2 matter of compatibility. Division 2 compatibility allows the Argeer.e.it States flexibility to be more stringent (i.e., the State could a

choose not to adopt self-guarantee as a method of financial assurance), if a State chooses not to adopt this regulation, the State's regulation, however, must contain provisions for financial assurance that include at least a subset of those provided in NRC's regulations, e.g., prepayment, surety method (letter of credit or line of credit), insurance or other guarantee method (e.g., a parent company guarantee).

Self-Guerantee regulations are included in the new Part 326, currently in draft. i

. Adoption is projected by Fall 1997.

i in addition, we would like to bring to the State's attention other regulations that will be  ;

needed, in the future, for compatibility. These rules are:

" Uranium Mill Tailings Regulations: Conforming NRC Requirements to EPA Standards," 10 CFR Part 40 (59 FR 28220) due by July 1,1997.

• " Timeliness in Decc,nunissioning of Materials Facilities," 10 CFR Parts 30,40, and 70 arnendments (59 FR 36026) due by August 15,1997.

• " Preparation, Transfer for Commercial Distribution and Use of Byproduct Material for Medical Use," 10 CFR Parts 30,32 r.nd 35 imendments (59 FR 61767,59 FR 65243,60 FR 322) due by January 1,1998.

• " Frequency of Medical Exarsations for Use of Respiratory Protection Equipment,"

10 CFR Part 20 amendments (60 FR 7900) due by March 13,1998. Note, this rule is designated as a Division 2 matter of compatibility. Division 2 cmmpetibidy allows the Agreement States flexibility to be more stringent (i.e., the Gtate could choose to continue to require annual medical examinations).

• " Low-Level Waste Shipment Manifest Information and f.eporting," 10 CFR Parts 20 and 61 amenJments (60 FR 15649,60 FR 25983) that will become effective

. March 1,1998. Illinois and other Agreement States are expected to have that equivalent rule effective on the same date.

• " Performance Requirements for Radiography Equipment," 10 CFR Part 34 amendments (60 FR 28323) due by June 30,1998.

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

10 CFR Parts 19 and 20 amendments (60 FR 36038) due by August 14,1998.

• " Medical Administration of Radiation and Radioactive Materials," 10 CFR Parts 20 and 35 (60 FR 48623) due by October 20,1998.

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lilinois Draft Report Page 15 I

• " Clarification of Decommissioning Funding Requirements," 10 CFR Parts 30,40, and 70 amendments (60 FR 38235) due by November 24,1998.

• " Compatibility with the International Atomic Energy Agency," 10 CFR Part 71  ;

amendment (60 FR 50248,61 FR 28724) due by April 1,1999. j

, " Termination or Transfer of Licensed Activities: Recordkeeping Requirements," 10 CFR Parts 20,30,40,61 and 70 (61 FR 24669) due by May 16,1999.

• " Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials: Clean i Air Act," 10 CFR Part 20 (61 FR 65119) due by January 9,2000,  ;

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• " Recognition of Agreement State Licenses in Areas Under Exclusive Federal j Jurisdiction Within an Agreement State," 10 CFR Part 150 (62 FR 1662) due by  !

January 13,2000.

• " Criteria for the Release of Individuals Administered Radioactive Material," 10 CFR Parts 20 and 35 (62 FR 4120) due by January 29,2000.

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

process and found that proposed regulations are published in the lilinois Reaister with a 45 l

day minimum comnerc csriod and may include a public hearing. According to DRM management, NRC it, provided with draft proposed regulations for comment early in the 1 promulgation process and again prior to final adoption.

The team notes that NRC staff is currently reviewing all Agreement State equivalent regulations to Part 20, Standards for Protection Against Radiation. These reviews are being conducted outside the IMPEP process and the States will be notified of the results.

Based on the IMPEP evaluation critene, the review team recommends that Illinois' performance with respect to the indicator, Legislation and Regulations, be found unsatisfactory due to the State's failure to adopt the Decommissioning Recordkeeping regulation, or equivalent legally binding requirements, within the specified period of time.

4.2 Sealed Source and Device Evaluation Proaram in evaluating the State's Sealed Source & Device (SS&D) evaluation program, the review team examined the information provided by the State relative to this indicator in their response to the questionnaire, reviewed a sample of the actions completed since the last review, reviewed new procedures and guidance, and interviewed the DRM staff and manager responsible for SS&D evaluations.

Since the last review, the State has issued or established a number of guidance documents to assist in the review of SS&Ds and help to ensure that all pertinent issues are addressed.

These include review and Quality Assurance (QA) checklists, a " Blue Sheet" to track l correspondence and staff work regarding SS&D actions, electronic templates of blank registry sheets, and Instructional Sets, which provide licensing guidance in specific areas

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! lilinois Draft Report Page 16 H

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, ~ including " Instructions for Preparation and Review of Quality Assurance Manuals for l

Licenses Authorizing Manufacture and Distribution of SS&Ds." In addition, the State has '

4 established "S" and "D" evaluation manuals, for sealed sources and devices respectively,

which are a collection of any applicable document or training guidance pertaining to SS&D i

reviews, and include a wide variety of information such as both State and NRC issued

policy letters, regulatory guides, national and international standards, and SS&D Workshop i materials.

4.2.1 Technical Quality of the Product Evaluation Proaram 4

{' The review team reviewed 11 registry sheets out of the 36 registry sheets reported for the period since the last review. The SS&D registry sheets issued by the State and evaluated

by the review team are listed with case-specific comments in Appendix G. Overall, the i

quality of the evaluatiuns was good, but the review team identified and discussed with the

staff several deficiencies in the files involving issues that may result in safety issues if not  !

, adequately addressed during all safety reviews. The review team identified weaknesses in j documenting major issues on 6 of the 11 cases reviewed. Although there were no

! immediate safety implications identified in the particular files reviewed, it was not possible j

to determine from the limited number of files reviewed and the staff interviews whether these deficiencies were isolated occurrences or if these issues may indicate a weakness in the review process. During the exit meetings with staff and DRM managers, the review team noted that the deficiencies were discussed with the State's technical staff. The i review team suggests that the issues identified in Appendix G be addressed as appropriate. l The review team suggests in future evaluations that the State ensure all major issues are documented by either correspondence from the manufacturer or a note to the file by the reviewer.

4.2.2 Technical Staffino and Trainina The State reported that a five-person team with combined staff efforts equaling approximstely one full time equivalent is dedicated to performing safety evaluations. The balance of staff time is spent in licensing actions. The State reported that 48 actions, involving 36 registry sheets, were completed during the review period. The actions reported by the State also included actions associated with Naturally Occurring or Accelerator-Produced Radioactive Materials (NARM), and staff efforts expended on several cases before the applications were withdrawn by the applicant.

The State utilizes a team approach in performing evaluations of sources and devices, and if needed, can obtain engineering assistance from the two certified professional engineers that work in the Low-Level Radioactive Waste and the Uranium Mill Tailings programs.

The head reviewer performs approximately one-half of the reviews and performs a concurrence-type review of most of the actions assigned to the other three reviewers. All SS&D deficiency letters, and draft and completed registration certificates generated by the staff are reviewed by the head reviewer, to ensu're that all engineering-related safety issues are addressed. The concurrence review for all SS&D deficiency letters, and draft and completed registration certificates are also reviewed by the Licensing Section Head. This

~lllinois Draft Report Page 17 !

team approach provides the technical expertise and experience needed for this size of program.

h The head reviewer has a B.S. degree, and demonstrated to the review team an ability to understand and interpret the information submitted by applicants as described in the performance criteria, including engineering-related issues. 'The three remaining reviewers have B.S. degrees and health physics training, and have demonstrated to the review team an ability to identify issues which need to be referred to the head reviewer or engineering support. All members have attended at least one SS&D workshop. There have been no additional staff involved in the SS&D Evaluation Program since the last program review.

4.2.3 Evaluation of Defects and incidents Reaardina SS&Ds The State evaluated three incidents associated with SS&D product failures or problems.

The State adequately addressed the issues involved. The review team identified no outstanding issues related to the three incidents.

Based on the IMPEP evaluation criteria, the review team recommends that Illinois' performance with respect to the indicator, Sealed Source and Device Evaluation Program, be found satisfactory.

4.3 Low-level Radioactive Waste (LLRW) Disoosal Proaram in the process of evaluating this performance indicator, the review team evaluated the State's response to the questionnaire; reviewed information provided by the State regarding the status of the LLRW program, regulations and procedures; the qualifications of the technical staff; and interviewed staff and managers.

The current status of the LLRW program is that the State is beginning the site selection process over and a disposal site application is not anticipated for several years. Therefore, the staff are working on other projects (see uranium recovery program discussion in Section 4.4) until a site has been selected. Previously, a LLRW disposal facility site was selected at Martinsville, Illinois but was later rejected by a Governor-appointed committee.

4.3.1 Status of Low Level Radioactive Waste Discosal Insoection l The State does not have a site at this time; therefore, no inspections have been conducted.

4.3.2 Technical Staffino and Trainina IDNS has designated certain staff for the LLRW program. The technical staff reports to the materials licensing supervisor. The LLRW staff works on the LLRW activities, uranium recovery activities, and special projects such as complex decommissioning cases. The technical qualifications of the LLRW staff are described in the uranium recovery program discussion (Section 4.4.2). IDNS has the appropriate number of staff and technical expertise mix needed to evaluate a LLRW disposal site application and has several contracts in place to provide assistance in the review of a LLRW disposal site application.

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. Illinois Draft Report Page 18 4 i 4.3.3 Technical Quality of Licensino The State did not conduct LLRW disposal site licensing activity during the review pariod. ,

-The LLRW staff developed several guidance documents which address the following:

(1) describe the licensing process, (2) provide guidance to the applicant, and (3) describe i the acceptance criteria for meeting the regulatory requirements. This latter document is '

considered by the review team to be a significant accomplishment by IDNS and has been 1 shared with several States that are developing LLRW disposal sites and regulatory j programs.

4.3.4 Technical Quality of Inspections Since there is no site selected to date, there were no inspections conducted.

4.3.5 Resoonse to incidents and Alleaations There were no incidents or allegations pertaining to the State's LLRW program activities during the review period. The State explained to the review team that incidents and allegations relating to LLRW disposal would be handled in the same manner as those  !

pertaining to any materials licensee.

Based on the IMPEP evaluation criteria for the above five performance areas, the review team recommends that lilinois' performance with respect to the indicator, Low Level Radioactive Waste Disposal Program, be found satisfactory.

4.4 yranium Recoverv Reaulatory Proaram in the process of evaluating this performance indicator, the review team evaluated the State's responses to the questionnaire; reviewed information provided by the State regarding the license status, inspection history, site status, financial assurances, and regulations status; reviewed selected licensing and inspection files; evaluated the qualifications of the technical staff; and interviewed staff and managers working in the uranium recovery regulatory area.

In 1990, the Illinois Agreement was amended to include the authority for 11e(2) byproduct material and the facilities that generate such material. The IDNS uranium recovery program is administered as part of the materials licensing program. The State has only one licensee, Kerr-McGee Chemical Corp., West Chicago site. This facility is in l decommissioning and the materialis being shipped out of State. The off-site contamination is being permitted back on-site for a limhed time prior to shipment out of State. The State has worked closely with the local community and the licensee to develop a decommissioning plan acceptable to all stakeholders.

4.4.1 Status of Uranium Recoverv Proaram Insoection IDNS inspection frequency for the West Chicago site is annually. This is consistent with the criteria in IMC 2800 and 2801. This frequency has been applied since the licensee

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Illinois Draft Report Page 19 began decommissioning operations in 1994. The last three inspections were conducted in September 1994, January 1996, and February 1997. Prior to the beginning of the decommissioning, inspections were conducted every two years.

IDNS has a resident health physics inspector at the site who conducts daily, weekly, and monthly operational checks and observes the site operations daily. In addition, there is a State contractor engineering resident that supports the health phveh resident and checks the engineering quality control on the site.

IDNS also reviews the annual environmental monitoring report submitted by the licensee

and determines compliance for the environmental program. This is conducted on a l separate schedule from the annual license compliance inspection. A separate quality i assurance inspection is conducted annually at the licensed sites. '

The review team found that there were no overdue or backlogged inspections in the

uranium recovery program. The last annual inspection notification letter was issued in 30 days. The previous inspection notification letter was issued in 80 days; however, the inspector became seriously ill shortly after the inspection which delayed the issuance of the letter. Allinspection reports are reviewed and signed by the Head, inspection and Enforcement Section, even when the inspections are conducted by the uranium recovery program staff.

, 4.4.2 Technical Staffina and Trainina The Licensing Section Head supervises the staff working in the uranium recovery program with the LLRW supervisor managing the resident inspector and the other staff engineer.

These supervisors have many years of experience in managing this type of facility. The technical staff consists of two health physicists, two engineers (both professional

, engineers), and a geologist, with a support contractor supplying additional expertise in these areas. The review team examined the training, education, and experience of the staff members and found that the qualifications of the technical staff are commensurate with the expertise identified as necessary to regulate uranium recovery and 11e(2)

' byproduct material.

Additional support is provided by the staff in the environmental surveillance division for environmental monitoring, verification surveys, and sample analyses on an as needed basis. The laboratory was visited by the review team and found to be a state-of-the-art facility which participates in three different laboratory inter comparison programs.

4.4.3 Technical Quality of Licensino Actions The review team evaluated the latest version (amendment 43) of the Kerr-McGee Chemical Corp. license. In examining the license and selected documentation in the file, the review team found that the license included appropriate license conditions for the decommissioning operations at the facility. The license authorize; the licensee to decommission the site in phases with a separate evaluation of ear.. phase going through a complete license evaluation process (separate safety evaluation report and other supporting

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] lilinois Draft Report Page 20 i

, documentation). Detailed procedures have been referenced by license conditions. The

license files were well organized and referenced documents examined by the review team

were quickly located.

j Most license reviews are conducted using the expertise of all staff in the uranium recovery U

program. The review team noted that the team approach is effective in achieving peer

review and applying the necessary expertise to the specific review. - l

j. 4.4.4 Technical Quality of Insoections

{~ 4 Inspection and enforcement is handled in the same manner as any lilinois licensee. I t

l The review team examined the compliance file for Kerr-McGee and reviewed the last three j routine inspection reports. The file also had documentation for the 1996 environmental

, monitoring data review and the 1996 quality assurance audit. The documentation for

, these activities show that past inspections and audits adequately covered the scope, '

completeness, and technical accuracy necessary to determine compliance with regulations, license conditions, and available guidance. Appropriate enforcement actions were taken given the scope of the violations noted.

=

Given the location of the licensed site, there is an extensive environmental monitoring l program with the licensee, IDNS, and the Illinois Environmental Protection Agency all

conducting independent monitoring programs. The State reviews the licensee's annual environmental monitoring report and any violations as noted are addressed as notice of l violations (NOVs), such as the NOV issued based on the 1996 review. l 4 'In addition to the annual compliance inspection, a Quality Assurance inspection was

} conducted to evaluate the licensee's checks on the construction and clean-up activities at j the site. The inspection was thorough and the violation identified was quickly addressed

]- by the licensee. i a '

4.4.5 Resoonse to incidents and Alleaations '

There was one incident but no allegations pertaining to the uranium recovery activities licensed by IDNS. The incident was addressed in a timely manner and the documentation was complete and timely. The documentation was located in both the license file and the Department's incident file. l Based on the IMPEP evaluation criteria for the above five performance areas, the review team recommends that Illinois' performance with respect to the indicator, Uranium Recovery Program, be found satisfactory.

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l lilinois Draft Report Page 21 l

5.0

SUMMARY

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

respect to each of the common performance indicators to be satisfactory. The non- I common indicators, Sealed Source and Device Evaluation Program, Low-Level Radioactive l Waste Disposal Program, and the Uranium Recovery Program were also found to be satisfactory. Based on the existing NRC compatibility policy and the IMPEP evaluation criteria, the review team found the State's performance with respect to the indicator, Legislation and Regulations to be unsatisfactory. Accordingly, the team recommends that the Management Review Board find the Illinois program to be adequate to protect public health and safety and not compatible with NRC's 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 team suggests that the State examine their procedures for preparing inspection nuorts and correspondence, and make modifications needed to assure timely issuance of inspection findings (Section 3.1).

2. Now that the inspection backlog has been overcome, the team suggests that the ,

State should reconsider the fMC 1220 guidance for conducting reciprocity inspections, and increase the reciprocity inspections to meet the guidance (Section 3.1).

3. The review team suggests that license reviewers check SS&D registry sheets prior  :

, to authorizing license modifications which result in a change in the handling of a sealed source or device (Section 3.3).

4. The review team suggests that, even if the RSO indicates a scheduling conflict, the inspection be conducted if license activities are continuing in the RSO's absence (Section 3.4).

5. 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 Headquarters Operations Center of events requiring immediate or 24-hour reporting by the licensee (Section 3.5).

6. The review team suggests that the State reconsider the benefits of participating in the NMED system (Section 3.5). ,

7. The review team recommends that IDNS expedite promulgation of Part 330 at the first opportunity (Section 4.1).

8. The review team suggests that the issues identified in Appendix G be addressed as appropriate (Section 4.2.1).

P lilinois Draft Report Page 22 I i

9. The review team suggests in future evaluations that the State ensure all major 1 issues are documented by either correspondence from the manuf acturer or a note to the file by the reviewer (Section 4.2.1).

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l LIST OF APPENDICES Appendix A IMPEP Review Team Members Appendix B lilinois Organization Charts Appendix C lilinois' Questionnaire Response Appendix D License File Reviews Appendix E Inspection File Reviews Appendix F Incident File Reviews Appendix G Sealed Source and Device Evaluation Reviews Attachment 1 lilinois' Response to Review Findings i

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APPENDlX A l lMPEP REVIEW TEAM MEMBERS '

Name Area of Responsibility Richard L. Woodruff Team Leader l RSAO, Ril Status of Materials inspection Program l Technical Staffing and Training i Response to Incidents and Allegations James L. Lynch Technical Quality of Licensing Actions RSAO, Rlll Legislation and Regulations James Johnson, Kansas Technical Quality of Inspections Michelle L. Burgess Sealed Source & Device Evaluation Program NMSS/IMNS/SSDB Dennis Sollent;-rger Low-Level Radioactive Waste Disposal Program OSP Uranium Recovery Program 4

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! l APPENDIX B lLLINOIS DEPARTMENT OF NUCLEAR SAFETY ORGANIZATION CHARTS

i.

I ILLINOIS DEPARTMENT OF NUCLEAR SAFETY i

}

NOR i l

i Tom Ortciger i

1 MnW LEGISLATNE LEGAL M I IM1N Steve England John Webb i

DMECTM N OORREUNICATIONS Patti Thompson i

D5ECTOR

-meCATIONS i Cordon Appel u

l E I I I 1

OFFICE OF OFFICE W OFFICE OF OFFICE OF

! Sillr1 Fast MM ADtmeSTRATNE EN N AL

} FACEJTYSAFETY SAFETY SERVICES SAFETY i

i Roy Wight Paul Eastvold Dave Josniak Rich Allen 4

N LOW.LEVELWASTE

, PRODUCTS SERVICES RAANAGERENT OPERATIONS COtrUTER SERVICES

, RADIOACTNE RADIOCHEteSTRY l REATEfEALS PERSOpeEL

! N& SERVICES j ANALYSIS ENVRONRENTAL BAANAtwaaFMT ,

RESIDENT SERVICES

BGSPECTOR &

CODECOtruANCE FEES

' COGAPUANCE 1

FEBRUARY 1997

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i OFFICE OF LEGAL COUNSEL 1

2 1

i I QEF LEGALCOWSEL _ gg Steve England SENIOR STAFF ATTORIEY i

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l SECRETARY  ;

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i SEfeORSTAFF PARALEGAL PMW RW AN STAFFATTORNEY STAFFATTORDEY gg m gy 1

i 4

I l FEBRUARY 1997

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OFFICE OF ENVIRONMENTAL SAFETY Rich Allen SECRETARY ADMINISTRATWE ASSISTANT SBeOR NNM ENVRONRENTAL g PROTECTION SPEQAUST

~

SENIOR SOENDST

CAUBRATION

LABORATORY i

_ N HYN

! I I LOWLEVELWASTE l

i w ENVIRONMENTAL MONITORNG MANAM M MT i DISPOSAL i RADIOOtERESTRY SURVEYAND MANAmasMT LABORATORY N f oENERcOR

MANAmasgr m F LABORATORY l FEBRUARY 1997 j . ..

]

l OFFICE OF RADIATION SAFETY I

3 l

j RAANAGER ASSISTANT Paul Eastvold i

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' ADGEGSTRATIVE I ASSISTANT i

4 SEDNOR PROJECT 4

t i SEC5ETARY 1

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! DIVISimi OF DIV610N OF

' ELECTROpeC RAD 00ACHVE i PRODUCTS RAATERIALS

. Paul Brown Steve Collins i X4tAY INSPECHON &

, DISPECTION E N NT

X-RAY l IEGISTRATION LICENSING i ANDENFORCERRENT i

NOGST ACCREDITATION l

I .

FEBRUARY 1997 l

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I RADICACTIVE IIATERIALS N.S. W El S. Col 1 Ins .

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offlee Spec. Office Assoc.

D. Sched K. Gibeen I I 4 LIENSING INSP. & ENFORCEIElli i N.S. WP 11 N.S. NP II j J. KlinWor - 5. Serua I I

! I I I

seMERIALS . LLW LIMBllll6 SPRINGFIELD ELEN ELLYN l N.S. NP I -

N.S. W I N.S. NP I N.S. NP I G. 1rinnen D. Price G. Iterrlhew A. Eulczynsitt N.S. W I -

N.S. W I l S. KessinWor C. Iielleday N.S. NP I J. Pependorf N.S. IIP I -

N.S. Enu. II II. Durithert G. IIcCandless N.S. NP I I

4 N.S. UP I D. Perrero N.S. Enu. II W.S. NP I J. Dercolou R. Muzzahpe j

DWeme N.S. IIP I j N.S. IIP II W. Mlcimen K. Grahn 4

4 O e 8

• - " - - - - ww .m,.. - _ - - - , , . ., , , _ . , , , . , , _ , , , , , , , , . .

. _ _ . _ . _ . _ . . . _ _ _ _ _ . . _ _ _ _ _ _ . _ . _ . . _ . . . . ~ . _ _ _ _ _ _ . _ . _ . _

r i i

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J j

APPENDIX C l

( INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM l

QUESTIONNAIRE Name of State: ILLINOIS Reporting Period: July 23,1994 to March 24,1997

!. A. COMMON PERFORMANCE INDICATORS

1. Status of Materials insnaction Proaram t

1. Please prepara a table identifying the licenses with inspections that are overdue by more than 25% of the scheduled frequency set out in NRC inspection Manual Chapter 2800 (issued 4/17/95). The list should include initialinspections that are overdue.

Insp. Frequency Licensee Name (Years) - Due Date Months O/D There are no radioactive materials, low-level radioactive waste disposa'l or uranium recovery inspections overdue.

l

2. Do you 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 questionnaire.

N/A q l

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3. Please identify individual licensees or groups of licensees the State / Region is i inspecting less frequently than called for in NRC Inspection Manual Chapter  !

2800 (issued 4/17/95) and state the reason for the change.  ;

1 There are no individual licensees or groups of licensees that the Department inspects less frequently than identified in NRC's IMC 2800.

1

4. How many licensees filed reciprocity notices in the reporting period?

77 licensees filed 1276 reciprocity notices during the reporting period,

a. Of these, how many were industrial radiography, well-logging or other users with inspection frequencies of three years or less?

42 i b. For those identified in 4a, how many reciprocity inspections were i conducted? <

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i j lilinois Draft Report Page C.2

~ State Questionnaire j Seven

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

3 i ..

There were seven radiographer field inspections performed for specific licensees.

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-t your goals, the number of inspections actually performed, and the reasons for any differences between the goals and the actual number of inspections

performed.

1

, -N/A.

11. Technical Staffino and Trainina l 7. Please provide a staffing plan, or complete a listing using the suggested

, format below, of the professional (technical) person-years of effort apolied 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 j

l. response,' LLW, U-mills, other. If these regulatory responsibilities are divided j between offices, the table should be consolidated to include all personnel i contributing to the radioactive materials program. Include all vacancies and j identify all senior personnel assigned to monitor work of junior personnel. If a

consultants were used to carry out the program's radioactive materials 1- responsibilities, include their efforts. The table heading should be:

a NAME POSITION AREA OF EFFORT FTE%

1 i

Thomas Ortciger Director Administration 20

Gordon Appel Deputy Director Administration 20 j Paul Er.stvold Manager Administration 50 l

. Wayno Kerr Assist. Manager Administration 50 Michael Ewan Sr. Project Manager Administration 50

Steven Collins Division Chief Administration 100 Assist, to Div. Chief

_ Kathy _ Allen Administration 100 j

Joe Klinger Licensing Head Licensing, LLW, 100 '

Supervision

Gibb Vinson License Reviewer Licensing 100 4

Mary Burkhart License Reviewer Licensing 100

. Sandi Kessinger' License Reviewer Licensing 100 l Daren Perrero License Reviewer Licensing _ 100 ,

Gary McCandless LLW License Reviewer LLW Licensing, 100 l Supervision i

~

lilinois Draft Report Page C.3 State Questionnaire John Barcelow LLW License Reviewer LLW Licensing 100 Kelly Grahn LLW License Reviewer LLW Licensing / Inspect. 100 l

l NAME POSITION AREA OF EFFORT FTE%

David Price LLW License Reviewer LLW Licensing 100 ,

Chris Halladay LLW License Reviewer - LLW Licensing 100 1 Bruce Sanza insp. & Enfore. Head insp. & Enforc., 100 Supervision Andy Gulczynski Reg. Insp. Supervisor insp. & Enforc., 100 Supervision Robin Bauer Inspector Insp. & Enfore. 100 Wendell Hickman Inspector Insp. & Enfore. 100 George Merrihew Inspector Insp. & Enforc. 100 ,

John Papendorf Inspector insp. & Enforc. 100 Joanne Tomkins inspector insp. & Enforc. 100 CONSULTING COMPANY NAME AREA OF EFFORT FTE%

1. Hanson Engineers, Inc. Engineering technical support for Approx. 35  !

license review and evaluation and individuals construction oversight of totalling i decommissioning activities at 8 FTE (FY97) l Kerr-McGee's W. Chicago facility. l subcontractors; i Rogers & Assoc. Eng. Health Physics l lNTERA Hydrology & Geotechnical  !

2. Consoer Townsend Engineering technical support for LLRW Approx.15 (formerly disposal facility license application individuals Envirodyne Engineers) evaluation. avail. *

• Only limited activity since 10/92 due to Siting Commission decision.

3. Performance Quality Assurance review for LLRW Approx. 2 Development Corp. disposal facility license application individuals evaluation and the Kerr-McGee avail, decommissioning project. Revised the updated Chem-Nuclear QA program for 1996.

Also performed extensive QA activities concerning the IDNS OES QA program for the Kerr-McGee project.  !

1

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l lilinois Draft Report Page C.4 State Questionnaire l

4. Thomas A. Prickett & Hydrology, geotechnical & engineering Primarily 1 l Assoc. review for LLW disposal facility individual license application evaluation, avail.

• i

• Only limited activity since 10/92 due to Siting Commission decision.

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

John Barcalow, P.E. B.E.M.E. Vanderbilt (Mechanical Engineering),1967; MBA Western New England College,1972._ Six years experience as a planning engineer for a mid-sized utility. Eight years experience as Lead QA engineer and systems engineer at a l BWR power plant. Five years with the Department in the Office of Environmental Safety tracking LLRW generated in the state.

Chris Halladay B.A. Lehigh University (Geology),1970; M.S. Lehigh University (Geology),1972. Nine years experience with a state geological survey. Ten years experience in private sector coordinating environmental impact studies for uranium mine and tailings areas. Five years experience directing state LLRW programs, including technical studies and review of performance assessments.

Wendell Hickman B.A. Roosevelt University (Biology),1980; M.S. University of Health Sciences, Chicago Medical School (Medical Radiation Physics) 1984. One year as Safety Officer at licensed medical facility. Ten years with the Department as an x-ray inspector.

Kelly Grahn B.G.S. University of Michigan (Biology / Zoology),1987; M.S.

University of Michigan (Radiation Protection),1989. Almost three years experience in the private sector in project management and waste management. Three years as a health physics consultant performing pathway analysis,

9. Please list all professional staff who have not yet met the qualification requirements of license reviewer / materials inspection staff (for NRC, inspection Manual Chapters 1245 and 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

l lilinois Draft Report Page C.5 State Questionnaire need to attend and a tentative schedule for completion of these requirements.

All professional staff are fully trained to perform the duties currently assigned.

10. Please identify the technical staff who left the RCP/ Regional DNMS program .

during this period.

Rick Raguse and Glenn Smith.

Ill. Technical Quality of Licensina Actions

11. Please identify any major, unusual, or complex licenses which were issued, l received a major amendment, terminated or renewed in this period. l For the Radioactive Materials Proaram:  ;

I CTl Services, Inc. (P.E.T. Net Pharmaceutical Services) new license, 1 Keystone Steel & Wire amendments concerning the contaminated baghouse due to the smelting of a Cs-137 source, BEBIG new license, Professional i Laundry Management new license, amendments concerning the isomedix irradiator CKC.LSA situation and the Sterigenics amendment for the new irradiator facility in Gurnee.

For the Sealed Source and Device Proaram:

See attached report of SSD actions for this evaluation period.

For the Low-Level Radioactive Waste Disoosal Proaram:

s There are no licensing actions to report for this time period.

For the Uranium Recoverv Proaram:

Amendments for Phase IA,lB and Phase 11 of the Kerr-McGee decommissioning project were issued during this review period.

We prepared Environmental Analysis Reports and Safety Evaluation Reports and afforded an opportunity for a public hearing for these actions. We also have pending the reports associated with proposed Phase ill actions.

12. Please identify any new or amended licenses added or removed from the list of licensees requiring emergency plans?

None added or removed since the last review.

j 1

4 1 Illinois Draft Report Page C.6 State Questionnaire j- 13. Discuss any variances in licensing policies and procedures or exemptions j from the regulations granted during the review period. i i

For the Radioactive Materials Proaram:

l The Department granted a couple of short-term exemptions from financial 4 surety requirements for short-lived radionuclides.

t For the Sealed Source and Device Proaram:

i 1

i No variances or exemptions granted.

For the Low-Level Radioactive Waste Disposal Proaram:

No variances or exemptions granted.

For the Uranium Rg.gpvery Proaram:

j; No variances or exemptions granted.

14. What, if any, chang'es were made in your written licensing procedures (new

procedures, updates, policy memoranda, etc.) during the reporting period? '

For the Radioactive Materials and Sealed Source and D;vice Proarams.

The Department issued several new licensing guidance documents in the form of Instructional Sets (listed below). Associated licensing checklists and

j. license document formats were modified to match the new guidance. Since j the last review we have also developed the "S" reference manual for sealed

' source evaluations, the "D" Manual for device evaluations, an HDR Manual l for afterloader applications and an ISO and Military Standards reference manual to assist in sealed source and device reviews.

.1 2

Instructional Set Title Number Rev. Date 1

Non-Medical Use of Radioactive Material 48.6 1 October 1994 i Use of Radioactive Materialin Gas Chromatographs and Non-Portable X-Ray Fluorescence Analyzers 29.8 1 June 1995 Use of Sealed Sources in Portable Devices 65.0 1 October 1995 d

Medical Use of Radioactive Material 52.2 1 November 1995 J

Use of Radioactive Material for Industrial Radiography (currently in development) 87.0 0 7

s Illinois Draft Report Page C.7 State Questionnaire Use of Sealed Sources in Fixed Gauges

• O (currently in development)

Instructions for Preparation and Review of l Quality Assurance Manuals fo- Radioactive i

Material Licenses Authorizing the Manufacture and Distribution of Sealed Sources and Devices (currently in development)

• O Administrative and Poliev Memoranda issued durina this review oeriod addressed the followina:

Expired license with no renewal applications-9/28/94 Financial Surety-7/7/95 Schema codes--6/12/95 Acceptance of telefacsimiles for licensing purposes--1/19/96 Authorized medical user training--2/2/96 New radiography license--4/17/96 Physicians /FDA approvals / Departure from package insert--5/9/96 For the Low-Level Radioactive Waste Discosal Proaram: '

A revised Plan for Licensing a Low-Level Radioactive Waste Disposal Facility l in Illinois was proposed during this review period. It is currently undergoing l in-house review. 1 For the Uranium Recoverv Proaram:

A proposed "MT" licensing reference manual for mill tailings licenses was prepared during this review period.

15. 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 IV. Technical Quality of Insoections  ;

1

16. What, if any, changes were made to your written inspection procedures  ;

during the reporting period?

l For the Radioactive Materials Proaram:

There were no changes to our written inspection procedures, other than changes in our inspection priorities that reflected changes to NRC's IMC 2800.

_ _ __ _. ._ . _ . . . _ . . _ _ . . _ . _ _ _ _ . . _ . _ _ _ ~ . - _ . . _ _ _ _ _ - . _

i O

• j lilinois Draft Report Page C.8 j State Questionnaire i

For the Low-Level Radioactive Waste Disoosal Proaram:

No changes made.

1 For the Uranium Recoverv Proaram:

J j The mill tailings inspection report is now a very lengthy and detailed report j- compared to the standard reports previously used.

j 17. Prepare a table showing the number and types of supervisory

accompaniments made during the review period. Include

! For the Radioactive Materials Proaram:

4 Suoervisor insoector License Cat. Date f

l Bruce Sanza George Merrihew Broad Academic 1/29 31/97

! Andy Gulczynski Robin Muzzalupo Broad Man./Dist. 11/26/96

Andy Gulczynski Robin Muzzalupo Portable Gauge 7/25/96

. Andy Gulczynski Wendell Hickman Broad Man./Dist. 7/30/96 i Bruce Sanza George Merrihew Nuclear Pharmacy -7/24/96 i Steve Collins George Merrihew Gas Chromatograph 5/29/96 a d

Andy Gulczynski Joanne Tomkins Type A Broad Academic 5/10/96 Andy Gulczynski Wendell Hickman Portable Gauge 5/8/96

Bruce Sanza Andy Guiczynski Nuclear Pharmacy 2/29/96 i Andy Gulczynski John Papendorf Broad Medical 1/23 25/96  ;

, Andy Gulczynski Joanne Tomkins Portable Gauge 12/20/95 i

, Andy Gulczynski Glenn Smith Portable Gauge 11/28/95 '

i Bruce Sanza Glenn Smith Specific Medical 11/2/95

! Steve Collisis Sandi Kessinger Wet Storage Irradiator 5/23/95 Bruce Sanza John Papendorf Broad Man./Dist. 5/2-3/95

Andy Gulczynski Robin Bauer Waste Repackaging 5/2 3/95 4 Andy Gulczynski John Papendorf Specific Medical 3/28/95 Bruce Sanza George Merrihew Specific Medical 3/15/95 Andy Gu!czynski Joanne Tomkins Specific Medical 3/3/95

?

, For the Low-Level Radioactive Waste Disposal Prooram:

] N/A

For the Uranium Recoverv Proaram

During this review period, the most recent inspection of the mill tailings facility was actually performed by supervisory personnel. In addition, there is a resident inspector at the Kerr-McGee factory site. Daily communication I

S . 5

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lilinois Draft Report Page C.9

State Questionnaire -

}

with this inspector helps to ensure that all requirements are enforced. Also, monthly meetings between IDNS licensing staff (including supervisory staff) and Kerr-McGee senior staff also aids in ensuring that all requirements are.

properly enforced. Minutes of these meetings are prepared and distributed widely. A copy of the minutes is maintained for public access in the Public Document Room in West Chicago.

18. Describe internal procedures for conducting supervisory accompaniments of inspectors in the field, if supervisory accompaniments were documented, please provide copies of the documentation for each accompaniment.

For the Radioactive Materials Proaram:

Supervisory accompaniments are dccumented by indicating the name of the lead inspector and all accompsnying inspectors on the inspection field notes and in the inspection database. The name of the lead inspector and any accompanying inspectors is also included on correspondence to the licensee.

A review sheet for each is completed by the accompanying supervisor.

For the Low-Level Radioactive Waste Discosal Proaram: .

1 There were no LLRW inspections performed during the review period.

For the Uranium Recoverv Prooram:

In the Mill Tailings area, we have a resident inspector at the Kerr-McGee site.

Annual inspections, however, are performed by Springfield headquartered personnel. l

19. Describe or provide an update on your instrumentation and inethods of  ;

calibration. Are allinstruments prope.1y calibrated at the present time? l Allinspectors are issued an instrument kit that contains: An ionization ,

chamber survey instrument; a rate meter with a pancake GM, low-energy gamma probe, 2x2 Nat and an alpha _ scintillation probe; a velometer ,

(qualitative measurements only); a self-reading pocket dosimeter; and a i microrem meter. These instruments (except for the velometer) are calibrated by the Department's calibration lab, and allinstruments currently in use are properly calibrated.

For incident response, each regional office (Glen Ellyn and Springvield) has access to a minimum of a kit similar to the one described above, a high-volume air grab sampler and a portable gamma spectroscopy device.

e-- ,- ,,,. .,- ,

4..

Illinois Draft Report Page C.10 l i State Questionnaire.

J l V. Responses to incidents and Alleaations I

20. Please provide a list of the most sianificant 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.) that occurred in the Region / State l during the review period. For Agreement States, information included in previous submittals to NRC need not be repeated. The list should be in the following format: I LICENSEE NAME LICENSE # DATE OF INCIDENT / REPORT TYPE OF INCIDENT For the Radioactive Materials Proaram:

All significant incidents have been reported to the NRC. )

For the Sealed Source and Device Proaram:

l The heat sensitized Amersham CKC.LSA Co-60 irradiator sources was the most significant concern during this review period. The problem was first noted in California on 5/8/96. Heat sensitized sources were also in North Carolina, Illinois and Ohio. The matter has been properly investigated and all 1 the affected sources have been removed and returned to the UK for further l analysis and disposal. This concern did not meet any reporting requirements but did consume a large staff effort to fully investigate and monitor the matter.

For the Uranium Recoverv Prooram:

None to report  !

21. During this review period, did any incidents occur that invclead 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 the Radioactive Materials, Sealed Source and Device, and Uranium Recovery Programs, there are no such incidents to report.

a. For States, was timely notification made to the Office of State Programs? For Regions, was an appropriate and timely PN generated?

N/A

. . - . - . . _ . . - . - - - . - . . - _ - - - . . . -. ~.- - -. -

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illinois Draft Report Page C.11 l

State Questionnaire l

22. For incidents involving failure of equipment or sources, was information on i . the incido provided to the agency responsible for evaluation of the device t

for an assessment of possible generic design deficiency? Please provide details for each case. j

. N/A i I

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

For the Radio 6 cove Materials, Sealed Source and Device, and Uranium Recovery Programs, there are no cases under review involving possible wrongdoing, as defined by NRC.

24. Identify any changes to your procedures for handling allegations that  !

occurred during the period of this review.

There have been no changes to our procedures for handling allegations. ,

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

VI. General

25. Please prepare a summary of the status of the State's or Region's actions taken in response to the comments and recommendations following the last review.

The only outstanding issues from our 1994 IMPEP and 1995 limited reviews are the status of rules, particularly emergency planning, financial assurance, 15-day patient notification, medical quality management and declared pregnant woman.

As indicated in the attached table, the emergency planning rules are currently incorporated by licensing staff, and will be included in the regulations in the near future.

The financial assurance regulations are currently being written to require surety from more categories of licensees.

We committed to discussing the 15-day patient notification and medica! l quality management with our Medical Use Advisory Board (MUAB). We have postponed meeting with MUAB while the NRC continues to sort out potential changes to the medical regulations resulting from the NAS/lOM study, the rebaselining initiative, and the proposed NRC/AS working group on medical regulations.

7 Illinois Draft Report Page C.12 State Questionnaire We continue to disagree with the NRC's criticism of our declared pregnant woman provisions. Our rule provides a margin of safety to a woman who does not or cannot provide an estimated date of conception, and the NRC's ruls does not afford protection until the woman provides an estimated date of conception. .

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 which occurred during this review period.

]

This program's greatest strength is the knowledge, experience and expertise l of the staff, coupled with a very low turnover rate. Department staff serve -

on many national committees, and are often asked to chair committees and speak at meetings.

Licensing actions and sealed source and device icviests that would be characterized as difficult or technically challenging aid handled routinely by the Licensing staff. The staff has licensed new radiopharmaceuticals (monoclonal antibodies) and evaluated sources for European source i manufacturers trying to establish a foothold in the United States. l The inspection staff has many years of experience in this program, and perform inspections at a wide variety of facilities. They routinely respond to i incidents and handle investigations competently and professionally.

In late December 1994 and early January 1995, program staff from several different offices in the Department responded to a high radiation reading at the Otis Oakley scrapyard in Chicago. When initial responders realized that i the problem was atypical, they secured the area and applied shielding to the area to reduce the exposure rate. Staff met over the holiday weekend (while the facility was closed) to plan the response that was implemented January 3. The experience and expertise of the responders resulted in a timely response under stressful conditions.

Regulations and user friendly guidance documents developed by our staff have greatly assisted licensees, and are often used as templates by foreign countries, the CRCPD and other Agreement States. Some guidance documents have been used by NRC as examples.

There are no significant program weaknesses.

l

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l Illinois Draft Report Page C.13 State Questionnaire B. . NON-COMMON PERFORMANCE INDICATORS l

• L 1. Leaislation and Reaulations l

L 27. Please list all currently effective legislation that affects the radiation control

program (RCP).

CENTRAL MIDWEST RADIOACTIVE WASTE COMPACT ACT, as amended i by P.A. 87-1166

[45 ILCS 140/0.01 - 140/1 (1992) Formerly Ill. Rev. Stat., ch.127, pars.

63v et seq.]

DEPARTMENT OF NUCLEAR SAFETY--POWERS ENABLING STATUTE

[20 ILCS 2005/71 - 2005/72, as amended by P.A.39-411, effective June 1, 1996 and P.A.89-445, effective February 7,1996]

FREEDOM OF INFORMATION ACT

[5 ILCS 140/1 - 140/11 as amended by P.A.88-444, effective January 1, 1994]

ILLINOIS ADMINISTRATIVE PROCEDURE ACT

[5 ILCS 100/1 15-10 as amended by P.A. 89-6, effective 3/6/95]

]

RADIATION INSTALLATION ACT as amended by P.A.89-199, [SB 452]

effective July 21,1995

[420 ILCS 30/0.01 - 30/8]

RADIATION PROTECTION ACT OF 1990 as amended by P.A.89-143 [SB-231), effective July 14,1995, by P.A.89-199 [SB-452), effective July 21, 1995, by P.A.89-187 [SB-1095), effective July 19,1995 and by P.A.89-624 [HB-3165), effective August 9,1996.

[420 ILCS 40/1 - 40/451 RADIOACTIVE WAC TE STORAGE ACT ,

[420 ILCS 35/0.01 - 35/6 (1992) Formerly 111. Rev. Stat., ch.111 %, pars.

230-230.6]

URANIUM AND THORIUM MILL TAILINGS CONTROL ACT as amended by P.A.88-638, effective September 9,1994.

[420 ILCS 42]

28. Are your regulations subject to a " Sunset" or equivalent law? If so, explain and include the next expiration date for your regulations.

i i

~ lilinois Draft Report Page C.14 State Questionnaire l

Yes. The current Radiation Protection Act has a sunset date of December 31,2000. This means the legislature will have to pass another Act to reauthorize the State's program prior to the sunset date.

4-l 29. Please complete the enclosed. table based on NRC chronology of j

amendments. Identify those that have not been adopted by the State, explain 4

why they were not adopted, and discuss any actions being taken to adopt i them.

f- See Table.

i

. 30. If you have not adopted all amendments within three years from the date of i 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. <

If the NRC adopts a rule that affects only a small number of licensees, the Department may choose to " adopt" those regulations by imposing similar requirements on licensees through the licensing process. Sometimes this is done because the Department is working on more pressing projects or rules, 'i and sometimes this is done as an interim step until a major rulemaking is finalized that may include the NRC changes in addition to other changes.

Once a rulemaking is contemplated, it is listed on the semiannual regulatory agenda. Department staff write the rule, taking into account NRC's rule, i comments previously submitted to the NRC, any CRCPD language available, i and comments on that section of the rule previously identified as needing to be fixed. After drafting, rules are typically provided to staff for internal review and comment. Writing a rule'can take anywhere from a couple of i weeks to several months, depending upon the number of changes to be made and the number of comments received.

A rule must be published as a proposed rule in the Illinois Reaister with a 45 day minimum comment period, and may include a public hearing. After the comment period, the Department must respond to any comments and provide the comments and responses to the Joint Committee on Accreditation of Rules (JCAR), a bipartisan group comprised of legislators from the State House of Representatives and the Senate. JCAR may also ask the Department to modify language it deems inappropriate or ambiguous.

When the Department has prepared the rule for second notice, it must be either:

A) Re-published for comment if there have been substantial changes to the rule, or B) Scheduled for a vote at the next available monthly JCAR meeting.

L i Illinois Draft Report Page C.15 State Questionnaire Once JCAR votes to approve a rule, it will be published in the Illinois Reaister with an effective date. Rules can usually be published as final within two weeks of approval by JCAR. l II. Sealed Source and Device Evaluation Prooram

]

31. Prepare a table listing new and revised SS&D registrations of sealed sources l and devices issued during the review period. The table heading should be: l SS&D Manufacturer, Type of 1

Registry Distributor or Device Number Custom User or Source See attached report.

32. What guides, standards and procedures are used to evaluate registry applications?

IDNS "S" and "D" evaluation manuals, IDNS Instructional Set," Instructions for Preparation and Review of Quality Assurance Manuals for Licenses Authorizing Manufacture and Distribution of SS&Ds", NRC Guides 10.10, 10.11 and 6.9, NRC SS&D Workshop Manual of Sept.1995, NUREGS 1550 AND 6074, NRC Policy and Guidance Directive 84-22,"What SS&D Designs Require an Evaluation", NRC SS&D Newsletters, ANSI N538, Prototype Testing for Gauges, ANSI N542, Prototype Testing for Sources and Mark's Standard Handbook for Mechanical Engineers.

. 33. Please include information on the following questions in Section A, as they apply to the Sealed Source and Device Program:

, Technical Staffing and Training - A.ll.7-10 Technical Quality of Licensing Actions - A.lli.11, A.lli.13-14 Responses to incidents and Allegations - A.V.20-23 111. Low-Level Radiative Waste Discosal Prooram

34. Please include information on the following questions in Section A, as they apply to the Low-level Radioactive Waste Disposal Program:

i Status of Materials inspection Program - A.I.1-3, A.I.6 1

Technical Staffing and Training - A.ll.7-10 Technical Quality of Licensing Actions - A.lll.11, A.lll.1314 Technical Quality of Inspections - A.IV.1619 l Responses to incidents and Allegations - A.V.20-23 4

4

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lilinois Draft Report Page C.16 State Questionnaire IV. Uranium Recovery Proaram '

35. Please include information on the following questions in Section A, as they apply to the Uranium Recovery Program:

Status of Materials inspection Program - A.I.1-3, A.I.6 Technical Staffing and Training - A.ll.7-10 Technical Quality of Licensing Actions - A.lil.11, A.llt.13-14 Technical Quality of Inspections - A.IV.16-19

' Responses to incidents and Allegations - A.V.20-23 t

-_ . - .. . - ~ .... - - .-- - - .. - - - - - , - . - _ ~ . - -... - - - - - - - . - - . - - .- --

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• Illinois Drcft Report Paga C.17 State Questionnaire -

TABLE FOR QUESTION 29. ,

OR s DATE DATE 10 CFR RULE DUE ADOPTED CURRENT EXPECTED r STATUS ADOPTION Any amendment due prior to 1991. Identify-each regulation (refer to the Chronology of i

)

Decommissioning, 7/27/91 3/29/94 Parts 30,40,70 Emergency Plannmg 4/7/93 In progress with several other changes to IDNS Part 330. fan 1997 j Parts 30,40,70 Emergency Planning requrements currently enforced through license tie-downs.

Standards for Protection Against Radiation, 1/1/94 1/1/94 '

Part 20 Safety Requirements for Radiographic 1/10/94 5/2194 Industrial Radiographer Certification rules added 6/23/94.

Equipment; Part 34 Notification of incidents, 10/15/94 6/12/95 Parts 20, 30, 31, 34, 39, 40, 70 Quality Management Program and 1/27/95 5/2/94 Misadmemstraten requrements incorporated 5/2/94 Misadministrations; Part 35 OMP not ye+ addressed in Part 335, pending outcome of changes in NRC rules ce to NAS/lOM study, rebaselining and NRC/AS working group on medical rules.

Licensing and Radetion Safety 7/1/96 Not adopted yet. Rules affect three hcensees and are currently Late 1997 Requirements for Irradiators; Part 36 enforced through license tie-downs and requrements of Part 330.630.

Definition of Land Desposal 7/22/96 5/1/96 and Waste Site QA Program; Part 61 Decommissioning Recordkeepmg Docu-d 10/25/96 In progress with several other changes to IDNS Part 330. Fall 1997 mentation Additions; Parts 30,40,70 Self-Guarantee as an Addehonal Financel 1/28/97 in progress with several other changes to IDNS Prrrt 330. Fall 1997 Mechanism; Parts 30,40,70 Uranium Mill Tashngs: Conforming to EPA 7/1/97 Not due.

Standards; Part 40

. _ . . - - _ _ _ _ __ .__ -_- . _ _ _ - _ _ _ _ _ _ _ _ _ - _ _ _ - - .--_--__________-____-_____--_________2

Illinois Drcft R port Page C.18 State Questionnaire .

OR DATE DATE .

10 CFR RULE DUE ADOPTED CURRENT EXPECTED STATUS ADOPTION Timeliness in Decommisssonmg 8/15/97 Not due.

Parts 30,40,70 Preparation. Transfer for Comnaercial Dis- 1/1/98 Not due.

tribution, and Use of Byproduct Material for Medical Use; Parts 30,32,35 Frequency of Medical Examinations for Use 3/13/98 Not due.

of Respiratory Protection Equipment Low-Level Waste Shipment Manifest 3/1/98 Not due.

Information and Reportog Performance Requirements for Radiography 6/30/98 Not due.

Equipment Radiation Protection Requirements: 8/14/98 Not due.

Amended Definitions and Criteria Clanfication of Decommissxxung Funding 11/24/98 Not due.

Requirements 10 CFR Part 71: Compatibility with the 4/1/99 Not due.

Intemational Atomic Energy Agency Medical Administration of Radiation and 10/20,98 Not due.

Radioactive Materials.

Termination or Transfer of Licensed 5/16/99 Not due.

Activities: Recordkeeping Requirements.

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APPENDIX D ,

LICENSE FILE REVIEWS {

File No.1 '

Licensee: BRK Brands, Inc. License No: IL-01835-01 Location: Aurora, IL Amendment No: 11 License Type: Research and Development Type of Action: Amendment Date Amendment issued: 4/9/96 License Reviewer: DMP File No. 2 Licensee: SteriGenics International License No: IL-01220-01 1 Location: Schaumburg, IL Amendment No: 13 l License Type: Pool Irradiator Type of Action: Amendment l Date Amendment issued: 1/6/97 License Reviewer: SMK '

File No. 3 Licensee: MOS Inspection, Inc. License No: IL-01136-01  !

Location: Elk Grove, IL Amendment No: 8 ,

License Type: Industrial Radiography Type of Action: Amendment Date Amendment issued: 11/9/35 License Reviewer: CGV File No. 4 Licensee: Knox College License No: IL-01626-01 '

Location: Galesburg, IL Amendment No: 2 License Type: Academic Type of Action: Renewal Date Amendment issued: 12/20/96 License Reviewer: DMP Comments:

a) License Conditions 4.B and 4.D are reaundant.

b) Decay-in-storage license condition references generator columns which are not authorized.

File No. 5 l Licensee: Illinois Bell Telephone Company License No: IL-01365-01  :

Location: Chicago, IL Amendment No: 2 License Type: Device Type of Action: Termination Date Amendment issued: 1/18/95 License Reviewer: MEB File No. 6 Licensee: NDC Systems License No: IL-01999-01 Location: Irwindale, CA Amendment No: 1 License Type: Service Type of Action: Amendment Date Amendment issued: 1/15/97 License Reviewer: DMP Comments:

a) This licensing action eliminated a requirement to perform leak tests on generally-licensed gauges upon installation, contradicting the SS&D safety evaluation sheet.

I!!inois Draft Report Page D.2 License File Reviews File No. 7 Licensee: Fox River Water Reclamation District License No: IL-01665-01 Location: Elgin, IL Amendment No: 1 License Type: Device Type of Action: Renewal Date Amendment issued: 7/11/96 License Reviewer: MEB l

File No. 8 Licensee: Saint Louis University {

License No: IL-01961-01 Location: St. Louis, MO Amendment No: O License Type: Portable Device Type of Action: New Date Amendment issued: 4/30/96 License Reviewer: MEB Comments:

a) Deficiency response letter, dated 1/2/96, not tied down, b) Storage security in Missouri questioned, improper jurisdiction, i I

File No. 9 '

Licensee: Edward Hospital License No: IL-01232-01

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Location: Naperville, IL Amendment No: 5 License Type: Medical Type of Action: Amendment Date Amendment issued: 2/23/95 License Reviewer: SMK File No.10  ;

Licensee: Bowser-Morner, Inc. License No: IL-01543-01 l Location: Dayton, OH Amendment No: 1 License Type: Portable Gauge Type of Action: Termination Date Amendment issued: 2/27/95 License Reviewer: CGV File No.11 Licensee: Saint Anthony's Health Center License No: IL-01509-01 Location: Alton, IL Amendment No: 8 License Type: Medical Type of Action: Renewal Date Amendment Issued: 4/26/96 License Reviewer: SMK File No.12 Licensee: lilinois State Police License No: IL-01701-01 Location: Springfield, IL Amendment No: 1 License Type: Portable Device Type of Action: Termination Date Amendment issued: 9/23/96 License Reviewer: DMP 4

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I tilinois Draft Report ' Page D.3 License File Reviews File No.13 -

l Licensee: Radiation Safety Services, Inc. License No: lL-01429-01 Location: Morton Grove, IL Amendment No: 4 License Type: Service Type of Action: Amendment Date Amendment issued: 1/22/97 License Reviewer: MEB Comment:

a) Tied down letter dated 11/18/96 not found in license file.

File No.14 Licensee: Mobil Oil Corporation License No: IL-01742-01 Location: Joliet, IL Amendment No: 3 License Type: Portable Gauge Type of Action: Amendment Date Amendment issued: 11/26/96 License Reviewer: CGV File No.15 Licensee: St. Mary's Hospital License No: IL-01604-01 Location: East St. Louis, IL Amendment No: 9 j License Type: Medical Type of Action: Renewal Date Amendment Issued: 11/17/95 License Reviewer: CGV File No.16 Licensee: Fox Valley Equine Clinic License No: IL-01996-01 Location: Wauconda, IL Amendment No: O License Type: Veterinary Medicine Type of Action: New Date Amendment issued: 12/23/96 License Reviewer: DMP Comment:

a) Decay-in-storage license condition leferences generator columns which are not authorized.  ;

i File No.17  :

Licensee: Kane County Health Department License No: IL-01770-01 Location: Geneva, IL Amendment No: 4 License Type: Portable Device Type of Action: Amendment j Date Amendment Issued: 12/29/95 License Reviewer: CGV l File No.18  ;

Licensee: Egyptian Drilling, Inc. License No: IL-01658-01 l Location: Fairfield, IL Amendment No: 1 '

License Type: Well Logging Type of Action: Termination Date Amendment issued: 11/30/95 License Reviewer: SMK j i

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( lilinois Draft Report Page D.4 i

License File Reviews i-File No.19 Licensee: Syncor Corporation License No: IL-01721-02 i

. Location: Chicsgo, IL Amendment No: 13 i

! L!ce=e Type: Nuclear Pharmacy Type of Action: Amendment

!. Date Amendment issued: 1/17/97 License Reviewer: CGV n

l File No. 20 i Licensee: SK Diagnostic Lab License No: IL-00305-GL6 i Location: Streamwood, IL Amendment No: 0 f License Type: In Vitro General License Type of Action: Renewal i Date Amendment issued: 6/20/96 License Reviewer: SCC File No. 21 Licensee: Kerr-McGee Chemical Corp.

• License No. STA-583 l Location: West Chicago, IL Amendment No. 43 j License Type: Rare Earth, Source, & 11e(2) byproduct Type of Action: Amendment

! Date Amendment Issued: 2/28/97 License Reviewers: DP, JB, GM, CH, JK i I

!' Comment:

! a) Noted that the only radionuclides listed were uranium and thorium. This licensee is mainly dealing with the wastes (11e(T byproduct material) at the site and the radionuclides are mainly the daughter products of the uranium and thorium. The  ;

license implies the daughters are licensed under the authorized use section even i though they are not listed under the radionuclides. Suggested the phrase, "and  !

their daughters," be added to the list of radionuclides to make it explicit they are licensed radionuclides.

File No.: 22 ,

l Licensee: Kerr McGee Chemical Corp. License No. STA 583 i Location: West Chicago, IL Amendment No. 35 License Type: Rare Earth, Source, & 11e(2) byproduct Type of Action: Amendment l Date Amendment lasued: 4/03/96 License Reviewers: DP, JB, GM, CH, JK File No.: 23 Licensee: Kerr-McGee Chemical Corp. License No. STA-583 Location: West Chicago, IL Amendment No. 34 License Type: Rare Earth, Source, & 11e(2) byproduct Type of Action: Amendment Date Amendment issued: 1/24/96 License Reviewers: DP, JB, GM, CH, JK File No.: 24 Licensee: Kerr-McGee Chemical Corp. License No. STA 583 Location: West Chicago, IL Amendment No. 32 License Type: Rare Earth, Source, & 11e(2) byproduct Type of Action: Amendment Date Amendment issued: 10/03/95 License Reviewers: DP, JB, GM, CH, JK

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APPENDlX E

. INSPECTION FILE REVIEWS l

L File No.: 1-

[_. Licensee: St. Therese Medical Center License No.: IL-01363-01 l Location: Waukegan, IL Inspection Type: Routine / Unannounced -

License. Type: Medical-Specific Priority: 3 inspection Date: 1/17/97 Inspector: RGM l

l Comment:

a)- The NOV was transmitted on 3/10/97, 22 days late.

File No.: 2 Licensee: Mallinckrodt, Inc. License No.: IL-01117-01 l Location: Chicago, IL Inspection Type: Routine / Unannounced l License Type: Nuclear Pharmacy Priority: 1 Inspection Date: 2/5-7/97 Inspector: RGM l

Comment:

a) NOV letter sent: 3/2'i/97 > 30 days. .

i File No.: 3 Licensee: Alnor Instrument Company License No.: IL-01356-01 Location: Skokie, IL Inspection Type: Routine / Announced ,

l License Type: Manufacturing-Specific Priority: 1 l Inspection Date: 5/13/96 Inspectors: JDP/WMH . J i Comment:

a) Inspection 5/13/96, NOV sent 6/14/96 > 30 days.

l File No.: 4 Licensee: Arrow Road Construction Co. License No.: IL-01592-01 Location: Mt. Prospect, IL Inspection Type: Routine / Unannounced License Type: Portable Gauge Priority: 5 Inspection

. Date: 5/31/91 Inspectors: JDP/RGM l

File No.: 5 Licensee: Methodist Hospital of Chicago License No.: IL-01144-01 Location: Chicago, IL Type inspection: Routine / Unannounced License Type: Medical-Specific Priority: 3 j Inspection Date: 1/17/97 Inspector: WHM  ;

Comment:

a) NOV sent on 3/20/97, over 30 days.

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l .y o I tilinois Draft Report Page E.2 Inspection File Reviews 1

File No.

6 i Licensee: Baxter Healthcare Corp.

' License No.: IL-01278-01 Location: Round Lake, IL Inspection Type: Routine / Unannounced License Type: Medical-Specific Priority: 1 inspection Date: 9/18/96 Inspectors: WMH/RGM 1 File No.: 7

, Licensee: Materials Testing Labs, Inc. License No.: lL-01569-01 j - Location: Westchester, IL . Inspection Type: Routine / Announced l License Type: Portable Gauge Priority: 5

Inspection Date: 11/25/96 Inspector: WMH i File No.: 8 i Licensee: Onley Cancer Center, Inc. License No.: IL-01088-01 l Location: Evansville, IN Inspection Type: Routine / Unannounced j

, License Type: Teletherapy Priority: 1 l

! ' Inspection Date: 1/12/95 Inspector: GEM  !

l Comments:

i a) 9/26/95 license terminated. License had: (amendment #5) Co-60 (14,000 curies) l

& U-238 41 kg. l i b) Teletherapy unit sent to Texas licensee LO1485 (fax 8/28/95). Inspection on l l 1/12/95, letter sent 2/6/95 by BJS within 30 days. l File No.

9 i Licensee: Eastern Services License No.: IL-01259-01

! Location: Carmi, IL Inspection Type: Routine / Announced

License Type: Wireline Priority: 2

inspection Date

8/26/96 Inspector: GEM i File No.: 10

! Licensee: MOS Inspection, Inc. License No.: IL-01136-01 i Location: Elk Grove Village insp. Type: Routine / Unannounced I License Type: Industrial Radiography Priority: 1 l Inspection Date: 1/14/97 Inspector: GEM i

l File No.: 11 l Licensee: Columbus-Cabrini Medical Center License No.: IL-01621-01

Location

Chicago, IL Inspection Type: Routine / Unannounced License Type: Broadscope medical Priority: 1 i inspection Date: 12/3-5/96 Inspectors: JDP/RGM Comment:

j a) NOV sent 1/24/97, > 30 days.

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Illinois Draft Report Page E.3 Inspection File Reviews File No.: 12 i Licensee: Chicago State University License No.: IL-01084-01 Location: Chicago, IL Inspection Type: Routine / Announced

, License Type: Academic Priority: 3 j inspection Date: 7/24/95 Inspector: JDP 2

j - Comment:

a) NOV sent on 9/15/95, > 30 days.

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. File No.: 13 Licensee: Gunite Corporation License No.: IL-01616-02 Location: Rockford, IL Inspection Type: Routine / Announced License Type: Industrial Radiography Priority: 1 Inspection Date: 1/7/97 Inspector: JDP l File No.: 14 i Licensee: Orland Park Equine Hospital License No.: IL 01752 01 i Location: Orland Park, IL Inspection Type: Routine / Unannounced j License Type: Vet Med. Priority: 5 6

Inspection Date: 2/16/96 Inspector: JKT

! Comment:

a) Letter sent 4/18/96, > 30 days. I i 1 l File No.: 15 Licensee: Interstate Nuclear Services License No.: IL-01008-01 i Location: Morris, IL Inspection Type: Routine / Unannounced License Type: Nuclear laundry Priority: 1 Inspection Date: 9/16-17/96 Inspector: 'JKT i Comment:

4 a) Inspection was overdue by one month.

4 File No.: 16 i Licensee: SteriGenics international License No.: IL-01220-01 'l j Location: Gurnee, IL Inspection Type: Initial / Announced I i

License Type: Irradiator > 10,000 curies Priority: 1 Inspection Date: 1/23/97 Inspectors: JDP/RGM l

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Illinois Draft Report Page E.4 l Inspection File Reviews  !

File No.: 17 Licensee: Children's Memorial Hospital License No.: IL-1165-01 Location: Chicago, IL Inspection Type: Routine / Announced License Type: Medical-Broadscope Priority: 1 Inspection Date: 4/30/96 Inspector: ASG Comments:

a) Letter sent 3 months overdue.

b) Inspection was 1 month overdue.

File No.: 18 Licensee: ADCO Services, Inc. License No.: IL-01347-01 Location: Tinley Park, IL Inspection Type: Routine / Announced License Type: Waste Packaging Priority: 5 Inspection Date: 11/18/96 and 2/29/96 Inspector: ASG 1

Comment:

a) NOV sent 2/10/97, over 30 days.  ;

File No.: 19 l Licensee: Lee Industrial Testing, Inc. License No.: IL-01970-01 Location: Joliet, IL Inspection Type: Routine / Announced License Type: Portable Gauge Priority: 5 '

Inspection Date: 2/4/97 Inspector: ASG File No.: 20 Licensee: Kerr-McGee Chemical Corp. License No.: STA-583 Location: West Chicago, IL inspection Type: Routine License Type: Rare Earth, Source,11e(2) byproduct Priority: 2 Inspection Date: 2/10,11, 25, 26, and 27/97 Inspectors: JK/GM File No.: 21 Licensee: Kerr-McGee Chemical Corp. License No.: STA-583 )

Location: West Chicago, IL Inspection Type: Routine  ;

License Type: Rare Earth, Source,11e(2) byproduct Priority: 2 Inspection Date: 1/10,11, 22-24/96 Inspector: DP Comment: 1 a) April 16,1996 letter to licensee identifying that it was a clear inspection. The letter was delayed due to serious illness of the inspector shortly after completing the inspection, i

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Illinois Draft Report Page E.5 Inspection File Reviews File No.: 22 Licensee: Kerr McGee Chemical Corp. License No.: STA-583 Location: West Chicago, IL Inspection Type: Routine License Type: Rare Earth, Source,11e(2) byproduct Priority: 2 Inspection Date: 9/21-23, 29-30/94 Inspector: DP Comment:  :

a) February 22,1995 NOV letter to licensee. The delay in the letter is not considered a serious problem since subsequent letter notifications have been timely.

File No.: 23 ,

Licensee: Kerr-McGee Chemical Corp. License No.: STA-583 Location: West Chicago, IL Inspection Type: Special License Type: Rare Earth, Source,11e(2) byproduct Priority: 2 Inspection Date:In office review of EM report inspector: DP File No.: 24 Licensee: Kerr-McGee Chemical Corp. License No.: STA-583 Location: West Chicago inspection Type: Special, QA inspection License Type: Rare Earth, Source,11e(2) byproduct Priority: 2 Inspection Date: July 10 12,1996 Inspector: GM Three inspector accompaniments were performed by a review team member during the period of March 11-14,1997 as follows:

A'ccompaniment No.1 Licensee: American Testing & Engineering Corp. License No.: IL-01664-01 Location: Davenport, IA Inspection Type: Routine, announced License Type: Portabie Gauge Priority: 5 inspection Date: 3/11/97 Inspector: GM Comment:

a) The inspector would benefit from additional training in reciprocity issues. )

Accompaniment No. 2 Licensee: Advanced Medical Imaging License No.: IL-01652-01 Location: Chicago, IL Inspection Type: Routine, announced License Type: Nuclear Medicine Priority 3 Inspection Date: 3/13/97 Inspector: RM Comment:

a) Missed cpportunities to question ancillary staff during inspection.

4 t-lilinois Draft Report Page E.6 inspection File Reviews Accompaniment No. 3 Licensee: Mac Brady Associates License No.: IL-01820-01 Location: LaGrange, IL Inspection Type: Routine, announced License Type: Portable Gauge Priority: 5 Inspection Date: 3/14/97 Inspectors: WH Comment:

a) The inspector would benefit from additional training in reciprocity issues.

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4 APPENDIX F INCIDENT CASEWORK FILES File No: 1 Licensee: Northwestern Steel & Iron

< Location: Sterling, IL License No.: Non-Licensee Event Date: 3/3/97 Type of Event: Located lost gauge Summary: The State was notified that the Kay-Ray device was located with the shutter open. The State investigated and the incident is still under investigation. The device originally was distributed to a State of Washington licensee, then shipped to a scrap dealer in the State of Iowa. The scrap came from lowa. The case is still open. The incident was coordinated with NRC, and the States of WA and lA.

File No: 2

, Licensee: River Gallery Location: Joliet, IL License No.: Non-Licensee Event Date: 2/27/97 l Type of Event: Contamination Event I Summary: A Drug Enforcement Agency aircraft was shot down in Peru, and an i investigator of the crash returned with a souvenir which turned out to be a sign with Pm- I 147. The device was being modified in the facility and contaminated the facility. The State investigated and conducted surveys, decontaminated the facility, and took possession of the material. The case is still open until disposition of the RAM and potential cost is resolved.

File No: 3 Licensee: St. Anthony's Memorial Hospital Location: Effingham, IL License No.: IL-01605-01 Event Date: 12/27/96 Type of Event: package dose rate Summary: Licensee reported a package with surface dose rates that pegged their GM meter in the Nuclear Medicine department. Investigation and survey by IDNS shows that the materials were not shielded properly for transport, and that paper work was improperly filled out. Shipper was a California licensee and the State of California was notified.

File No.: 4 Licensee: CBI Services, Inc.

Location: Bourbonnais, IL License No.: IL-01813-01 Event Date: 09/17/96 Type of Event: excessive exposure Summary: Licensee personnel failed to return the source in an industrial radiography camera to the shielded position, did not perform a survey and exposed one hand to 6.4 rem as determined by an interview, enactment, and IDNS investigation. Enforcement actions were taken.

4' Illinois Draft Report Page F.2 incident Casework Files a File No.: 5 Licensee: Industrial NDT Services Location: Danville, IL j License No.: 13-06147-04 i

Event Date: 08/23/96

Type of Event: excessive exposure Summary: Two radiographers (brothers working at night) approached a source that had j not been retracted. Both had survey meters but failed to survey, or read the meter

, response. Reportedly, their ratemeters also failed to alarm. Operations were stopped for

! duration of shift and the dosimeters sent for evaluation. One person's dose was estimated at 2.5 rem DDE, and the other person's estimated exposure was 0.29 rem DDE.

Enforcement actions were taken. Licensee also has lilinois license. NRC notified.

File No.: 6 Licensee: Union Pacific Railway Location: Galt, IL l License No.: Non-Licensee i Event Date: 07/03/96 i Type of Event: Derailment Summary: A train carrying soil contaminated with thorium derailed. The shipment was j enroute to Envirocare, Utah from a DOE clean-up site in New Jersey. The railway hired a 'I consultant to supervise the clean up. The State remained on site throughout the clean-up l and shipment on to Utah. i i

File No.: 7 Licensee: Michael Reese Hospital  !

Location: Chicago, IL I License No.: IL-01097-01 Event Date: 3/14/96 Type of Event: Misadministration Summary: The Licensee reported that a therapy procedure was terminated when the patient removed the sources after 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> of a planned 62 hour7.175926e-4 days <br />0.0172 hours <br />1.025132e-4 weeks <br />2.3591e-5 months <br /> treatment time (77%).

The licensee took appropriate action. The physician terminated the treatment for medical reasons.

File No.: 8 Licensee: St. Joseph Hospital Location: Elgin, IL License No.: IL-01268-01 Event Date: 12/15/95 Type of Event: Misadministration Summary: A patient removed a ribbon containing five Ir-192 seeds after 14.2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> of a 25 hour2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br /> planned treatment time. The nursing staff noticed and took appropriate emergency and corrective action. Physician to observe patient for another month before making decision on continued treatment.

1 i Illinois Draft Report Page F.3 Incident Casework Files File No.: 9 Licensee: Methodist Medical Center i Location: Peoria, IL I

License No.: IL-01204-01 i Event Date: 11/27/95 2

Type of Event: Misadministration Summary: A therapy out-patient was given only 4.8 millicuries of I-131 instead of 1

intended 12 millicuries. Event was discovered when 2 of the 3 capsules were returned to the pharmacy. Radiologist reported that there would be no harmful effects to the patient.

File No.: 10 Licensee: Associated Couriers Location: Lemont, IL i License No.: Non-Licensee

, Event Date: 10/03/95 j- Type of Event: Transportation

! Summary: A spent nuclear medicine generator fell from a moving vehicle on a bridge, 1 contaminating several spots with material. The local police, US DOE, and IDNS responded 1

to the incident. The bridge was closed to traffic until the contamination was removed. A civil penalty was issued to the courier.

File No.: 11 4

Licensee: SDI Consultants Location: Oak Brook, IL

! License No.: lL-01945-01 Event Date: 09/23/95 Type of Event: Damaged equipment l Summary: A Troxler portable gauge was crushed at a construction site when the i licensee's vehicle was struck by heavy equipment, driving the vehicle into the device. The source rod was sheared off, leaving the source embedded in the soil. The source was recovered and returned back to the manufacturer. No leakage occurred and no excessive exposure.

File No.

12 Licensee: Otis Oakley Scrap Yard Location: Chicago, IL License No.: Non-Licensee Event Date: 12/29/94 Type of Event: Source Discovery Summary: A consultant identified high radiation levels in the compacted soil at the

, facility. IDNS responded and uncovered areas in the soil at 400 millirem per hour, and secured area until recovery options could be evaluated. During preparation for additional surveys, the' source was uncovered. The source was placed in a shielded container with j

remote tools and transported to Argonne National Lab. The source was a sealed cesium-137 capsule.

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Illinois Draft Report Page F.4 incident Casework Files File No.: 13 Licensee: Syncor Corporation Location: Chicago, IL License No.: IL-01721-02 Event Date: 11/25/94 Type of Event: Equipment I Summary: Licensee notified State that on two occasions, a cardiolite vial broke in a i boiling water bath, creating an airborne contamination problem. The licensee determined that the cause was from a defective batch of vials from DuPont. The other vials from the suspect lot, were returned to DuPont. Maximum dose to any person was estimated to be I 170 millirem CEDE.

File No.: 14 Licensee: Terracon Consultants, Inc. 1 Location: Bolingbrook, IL License No.: IL-01402-01 Event Date: 09/29/94 '

Type of Event: Equipment Summary: Licensee reported that a Troxler device was damaged by earth moving equipment at a construction site. IDNS responded and conducted surveys and wipe test.

IDNS provided a lead shield and transferred the device to another IL location for final disposition via the manufacturer of the device.

File No.: 15 Licensee: Applied Soil Mechanics Location: Naperville, IL License No.: IL-01473-01 Event Date: 09/26/94 Type of Event: Stolen Vehicle Summary: An employee's automobile was stolen with the gauge locked inside the trunk. Vehicle was recovered about one week later but the device was not recovered.

Enforcement action taken by IDNS.

File No.: 16 Licensee: Midwest Metallics Location: Chicago, IL License No.: Non-Licensee Event Date: 08/02/94 Type of Event: Scrap Summary: A scrap broker reported that a contaminated load of scrap had been received from another broker. IDNS responded and identified the material as two vials of uranyl-nitrate powder and another piece of uranium ore. The material and some contaminated soil was collected and placed in a DOT approved overpack and transferred to a waste broker for disposal.

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4 lilinois Draft Report Page F.5 incident Casework Files l

File No.: 17 l Licensee: XRI Testing a'

Location: Oak Lawn, IL License No.:ll-01787-01 ,

Event Date: 01/11/95 l Type of Event: Exposure 7

Summary: The Licensee reported that while conducting radiography at a refinery (temporary job site), another contractor employee performing asbestos work crossed two barriers posted by the radiographers. IDNS conducted an investigation, and ordered the radiographers to cease all work and surrender their radiography certificates, and the Licensee was fined $22,000.00. The individual received an estimated 3.6 rem exposure.

4 File No.: 18 Licensee: Kerr-McGee Location: West Chicago, IL License No.: STA-583 Event Date: 03/31/95 Type of Event: Licensable material found buried at site.

Summary of Incident: Late in the day construction workers discovered a bottle of material buried on the property adjacent to the current licensed site. The State was notified the following morning and the State and licensee responded to the area and

. collected the material and surveyed to ensure that the area was clean. Final report dated April 7,1995.

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I APPENDIX G 1 SEALED SOURCE AND DEVICE D.dVIEWS i

[ File No.: 1

Registry No.

IL-0599-D 103-G Manufacture: Heuft USA, Inc.

SSD Type: Gamma Fill Level Gauge Date issued: 11/26/96 Comments: l a) No documentation providing justification for longer than 6 month leak test interval.

b) Only operational history from 1980 for prototype testing. Prototype testing .ection on the sheet says "without operational problems," but information in file indicates that the shutter coile have failed on 7 of the 1036 units which have been installed.

No information was in the file concerning cause of these failures. Due to the design  !

of the device, all failed in the closed position. Since failure rate low (0.7%) and all failed in safe position, not an immediate safety concern. Since no actual prototype testing was performed, suggest that additional information be obtained from the manufacturer regarding history of the device to verify that there were no other operational problems or product failures that the manufacturer is aware of, and the cause of those problems / failures. Since this is a GL device for use by persons with little or no training in radiation safety in the case of a failure, this additional supporting information in this area would be appropriate if the manufacturer wants to use operational history in lieu of actual prototype testing.

c) The sheet lists only one set of values for the external radiation levels and not j indicate whether the values are for the on or off position.

d)- Not apparent from the file that estimated yearly doses for GL user were calculated.

e) in QA, there is no indication that a check is being done to ensure that the product is being manufactured according the information submitted in support of the safety evaluation.

f) Given that most GL users do not have the experience and training requirad for specifically licensed device users, the device manufacturer should provide clear instructions on the use of the device, including the " shutter lock-out" procedure that is need by the user to reduce the possibility for over-exposure when clearing jams in the product line. Additional clarification of the user procedures should be discussed with the manufacturer during the next licensing action, g) Suggest that the installation QA be included in the certificate.

h) Suggest that the Labeling section list the pertinr.nt information that will be required to be placed on the label instead of listing the IL regulations.

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filinois Draft Report Page G.2 Sealed Source & Device Reviews i

• L File No.: 2 i Registry No.: IL-0360-D-114-S

Manufacture: ICN Pharmaceutical, Inc.

SSD Type: Calibration Camera - CUSTOM

! Date issued: 01/22/97 File No.: 3 3

P.egistry No.: IL-0412-D 123-B j Manufacture: Kay-Ray /Sensall, Inc.

SSD Type: Gamma Source Housing Date issued: 08/11/94 i l Comments:

a) For the request to increase the inner diameter of the source holder tube PN 630-000075, there was no indication that the review addressed this issue of reduced wall thickness and any adverse effects it may have on the integrity of the holder and its ability to perform throughout its lifetime, b)

For the request to modify the 7064/7064P source housing tube to accommodate the larger Amersham X.38 capsule, ]

1. Missing dre: wing 630-000323 Rev. O

2. Does not appear that the review addressed the issue of reduced wall thickness and any adverse effects it may have on the integrity of the holder and its ability to perform throughout its lifetime, information in the file is not adequate to determine the exact dimension changes to the holder.

3. Does not address whether there is a way to physically distinguish this version from the others with the originally approved source capsule.

File No.: 4 Registry No.: lL-0353-D-101-G Manufacture: Gamma instruments, Inc.

SSD Type: Gamma Gauge Date lasued: 06/11/96 Comment:

a) File did not contain any documentation regarding approval of an additional source model. Missing information (applicant letter dated 5/6/96 and the reviewer's

" Reviewer's Notes" sheet dated 6/5/96) in the license file.

File No.: 5 Registry No.: lL-0422-D-101-S Manufacturer: Lixi, Inc.

SS&D Type: Gamma Gauge Date issued: 06/11/96 Comments:

a) Registry sheet lists Attachments 2 and 3, doesn't list Attachment 1 b) File did not contain 12/93 application or the letters dated 4/18/94 and 5/11/96.

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tilinois Draft Report Page G.3 i Sealed Source & Device Reviews 4-l File No.

6

{ Registry No.: IL-0136-S-344-S

! Manufacture: Amersham i SSD Type: Gamma Source (gauging) i Date issued: 09/27/95 1 f I l Comment:

a) No documentation in file concerning void space and bubble testing

! File No.: 7 i Registry No.: IL-0136-S-913-S (replaced IL-0136-S 175-S)

Manufacture: Amersham

. SSD Type

Low Energy Gamma Point Source j- Date issued: 11/25/96 l

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Comment:

a) Request was to change the manufacturing QA procedures for use of the charcoal 1 . leak test instead of the wipe test was approved on 11/25/96, but new sheet still had only visual, wipe, bubble, and immersion tests as the QA listed. Charcoal test I should be listed here in place of the wipe test.

] I File No.: 8 Registry No.: IL-599-D-801 -G i i Manufacture: Amersham SSD Type: Level Gauge .

Date issued: 11/1/94 and 2/14/95 i

1 File No.: 9 Registry No.: IL-136-S-215 S Manufacture: Amersham  !

i -SSD Type: Source -

I Type of action: amendment j Date lasued: 11/1/96 g

Comment:  :

a) File did not contain documentation of either the QA commitments of the second' manufacturer, or a statement that the second manuf acturer will abide by the QA commitments already in place.

l Illinois Draft Report Page G.4 l

( Sealed Source & Device Reviews l File No.: 10 Registry No.: IL-234-D-101-G Manufacture: E.S.C. Resources

SSD Type: Gamma Gauge j Date issued: 2/15/96 Comments:

! a) Application says that the user needs to use a mirror to view the mechanical on/off indicator. Suggest that this indicator should be in a location on the device that is i 1 easily visible to the user when mounted. i

, b) It was not apparent from the documentation in the file that a calculation of the estimated yearly dose to users was performed. i 1 \

File No.: 11 Registry No.: IL-103-S-107-S Manufacture: BEBIG Trade, Inc. l SSD Type: Gamma Source l

Date issued: 5/7/96 '