ML20149F763

Final Rept, Integrated Matls Performance Evaluation Program,Review of Illinois Agreement State Program, Dtd 970324-28

ML20149F763
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Issue date:	03/24/1997
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INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW OF ILLINOIS AGREEMENT STATE PROGRAM MARCH 24-28,1997 I

i FINAL REPORT l

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U.S. Nuclear Regulatory Commission I

9707220292 970708 I PDR STPRG ESGIL PDR

lilinois Final Report Page 2

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 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 conducted in accordance with the " interim implementation of the Integrated Materials Performance Evaluation Program Pending Fmal Commission Approval of the Statement of Principles and Policy for the Agreement State Program and the Policy Statement on Adequacy and Compatibility of Agreement State Programs," published in the Federal Reaister on October 25,1995, and the September 12,1995, NRC Management Directive 5.6, " Integrated Materials Performance Evaluation Program (IMPEP)." Preliminary results of the review, which covered the period July 23,1994 to March 28,1997, were discussed with Illinois management on March 28,1997.

A draft of this report was issued to Illinois for factual comment on April 15,1997. The State of Illinois responded in a letter dated June 2,1997 (Attachment 1). The State's factual comments were considered by the team and accommodated in the report as described in the June 25,1995 memorandum to the Management Review Board (MRB) transmitting the proposed final report (Attachment 2). The MRB met on July 2,1997, to consider the proposed final report. Based on the existing NRC compatibility policy and the IMPEP evaluation criteria, the review team recommended that Illinois' performance with respect to the indicator, Legislation and Regulations, be found unsatisfactory. Illinois has not yet adopted the Decommissioning Recordkeeping regulation, or equivalent legally binding requirements, within the specified period of time. At the MRB, Illinois noted that this regulation is in process and projected for final adoption in late 1997 or early 1998.

Because of the progress to date in the promulgation of this rule, the expected adoption date in early 1998, and the lack of disruption to the collective regulatory efforts of NRC and the Agreement States, the MRB determined that a sufficient basis did not exist to support a finding of unsatisfactory for this indicator. The MRB noted that if significant delays in rule adoption occur or if Illinois adopts a rule that is not compatible with the NRC equivalent regulations, the MRB could always reconsider the program compatibility finding at a future date. The MRB final recommendation for Legislation and Regulations is satisfactory. The MRB found the Illinois radiation control program was adequate to protect public health and safety and compatible with NRC's program The Illinois Department of Nuclear Safety (IDNS) is a cabinct level agency within Illinois State Government. The Director is appointed by and reports directly to the Governor. The Office of Radiation Safety (ORS), which includes the Division of Radioactive Materials (DRM), and the Office of Environmental Safety (OES), report directly to the Department Director. The IDNS organization charts are included as Appendix B. The DRM program regulates approximately 857 materials licenses, has an 11e(2) uranium (thorium) recovery program for the decommissioning of the Kerr-McGee West Chicago site, and is the host State for the Central Midwest Low-Level Radioactive Waste Compact. In addition to the radioactive materials program, the IDNS administers programs for inspections at nuclear power plants and emergency response under the Office of Nuclear Facility Safety, and an environmental monitoring program and laboratory under the Office of Environmental Safety.

lilinois Final Report Page 3 The review focused on the materials program as it is carried out under the Section 274b. *

(of the Atomic Energy Act of 1954, % amended) Agreement between the NRC and the State of Illinois.

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

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

(1) examination of Illinois' response to the questionnaire, (2) review of applicable Illinois 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 site that is undergoing decommissioning, and (7) interviews with staff and management to answer questions or clarify issues. The team evaluated the information that it gathered against the IMPEP performance criteria for each common and non-common indicator and made a preliminary essessment of the radiation control programs's performance.

Section 2 below discusses the State's actions in response to recommendations made j following the previous review. Results of the current review for the IMPEP common performance indicators are presented in Section 3. Section 4 discusses results of the applicable non-common indicators, and Section 5 summarizes the review team's findings and recommendations.

l 2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS I l

The previous routine review concluded on July 22,1994. It should be noted that Illinois l' 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.

l The July 1994 review findings resulted in recommendations in eight program indicators: 1 (1) Status and Compatibility of Regulations; (2) Legal Assistance; (3) Administrative l 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 lll 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.

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lilinois Final Report Page 4 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 i Allegations.

3.1 -Status of Materials insoection Proaram The team focused on four factors in reviewing this indicator: inspection frequency, overdue inspections, initial inspection of new licenses, and timely dispatch of inspection findings to licensees. The team evaluation is based on the lilinois' questionnaire response i relative to this indicator, data gathered independently from the State's licensing and inspection data tracking system, the examination of licensing and inspection casework files, and interviews with managers and staff.

The team's review of the State's inspection priorities verified that the State's inspection j 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 l 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 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 year frequency for type l 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, l 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 l frequency.

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.

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 ware conducted to determine how initial inspections are assigned and how data are entered into the system. The inspection data system is updated as inspection reports are developed, and the " inspections due" listing is 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.

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' 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 licenses following completion of the inspection. Of these late notifications, two were clear  ;

i inspections, and the other six required from 50 to 84 days for the findings to be l

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

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The State reported in their response to the questionnaire that 77 licensees had submitted I I 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 sev9 reciprocity licenses were inspected, which represents about 17 percent of the reciprocity licenses 1 available for inspection. Four of the inspections were industrial radiography, two were j j source exchanges, ar.; one was a welllogger, in addition, the State conducted seven j additional non-reciprocity inspections of industrial radiography field sites. The team j considered that the State had expended considerable r,esources since the last review to overcome the previous inspection backlog, and that in this instance, the numbers of reciprocity type inspections were adequate. Representatives from the State of Illinois l

stated that it was not necessary to inspect 50 percent of the reciprocity licensees to ensure safe licensee operations, and the State reiterated this opinion in the June 2,1997 response _to the draft report. However, now that the inspection backlog has been i overcome, the team suggests that the State should reconsider the IMC 1220 guidance for conducting reciprocity inspections, and increase the reciprocity inspections to meet the i

guidance.

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

3.2 Technical Staffino and Trainina in reviewing this indicator, the review team considered the radioactive materials program

- staffing level, technical qualifications of the staff, training, and staff turnover. To evaluate these issues, the review team examined the State's questionnaire responses relative to this indicator, interviewed IDNS management and rtaff, reviewed training records, and considered any possible workload backlogs.

The IDNS organization chart shows that the Department consists of the Office of Legal Counsel, the Office of Nuclear Facility Safety, the OES, the Office of Administrative Services, and the ORS.

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 and uranium / thorium ,

milllicensing. The Inspection and Enforcement Section has one inspector located in j r / l i

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• Springfield and five inspectors in the Glen Ellyn Regional Office. The West Chicago office ,

provides support for the Mill Program which will be discussed under the appropriate non-l common indicator (Section 4.4). The Section managers and the DRM Chief are technical j managers.

j IDNS has established qualifications for all of the technical positions. Applicants for health

. physicist and engineer positions are required to have a baccalaureate degree and are assigned duties in the program based upon their experience and training. The experience 1

and training of each person is evaluated and additional training is given based upon the

! specific needs of the position. Several of the personnel have advanced degrees in Health 1

Physics, two persons are certified health physicists, and two low-level radioactive waste

! persons have degrees in Engineering, both are professional. engineers, and one with an

advanced degree in Geology.

i t 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

j. are assigned increasingly complex licensing duties under the direestion of senior staff, and

accompany experienced inspectors during increasingly complex compliance inspections.

[ Staff are required to demonstrate competence as determined during accompaniments by

their supervisors. This information was verified through discussions with managers and j staff, review of the questionnaire response, and review of the position descriptions. The l team determined that all staff utilized for the agreement materials program were technically j qualified by evidence of their training and experience. l DRM reported that the program had experienced only two turnovers since the previous I review. One person left for additional schooling and the other person accepted a position j with a licensee. The vacancies were filled within a matter of months and the prograrn l

} manager related that DRM had not experienced any problems in replacing personnel in l vacated positions.

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l Although DRM has not participated in NRC training courses this fiscal year, a review of the j training records, and statements made by managers, confirmc that DRM is committed to continued staff training as needed to allow the staff to carry out the duties and functions I

of the radiation control program. The DRM manager related that special training could be i provided as needed through contracts.

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

}. 3.3 Technical Quality of Licensina Actions i

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.The review team examined casework and interviewed the reviewers for 19 specific j licenses. Licensing actions were reviewed for completeness, consistency, proper j radionuclides and quantities used, qualifications of authorized users, adequate facilities and j equipment, and operating and emergency procedures sufficient to establish the basis for a

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! licensing actions. Casework was reviewed for timeliness, adherence to good health

• l 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 j files were checked for retention of necessary documents and supporting data.

j The cases were selected to provide a representative sample of licensing actions which had j been completed fn 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, j service, industrial radiography, portable gauges and devices, wireline services' and in-vitro i general license. Licensing actions included one new license, five renewals, nine

! amendments, and four terminations. A list of these licenses with case-specific comments may be found in Appendix D.

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. The review team found that the licensing actions were generally thorough, complete, l consistent, and of acceptable quality with twith and safety issues properly addressed.

j 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 j between licensing and inspection staff via " green sheets" placed in license files, j Reviewers appropriately used the State's licensing guides, license templates, standard 3 conditions and checklists. The licensing supervisor reviews and signs alllicensing actions, j No potentially significant health and safety issues were identified.

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One file review of a nuclear gauge distribution and installation license identified a j contradiction between a leak test license condition and the sealed source and device (SS&D) registry sheet for a gauge. After the review, IDNS contacted the State of I California and determined that the SS&D registry sheet inappropriately required leak testing of gauges at installation. California will correct the sheet at the next amendment. The review team sugge'sts that license reviewers check SS&D registry sheets prior to authorizing 1

cense niodifications which result in a change in the handling of a sealed source or device. During the MRB, Illinois noted that IDNS staff's normal practice is to check SS&D registry sheets in licensing actions.

IDNS maintains an aggressive program in the decommissioning area. In addition, since 1993, NRC Region lli has sent copies of 54 terminated NRC license files, authorizing use of radioactive material at facilities in Illinois, to IDNS for review and close-out. These license 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 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

lilinois Final Report Page 8 1

for inclusion in the terminated license files. Tnis effort was an excellent independent and .

cooperative effort by IDNS.

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

3.4 Technical Quality of Insoections l

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, 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 i reviewed in depth with case-specific comments. )

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

In addition, several spot checks were performed on the files to verify that enforcement correspondence was being maintained in a consistent manner and to verify the implementation of the proper inspection frequency, in all cases, license files selected from the data base for the spot checks were determined to have the proper inspection frequency 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 considers inspection findings when completing a licensing action.

The review team noted that routine inspections adequately cover the licensee's radiation 4 program and include a written summary of the scope of the licensed activities and a root 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 l DRM Chief, the Inspection and Enforcement Head, as well as the Glen Ellyn office j supervisor. Accompaniments give the IDNS program management a better understanding l of both the inspectors' abilities and competence to perform license inspections and provide  !

a better insight into licensee programs.

The inspection field notes provided documentation of inspection findings in a consistent manner. The State uses separate inspection field notes for various classes of licensees, such as industrial radiography, wireline services, broad scope university, broad scope research and development, broad scope medical, teletherapy, manufacturing and i

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1 lilinois Final Report Page 9 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 specific field notes for radiography field sites and follow-up forms for documenting follow-up inspections to ensure previously cited violations have been corrected.

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 case werk, 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 ,

the Head, inspection and Enforcement Section. However, none of the issues indicated a I systemic problem in the technical quality of inspections. The review team found that the 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 l verified as having been reviewed and signed off by the Head, inspection and Enforcement l Section, before issuing the results to licensees. The review team concluded that this l supervisory review enhanced the qubuty of the inspection and enforcement documents.

The appropriateness of announcing routine materials inspections was discussed with DRM managers during this review. As iterated during the previous review, IDNS' philosophy with regard to the announcing of inspections considers less than 24-hour notification to a ,

licensee to be an " unannounced" inspection. DRM staff members stated that if a licensee, '

upon notification of an inspection the next day, indicated that the Radiation Safety Officer '

(RSO) would not be available for the inspection, the inspection would likely be deferred.

Although this scheduling practice is not consistent with NRC guidt"ce, it is a reasonable approach. The review team suggests that the State evaluate whether the practice of deferring inspections due to licensee scheduling conflicts is being abused.

Three inspector accompaniments were performed by a review team member during the period of March 11-14,1997. One inspector was accompanied during the inspection of a nuclear medicine program, and the other two inspectors were accompanied on portable gauge inspections. These accompaniments are identified in Appendix E. The three other 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 well prepared and thorough in their reviews of the licensees' radiation safety programs. Overall, the technical performance of the inspectors was satisfactory, and their inspections were adequate to assess radiological health and safety at the licensed facilities.

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

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National Institute of Science and Technology traceable sealed sources to determine the .

efficiency of beta / gamma hstrumentation. I I

1 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, l 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 I is also available. The portable instruments used during the inspector accompaniments were observed to be operational and calibrated. The portable instruments maintained in 1 the DRM office were also observed to be calibrated. l Based on the IMPEP evaluation criteria, the review team recommends that Illinois' ,

performance with respect to the indicator, Technical Quality of Inspections, be found I satisfactory.  ;

l 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 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 I five allegation files, in addition, the review team interviewed the DRM Chief, the Head, l inspection and Enforcement Section, and the Freedom of Information Act (FO!A) Officer.

i Responsibility for initial response and follow-up actions to materials incidents and I allegations rests with the inspection and Enforcement Section. IDNS procedures require I 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 1 with the appropriate field staff including an on-site inspection as appropriate. The I managers related that allincidents, complaints, and allegations are evaluated by l rnanagement, 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 l 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.

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. l l

The review team examined in detail the State's response and documentation of the 17 '

events listed in Appendix F and verbally discussed several other events with the Head, 1 Inspection and Enforcement Section. This effort included the State's incident and l l

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lilinois Final Report Page 11 allegation process, tracking system, file documentation, open records laws and policies, e and notification of events to other Federal and State agencies.

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 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 the progress of the investigation through until close out.

As noted above, Illinois does not participate in the NMED program offered by NRC. The State has their own tracking system and data / report entry system, and all events and allegations are tracked chronologically by date. Significant events are reported to the RSAO, Region ll!, 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 Chief 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 suggests that the State reconsider the benefits of participating in the NMED system.

All five allegation files reviewed were referred to the State from Region 111, and all were closed out with Region Ill. Region ill reported that there were no outstanding allegations that had been referred to the State of Illinois. Allegations were responded to promptly with appropriate investigations and follow-up actions. The identity of a Concerned Individual (Cl) can be protected under the State's open record law. IDNS rnanagement related that all confidential information is approved and processed by the FOIA 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

iose out action was confirmed by the reviewer. All allegations received by the State are handled in accordance with the same procedures as those used for allegations referred to the State of Illinois by NRC. 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 systern printout for Illinois.

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

4.0 NON-COMMON PERFORMANCE INDICATORS 1

IMPEP identifies four non-common performance indicators to be used in reviewing i Agreement State programs: (1) Legislation and Regulations, (2) Sealed Source and Device l Evaluation Program, (3) Low-Level Radioactive Waste Disposal Program, and (4) Uranium I l

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1 Recovery Program. Illinois is the host State for the Central Midwest Low-Level Radioactive-Waste Compact, and received an amended Agreement in 1990 to include authority for 11e(2) byproduct material; therefore, all of the four non-common performance indicators were applicable to this review.

4.1 Leaislation and Reaulations 4.1.1 Leaislative 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 IDNS 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/O.01-35/6], the Illinois Low-Level Radioactive Waste Management Act [420 ILCS 20/120/24) and the Uranium and Thorium Mill Tailings Control Act [420 ILCS 42), provide authority for the low level radioactive ~ waste disposal and uranium recovery programs.

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

4.1.2 Status and Comoatibility of Reaulations in a December 19,1994, letter from NRC to IDNS, a number of unresolved compatiLility 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 competibility issues as reflected in the September.7,1995, letter to i the State. That letter discussed the implementation deferral for the " Policy Statement on Adequacy and Compatibility of Agreement State Programs." The Staff Requirements Memorandum approving this policy was issued June 30,1997. The implementing procedures for the new policy indicate that any Agreement State rule that is not compatible with NRC'S rule should be changed to conform with the new policy within 3 years after the policy's effective date.

The unresolved compatibility issues remaining are as follows:

• Financial assurance for decommissionina, 330.250 "Generai 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.

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l Illinois Final Report Page 13 i 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 Proaram arid Misadministrations." 10 CFR Part 35 1

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 stated 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 continuing to defer compatibility findings for Agreement States that have not yet adopted a compatible Quality Management rule, until NRC issues a revised Part 35 rule, compatibility designations for the new rule are established, and an effective date for Agreement State implementation has been set.

• 10 CFR Part 20-eauivalent rules in Ill. 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.

This issue relates to Section 340.280 " Dose to an Embryo / Fetus" (also Division 1 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 mSv) per month. This definition does not meet Division 1 compatibility standards.

The State believes that this definition protects a woman's right to privacy with respect to the date of conception. During the MRB, IDNS offered additional insight into effectiveness of their definition and the differences between NRC and the Illinois definitions. The MRB recommends that NRC staff reevaluate the compatibility classification for the definition of " Declared pregnant woman" under the new Adequacy and Compatibility Policy Statement.

Two additiona! regulations required for compatibility 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.

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

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$ lilinois Final Report Page 14 .;

w Radiological contingency plans are required by license condition for all affected * '

i- licensees. The State has verified by inspection that the three licensees requiring r contingency plans have them implemented. This regulation is planned to be 0 adopted with the revision of Part 330, currently in process.

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

The State reported that all irradiator licenses issued implement the rule through p license conditions. This regulation is planned to be adopted with the issuance of  !

i Part 336, projected for late 1997. -

t:

Since the last review, the State adopted regulations to satisfy compatibility for the .g

{z following: ,

I

• . " Notification 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 Reg'uirements 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 legaliy binding requirements no later than three years after they j are effective. As of the date of the review, two regulations are overdue for adoption, j * " Decommissioning Recordkeeping, and License Termination

Documentation

Additions," 10 CFR Parts 30,40,70, and 72 amendments (58 FR 39628) which l

j. was due on October 25,1996. IDNS drafted regulations for compatibility with this l l regulation in their proposed restructuring of Part 330. The availability of this

, section for public comment is projected for Summer / Fall 1997. Adoption is projected for late 1997 or early 1998. The review team recommends that IDNS j expedite promulgation of Part 330 at the first opportunity.

l * "Self-Guarantee as an Additional Financial Mechanism," 10 CFR Parts 30,40, and  ;

+

70 amendments (58 FR 68726) which was due on January 28,1997. Note, this '

t rule is designated as a Division 2 matter of compatibility. ~ Division 2 compatibility i

. allows the Agreement States flexibility to be more stringent (i.e., the State could i '

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 i j provisions for financial assurance that include at least a subset of those provided in i NRC's regulations, e.g., prepayment, surety method (letter of credit or line of I l credit), insurance or other guarantee method (e.g., a parent company guarantee).

I' Self-Guarantee regulations'are included in the new Part 326, currently in draft.

j Adoption is projected by late 1997 or early 1998. i

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i Illinois Final Report Page 15 I

$ in addition, we would like to bring to the States attention other regulations that will be .

l needed, in L.3 future, for compatibility. These rules are:

l *

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

Standerds," 10 CFR Part 40 (59 FR 28220) due by July 1,1997. The State is

~

l evaluating the need to promulgate this regulation since there is only one license to 3

which it applies.

1

' i l * " Timeliness in Decommissioning of Materials Facilities," 10 CFR Parts 30,'40, and l

! 70 amendments (59 F3 36026) due by August 15,1997,

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

/' , ,

!- * " Frequency of Medical Examinations for Use of Respiratory Protection Equipment," l 10 CFR Part 20 amendments (60 FR 7900) due by March 13,1998. Note, this rule '

g is designated as a Division 2 matter of compatibility. Division 2 compatibility allows i j the Agreement States flexibility to be more stringent-(i.e., the State could choose to l continue to require annual medical examinations).

d

• " Low-Level Waste Shipment Manifest information and Reporting," 10 CFR Parts 20 and 61 amendments (60 FR 15649,60 FR 25983) that will become effective March 1,1998. 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 amendmerss (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. 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 7_1

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

" 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. i

• " 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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Illinois Final Report Page 16

• " Recognition of Agreement State Licenses in Areas Under Exclusive Federal

• 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 Illinois Reaister with a 45 day minimum comment period and may include a public hearing. According to DRM management, NRC is provided with draft proposed regulations for comment early in the 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 existing NRC compatibility policy and the IMPEP evaluation criteria, the review team recommended in the proposed final rep' i Gat Illinois' performance with respect to the indicator, Legislation and Regulatine e found unsatisfactory. Illinois has not yet adopted the Decommissioning Recordke , .g regulation, or equivalent legally binding requirements, within the specified perir 4 t time. At the MRB, Illinois noted that this regulation is in process and projected for ; 41 adoption in late 1997 or early 1998.

Because of the progress to date in the promuigation of this rule, the expected adoption date in early 1998, and the lack of disruption to the collective regulatory efforts of NRC and the Agreement States, the MRB determined that a sufficient basis did not exist to support a finding of unsatisfactory for this indicator. The MRB noted that if significant delaya :n rule adoption occur or if Illinois adopts a rule that is not compatible with the NRC  ;

OQJivalent regulations, the MRB could always reconsider the program compatibility finding j at a future date. The MRB final recommendation for Legislation and Regulations is 1 satisfactory. 4 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 i 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 l to assist in the review of SS&Ds and help to ensure that all pertinent issues are addressed.

l These include review and Quality Assurance (QA) checklists, a " Blue Sheet" to track  !

correspondence and staff work regarding SS&D actions, electronic templates of blank  :

registry sheets, and Instructional Sets, which provide licensing guidance in specific areas 1 including " Instructions for Preparation and Review of Quality Assurance Manuals for Licenser, Authorizing Manufacture and Distribution of SS&Ds." In addition, the State has

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l Illinois Final Report Page 17 )

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

which are a co'lection 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 I policy letters, regulatory guides, national and international standards, and SS&D Workshop )

materials.

4.2.1 Technical Quality of the Product Evaluation Proaram 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 I by the review team are listed with case-specific comments in Appendix G. Overall, the l quality of the evaluations was good, but the review team identified and discussed with the I staff several deficiencies in the files involving issues that may result in safety issues if not l adequately addressed during all safety reviews. The review team identified weaknesses in i documenting major issues on 6 of the 11 cases reviewed. Although there were no l immediate safety implications identified in the particular files reviewed, it was not possible l to determ:ae from the limited number of files reviewed and the staff interviews whether these deficiencies were isolated occurrences. The review team suggests that the State evaluate the review information supporting the registry sheets issued during this period to  ;

ensure there is no weakness in the review process. During the exit meetings with staff l and DRM man 9gers, the review team noted that the deficiencies were discussed with the '

State's technical staff. The review team suggests that the documentation issues identified in Appendix G be addressed as appropriate. 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.

l 4.2.2 Technical Staffino and Trainina The State reported that a five-person team with combined staff efforts equaling approximately one full time equivalent is dedicated to performing safety evaluations. The I balance of staff time is spent la 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 sourcec and devices, and if needed, can obtain engineering assistance from the two registered professional engineers that work in the Low-Level Radioactive Waste and the Uraniu'm 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 i SS&D deficiency letters, and draft and completed registration certificates generated by the staff are reviewed by the head reviewer, to ensure 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 team approach provides the technical expertise and experience needed for this size of program.

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• lilinois Final Report Page 18 l

The head reviewer has a B.S. degree, and demonstrated to the review team an ability to a understand and interpret the information submitted by applicants as described in the performance criteria, including engineering-related issues. The three remaining reviewers have a B.S. in bioengineering (providing some background in mechanics and materials), a B.S. in Health Physics, and a B.S. in Health Care /A.A.S. in Radiological Physics. The l Licensing Section Head, who supervises the reviewers, has a B.A. in Microbiology and an M.S. in Health Care Management. All members are trained in health physics principles and l 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.

1 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' l performance with respect to the indicator, Sealed Source and Device Evaluation Program, I be found satisfactory. I 1

4.3 Low-Level Radioactive Waste (LLRW) Disposal Proaram l

in the process of evaluating this performance indicator, the review team evaluated the l State's response to the questionnaire; reviewed information provided by the State l 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 j 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 Inspection The State does not have a site at this time; therefore, no inspections have been conducted.

4.3.2 Technical Staffina 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.

9 lilinois Final Report Page 19 4.3.3 Technical Quality of Licensina ,

The State did not conduct LLRW disposal site licensing activity during the review period.

The LLRW staff developed several guidanco documents which address the following:

(1) describe the licensing process, (2) provide guidance to the applicant, and (3) describe 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 shared with several States that are developing LLRW disposal sites and regulatory programs.

4.3.4 Technical Quality of Insoections 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 i team recommends that lilinois' performance with respect to the indicator, Low-Level .

Radioactive Waste Disposal Program, be found satisfactory.

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1 4.4 Uranium Recoverv Reaulatorv Proaram I 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 l is administered as part cf the materials licensing program. The State has only one

, licensee, Kerr-McGee Chemical Corp., West Chicago site. This facility is in decommissioning and the materialis being shipped out of State. The off-site contamination is being permitted back on-site for a lim'ted 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 Recovery Prooram 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

I tilinois Final Report Page 20 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 physics 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 separate schedule from the annual license compliance inspection. A separate quality 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 Er.iorcement Section, even when the inspections are conducted by the uranium recovery program staff, 4.4.2 Technical Staffino 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 j 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 l decommissioning operations at the facility. The license authorizes the licensee to l decommission the site in phases with a separate evaluation of each phase going through a l complete license evaluation process (separate safety evaluation report and other supporting l l

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lilinois Final Report Page 21 l .

' documentation). Detailed proceduras have been referenced by license conditions. The

• i license files were well organized and referenced documents examined by the review team were quickly located.

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

program. The review team noted that the team approach is effective in achieving peer review and applying the necessary expertise to the specific review.

4.4.4 Technical Quality of insoections Inspection and enforcement is handled in the same manner as any lilinois licensee.

The review team examined the compliance file for Kerr-McGee and reviewed the last three 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 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 violations (NOVs), such as the NOV issued based on the 1996 review, 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 the site. The inspection was thorough and the violation identified was quickly addressed by the licensee.

4.4.5 Resoonse to incidents and Alleoations 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.

Based on the IMPEP evaluation criteria for the above five performance areas, the review team recommends that lilinois' performance with respect to the indicator, Uranium Recovery Program, be found satisfactory, a

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Illinois Final Report Page 22 5.0

SUMMARY

1 As noted in Sections 3 and 4 above, the review team found the State's performance with i respect to each of the common and non-common performance indicators to be 4

satisfactory. Accordingly, after consideration of the satisfactory finding for the non-common indicator " Legislation and Regulation," the team recommended, and the MRB concurred, in finding the Illinois program to be adequate to protect public health and safety and 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.

l 1. The team suggests that the Stats examine their procedures for preparing inspection

' reports 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 IMC 1220 guidance for conducting reciprocity inspections, and increase the reciprocity inspections to meet the guidance l (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 SS&D (Section 3.3).

4. The review team suggests that the State evaluate whether the praccice of deferring i

inspections due to licensee scheduling conflicts is being abused (Section 3.4).

s 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 State evaluate the review information supporting

, the registry sheet issued during this period to ensure there is no weakness in the review process (Section 4.2.1).

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

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l. Illinois Final Report Page 23 i

t i 10. 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 -

j the file by the reviewer (Section 4.2.1).

4 j For NRC, the MRB recommends that the NRC staff reevaluate the compatibility j classification for the definition of " Declared pregnant woman" under the new Adequacy .

1 and Compatibility Policy Statement.

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A LIST OF APPENDICES Appendix A IMPEP Review Team Members e Appendix B lilinois Organization Charts Appendix C lilinois' Questionnaire Response l Appendix D License File Reviews 1 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

Attachment 2 Responses to IDNS comments on the Draft I IMPEP Review Report

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APPENDIX A IMPEP REVIEW TEAM MEMBERS Name Area of Responsibility

- Richard L. Woodruff Team Leader

RSAO, R

1- Status of Materials Inspection Program Technical Staffing and Training Response to incidents and Allegations James L. Lynch Technical Quality of Licensing Actions RSAO, Rlli Legislation and Regulations James Johnson, Kansas Technical Quality of Inspections Michelle L. Burgess Sealed Source & Device Evaluation Program NMSS/IMNS/SSDB Dennis Sollenberger Low-Level Radioactive Waste Disposal Program OSP Uranium Recovery Program

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APPENDIX B ILLINOIS DEPARTMENT OF NUCLEAR SAFETY ORGANIZATION CHARTS d

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4 APPENDIX C

, INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM QUESTIONNAIRE Name of State: ILLINOIS Reporting Period: July 23,1994 to March 24,1997 A. COMMON PERFORMANCE INDICATORS

1. Status of Materials insoection Proaram

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

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

3. Please identify individual licensees or groups of licensees the State / Region is inspecting less frequently than called for in NRC Inspection Manual Chapter 2800 (issued 4/17/95) and state the reason for the change.

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

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

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

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h, 'lllinois Final Report Page C.2

! State Questionnaire Seven .

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

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There were seven radiographer field inspections performed for specific licensees.

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

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

performed.

N/A.

ll. .' Technical Staffino and Trainina

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

responsibilities, include their efforts. The table heading should be: l NAME POSITION AREA OF EFFORT FTE%

Thomas Ortciger Director Administration 20 Gordon Appel Deputy Director Administration 20 Paul Eastvold Manager Administration 50 Wayne Kerr Assist. Manager Administration 50 ,

Michael Ewan Sr. Project Manager Administration 50 i

' Steven Collins Division Chief Administration 100 l Kathy Allen Assist. to Div. Chief Administration 100

' Joe Klinger Licensing Head Licensing, LLW, 100 Supervision Gibb Vinson License Reviewer Licensing 100 Mary Burkhart License Reviewer Licensing 100  ;

Sandi Kessinger Licensing License Reviewer 100 Daren Perrero . License Reviewer Licensing 100 Gary McCandless LLW License Reviewer LLW Licensing, 100 Supervision

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Illinois Final Report Page C.?

State Questionnaire l

$ John Barcalow LLW License Reviewer LLW Licensing 100 , ,

Kelly Grahn LLW License Reviewer LLW Licensing / Inspect. 100 )

! NAME POSITION AREA OF EFFORT FTE%

L David Price LLW License Reviewer LLW Licensing - 100 Chris Halladay LLW License Reviewer LLW Licensing 100 Bruce Sanza insp. & Enfore. Head Insp. & Enforc., 100 Supervision Andy Gulczynski Reg. Insp. Supervisor insp. & Enforc., 100 Supervision l Robin Bauer Inspector insp. & Enfore. 100 l Wendell Hickman Inspector insp. & Enfore. 100 i George Merrihew Inspector insp. & Enfore. 100 3

John Papendorf Inspector insp. & Enfore. 100

Joanne Tomkins Inspector insp. & Enfore. 100 i CONSULTING COMPANY NAME AREA OF EFFORT FTE%

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

license review and evaluation and individuals l construction oversight of totalling i decommissioning acGities at 8 FTE (FY97)

I Kerr-McGee's W. Chicago facility.

! subcontractors:

i Rogers & Assoc. Eng. Health Physics e INTERA- Hydrology & Geotechnical .

l 2. Consoer Townsend Engineering technical support for LLRW Approx.15 4

(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 4' 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.

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O Illinois Final Report Page C.4 State Questionnaire

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

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

8. Please provide a listing of all new professional personnel hired since the last ,

review, indicate +'.ie degree (s) they received, if applicable, and additional l 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 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

Illinois Final Report Page C.5 State Questionnaire need to attend and a tentative schedule for completion of these ,

i 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.

111. Technical Quality of Licensina Actions

. 11. Please identify any major, unusual, or complex licenses which were issued, received a major amendment, terminated or renewed in this period.

For the Radioactive Materials Proaram:

CTI Services, Inc. (P.E.T. Net Pharmaceutical Services) new license, Keystone Steel & Wire amendments concerning the contaminated baghouse due to the smelting of a Cs-137 source, BEBIG new license, Professional 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 actb ns for this evaluation period.

For the Low-Level Radioactive Worte Discosal Proaram:

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

For the Uranium Recoverv Proaram:

Amendments for Phase IA,18 and Phase ll of the Kerr-McGee decommissioning project were issued during this review period.

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

4 lilinois Final Report Page C.6 State Questionnaire

13. Discuss any variances in licensing policies and procedures or exemptions ,

from the regulations granted during the review period.

For the Radioactive Materials Proaram:

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

For the Sealed Source and Device Procram:

' No variances or exemptions granted.

For the Low-Leve' Radioactive Waste Discosal Proaram:

No variances or exemptions granted.

For the Uranium Recovery Proaram:

l No variances or exemptions granted. j

14. What, if any, changes 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 Device Procrams:

The Department issued several new licensing guidance documents in the l form of instructional Sets (listed below). Associated licensing checklists and license document formats were modified to match the new guidance. Since the last review we have also developed the "S" reference manuel for sealed source evaluations, the "D" Manual for device evaluations, an HDR Manual for afterloader applications and an ISO and Military Standards reference manual to assist in sealed source and device reviews, instructional Set Title Number Rev. Date Non-Medical Use of Radioactive Material 48.6 1 October 1994 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 Medical Use of Radioactive Material 52.2 1 November 1995 Use of Radioactive Material for industrial Radiography (currently in development) 87.0 0

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

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l (currently in development)  !

Instructions for Preparation and Review of

- Quality Assurance Manuals for Radioactive Material Licenses Authorizing the i Manufacture and Distribution of Sealed l Sources and Devices (currently in development)

• O I

Administrative and Poliev Memoranda issued durina this review period -

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 pGrposes--1/19/96 Authorized medical user training--2/2/96 New radiography license--4/17/96 i Physicians /FDA approvals / Departure from package insert -5/9/96 For the Low-Level Radioactive Waste Disoosal Proaram:

A revised Plan for Licensing a Low-Level Radioactive Waste Disposal Facility  !

in Illinois was proposed during this review period. It is currently undergoing in-house review. j 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 insoeglgng

16. What, if any, changes were made to your written inspection procedures during the reporting period?

For the Radioactive Materials Proaram:

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

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Illinois Final Report - Page C.8 State Questionnaire .

For the Low-Level Radioactive Waste Disoosal Proaram:

No changes made.

For the Uranium Recovery Proaram:

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

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

For the Radioactive Materials Prooram:

Suoervisor inspector License Cat. Date 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 Bruce Sanza George Merrihew. Nuclear Pharmacy 7/24/96 -

Steve Collins George Merrihew Gas Chromatograph 5/29/96 Andy Gulczynski Joanne Tomkins Type A Broad Academic 5/10/96 Andy Gulczynski Wendell Hickman Portable Gauge 5/8/96 Bruce Sanza Andy Gulczynski Nuclear Pharmacy 2/29/96 Andy Gulczynski John Papendorf Broad Medical 1/23-25/96 Andy Gulczynski ~ Joanne Tomkins Portable Gauge 12/20/95 Andy Gulczynski Glenn Smith Portable Gauge 11/28/95 Bruce Sanza Glenn Smith Specific Medical 11/2/95 Steve Collins 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 Andy Gulczynski John Papendorf Specific Medical 3/28/95 Bruce Sanza George Merrihew Specific Medical 3/15/95-Andy Gulczynski Joanne Tomkins Specific Medical 3/3/95 For the Low-Level Radioactive Waste Disoosal Proaram:

N/A For the Uranium Recoverv Prooram_t 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

' / ...

lilinois Final 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 9ecompaniment.

4 For the Radioactive Materials Proaram:

Supervisory accompaniments are documented by indicating the name of the lead inspector and all accompanying 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 Disoosal Proaram:

There were no LLRW inspections performed during the review period.

For the Uranium Recoverv Proaram:

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

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

19. Describe or provide an update on your instrumentation and methods of calibration. Are allinstruments properly calibrated at the present time? I Allinspectors are issued an instrument kit that contains: An ionization charr. bin survey instrument; a rate meter with a pancake GM, low-energy gamma plobe,2x2 Nat and an alpha scintillation probe; a velometer (qualitative measurements only); a self-reading pocket dosimeter; and a microrem meter. These instruments (except for the velometer) are calibrated by tha Department's calibration lab, and allinstruments currently in use are properly calibrated.

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For incident response, each regional office (Glen Ellyn and Springfield) 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.

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lilinois Final Report Page C.10

. State Questionnaire

! V.- Resoonses to incidents and Alleastions .

L 4 :20. 'Pisase provide a list of the most sianificant incidents (i.e., medical 4 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

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:

1 LICENSEE NAME LICENSE # DATE OF INCIDENT / REPORT TYPE OF INCIDENT

! For the Radioactive Materials Proaram:

All significant incidents have been reported to the NRC.

i For the Sealed Source and Device Proaram:

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The heat sensitized Amersham CKC.LSA Co 60 irradiator sources was the'  !

most significant concern during this review period. The problem was first i 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 the affected sources have been removed and returned to the UK for further 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 Proaram:

4:

None to report

21. During this review period, did any incidents occur that involved equipment or source failure or approved operating procedures that were deficient? If so, how and when were other State /NRC licensees who might be affected notified?

For 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?

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j lllinois Final Report. Page C.11 State Questionnaire 4

- 22. For incidents involving failure of equipment or sources, was information on C 1 the incident provided to the agency' responsible for evaluation of the device for an assessment of possible generic design deficiency? Please provide 4

details for each case.

N/A i- 23. In the period covered by this review, were there any cases involving possible 1 wrongdoing that were reviewed or are presently undergoing review? If so,

} please describe the circumstances for each case.

l For the Radioactive Materials, Sealed Source and Device, and Uranium Recovery Programs, there are no cases under review involving possible

wrongdoing, as defined by NRC.

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

! occurred during the period of this review.

! ~

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

a. For Agraement States, please identify any allegations referred to your

program by the NRC that have not been closed.

j VI. General i

i 25. Please prepare a summary.of the status'of the State's or Region's actions O 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, j 15-day patient notification, medical quality management and declared pregnant woman. .

1 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 a surety from more categories of licensees.

We committed to discussing the 15-day patient notification and medical quality management with our Medical Use Advisory Board (MUAB). We have a 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 l regulations, j 1

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! lilinois Final Report Page C.12 State Questionnaire 1

We continue to disagree with the NRC's criticism of our declared pregnant i

! woman provisions. Our rule provides a margin of safety to a woman who 3 does not or cannot provide an estimated date of conception,~ and the NRC's i

rule 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.

i This program's greatest strength is the knowledge, experience and expertise i of the staff, coupled with a very low turnover rate. Department staff serve L on many national committees, and are often asked to chair committees and speak at meetings.

l Licensing actions and sealed source and device reviews that would be characterized as difficult or technically challenging are 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.

} The Inspection staff has many years of experience in this program, and

', perform inspections at a wide variety of facilities. They routinely respond to 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 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 i i lllinois Final Report Page C.13 State Questionnaire B. NON COMMON PERFORMANCE INDICATORS

1. Leaislation and Reaulations

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

CENTRAL MIDWEST RADIOACTIVE WASTE COMPACT ACT, as amended

by P.A. 87-1166 i [45 ILCS 140/0.01 - 140/1 (1992) Formerly. Ill. Rev. Stat., ch.127, pars. l j 63v et seq.]

[ DEPARTMENT OF NUCLEAR SAFETY--POWERS ENABLING STATUTE <

[2O ILCS 2005/71 2005/72, as ahiended by P.A.89-411, effective June 1, I 1996 and P.A.89-445, effective February 7,1996] l FREEDOM OF INFORMATION ACT i l [5 ILCS 140/1 - 140/11 as amended by P.A.88-444, effective January 1, .

j 1994]

j ILLINOIS ADMINISTRATIVE PROCEDURE ACT

[5 ILCS 100/1 15-10 as amended by P.A. 89-6, effective 3/6/95) l RADIATION INSTALLATION ACT as amended by P.A. 89199, [SB-452]

effective July 21,1995

[420 ILCS 30/0.01 - 30/8]

RADIATION PROTECTION ACT OF 1990 as amended by P.A. 89143 [SB-231], effective July 14,1995, by P.A.89-199 [SB-452), effective July 21,

-1995, by P.A. 89187 [SB-1095), effective July 19,1995 and by P.A.89-624 [HB-3165), effective August 9,1996.

[420 ILCS 40/1 - 40/45]

RADIOACTIVE WASTE STORAGE ACT

[420 ILCS 35/O.01 - 35/6 (1992) Formerly ill. 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]

2P Are your regulations subject to a " Sunset" or equivalent law? If so, explain and include the next expiration date for your regulations.

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lilinois Final Report Page C.14

, . State Questionnaire i Yes. The current Radiation Protection Act has a sunset date of December +

j 31,2000. This means the legislature will have to pass another Act to reauthorize the State's program prior to the sunset date.

29. Please complete the enclosed table based on NRC chronology of l 1 amendments, Identify those that have not been adopted by the State, explain )

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

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

. NRC rule promulgation, briefly describe your State's procedures for amending ')

regulations in order to maintain compatibility with the NRC, showing the ll - normal length of time anticipated to complete each step.

4 If the NRC adopts a rule that affects only a small number of licensees, the l Department may choose to " adopt" those regulations by imposing similar j requirements on licensees through the licensing process. Sometimes this is i j- done because the Department is working on more pressing projects or rules,

and sometimes this is done as an interim step until a major rulemaking is j finalized that may include the NRC changes in addition to other changes.

p Once a rulemaking is contemplated, it is listed on the semiannual regulatory

agenda. Department staff write the rule, taking into account NRC's rule, comments previously submitted to the NRC, any CRCPD language available, 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 j review and comment. ' Writing a rule can take anywhere from a couple of  ;

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 i comment period, the Department must respond to any comments and j l provide the comments and responses to the Joint Committee on Accreditation of Rules (JCAR), a bipartisan group comprised of legislators i 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.

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lilinois Final Heport 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.

II. ' Sealed Source and Device Evaluation Proaram 1

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

SS&D Manufacturer, Type of i Registry Distributor or Device I 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 AN'D6074, 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. i

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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.lll.11, A.lli.13-14 Responses to incidents and Allegations - A.V.20-23 Ill. Low-Level Radiative Waste Disposal Proaram i

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

[

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

' Technical Staffing and Training A.ll.7-10 i Technical Quality of Licensing Actions - A.lli.11, A.lli.1314 Technical Quality of Inspections - A.IV.16-19 1

,l Responses to Incidents and Allegations - A.V.20 23 i

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lilinois Final Report Page C.16 State Questionnaire IV. Uranium Recoverv Proaram *

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

1 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.lli.11, A.lli.13-14 Technical Quality of Inspections - A.IV.16-19 Responses to incidents and Allegations - A.V.20-23 i

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.t Illinois Final RIport Page C.17  ;

State Questionnaire i TABLE FOR QUESTION 29. t i

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.OR l DATE DATE r 10 CFR RULE DUE ADOPTED CURRENT EXPECTED  !

STATUS ADOPTION Any amendment due prior to 1991, Identify' l each regulabon (refer to the Chronology of {

Amendments)  :

Decommessoning, 7/27/91 3/29I94 l Parts 30,40,70  !

Emergency Planning, 4/7/93 in progress with several other changes to IDNS Part 330. fab 1997 Parts 30,40,70 Emergency Planmng requirements currently enforced through license tie-downs  !

i Standards for Protection Agaenst Radehon, 1/1/94 1/1/94 i Part 20 .

Safety Requirements for Radiographic 1/10/94 5/2/94 industnal Radiographer Certification rules added 6/23/94. j Equipment; Part 34 - l t

Nohfication ofincidents; 10/15/94 6/12/95  !

Parts 20, 30, 31, 34, 39, 40, 70 i i

Quality Management Program and 1/27/95 5/2/94 Misedmemstration requirements incorporated 5/2/94  !

Misadministrahons; Part 35 QMP not yet addressed in Part 335, pending outcome of changes in [

NRC rules due to NAS/lOM study, rebasehnig and NRC/AS l wortung group on medical rules.  !

r i Licensing and Radehon Safety 7!1/96 Not adopted yet. Rules affect three licensees and are currently late 1997 Requirements for Irradiators; Part 36 enforced through license te-downs and requrements of Part i 330.630. i t

Defimhon of Land Deposal 7/22/96 5/1/96  ;

and Waste Site OA Pivy.m, Part 61

-l Decommissiomng Recordkeeping Docu- 10/25/96 in progress with several other changes to IDNS Part 330. Fa51997 mentation Addshons; Parts 30,40,70 l Self-Guarantee as an Addshonal Financial 1/28/97 in progress with several other changes to IDNS Part 330. Fa51997 l Mechanism; Parts 30,40,70 i f

Uranium mig Tashngs: Confor!.sig to EPA 7/1/97 Not due. l Standa ds: Part 40  !

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Illinois FinIl Report Page C.18 -  !

State Questionnaire l t

t OR' f DATE DATE  !

10 CFR RULE - DUE ADOPTED CURRENT EXPECTED ,

STATUS ADOPTION l Timeliness in Decommissiomng 8/15/97 Not due.  !

Parts 30,40,70 ,

Preparation Transfer for Commeraal Dis- 1/1/98 - Not due.  !

tnbuhon, and Use of Byproduct Material for Medical Use; Parts 30,32,35  ;

t Frequency of Medical Examinations for Use 3/13/98 Not due.

f of Respiratory Protechon Equipment c Low-Level Weste Shipment Mansiest 3/1/98 Not due. I Information and Reporhng

[

Performance Requirements for Radiography 6/30/98 Not due. '!

Equipment [

Radishon Protechon Requirements 8/14/98 Not due. I Amended Definstions and Criteria ,

L Clanficahon of Decommissioning Fundmg 11/24/98 Not due. [

Requrements  ;

10 CFR Part 71: Compatibility with the 4/1/99 Not due. f Intemahonal Atomic Energy Agency l

Medical Administrabon of Radehon and 10/20/98 Not due.  !

Radioactive Materials. .

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

Activities: Recordkeepag Requrements.

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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 i Licensee: SteriGenics International License No: IL-01220-01 i Location: Schaumburg, IL Amendment No: 13 License Type: Pool Irradiator Type of Action: Amendment )

i 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 i License Type: Industrial Radiography j Type of Action: Amendment

Date Amendment issued

11/9/95 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 1

l_ Comments:

l a) License Conditions 4.B and 4.D are redundant.

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

File No. 5 1 Licensee: lilinois Bell Telephone Company License No: IL-01365-01 i Location: Chicago, IL ~ Amendment No: 2  !

License Type: Device '

Type of Action: Termination Date Amendment issued: 1/18/95 License Reviewer: MEB i i

_ 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:

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

After the review, IDNS contacted the State of California and determined that the i SS&D registry sheet inappropriately required leak testing of gauges at installation, j California will correct the sheet at the next amendment. '

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l lilinois Final 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 File No. 8 Licensee: Edward Hospital License No: IL-01232-01 Location: Naperville, IL Amendment No: 5 l License Type: Medical Type of Action: Amendment Date Amendment issued: 2/23/95 License Reviewer: SMK File No. 9 Licensee: Bowser-Morner, Inc. License No: IL-01543-01 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.10 Licensee: Saint Anthony's Health Center License No: IL-01509-01 Lecation: Alton, IL Amendment No: 8 License Type: Medical Type of Action: Renewal i Date Amendment issued: 4/26/96 License Reviewer: SMK File No.11 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 File No.12 Licensee: Radiation Safety Services, Inc. License No: IL-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 r -

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Illinois Final Report Page D.3 License File Reviews File No.13 .

Licensee: Mobil Oil Corporation License No: IL-01742-01  ;

Location: Joliet, IL Amendment No: 3 1 License Type: Portable Gauge Type of Action: Amendment Date Amendment issued: 11/26/96 License Reviewer: CGV File No.14 Licensee: St. Mary's Hospital License No: IL-01604-01 Location: East St. Louis, IL Amendment No: 9 License Type: Medical Type of Action: Renewal Date Amendment Issued: 11/17/95 License Reviewer: CGV File No.15 Licensee: Fox Valley Equine Clinic License No: IL-01996-01 Location: Wauconda, IL Amendment No: O License Type: Veterinary Medicine Type of Action: New l Date Amendment issued: 12/23/96 License Reviewer: DMP Comment:

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

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File No.16 Licensee: Kane County Health Department License No: IL-01770-01 i i Location: Geneva, IL Amendment No: 4 License Type: Portabla Device Type of Action: Amendment t

Date Amendment issued: 12/29/95 License Reviewer: CGV

} File' No.17 Licensee: Egyptian Drilling, Inc. License No: IL-01658-01 '

Location: Fairfield, IL Amendment No: 1 License Type: Well Logging Type of Action: Termination

. Date Amendment issued: 11/30/95 License Reviewer: SMK 4

i File No.18 1 Licensee: Syncor Corporation License No: IL-01721-02 3- Location: Chicago, IL Amendment No: 13 License Type: Nuclear Pharmacy Type of Action: Amendment j Date Amendment issued: 1/17/97 License Reviewer: CGV File No.19 i Licensee: SK Diagnostic Lab License No: IL-00305-GL6 -

- Location: Streamwood, IL Amendment No: 0 License Type: In Vitro General License Type of Action: Renewal

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Date Amendment issued: 6/20/96 License Reviewer: SCC i

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Illinois Final Report Page D.4 License File Reviews File No. 20 .

Licensee: Kerr McGee Chemical Corp. . License No. STA-583 Location: West Chicago, IL Amendment No. 43 License Type: Rare Earth, Source, & 11e(2) byproduct Type of Action: Amendment i Date Amendment issued: 2/28/97 License Revit + ers: DP, JB, GM, CH, JK Comment:

a) Noted that the only radionuclides listed were uranium and thorium. This licensee is i mainly dealing with the wastes (11e(2) byproduct material) at the site and the l radionuclides are mainly the daughter products of the uranium and thorium. The '

license implies the daughters are licensed under the authorized use section even 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.: 21 Licensee: Kerr-McGee Chemical Corp. License No. STA-583 Location: West Chicago, IL Amendment No. 35 i License Type: Rare Earth, Source, & 11e(2) byproduct Type of Action: Amendment l Date Amendment issued: 4/03/96 License Reviewers: DP, JB, GM, CH, JK l

File No.: 22 I 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.: 23 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

APPENDlX E INSPECTION FILE REVIEWS  ;

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• i File No.: .1  !

l Licensee: St. Therese Medical Center License No.: IL-01363-01 I Location: Waukegan, IL Inspection Type: Routine / Unannounced License Type: Medical-Specific Priority: 3 Inspection Date: 1/17/97 Inspector: RGM l

Comment:

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

I File No.: 2 I Licensee: Mallinckrodt, Inc. License No.: IL-01117-01

Location

Chicago, IL Inspection Type: Routine / Unannounced 1 License Type: Nuclear Pharmacy Priority: 1 i Inspection Date: 2/5-7/97 Inspector: RGM l

Comment:

)

a) NOV letter sent: 3/21/97 > 30 days. '

File No.: 3 Licensee: A!nor instrument Company . License No.: lL-01356-01 1 Location: Skokie, IL Inspection Type: Routine / Announced License Type: Manufacturing-Specific Priority: 1  ;

j inspection Date: 5/13/96 Inspectors: JDP/WMH

, Comment:

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

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 i

File No.: 5 Licensee: Methodist Hospital of Chicago Licenn No.: IL-01144-01

' Location: Chicago, IL Type Inspection: Fautine/ Unannounced License Type: Medical Specific Priority: 3  ;

Inspection Date: 1/17/97 Inspector: WHM Comment:

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

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0 Illinois Final Report Page E.2 inspection File Reviews File No.: 6 .

Licensee: Baxter Healthcare Corp. License No.: IL-01278-01 Location: Round Lake, IL Inspection Type: Routine / Unannounced License Type: Medical-Specific Priority: 1 i inspection' Date: 9/18/96 Inspectors: WMH/RGM l

1 File No.:.7 Licensee: Materials Testing Labs, Inc. License No.: IL-01569-01 Location: Westchester, IL Inspection Type: Routine / Announced License Type: Portable Gauge Priority: 5

• Inspection Date: 11/25/96 Inspector: WMH File No.: 8 '

Licensee: Onley Cancer Cen'er, Inc. License No.: IL-01088-01 Location: Evansville, IN Inspection Type: Routine / Unannounced License Type: Teletherapy Priority: 1 Inspection Date: 1/12/95 Inspector: GEM Comments:

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

& U-238 41 kg.

b) _ Teletherapy unit sent to Texas licensee LO1485 (fax 8/28/95). Inspection on 1/12/95, letter sent 2/6/95 by BJS within 30 days. i File No.: 9 l Licensee: Eastern Services License No.: IL-01259-01 l Location: Carmi, IL Inspection Type: Routine / Announced License Type: Wireline Priority: 2 Inspection Date: 8/26/96 Inspector: GEM File No.: 10 Licensee: MQS Inspection, Inc. License No.: IL-01136-01 Location: Elk Grove Village insp. Type: Routine / Unannounced License Type: Indust. rial Radiography Priority: 1 )

Inspection Date: 1/14/97 Inspector: GEM File No.: 11 Licensee: Columbus-Cabrini Medical Center License No.: IL-01621-01 Location: Chicago, IL Inspection Type: Routine / Unannounced .

License Type: Broadscope medical Priority: 1 Inspection Date: 12/3-5/96 Inspectors: JDP/RGM Comment:

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

lilinois Final Report Page E.3 Inspection File Reviews File No.: 12 '

Licensee: Chicago State University License No.: IL-01084-01 Location: Chicago, IL Inspection Type: Routine / Announced ,

License Type: Academic Priority: 3 I Inspection Date: 7/24/95 Inspector: JDP )

Comment:

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

File No.: 13 4

Licensee: Gunite Corporation License No.: IL-01616-02 Location: Rockford, IL Inspection Type: Routine / Announced License Type: Industrial Radiography Priority: 1 i inspection Date: 1/7/97 ,

inspector: JDP 1 l

File No.: 14 '

Licensee: Orland Park Equine Hospital License No.: IL-01752-01 Location: Orland Park,IL Inspection Type: Routine / Unannounced License Type: Vet Med. Priority: 5 q inspection Date: 2/16/96 Inspector: JKT i 4 Comment:

a) Letter sent 4/18/96, > 30 days.

File No.: 15 Licensee: Interstate Nuclear Services License No.: IL-01008-01 Location: Morris, IL . Inspection Type: Routine / Unannounced License Type: Nuclear laundry Priority: 1 Inspection Date: 9/16-17/96 Inspector: JKT Comment: '

a) Inspection was overdue by one month.

File No.: 16 Licensee: SteriGenics International License No.: IL-01220-01 Location: Gurnee, IL Inspection Type: Initial / Announced License Type: Irradiator > 10,000 curies Priority: 1

. Inspection Date

1/23/97 Inspectors: JDP/RGM 4

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lilinois Final Report Page E.4 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 Comment:

a) NOV sent 2/10/97, over 30 days.

File No.: 19 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:

a) April 16,1996 letter to licensee identifying that there were no violations cited as a result of the inspection. The letter was delayed due to serious illness of the inspector shortly after competing the inspection.

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lilinois Final Report Page E.5

Inspection File Reviews

File No.: 22 - .

I Licensee: Kerr-McGee Chemical Corp. License No.: STA-583

. Location: West Chicago, IL inspection Type: Routine j i 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.

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- _ File No.

23 4 Licensee: Kerr-McGee Chemical Corp.

License No.: STA-583 )

i Location: West Chicago, IL Inspection Type: Special 4

License Type: Rare Earth, Source,11e(2) byproduct Priority: 2 2

-Inspection Date:In office review of EM report inspector: DP

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File No.: 24

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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 l Inspection Date: July 10-12,1996 Inspector: GM l

j. Three inspector accompaniments were performed by a review team member during the ,

j period of March 11-14,1997 as follows:  !

i Accompaniment No.1 I

Licensee: American Testing & Engineering Corp. License No.: IL-01664-01 j Location: Davenport, IA Inspection Type: Routine, announced

! License Type: Portable Gauge Priority: 5

Inspection Date

3/11/97 Inspector: GM i

- Comment

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

l Accompaniment No. 2 i Licensee: Advanced Medical imaging License No.: IL-01652-01

! Location: Chicago, IL Inspection Type: Routine, announced License Type: Nuclear Medicine Priority 3 2

Inspection Date: 3/13/97 Inspector: RM 1

! Comment:

a) Missed opportunities to question ancillary staff during inspection.

1 f;nois Final 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. l 1

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APPENDIX F INCIDENT CASEWORK FILES

File No: 1 *

! Licensee: Northwestern Steel & Iron  !

Location: ' Sterling, IL - I i

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 4

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 j 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 l License No.: Non-Licensee f Event Date: 2/27/97

[

Type of Event: Contamination event Summary: A Drug Enforcement Agency aircraft was shot down in Peru, and a DEA agent who was injured in the crash returned with a souvenir which turned out to be a sign

. with Pm-147. The device was being modified in the facility and contaminated the facility.

The State investigated and conducted surveys, decontaminated the facility, and took-t 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 oepartment. . investigation and survey by IDNS shows that

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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 ,

tem as determined by an interview, enactment, and IDNS. investigation. Enforcement

" actions were taken.

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Illinois Final Report Page F.2 l Incident Casework Files '

File No.: 5 ,

Licensee: Industrial NDT Services Location: Danville, IL License No.: 13-06147-04 Event Date: 08/23/96 Type of Event: Excessive exposure Summary: Two radiographers (brothers working at night) approached a source that had not been retracted. Both had survey meters but failed to survey, or read the meter l 4

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

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

File No.: 7 i Licensee: Michael Reese Hospital 2

Location: Chicago, IL License No.: IL-01097-01 2 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.

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! lilinois Final Report Page F.3 Incident Casework Files File No.: 9 . ,

Licensee: Methodist Medical Center Location: Peoria, IL License No.: IL-01204-01 Event Date: 11/27/95 Type of Event: Misadministration Summary: A therapy out-patient was given only 4.8 millicuries of I-131 instead of 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 1 License No.: Non-Licensee i Event Date: 10/03/95 i Type of Event: Transportation

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

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

1 File No.: 11 Licensee: SDI Consultants j Location: Oak Brook, IL 1 i License No.: IL-01945-01 l Event Date: 09/23/95 Type of Event: Damaged equipment 4 Summary: A Troxler portable gauge was crushed at a construction site when the

, licensee's vehicle was struck by heavy equipment, driving the vehicle into the device. The  !

cource rod was sheared off, leaving the source embedded in the soil. The source was i recovered and returned back to the manufacturer. No leakage occurred and no excessive 4 exposure.

• d i- File No.: 12 t 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 remote tools and transported to Argonne National Lab. The source was a sealed cesium-137 capsule.

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.lilinois Final Report - . Page F.4 Incident Casework Files i . .

p . File No.: 13 .

! Licensee: Syncor Corporation I i Location: Chicago, IL-F License No.: IL-01721-02

Event Date

11/25/94 j Type of Event: Equipment

Summary

Licensee notified State that on two occasions, a cardiolite vial broke in a

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 170 millirem CEDE. .

File No.

14 Licensee: Terracon Consultants, Inc.

Location: Bolingbrook,. IL ,

License No.: IL-01402-01 i s 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.

-lDNS provided a lead shield and transferred the device to another IL location for final disposition via the manufacturer of the device. i File .No.: 15 Licensee: Applied Soil Mechanics j Location: Naperville, IL i License No.: IL-01473-01 Event Date: 09/26/94 Type of Event: Stolen Vehicle j 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 Metallies Location: Chicago, IL License No.: Non-Licensee l 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

.i was collected and placed in a DOT approved overpack and transferred to a waste broker ,

for disposal.

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i filinois Final Report Page F.5 incident Casework Files File No.: 17 .

Licensee: XRI Testing

i. Location: Oak Lawn, IL License No.:ll-01787-01 Event Date: 01/11/95

j. Type of F. vent: Exposure ..

4 Summary: The Licensee reported that while conducting radiography at a refinery

. (temporary job site), another contractor employee performing asbestos work crossed two i barriers posted by the radiographers. IDNS conducted an investigation, and ordered the I

radiographers to cease all work and surrender their radiography certificates, and the

, Licensee was fined $11,000.00. The individual received an estimated 3.6 rem exposure.

i File No.: 18 Licensee: Kerr-McGee 3

Location: West Chicago, IL

! License No.: STA-583

{ Event .Date: 03/31/95 Type of Event: Licensable material found buried at site.

Summary: 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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APPENDIX G SEALED SOURCE AND DEVICE REVIEWS 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:

a). - Registry file did not contain documentation of the justification for a leak test frequency longer than 6 months. Information provided by State of lilinois staff subsequent to the IMPEP review indicated that the 36-month frequency was approved based on comparison with similar enodel c.'evices that were already approved for the 36-month frequency. The IMPEP teim suggests that the basis for the decision to allow the longer frequency be documented in the registry file, b) Only operational history from 1980 for prototype testag. Prototype testing section on the sheet says "without operational problems," but information in file indicates that the shutter coils 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) Registry sheet does not list external radiation levels for both open and closed shutter positions. The IMPEP ream suggests that the levels should be listed at three distances from the surface of the device, with the shutter both in the open and the

- closed positions. For ALARA considerations, these levels can be calculated, d) Not apparent from the file that estimated yearly doses for GL user were calculated, e) Upon initial review, there was no indication that a check was being done to ensure that the product was being manufactured according to the information submitted in support of the safety evaluation. Information provided by State of Illinois staff subsequent to the IMPEP. review indicated that the distributor's QA program was approved in conjunction with another registry sheet (IL-0599-D-101-G), and that the manufacture and distribution of the device on the 103 sheet would be included in that program. It does not appear that the 103 file registry sheet reflected this apparent change in QA procedures, f) Suggest that the Labeling section_ list the pertinent information that will be required to be placed on the label instecd of listing the IL regulations.

File No.: 2 Registry No.: IL-0360-D-114-S Manufacture: ICN Pharmacetriical, Inc.

SSD Type: Calibration Camera -- CUSTOM Date issued: 01/22/97

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lilinois Final Report Page G.2 Sealed Source & Device Reviews

^ File No.: 3 Registry No.: IL-0412-D-123-B

' Manufacture: Kay-Ray /Sensall, Inc.

SSD Type: Gamma Source Housing Date issued: 08/11/94 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. i b) For the request to modify the 7064/7064P source housing tube to accommodate l the larger Amersham X 38 capsule,

1. Missing drawing 630-000323 Rev. O. i

2. Does not appear that the review addressed the issue of reduced wal1 _

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 changeq to the holder.

File No.: 4 -

Registry No.: IL-0353-D-101 -G 1 Manufacture: Gamma instruments, Inc. I SSD Type: Gamma Gauge 1 Date issued: 06/11/96  !

l Comment: 1 a) Registry file did not contain any documentation regarding approval of an additional source model. This information (applicant letter dated 5/6/96 and the reviewer's ,

" Reviewer's Notes" sheet dated 6/5/96) was found in the license file. The IMPEP l team suggests copies of this information be placed in the registry file.

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

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

a) ' Registry file did not contain 12/93 application or the letters dated 4/18/94 and 5/11/96. These letters were found in the license file. The IMPEP team suggests copies of tHs information be placed in the registry file.

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lilinois Final Report Page G.3 ,

! Sealed Source & Device Reviews i File No.: 6. .

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

. Manufacture: Amersham SSD Type: Gamma Source (gauging)

Date issued: 09/27/95 Comment:

No documentation was present in the registry file concerning void space and bubble a) testing. Information provided by State of Illinois staff subsequent to t,he IMPEP l review indicated that this source was approved based on engineering analysis and l comparison with a previously tested source, and therefore, the bubble testing and void space concerns as a part of prototype testing are not applicable. The IMPEP

. team suggests that allinformation which is used to reach a determination that the 1 source (or ' device) under evaluation is acceptable for use, and that is not )

represented in correspondence from the applicant, be clearly documented in a i

" Reviewer Note" in the registry file.

4 File No.: 7 Registry No.: IL-0136-S-913 S (replaced IL-0136-S 175-S) f

~

' Manufacture: Amersham '

SSD Type: Low Energy Gamma Point Source Date issued: 11/25/96 Comment:

a) Request was to change the manufacturing QA procedures for use of the charcoal 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 should be listed here in place of the wipe test.

File No.: 8 Registry No.: ll-599-D-801 -G Manufacture: Heuft USA, Inc.

SSD Type: Level Gauge Date issued: 11/1/94 and 2/14/95

J liiinois Final Report Page G.4 Sealed Source & Device Reviews i i

File No.: 9 J Registry No.: IL-136-S-215 S Manufacture: Arnersham SSD Type: Source Type of action: amendment '

Date issued: 11/1/96 .l

. Comment:

a) Registry file did not contain documentation of either the QA commitments of the second manufacturer, or a statement that the second manufacturer will abide by the QA commitments already in place. Information provided by the State of Illinois staff subsequent to the IMPEP review indicated that this information is contained in the i license file. The IMPEP team suggests copies of this information be placed in the registry file.

, l File No.: 10  ;

} Registry No.: IL-234-D-101-G l Manufacture: E.S.C. Resources '

- SSD Type: Gamma Gauge l 2

Date issued: 2/15/96 File No.: 11 Registry No.: IL-103-S-107-S Manufacture: BEBIG Trade, Inc. I SSD Type: Gamma Source i Date issued: 5/7/96 I

j l

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1 . IS DEPARTMEN . _.

R SAFETY 10

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.c vfi62704 l Jim Edgar f Governor

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Director June 2,1997

)

Mr. Richard Bangart, Director Office of State Programs U.S. Nuclear Regulatory Commission j Washington, D.C. 20555

! Re: Re'sponse to your letter dated April 25,1997, with attached draft report of the

IMPEP review conducted March 24 - 28,1997 i

1 -

Dear Mr..Bangart:

i Thank you for the cygnionity to comment on the draft report presenting the results of the NRC's mcent review of the Illinois Agreement State program. The

Depanment continues to believe that the IMPEP process is an improvement on the j

approach taken in the past. However, based on the draft results of our recent IMPEP l

' review and the fact that the Office of State Propams has drafted procedures for ongoing review of state regulations, additional modifications are required.

Specifically it is time to either modify the "I.4gislation and Regulations" non-common indicator, or completely remove it from the IMPEP evaluation.

NRC's 1992 policy statement on review of Agreement State programs, stated that the indicators addressed during IMPEP " address primary program functions which directly relate to the State's ability to prote::t the public health and safety." Without

. question, this is the appropriate objective for such a review process. However, Compatibility determinations do not fit neatly within this objective context or into the IMPEP process, even when labeled as a "non-common performance indicator." Only the most egregious example ofincompatibility could negatively impact a State program's cep:rbility to pueect the public. Yet, because it is an element of the review process, redew teams feel compelled to draw conclusions on the topic, independent of rational criteda that might allow them to relate compatibility to impact on health and safety.

4 7

f 1

Mr. Richard Bangart i June 2,1997 Page 2 1

As a result, the draft report classifies our program as Unsatisfactory for the l 4 " Legislation and Regulations" indicator based on failure of the Department to impose recordkeeping requirements on licensees, thereby indicating that the State's ability to protect public health and safety has somehow been reduced. We emphatically disagree with this finding and protest NRC's basis for the draft conclusion.

Currently, the " Legislation and Regulations" indicator is divided into two

, subsections: " Legal Authority" and " Status and Compatibility of Regulations." Our

recommendation is to separate determinations of compatibility from IMPEP entirely, i If NRC's intent in implementing program reviews for the " Legislation and Regulations" indicator is to evaluate the State's process ofimplementing revisions to l legislation and regulations or the timeliness ofimplementing regulations, conclusions on the t'opic should use a different terminology than that applied to matters that might i directly impact public heafth and safety (i.e, findings of satisfactory, satisfactory with improvements needed, or unsatisfactory); we suggest NRC use the terms " objective

met" or " objective not met." Alternatively, NRC should identify the specific criteria to be applied in determining that transgressions in this area have an impact on health i and safety. Frankly, in the final analysis, we believe that evaluations in this area offer

! little meaning in the context of health and safety and recommend that the criterion be j deleted.

Additional specific comments concerning the Draft IMPEP report are attached 4

for your use. If you have any questions regarding the Department's comments, please

. contact Steve Collins or Kathy Allen at (217) 785-9948.

Sincerely .

T l

Thomas W. Ortcige Director TWO:ka Enclosure cc: Jim Lynch, State Agreements Officer

I 2 Specific Comments on the draft report of the IMPEP review i conducted March 24 - 28,1997, ofIDNS

1. Page 4, Sec. 3.1, fifth paragraph, " timeliness of the issucce ofinspection findings...": The Department's goal is to dispatch inspection findings to licensees within 30 days. The Head, Inspection and Enforcement has taken  :

action to ensure that most written findings are dispatched accordingly. All j inspection staff were reminded of a written performance goal to submit findmgs to the Head, Inspection and Enforcement within 15 working days following the  ;

conclusion of an inspection. This will be more closely monitored by i supervisory review. The preliminary findings of each inspection, however, are  ;

always communicated to the licensee by the inspector at the end of the  :

inspection.

2. Page 5, Section 3.1, Status of Materials Insnection Procram, last sentence of

. to'p paragraph: The review team suggested that "the State should reconsider the l

IMC 1220 guidance for conducting reciprocity inspections, and increase the reciprocity inspections to meet this guidance." This suggestion is unfortunate l because the team mentioned guidance about which the states were never given any opportunity to provide early or substantial input. We attempted to provide written comment in our letter dated November 2,1994 to Paul Lohaus <

regarding draft manual chapter 2800 offered for comment in SP-94-144. In this document, we commented that the ambitious inspection plan described in IMC

1220 is extremely labor-intensive and fails to acknowledge the inspection

! activities by Agreement States of their own licensees.

)

! We offered a more reasonable goal that would involve 10 to 20 percent of l priority I licensees and reactive inspections for priorities 2 through 4. Our i incredulity at the statement in IMC 1220 that "the proposed inspection I frequencies do not pose an FTE burden above that already incorporated into the l current operating plan" still holds. We are dismayed that IMC 1220 is even l mentioned in the draft report in light of our caution against using it as a review l criterion. Our position on this issue is that, because the Agreement States were not offered an opportunity to participate in the development of the procedure l and our attempts to provide input during the guidance development process i were rebuffed, we are not compelled to observe its guidance. We will continue

[ to strive to meet the alternative goal described above.

^

3. Page 5, Sec. 3.2, third paragraph, third line, after " low-level radioactive waste" add "and uranium / thorium mill licensing".

l 4. Page 5, Sec. 3.2, third paragraph, fifth line, the phrase "The Glen Ellyn office i

also provides support for the Mill Program..." needs replaced. It is the West l

4 e

-, - - -,r,., .- -. , , - - --- -m -

+ , ,

J

[..

Comments to draft IMPEP Report j Page 2 Chicago office of the Licensing Section which is on site providing direct 3 oversight oflicensed activities. The Glen E9yn office has little to do with the

West Chicago mill site unless called upon for incident response.

5. Page 5, Sec. 3.2, third paragraph, last line, after "DRM" change " Director" to

, " Chief" or " manager". I l

6. Page 5, Sec. 3.2, fourth paragraph, second line, the phrase " entry level are l required to have a baccalaureate degree..." is accurate for the health physicist i , and engineer positions in the Division of Radioactive Materials but not for all i the technical positions in the Department. The sentence should be rephrased to i be accurate for all positions or should address only the health physicists and

! engineers positions.

! 7. Page 6, Sec. 3.3, first paragraph, second line, change "isot' opes" to

" radionuclides" to be technically correct. -

8. Page 7, Sec. 3.3, second paragraph, this paragraph should be removed from the report. The SS&D in question has been determined to be in error by the State of California. There are very few instances, if any, where sealed sources have

. to be leak tested at installation as opposed to within six months prior to use.

Also, see IDNS Comment No. 22 for details.

9. Page 8, Sec. 3.4, second paragraph, after "DRM" change " Director" to " Chief" or " manager".

10. Page 9, Sec. 3.4, fourth paragraph, last sentence, while this sentence may be generally true, it is a statement that IDNS does not accept as policy. This issue was addressed in the draft IMPEP Report dated September 7,1994, and the enclosure with the October 7,1994, IDNS response, which on page 4 stated:

"Section 3.4; page 9, paragraph 12, lines 16 through 21, the review team recommended that "DRM. calibrate all survey instnamentation at a frequency at or more frequent than that required of the licensee being inspected, or only use instruments on inspections that have been calibrated within the standards applicable to the licensee. For instance, survey meters used on inspections of radiographer should be calibrated within the past 3 months." The Department is revising its regulations, as is the NRC, to change the required frequency of calibration for industrial radiography survey meters to six months rather than three months. One of the reasons is that survey instruments are more reliable now than when the regulations were originally drafted. The Department has no r  : ...

6 4

% i Comments to draft IMPEP Report Page 3 I  :

j other category oflicensee that is required to have survey meters calibrated more frequeritly than annually. The Department's many years of experience j

have proven that annual calibration is sufficient for maintaining accuracy of the instrument response for equipment used exclusively by Department staff. The Department's instruments are not subjected to the same hazards on a frequent j

basis as survey meters used by industrial radiographers. Therefore, the 4

Department will be revising its inspection procedures to state that_ "the inspector will use survey instruments that have been calibrated within the last twelve j

months." Because the Department staffinfrequently use survey meters in 1

. , environments as harsh as those in which industrial radiographers routinely use their survey meters, this policy is justified. The Department recommends that

! the NRC consider reevaluation of the NRC policy on this, because it will result

!' is cost savings with no decrease in safety."

! .An enclosure with the NRC's September 7,1995, letter to IDNS regarding this l issue in the 1994 IMPEP review quoted a portion of the above on page 5 as {'

[ follows: " Recommendation We recommend that the State calibrate all survey -

) instrumentation at a frequency at or more frequent than that required of the j licensee being inspected, or only use instruments on inspections that have been .

l calibrated within the standards applicable to the licensee. For instance, survey 3 l meters used on inspections of radiographer should be calibrated within the past 3 months."

The NRC's September 7,1995, letter to IDNS also summarized the IDNS Febmarv 1995 Resoonse as follows: "This issue was also addressed in the i j enclosure to our October 7,1994 letter. In that letter, the Department indicated l that annual calibration is sufficient for maintaining accuracy of the instruments

! l used by our inspectors. Our instrumentation is not subject to the same harsh  !

I conditions as those used by industrial radiographers or well loggers (the only j

categories of licensees with a required calibration frequency less than one .

year)."

4 l

l The NRC provided its Evaluation of Stata's Racnonne as follows: "The State's response of an annual calibration is appropriate, however, inspectors should l utilize instruments, whose calibration date is within the same time interval as 1

[ required of the licensee being inspected. His practice will preclude challenges from any licensee about the validity of survey results. His item is closed.

The Department believes, as stated above that "an annual calibration is appropriate" and that challenges with any technical merit from any licer.see i I

l l

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Comments to draft IMPEP Reput Page 4 being inspected is so improbable as to not be a logical basis for changing IDNS l policy. Therefore, the NRC should delete the last sentence of the fourth .  !

, paragraph on page 9 of its 1997 draft IMPEP Report.

I1. Page 10, Sec. 3.5, third line, after "DRM" change " Director" to " Chief" or

" manager".

12. Page 10, Sec. 3.5, third paragraph, the NRC states: "The review team i

suggests that the procedures for notifying the NRC ofincidents be revised to

!- reflect the current guidance to Agreement States to notify the NRC Headquarters Operations Center of events requiring immediate or 24-hour ,

l reporting by the licensee." IDNS prefers 'to notify our regional state '

agreements officer (RSAO) or regional liaison because those individuals are

'. more familiar with the Department's capabilities. In the event that the RSAO is i

} not available, we would consider contacting either the Operations Center or the l Office of State Progeams.

j Since events that meet the threshold for immediate reporting have the potential j for media interest, the NRC Region III office would be most appropriate for the

most timely information. Ifinformation reported to Region III is not being j forwarded to NRC Headquarters, your internal communications procedures i

should be examined. We contend that each member of the Commission staff i may represent the agency for the notification and should be competent to j- forward the events information to the appropriate individual or group.

13. Page 10, Sec. 3.5, sixth paragraph, after "DRM" change " Director" to " Chief" l or " manager".

1

14. Page' 10, Sec. 3.5, sixth paragraph, last sentence (last two lines), the NRC i states: "The review team suggests that the State reconsider the benefits of participating in the NMED system." No benefits to the citizens ofIllinois have ever been suggested by NRC to offset the burden of maintaining duplicate databases of events information. Our comments transmitted on May 24,1995, in response to SP-95-036 still hold true regarding the unnecessary detail 4

required for events and the narrow focus of the national system to by-product i material only.

i i We acknowledge that we have not tested the Access-based revision of NMED.

i Since we are currently developing an Access-based system to manage our own l licensing and inspection program, we may test the new system at some time in 1

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Comments to draft IMPEP Repon l Page 5 l'

the future. This test would only occur, however, after our new data base

! package has been fully tested and placed into service.

i 15. Page 14, Sec. 4.1.2, first and second lines, as indicated to the review team,  !

l IDNS anticipates several changes to be proposed to its regulations within the i next few months.

i

16. Page 15, Sec. 4.1.2, third paragraph, the NRC states

"found unsatisfactory i due to the State's failure to adopt the Decommissioning Recordkeeping j regulation, or equivalent legally binding requirements, within the specified j period of time." The Department takes exception to the term " unsatisfactory" '

for the finding on the Legislative and R6gulations indicator. In this instance, it is hard to believe that the Department cannot adequately protect public health '

and safety because our rules do not yet require licensees to maintain certain records. This would be akin to saying that the entire National decommissioning process prior to implementation of these recordkeeping requirements was '

inadequate. While we agree that the availability of certain records would be beneficial to regulators and the licensees when facilities are closed or decontaminated, we do not believe that all efforts prior to implementation of these requirements have been inadequate or " unsatisfactory."

For the reasons stated above, and because we have committed to proposing the necessary rule revisions within the next few months, the Department recommends a finding of " Satisfactory but Needs Improvement."

17. Page 16, Sec. 4.2.1, Technical Ouality of the Product Evaluation Prorram.

lines 4 through 16, the Department does not agree with the classification of the items noted as " major issues." The Department also does not agree with the statement that the items noted "may indicate a weakness in' the review process."

The Department believes that the conclusions drawn and the NRC's comments are not of the magnitude ressey to be included in the final report. Nearly all of these (except File No.: 6) were discussed with Mr. Lynch and resolutions agreed to during the audit. We believe that the files reviewed during this and previous IMPEP audits indicate that our reviews meet or exceed the specifications of the regulations and guidance that constitute the review process.

IDNS would like these comments amended or removed from the repon. IDNS staff has, does and will continue to make a concerted effort to document all conclusions drawn regarding, product quality and efficacy that are not evident in the file. Also, see Item 32 and 33 below for details.

l r  : l Comments to draft IMPEP Report Page 6 ,

! 18. Page 16, Sec. 4.2.2, last paragraph, second line, replace "cenified" with j registered".

19. Page 17, Sec. 4.2.2, last paragraph, this paragraph does not accurately detail the degree of experience and training or capabilities of the staff. The NRC reviewer stated "The three remaining reviewers have B.S. degrees and H.P.

training and have demonstrated to the review team an ability to identify issues 1 which need to be referred to the head reviewer or engineering support." One of the staff has an engineering degree from the University of Blinois. In addition, even the least experienced reviewer has five years experience performing SS&D reviews. Furthermore, each reviewer completes m. ore SS&D actions on an annual basis than most state programs complete during the same interval. Also, each staff member involved has attended either one or both of the two workshops that NRC and some Blinois staff presented. IDNS would I like this section revised to accurately reflect the level of training and experience ofits staff. -

20. Page 21, Sec. 5.0,

SUMMARY

NRC No.1, see IDNS Comment No.1.

NRC No. 2, see IDNS Comment No. 2.

NRC No. 3, see IDNS Comment No. 8 and 22. '

NRC No. 4, This comment should be deleted as there is no supporting observations in the body of the report.

NRC No. 5, see IDNS Comment No.12.

NRC No. 6, see IDNS Comment No.14.

NRC No. 7, see IDNS Comment No.15 and 16.

NRC No. 8, see IDNS Comments No.17 - 19, and 32 - 41.

NRC No. 9, see IDNS Comment No.17.

/ ./ ,,

( ,

Comments to draft IMPEP Report Page 7 Appendix D, License File Reviews, the NRC's reference and comment is followed by the IDNS reply.

21. Appendix D I

. File No.: 4 i i

Licensee: Knox College License No.: IL-01626-01 License type: Academic Date Issued: 12/20/96 "NRC Comments:

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

. b) Decay-in-storage license condition references generator columns which are not authorized." l IDNS Reply: 'Both of the conditions are standard conditions that were not customized to match the limited license schedule and both have been changed i by issuance of a " CORRECTED' COPY'" of the license.

22. Appendix D File No.: 6 '

Licensee: NDC Systems License No.: IL-01999-01 License Type: Seivice Date Issued: 1/15/97 "NRC 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."

IDNS Reply: This item was also noted in Section 3.3, Technical Oumlitv of Licensine Actions. on page 7 of the report. The IDNS reviewer has subsequently spoken with David Wesley of the California program where NDC's headquarters is located, and Mr. Wesley indicated that it is not a

. common practice to perform leak testing at installation. He further stated that there were no outstanding concerns in this registry which would warrant such a limitation and that the California registry will be corrected at the next amendment. The NRC should delete this comment.

O D

!, Comments to draft IMPEP Report Page 8 i

, 23. Appendix D File No.: 8

Licensee: St. Louis University j- License No.: IL-01961-01 l License Type: Portable Device l Date Issued: 4/30/%

"NRC Comments:

! a) Deficiency response letter, dated 1/2/%, not tied down.

j b) Storage security in Missouri questioned, improper jurisdiction."

i l IDNS Reply:

l a) The tie-down has been changed and a corrected copy issued.

b) The Department does not agree with the concern with requesting security >

' precautions for a source stored in another state but used in Illinois -

regardless of jurisdictional issues; If we believe there is a weakness in the licensee's program, we will point it out and, if necessary, notify the appropriate regulatory body. In this case, the device was a NARM source with little regulatory oversight at the storage location and not within NRC's jurisdiction for the IMPEP review. The NRC should delete this comment.

24. Appendix D File No.: 13 Licensee: Radiation Safety Services License No.: IL-01429-01 License Type: Service Date Issued: 1/22/97 - -

• NRC Comment:

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

IDNS Reply: This tied-down letter was found in the SS&D file during the audit and shown to Mr. Lynch. Copies also have been filed in the license file.

The NRC should delete this comment.

25. Appendix D File No.: 16 Licensee: Fox Valley Equine Clinic

../ . ...

.- 1

Comments to draft IMPEP Report

! Page 9 l

j License No.:IL-01996-01 i License Type: Veterinary Medicine Date Issued: 12/23/96

?

I

' NRC Comment:

a) Decay-in-storage license condition references generator columns which

are not authorized."

3

• l IDNS Reply: The condition is a standard condition that was not customized to

, match the limited license schedule, and it has been changed by issuance of a j " CORRECTED COPY" of the license, i

i 26. Appendix D i . File No.: 21 i

Licensee: Kerr-McGee Chemical Corp. -

License No.: STA-583 License Type: Rare Earth, Source, & 11e(2) byproduct Date Amendment Issued: 2/28/97 l "NRC Cominent:

a) Noted that the only radionuclides listed were uranium and thorium. This licensee is mainly dealing with the waste (11e(2) byproduct material) at l 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 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."

IDNS Reply: The suggestion had been implemented.

27. Appendix E, page E.5, Accompaniment No.1, item a NRC Comment: "The inspector would benefit from additional training in reciprocity issues." .

IDNS Reply: Additional training has been provided on jurisdictional issues related to reciprocal recognition oflicenses.

Comments to draft IMPEP Repon Page 10

28. Appendix E, page E.5, Accompaniment No. 2, item a NRC Comment: " Missed opportunities to question ancillary staff during inspection."

IDNS Reply: The Department appreciates the guidance the RSAO provided in

, this area.

29. Appendix E, page E.6, Accompaniment No. 3, item a NRC Comment: "The inspector would benefit from additional training in reciprocity issues." -

IDNS Reply: Additional training has been provided on jurisdictional issues related to recip{ocal recognition oflicenses.

30. Appendix F, page F.1, File No: 2, Summary, line 2 NRC Comment: ... investigator of the crash returned with a souvenir.~.."

IDNS Reply: It was not an " investigator of the crash" who returned with a souvenir. It was a DEA agent who was injured in the crash and returned with a souvenir.

31. Appendix F, page F.5, File No: 17, Summary ofIncident, line 5 l

NRC Comment: "... Licensee was fined $22,000.00."

i IDNS Reply:. The licensee was fined $11,000.00.

Appendix G, Sealed Source and Device Reviews.

32. Clarification is needed regarding the significance of many of these comments.

' Some case files were reviewed and commented on in the report but were not discussed with the reviewers at'the time of the review. Other files were reviewed and not even listed in the report. Several significant comments were made during interviews for these files with staff that did not make the report.

These included a comment regarding quality control c'iecks of suppliers components by one manufacturer and a recommendation far r.n:refacturers to j submit separate maintenance and instruction manuals for generally licensed 4

y , - . . - ,- - - . -

h-r

Comments to draft IMPEP Report ,

Page 11 l I devices so that these users will not be encouraged to perform ,

maintenance / installation that may be reserved for specifically licensed

individuals. We are not sure which files were referred to by this last sentence. -

! 33. File No.: 1 4

Registry No.: IL 0599-D-103-G

! Manufacturer: Heuft USA, Inc.

l SSD Type Gamma Fill Level Gauge l_ .Date Issued: 11/26/96 .

i 33'.a NRC Comment 1.a.: "No documentation providing justification for longer than j 6 month ~ leak test interval." '

i i

IDNS Reply: Appendix 1. of de submitted application indicates the design and j

construction of the source holder assembly and electrically controlled internal j shutter mechanism is almost identical to models 45US and 100US (i.e., IL-599-D-101-G) with the inclusion of an additional lockable manual shutter and visible

! mechanical shutter status indicator. This registry was going to be amended to j add the model Maxi 100, but the licensee decided it wanted a separate registry.

i Models 45US and 100US have been approved for a 36 month leak test i frequency since 1989.

32 Ill. Adm. Code 330.280(d)(2) allows the Department to approve a leak test frequency et intervals greater than 6 months. Item J. of that rule cites operating experience with identical devices or similarly designed and constructed devices to be one of the criteria considered in the review prior to such approval. The NRC should delete this comment.

33.b NRC Comment 1.b.: "Only operational history from 1980 for prototype testing. Prototype testing section on the sheet says "without operational problems," but information in file indicates that the shutter coils 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 e+ - - ' ' '^"

0 Comments to draft IMPEP Report Page 12

additional supporting informat

on in this area would be appropriate if the 4- manufacturer wants to use operatio~ 4 history in lieu of actual prototype testing."

! IDNS Reply: In accordance with ANSI N542, the rating for an unprotected gamma gauge source is 43333 and the rating for a source in a device is 43232.

1 The source alone meets a rating of 64344, which is above both of the ratings listed for gamma gauges. The failure rate was low and all of the failures in the i safe or closed position, with 1036 gauges in the field, the device appears

adequately field tested.

j 33.c NRC Comment 1.c.: "The sheet lists only one set of values for the external 1

radiation levels and not indicate whether the values are for the on or off position."

i IDNS Reply: The exposure rates listed in the registry indicate:

The maximum levels surrounding the device containing a 100 mci source...:

i i 5 cm 0.2 mR/hr 30 cm 20 mR/hr in front of the shutter, BKG at the sides of the

! device j

100 cm BKG

} If the maximum exposure rate at 5 cm is 0.2 mR/hr and the next measurement is listed as 20 mR/hr in front of the shutter, you should be able to determine l this is with the shutter open. Shutter open is not indicated at the 5 cm j

j measurement because the measured radiation level at that distance would not be considered ALARA with a 100 mci source. Additionally, the Department j would not issue a registry sheet for a generally licensed device measuring an l exposure rate of 20 mR/hr at 30 cm with the shutter closed.

h.

33.d NRC Comment 1.d.

"Not apparent from the file that estimated yearly doses l for GL user were calculated." .

t i

IDNS Reply: Due to similarity of this device to the Models 45US and 100US l

i with the exception that the 45US model device is approved for a higher activity i of the same radionuclide (i.e.,120 mci), these calculations were not needed j nor performed.

} ./ l

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Comments to draft IMPEP Report

Page 13 l 33.e NRC Comment 1.e.: "In QA, there is no indication that a check is being done i to ensure that the product is being manufactured accord!::g the

• formation j submitted in support of the safety evaluation."

l l IDNS Reply: This item was not discussed with the reviewer during the audit.

i The QA manual was not reviewed for this device due to the recent review of

! the QA program in its entirety in Febmary 1996 for IL-599-D-101-G and the i licensee indicating nothing had changed. A copy of the QA manual was

submitted in its entirety with this SSD request. In the QA Manual, Heuft USA,

[ Inc. has committed to performing audits of Heuft Systemtechnik GmbH and i companies supplying parts for its devices and included a checklist of the items i it.will review. Heuft USA has indicated'it will maintain records indicating the i -name of the company audited, audit results and corrective actions if problems

] exist, the signature of the individual performing the audit and the date the audit j was performed. This QA Manual is tied-down in Heuft's license and in the SS&D registry. The NRC should delete this comment.

! 33.f NRC Comment 1.f.: "Given that most GL users do not have the experience i and training required for specifically licensed device users, the device j manufacturer should provide clear instruction on the use of the device, j 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.

l Additional clarification of the user procedures should be discussed with the

~

manufacturer during the next licensing action." l

]

IDNS Reply: Page 0-4 of the Operator's Manual describes lock-out procedures. Discussions on page 3 ofletter with attachment dated October 18, j 1996, describes the physical lock-out of the shutter. Appendix 6 of this

' October 18,1996,. letter specifically indicates the lock-out procedures are to be implemented during a product jam on the conveyor. Page 0-4 of the Operator's 1

Manual submitted with letter with attachment dated July 6,1996, also addresses

! lock-out procedures including when and how they should be performed. This submittal discusses yihysically closing and locking the shutter, observance of the illuminator lights and disconnection of the power srpply. Additionally, the licensee submitted instructions (page 0-6 of the Operators Manual) to be given to the licensee ertitled, " Safety for Unusual Situations". This includes emergency procedures, which include isolating the device, cordoning off the area, performing or having someone perform an area survey, methods of determining whether or not the shutter is in the open or closed position by i.

l <

Comments to draft IMPEP Report

-Page 14

' surveys as well as the indicator light. and limiting access to the device until a

~

leak test can be performed. l The licensee has committed to providing operating and safety training to users when the device is commissioned and placed into service. Advanced training is also offered as is follow-up training. This training is clearly indicated in the SS&D registry. The NRC should delete this comment.

l 33.g NRC Comment 1.g.: "Suggest that the installaticn QA be included in the l certificate."

i IDNS Reply: This item was not discussed with the reviewer during the audit.

The comment refers to installation of the device and this registry sheet is for general licensees who are not authorized to perform installation. Only specific

licensees would be allowed to perform device installation and they should be

{ required to follow the device manufacturer's instructions. We do not see the l' benefit in adding this to the registry. The NRC should delete this comment.

,4 33.h NRC Comment 1.h.: "Suggest that the Labeling section list the pertinent j information that will be required to be placed on the label instead oflisting the

! IL regulations."

i l IDNS Reply: IDNS followed precedents set by NRC in previous registrations i

by citing the regulation. For example, the sheet in question.is for a new device based on NR-599-D-102-G dated July 29,1988,'in which on Page 3 of 7 the

NRC had cited the regulation. This is perfectly acceptable where specific i requirements are listed in the rule and generally compatible with every state.

j For specifically licensed devices the Department does list labelling requirements

, because the rules do not detail labelling for these devices to the extent that they

do for generally licensed devices. The NRC should delete this comment or consult with the states for agreement then advise all states performing SS&D j reviews that the policy regarding this matter has changed, 34 Appendix G, page G.2 3

File No.: 3 Registry No.: IIe0412-D-123-B i Manufacturer: Kay-Ray /Sensall, Inc.

SSD Type: Gamma source housing j Date Issued: 8/l1/94 t

4 Comments to draft IMPEP Report Page 15 -

NRC Comments:

"a) For the request to increase the inner diameter or the source holder tube PN 630675, 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 drawing 630-000323 Rev. 0

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 i 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."

} IDNS Reply:

j a) The wall thickness of the re-designed inner holder is still 1.7 mm of l stainless steel at its thinnest point and more than adequate to retain the source capsule in the gauging device.

! b) 1. The missing drawing has been obtained, reviewed and included in the registry file.

4 b) 2. The same statement as noted in IDNS Reply to (a) above applies. The wall thickness was reduced to 1.5 mm of stainless at its thinnest point

and should be more than enough to retain the source capsule.

b) 3. The X.38 capsule is included under the Amersham CDC.711m sources.

The CDC.711m is also approved under the Kay-Ray 7700-Y Series of sources approved for this device. We are not aware of any . 1 i

' requirement / guidance to label or make users aware of subtle changes in  !

the design of inner components, nor do we see the advantage in doing so. The inner source holder could be removed and measured to determine which version was used in the event of an incident.

la .

?.

l Comments to draft IMPEP Report  ;

Page 16 l t

35. Appendix G, page G.2 File No.: 4 Registry No.: Il-0412-D-123-B Manufacturer: Kay-Ray /Sensall, Inc.

3 SSD Type: Gamma Source Housing Date Issued: 8/11/94 NRC 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.'

IDNS Reply: Documents found in the licensing file were shown to the NRC reviewer. It was indicated that this was acceptable during the review. The NRC should delete this comment. .

36. Appendix G, page G.2 l File No.: 5 Registry No.: Il-0422-D-101-S Manufacturer: Lixi, Inc.

SSD Type: gamma gauge Date issued: 6/11/96 NRC Comments:

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

IDNS Reply:

a) The attachments are correct. Attachments 2 and 3 are diagrams of the device and were listed under the " Diagram" section of the registry.

' Attachment 1 is a description of the various models of Lixiscopes and is referenced in the " Description" section of the registry. The NRC should delete this comment.

Comments to draft IMPEP Report Page 17 b) All of these documents are included with the lice'se file for Lixi. Since j many of-the manufacturing and quality assurance issues were addressed i with the license renewal these were filed in the license file accordingly, In fact, a majority of the license file deals with device manufacturing.

i .

It was noted that the April 18,1994, letter was actually dated August 18, a 1994. This will be corrected in the registry.

37. - Appendix G, page G.2.

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File No.: 6 i Registry No.: IL-0136-S-344-S j Manufacturer: Amersham i SSD Type: Gamma Source

[

Date Issue: 9/27/95 NRC Comment:

j "a) No documentation in the file concerning void space and bubble testing" l

}

! IDNS Reply: This source was approved based on engineering analysis and j comparison with a previously approved design. Therefore, bubble testing and j void space concerns as part of prototype testing are not applicable. The NRC i should delete this comment.

l l 38. Appendix G, page G.3 i

i File No.: 7 i Registry No. IL-0136-S-913-S (replaced II.e0136-S-175-S)

Manufacture: Amersham Corp.

SSD Type: Low Energy Gamma Point Source Date Issued: 11/25/96 i

h NRC Comment:

"a) ' Request was to change the manufacturing QA procedures for use of the charcoal leak test instead of the wipe test was approved on 11/25/96, but l

I new sheet ntill had only visual, wipe, bubble, and immersion tests as the l QA listed. Charcoal test should be listed here in place of the wipe test."

IDNS Reply: This item was not discussed with the IDNS license reviewer during the IMPEP review. The original amendment request was to add a '

/ .

es,

F f< Comments to draft IMPEP Report

! Page 18 ,

4

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l charcoal test because the manufacturer suspected problems with some sources

! and wanted to add additional leak testing methods. The licensee had only two

! sources that it wanted to distribute, then it was no longer going to manufacture

, or distribute these sources. The approval of performing the charcoal tests was

! done by amending the license (i.e., tie-down letter dated August 23,1995).

Because the, licensee was adding a charcoal test, and not removing the wipe j test, there was no need to list the charcoal test in place of the wipe test.

Although the original request was to add this charcoal testing method, the licensee later requested to inactivate the sheet (i.e., the charcoal test was only for the remaining two sources). Since the sheet was inactivated, the charcoal test would not be applicable because inactivating the sheet means the licensee is no longer approved to manufacture or distribute the source; therefore, the charcoal test would not be applicable and was not added to the registry. The NRC should delete this comment.

9

39. Appendix G, page G.3 File No.: 8 Registry No.: IL-0599-D-801-G l Manufacturer: Amersham '

SSD Type: Level Gauge Date Issued: 11/94 and 2/14/95 NRC had no comments on this file.

IDNS Comment: Either the referenced registry number is incorrect or the listed manufacturer, Amersham, is incorrect. The original request of files from NRC's reviewer to our secretarial staff requested file II-599-D-102-G, Heuft USA, Inc. Model 100US. This registry had already been inactivated and was changed to IL-599-D-801-G. Model 100US was added to the IL-599-D-101-G registry. Possibly, the actual file number listed is correct but the manufacturer should be changed to Heuft USA, Inc.

40. Appendix G, page G.3 File No.: 9 Registry No.: IL-0136-S-215-S Manufacturer: Amersham

/ / .,,

3 < . .

'. I e

Comments to draft IMPEP Report Page 19 i

SSD Type: Scaled source l Date Issued: 11/1/%

j  !

NRC Commenti "a) File did not contain documentation of either the QA commitments of the  !

' second manufacturer, or a statement that the second manufacturer will

. abide by the QA commitments already in place."

I

, IDNS Reply: This file was not discussed with the IDNS license reviewer. As i

a rule, all Quality Assurance matters are completed through licensing'and tied down in the license document. This is why the documents were not found in  ;

j the registry file. The NRC should delete'this comment. )

i

41. Appendix G, page G.4 l File No.: 10

! Registry No: IL-0234-D-101-G l Manufneturer: ESC Resources

! SSD Type: Gamma gauge Date Issued: 2/15/96 i NRC 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 easily visible to the user when mounted, i b) It was not apparent from the documentation in the file that a calculation j of the estimated yearly dose to users was performed."

IDNS Reply: a) & b) This file was discussed with the IDNS reviewer but not I for the two items noted in the report. The noted points were addressed in great i detail in the application. The device has redundant on/offindicators and a consultant was hired to determine the estimated yearly dose. In fact, the dose -

was calculated using draft guidance prepared by the NRC's Steve Baggett for licensee's applying for general license distdbution. The NRC should delete this comment.

42. The NRC reviewer also reviewed II-412-D-129-B with Mary Burkhart but it does not appear in the report.

0 o

Responses to IDNS Comments on the Draft IMPEP Review Report 4

i 1-

1. Page 4, Sec. 3.1, fifth paragraph, " timeliness of the issuance of inspection findings...": The Department's goal is to dispatch inspection findings to licensees within 30 days. The Head, inspection and Enforcement has taken action to ensure i

that most written findings are dispatched accordingly. Allinspection staff were reminded of a written performance goal to submit findings to the Head, inspection and Enforcement within 15 working days following the conclusion of an inspection.

This will be more closely monitored by supervisory review. The preliminary findings j of each inspection, however, are always communicated to the licensee by the

! inspector at the end of the inspection.

Response: . No revision to report requested. Response is appropriate.

i i l

2. Page 5, Section 3.1, Status of Materials Insoection Proaram, last sentence of top i paragraph: The review team suggested that "the State should reconsider the IMC l l 1220 guidance for conducting reciprocity inspections, and increase the reciprocity )

j- inspections to meet this guidance." This suggestion is unfortunate because the j e team mentioned guidance about which the states were never given any opportunity  !

j to provide early or substantialinput. We attempted to provide written comment in  !

our letter dated November 2,1994 to Paul Lohaus regarding draft manual chapter

2800 offered for comment in SP-94-144, in this document, we commented that i the ambitious inspection plan described in IMC .1220 is extremely labor-intensive

. and fails to acknowledge the inspection activities by Agreement States of their own

licensees.

1 1

We offered a more reasonable goal that would involve 10 to 20 percent of priority 1 licensees and reactive inspections for priorities 2 through 4. Our incredulity at the 4 statement in IMC 1220 that "the proposed inspection frequencies do not pose an I

! FTE burden above that already incorporated into the current operating plan" still I

holds. We are dismayed that IMC 1220 is even mentioned in the draft report in

light of our caution against using it as a review criterion. Our position on this issue 1 is that, because the Agreement States were not offered an opportunity te  ;

, participate in the development of the procedure and our attempts to provide input during the guidance development process were rebuffed, we are not compelled to i observe its guidance. We will continue to strive to meet the alternative goal 1' described above.

Response: State's response is noted in proposed final report. The suggestion is essentially unchanged.

ATTACHMENT 2 1

..-,n.. , , .,

, , . ..---e. . . -- - ~ --n e

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3. Page 5, Sec. 3.2, third paragraph, third line, after " low level radioactive waste" add i "and uranium / thorium mill licensing". i Response: The proposed final report has been revised to reflect this correction. *

4. Page 5, Sec. 3.2, third paragraph, fifth line, the phrase "The Glen Ellyn office also provides support for the Mill Program..." needs replaced, it is the West Chicago I office of the Licensing Section which is on site providing direct oversight of licensed I activities. The Glen Ellyn office has little to do with the West Chicago mill site unless called upon for incident response.

Response: The proposed final report has been revised to reflect this correction.

5. Page 5, Sec. 3.2, third paragraoh, last line, after "DRM" change " Director" to

" Chief" or " manager".

Response: The proposed final report has been, revised to reflect this correction. l

6. Page 5, Sec. 3.2, fourth paragraph, second line, the phrase " entry level are required to have a baccalaureate degree..." is accurate for the health physicist and engineer positions in the Division of Radioactive Materials but not for all the technical positions in the' Department. The sentence should be rephrased to be accurate for I all positions or should address only the health physicists and engineers positions.

l Response: The proposed final report has been revised to reflect this correction.

7. Page 6, Sec. 3.3, first paragraph, second line, change " isotopes" to " radionuclides" to be technically correct.

Response: The proposed final report has been revised to reflect this correction.

8. Page 7, Sec. 3.3, second paragraph, this paragraph should be removed from the report. The SS&D in question has been determined to be in error by the State of California. There are very few instances,if any, where sealed sources have to be leak tested at installation as opposed to within six months prior to use. Also, see IDNS Comment No. 22 for details.

Response: Paragraph remains in report, however main report and Appendix D File No. 6, have been revised to mention information received from California. Report revised as follows:

After the review, IDNS contacted the State of California and determined that the SS&D registry sheet inappropriately required leak testing of gauges at installation. California will correct the sheet at the next amendment.

Note: Also see IDNS comment #22.

2

4' '9. Page.8, Sec. 3.4, second paragraph, after "DRM" change " Director" to " Chief" or i

" manager".  ;

Response: The proposed final report has been revised to reflect this correction. ,

10. Page 9, Sec. 3 A, fourth paragraph, last sentence, while this sentence may be  !

generally true, it is a statement that IDNS does not accept as policy. This issue l was addressed in the draft IMPEP Report dated September 7,1994, and the enclosure with the October 7,1994,IDNS response, which on page 4 stated:

"Section 3.4; page 9, paragraph 12, lines 16 through 21, the review team recommended that "DRM calibrate all survey instrumentation at a frequency at or more frequent than that required of the licensee being inspected, or only use instruments on inspections that have been calibrated within the standards applicable to the licensee. For instance, survey meters used on inspections of radiographer should be calibrated within the past 3 months." The Department is revising its regulations, as is the NRC, to change the required frequency of calibration for -

industrial radiography survey meters to six months'rather than three months. One l of the reasons is that survey instruments are more reliable now than when the regulations were originally drafted. The Depar'tment has no other category of licensee that is required to have survey meters calibrated more frequently than  !

annually. The Department's many years of experience have proven that annual calibration is sufficient for maintaining accuracy of the instrument response for equipment used exclusively by Department staff. The Department's instruments are not subjected to the same hazards on a frequent basis as survey meters used by industrial radiographers. Therefore, the Department will be revising its inspection procedures to state that "the inspector will use survey instruments that have been  !

calibrated within the last twelve months." Because the Department' staff -

infrequently use survey meters in environments as harsh as those in which industrial radiographers routinely use their survey meters, this policy is justified. .The Department recommends that the NRC consider reevaluation of the NRC policy on this, because it will result is cost savings with no decrease in safety."

An enclosure with the NRC's September 7,1995, letter to IDNS regarding this issue in the 1994 IMPEP review quoted a portion of the above on page 5 as follows:

" Recommendation We recommend that the State calibrate all survey instrumentation at a frequency at or more frequent than that required of the licensee being inspected, or only use instruments on inspections that have been calibrated within the standards applicable to the licensee. For instance, survey meters used on inspections of radiographer should be calibrated within the past 3 months."

The NRC's September 7,1995, letter to IDNS also summarized the IDNS Februarv j 1995 Resoonse as follows: "This issue was also addressed in the enclosure to our October 7,1994 letter. In that ;etter, the Department indicated that annual calibration is sufficient for maintaining accuracy of the instruments used by our  !

inspectors. Our instrumentation is not subject to the same harsh conditions as those used by industrial radiographers or wellloggers (the only categories of licensees with a required calibration frequency less than one year)."

3

f- .

The NRC provided its Evaluation of Statai s Resoonse as follows: "The State's

! response of an annual calibration is appropriate, however, inspectors should utilize instruments, whose calibration date is within the same time interval as required of the licensee being inspected. This practice will preclude challenges from any '

licensee about the validity of survey results. This item is closed.

The Department believes, as stated above that "an annual calibration is appropriate" and that challenges with any technical merit from any licensee being inspected is so improbable as to not be a logical basis for changing IDNS policy. Therefore, the i NRC should delete the last sentence of the fourth paragraph on page 9 of its 1997 draft IMPEP Report.~

!' Response: This comment has been adopted and the proposed final has bean revised to eliminate the sentence.

j. 11. Page 10, Sec. 3.5, third line, after "DRM" cl'ange " Director" to " Chief" or

" manager",

b Response: The proposed final report has been avised to reflect this correction.

12. Page 10, Sec. 3.5, third paragraph, the NRC states: "The review team suggests that the procedures for notifying the 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." IDNS j prefers to notify our regional state agreements officer (RSAO) or regional liaison because those individuals are more familiar with the Department's capabilities. In the event that the RSAO is not available, we would consider contacting either the i

- Operations Center or the Office of State Programs.

Since events that meet the threshold for immediate reporting have the potential for -

media interest, the NRC Region 111 office would be most appropriate for the most ,

timely information. If information reported to Region ill is not being forwarded to NRC Headquarters, your internal communications procedures should be examined.

We contend that each member of the Commission staff may represent the agency for the notification and should be competent to forward the events information to .

the appropriate individual or group. '

Response: The IMPEP team continues to believe that the advantages associated with notification to the Headquarters Operations Center support the suggestion.

These advantages include the ability to notify NRC around the clock and the availability of an extensive communications network that can be used to facilitate exchange of information between the State and NRC.

13. - Page 10, Sec. 3.5, sixth paragraph, after "DRM" change " Director" to " Chief" or

" manager".

Response: The proposed final report has been revised to reflect this correction.

4

O

14. Page 10, Sec. 3.5, sixth paragraph, last sentence (last two lines), the NRC states:

j "The review team suggests that the State reconsider the benefits of participating in j the NMED system." No benefits to the citizens of Illinois have ever been suggested by NRC to offset the burden of maintaining duplicate databases of events .

., information. Our comments transmitted on May 24,1995,in response to SP 95- I

! 036 still hold true regarding the unnecessary detail required for events and the

narrow focus of the national system to by-product material only.

We acknowledge that we have not tested the Access-based revision of NMED.

l Since we are currently developing an Access-based system to manage our own i

licensing and inspection program, we may test the new system at some time in the future. ' This test would only occur, however, after our new data base package has been fully tested and placed into service.

!l ..

1:

t Response: No action taken. Reporting of event informatio.n to NRC by methods other-than NMED is acceptable.

i l .15. P, age 14, Sec. 4.1.2, first and second lines, as indicated to the review team, IDNS  :

l anticipates several changes to be proposed to its regulations within the next few j

months.

Response: No action taken. Anticipated changes do not affect IMPEP findings.

16.- Page 15, Sec. 4.1.2, third paragraph, the NRC states: "found unsatisfactory due to the State's failure to adopt the Decommissioning Record keeping regulation, or equivalent legally binding requirements, within the specified period of time." The Department takes exception to the term " unsatisfactory" for the finding on the Legislative and Regulations indicator, in this instance, it is hard to believe that the Department cannot adequately protect public health and safety because our rules do

- not yet require licensees to maintain certain records. This would be akin to saying that the entire National decommissioning process prior to implementation of these record keeping requirements was inadequate. While we agree that the availability of certain records would be beneficial to regulators and the licensees when facilities are closed or decontaminated, we do not believe that all efforts prior to implementation of these requirements have been inadequate or " unsatisfactory."

For the reasons stated above, and because we have committed to proposing the necessary rule revisions within the next few months, the Department recommends a  :

finding of "Satisf actory but Needs improvement."

Response: Finding not changed. State's response to the draft report has been summarized in proposed final report.

17. Page 16, Sec. 4.2.1, Technical Quality of the Product Evaluation Proaram, lines 4 through 16, the Department does not agree with the classification of the items I noted as " major issues." The Department also does not agree with the statement that the items noted "may indicate a weakness in the review process." The Department believes that the conclusions drawn and the NRC's comments are not 5

~ ,

of the magnitude necessary to be included in the final report. Nearly all of these (except File No.: 6) were discussed with Mr. Lynch and resolutions agreed to during the audit. We believe that the files reviewed during this and previous IMPEP audits indicate that our reviews meet or exceed the specifications of the regulations and '

guidance that constitute the review process. IDNS would like these comments 1 amended or removed from the report. IDNS staff has, does and will continue to make a concerted effort to document all conclusions drawn regarding product quality and efficacy that are not evident in the file. Also, see item 32 and 33 below ]

for details.

l Response: No action taken. It was the decision of the IMPEP team that these deficiencies should be included in the report. The IMPEP team believes the text of the report accurately describes their assessment.

18. Page 16, Sec. 4.2.2,last paragraph, second line, replace " certified" with

" registered".

Response: The proposed final report has been revised to reflect this correction.

19. Page 17, Sec. 4.2.2,last paragraph, this paragraph does not accurately detail the degree of experience and training or capabilities of the staff: The NRC reviewer stated "The three remaining reviewers have B.S. degrees and H.P. training and have dernonstrated to the review team an ability to identify issues which need to be referred to the head reviewer or engineering support." One of the staff has an engineering degree from the University of Illinois. In a'ddition, even the least experienced reviewer has five years experience performing SS&D reviews.

Furthermore, each reviewer completes more SS&D actions on an annual basis than most state programs complete during the same interval. Also, each staff member involved has attended either one or both of the two workshops that NRC and some Illinois staff presented. IDNS would like-this section revised to accurately reflect the level of training and experience of its staff.

Response: The paragraph has been rewritten in the report:

The head reviewer has a B.S. in Biology, and has 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 a B.S. in bioengineering (providing some background in mechanics and materials), a B.S. In Health Physics, and a B.S. In Health Care /A.A.S. in Radiological Physics. The licensing head, who supervises the reviewers, has a B.A. in Microbiology and a M.S. in Health Care Management. All members are trained in health physics principles and have attended at least one SS&D workshop. There have been no new hires of staff involved in the SS&D Evaluation Program since the last program review.

6

20. Page 21, Sec. 5.0,

SUMMARY

No.1, see IDNS Comment No.1.

No. 2, see IDNS Comment No. 2. .

No. 3, see IDNS Comment No. 8 and 22.

No. 4, This comment should be deleted as there is no supporting observations in the body of the repon.

No. 5, see IDNS Comment No.12.

No. 6, see IDNS Comment No.14.

No. 7, see IDNS Comment No.15 and 16.

No. 8, see IDNS Comments No.17 - 19, and 32 - 41.

No. 9, see IDNS Comment No.17.

Response: See the individual responses to each of the comments. Supporting observations for No. 4 can be found in the second paragraph of page 9.

Appendix D, License File Reviews, the NRC's reference and comment is followed by the IDNS reply.

21. Appe idix D F H < Q .: 4 f a ensee: Knox College a anse No.: IL-01626-01

' :ense type: Academic Date issued: 12/20/96 NRC Comments:

"a) License Conditions 4.B and 4.D are redundant, b) Decay-in-storage license condition references generator columns which are not authorized."

IDNS Reply: Both of the conditions are standard conditions that were not customized to match the limited license schedule and both have been changed by issuance of a " CORRECTED COPY" of the license.

Response: No revision requested. Response is appropriate.

22. Appendix D File No.: 6 Licensee: NDC Systems License No.: IL-01999-01 License Type: Service Date issued: 1/15/97 NRC 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."

7

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l

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IDNS Reply: This item was also noted in Section 3.3,lechnical Quality of Licensina Actions, on page 7 of the report. The IDNS reviewer has subsequently spoken with l David Wesley of the California program where NDC's headquarters is located, and l Mr. Wesley indicated that it is not a common practice to perform leak testing at .

, installation. He further stated that there were no outstanding concerns in this registry which would warrant such a limitation and that the California registry will  ;

be corrected at the next amendment. The NRC should delete this comment. i

)

. Response: Paragraph remains in report, however main report and Appendix D File No. 6, )

have been revised to mention information received from California. Report l revised as follows:

I After the review, IDNS contacted the State of California and  ;

determined that the SS&D registry sheet inappropriately required leak l testing of gauges at installation. California will' correct the sheet at I the next amendn ent.

Note: Also see IDNS comment #8.'

23. Appendix D  !

File No.: 8 l 4 Licensee: St. Louis University License No.: IL-01961-01 License Type: Portable Device Date issued: 4/30/96 NRC Comments: I "a) Deficiency response letter, dated 1/2/96, not tied down.

b) Storage security in Missouri questioned, improper jurisdiction."

lDNS Reply:

a) The tie-down has been changed and a corrected copy issued.

b) The Department does not agree with the concern with requesting security precautions for a source stored in another state but used in Illinois regardless of jurisdictionalissues. If we believe there is a weakness in the licensee's program, we will point it out and, if necessary, notify the appropriate rsgulatory body. In this case, the device was a NARM source with little regulatory oversight at the storage location and not within NRC's jurisdiction for the IMPEP review. The NRC should delete this comment.

Response: The proposed final report has been revised to reflect this correction.

8

o a

. ~ 24. Appendix D j File No.: 13 Licensee: Radiation Safety Services 1 License No.: it-01429 01

• i License Type: Service Date issued: 1/22/97 i.

1 NRC Comment:

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

IDNS Reply: This tied-down letter was found in the SS&D file during the audit and shown to Mr. Lynch. Copies also have been filed in the license file. Ths NRC j should delete this comment.

Response: Report modified. After considering IDNS comment, Appendix G, File No.13 comment was removed from the report.

4

25. Appendix D File No.: 16 I- Licensee: Fox Valley Equine Clinic

License No.

ll-01996-01 License Type: Veterinary Medicine Date issued: 12/23/96 l

1:

i NRC Comment:

"a) Decay-in-storage license condition references generator columns which are

[

i not authorized."

i IDNS Reply: The condition is a standard condition that was not customized to 4

match the limited license schedule, and it has been changed by issuance of a i " CORRECTED COPY" of the license.

Response: No revision to report raquested. Response is appropriate.

4

- 26. Appendix D File No.

21 i Licensee: Kerr-McGee Chemical Corp.

License No.: STA 583 License Type: Rare Earth, Source, & 11e(2) byproduct Date Amendment issued: 2/28/97 j' NRC Comment:

{~ "a) Noted that the only radionuciides listed were uranium and thorium. This licensee is mainly dealing with the waste (11e(2) 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 though they are not listed under the i radionuclides. Suggested the phrase, 'and their daughters,' be added to the i

9 4

[ ..

3 . w .-

7 y y. - 7.+-

list of radionuclides to make it explicit they are licensed radionuclides."

IDNS Reply: The suggestion had been implemented.

Response: No revision to report requested. Response is appropriate.

27. Appendix E, page E.5,' Accompaniment No.1, item a NRC Comment: "The inspector would benefit from additional training in reciprocity j issues "

j IDNS Reply: Additional training has been provided on jurisdictional issues related to

- reciprocal recognition of licenses.

Response: No revision to report requested. Response is appropriate.

28. Appendix E, page E.5, Accompaniment No. 2, item a NRC Comment: " Missed opportunities to question ancillary staff during inspection."

9 IDNS Reply: The Department appreciates the guidance the RSAO provided in this area.

Response: No action taken.

29. Appendix E, page E.6, Accompaniment No. 3, item a NRC Comment: "The inspector would benefit from additional training in reciprocity issues."

IDNS Reply: Additional training has been provided on jurisdictionalissues related to reciprocal recognition of licenses.

Response: No revision to report requested. Response is appropriate.

30.' Appendix F, page F.1, File No: 2, Summary,line 2 NRC Comment: "... investigator of the crash returned'with a souvenir..."

IDNS Reply: It was not an " investigator of the crash" who returned with a souvenir. It was a DEA agent who was injured in the crash and returned with a souvenir.

- Response: The proposed final report has been revised to reflect this correction.

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j 31. Appendix F, page F.5, File No: 17, Summary of incident, line 5 .

l, NRC Comment: "... Licensee was fined $22,000.00."

[ IDNS Replyr The licensee was fined $11,000.00.

Response: The proposed final report has been revised to reflect this correction.

Appendix G, Sealed Source and Device ReviewL

32. Clarification is needed regarding the significance of many of these comments.

! Some case files were reviewed and commented on in the report but were not

discussed with the reviewers at the time of the review. Other files were reviewed l and not even listed in the report. ' Several significant comments were made during j interviews for these files with staff that did not make the report. These included a j comment regarding quality control checks of suppliers components by one j' manufacturer and a recommendation for manufacturers to submit separate j- maintenance and instruction manuals for generally licensed devices so that these .

users will not be encouraged to perform maintenance / installation that may be

reserved for specifically licensed individuals. We are not sure which files were l referred to by this last sentence.

i Response: No action taken. Some points were mentioned but not discussed in detail,

! due to the type of comment or the fact that the same issue had already been

' discussed with respect to another file. Some of the files that were on the lilinois list and pulled for review were NARM. Also, some of the files were for cases where review had begun, then the request was withdrawn.

33. File No.: 1 Registry No.: IL-0599-D 103-G Manuf acturer: Heuft USA, Inc.

SSD Type: Gamma Fill Level Gauge Date issued: 11/26/96 33.a NRC Comment 1.a.: "No documentation providing justification for longer than 6 month leak test interval."

IDNS Reply: Append!x 1. of the submitted application indicates the design and construction of the source holder assembly and electrically controlled internal shutter mechanism is almost identical to models 45US and 100US (i.e., IL-599-D-101-G) with the inclusion of an additionallockable manual shutter and visible mechanical shutter status indicator. This registry was going to be amended to add the model Maxi 100, but the licensee decided it wanted a' separate registry. Models 45US and 100US have been approved for a 36-month leak test frequency since 1989.

32 Ill. Adm. Code 330.280(d)(2) allows the Department to approve a leak test frequency at intervals greater than 6 months. Item J. of that rule cites operating 11

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e- experience with identical devices or similarly designed and constructed devices to be one of the criteria considered in the review prior to such approval. The NRC should delete this comment.

Response: Report modified. New paragraph is as follows:

Registry file did not contain documentation of the justification for a leak test frequency longer than 6 months. Information provided by

- the State of Illinois staff subsequent to the IMPEP review indicated that the 36-month frequency was approved based on comparison with sirnilar mcdel devices that were already approved for the 36-month frequency.. The IMPEP team suggests that the basis for the decision to allow the longer frequency be documented in the registry file.

33.b NRC Comment 1.b.: "Only operational history from 1980 for prototype testing.

Prototype testing section on the sheet says "without operational problems," but information in file indicates that the shutter coils 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."

IDNS Reply: In accordance with ANSI N542, the rating for an unprotected gamma gauge source is 43333 and the rating for_a source in a device is 43232. The source alone meets a rating of 64344, which is above both of the ratings listed for gamma gauges. The failure rate was low and all of the failures in the safe or closed

position, with 1036 gauges in the field, the device appears adequately field tested.

l Response: No action taken. The fact that the source meets the expected conditions of use does not address the fact that the design as approved was intended to l control exposure as well as release of material. Though the failure rate for 1

that type of failure is low, the operational history in the file does not appear to be equivalent to full prototype testing (drop, impact, shutter test).

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' 33.c NRC Comment 1.c.: "The sheet lists only one set of values for the external

radiation levels and not indicate whether the values are for the on or off position."

! IDNS Reply: The exposure rates listed in the registry indicate: *

} The maximum levels surrounding the device containing a 100 mci source...:

{ 5cm 0.2 mR/hr 30 cm - 20 mR/hr in front of the shutter, BKG at the sides of the device 100 cm BKG l If the maximum exposure rate at 5'cm is 0.2 mR/hr and the next measurement is i listed as 20 mR/hr in front of the shutter,' you should be able to determine this is l with the shutter open. Shutter open is not indicated at the 5 cm measurement j- because the measured radiation level at that distance would not be considered l

ALARA with a 100 mci source. Additionally, the Department would not issue a l registry sheet for a generally licensed device measuring an exposure rate of 20 l I mR/hr at 30 cm with the shutter closed.

Response: Report modified. New text is as follows:

Registry sheet does not list external radiation levels for both open and closed shutter positions. The IMPEP team suggests that the levels should be listed at three distances from the surface of the device, p with the shutter both in the open and closed positions. For ALARA considerations, these levels can be calculated.

33.d NRC Comment 1.d.: "Not apparent from the file that estimated yearly doses for GL user were calculated."

IDNS Reply: . Due to similarity of this device to the Models 45US and 100US with the exception that the 45US model device is approved for a higher activity of the same radionuclide (i.e.,120 mci), thete calculations were not needed nor performed.

Response: No action taken. The IMPEP review team believes that this comparison is an acceptable practice; however, it should be documented in the file.

33.e ~ NRC Comment 1.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."

.IDNS Reply: This item was not discussed with the reviewer during the audit. The QA manual was not reviewed for this device due to the recent review of the QA program in its entirety in February 1996 for IL-599-D 101-G and the licensee indicating nothing had changed. A copy of the QA manual was submitted in its entirety with this SSD request. In the QA Manual, Heuft USA, Inc. has committed to performing audits of Heuft Systemtechnik GmbH and companies supplying parts for its devices and included a checklist of the items it will review. Heuft USA has 13 l

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- indicated it will maintain records indicating the name of the company audited, audit

. results and corrective actions if problems exist, the signature of the individual

performing the audit and the date the audit was performed. This QA Manual is tied-down in Heuft's license and in the SS&D registry. The NRC should delete this ,

comment.

4 Response: Report modified. New text is as follows:

Upon initial review, there was no indication that a check was being

done to ensure that the product was being manufactured according to the information submittod in support of the safety evaluation.

Information provided by State of Illinois staff subsequent to the IMPEP review indicated that the distributor's QA program was approved in 1

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conjunction with another registry sheet (IL-0599-D-101-G), and that theinanufacture and distribution of the device on the 103 sheet would be included in that program. It does not appear that the 103 file or registry sheet reflected this apparent change in QA procedures.

33.f NRC Comment 1.f.: "Given that most GL users do not have the experience and training required for specifically licensed device users, the device manufacturer should provide clear instruction on the use of the device, including the " shutter lock-out" procedure that is needed 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."

IDNS Reply: Page 0-4 of the Operator's Manual describes lock-out procedures.

Discussions on page 3 of letter with attachment dated October 18,1996, describes the physicallock-out of the shutter. Appendix 6 of this October 18,1996, letter specifically indicates the lock out procedures are to be implemented during a product jam on the conveyor. Page 0-4 of the Operator's Manual submitted with letter with attachment dated July 6,1996, also addresses lock-out procedures including when and how they should be performed. This submittaldiscusses 1 physically closing and locking the shutter, observance of the illuminator lights and disconnection of the power supply. Additionally, the licensee submitted instructions (page 0-6 of the Operators Manual) to be given to the licensee entitled, " Safety for Unusual Situations". This includes emergency procedures, which include isolating the device, cordoning off the area, performing or having someone perform an area survey, methods of determining whether or not the shutter is in the open or closed position by surveys as well as the indicator light, and limiting access to the device until a leak test can be performed. j The licensee has committed to providing operating and safety training to users 'j when the device is commissioned and placed into service. Advanced training is also  :

offered as is follow up training. This training is clearly indicated in the SS&D i registry. The NRC should delete this comment.  !

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!~ Response: Information detailing lock out procedures for the GL user were not found in the file at the time of inspection. On 6/9/97 the State was asked to provide this information. Based on information provided by the State on 6/24/97, which is in the SS&D file, this comment has been deleted from the proposed

• final report.

33.g NRC Comment 1.g.: "Suggest that the installation QA be included in the certificate."

l IDNS Reply:- This item was not discussed with the reviewer'during the audit. The comment refers to installation of the device and this registry sheet is for general licensees who are not authorized to perform installation. Only. specific licensees l would be allowed to perform device installation and they should be required to follow the device manufacturer's instructions. We do not see the benefit in adding this to the registry. The NRC should delete this comment.

Response: After considering IDNS comment, Appendix G, File No.1 NRC comment (g) I was removed from the report. l 33.h _ NRC Comment 1.h.: "Suggest that the Labeling section list the pertinent  !

information that will be required to be placed on the label instead of listing the IDNS regulations."

IDNS Reply: IDNS followed precedents set by NRC in previous registrations by citing the regulation. For example, the sheet in question is for a new device based on NR-599-D-102-G dated July 29,1988,in which on Page 3 of 7 the NRC had cited the regulation. This is perfectly acceptable where specific requirements are listed in the rule and generally compatible with every state. For specifically licensed devices the Department does list labeling requirements because the rules do not detail labeling for these devices to the extent that they do for generally licensed i devices. The NRC should delete this comment or consult with the states for i agreement then advise all states performing SS&D reviews that the policy regarding  !

this matter has changed. -

Response: No action taken. The IMPEP review team believes that listing the pertinent -

labeling information facilitates the use of the registration sheets by license reviewers and inspectors outside Illinois' juri:, diction. This is the approach discussed in NUREG 1550," Standard Review Plan for Applications for ,

Sealed Source and Device Evaluations and Registrations," Section 7.4, dated l November 1996.

- 34. Appendix G, page G.2 File No.: 3 Registry No.: IL-0412 D-123 B Manuf acturer: Kay-Ray /Sensall, Inc.

SSD Type: Gamma source housing Date Issued: 8/11/94 15 t ./

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"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 l reduced wall thickness and any adverse effects it may have on the integrity *

] 'of the holder and its ability to perform throughout its lifetime. 1 b) For the request to modify the 7064/7064Psource housing tube to I accommodate the larger Amersham X.38 capsule,

1. Missing drawing 630-000323Rev. 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.

4 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 l version from the others with the originally approved source capsule."

L IDNS Reply:

j' a) The wall thickness of the re-designed inner holder is still 1.7 mm of stainless

steel at its thinnest point and more than adequate to retain the source capsule in the gauging device. l 4

, Response: No action taken. No revision to report requested. Response is appropriate.

{. This determination and asscoiated analysis should be included in the file.

i s- b) 1. The missing drawing has been obtained, reviewed and included in the

[ registry file.

Response: No revision to report requested. Response is appropriate.

1 b) 2. The same statement as noted in IDNS Reply to (a) above applies. The wall

. thickness was reduced to 1.5 mm of stainless at its thinnest point and ,

should be more than enough to retain the source capsule.

! Response: No action taken. No revision to report requested. Response is appropriate.

This determination and associated analysis should be included in the file.

!- b) 3. The X.38 capsule is included under the Amersham CDC.711m sources. The CDC.711m is also approved under the Kay-Ray 7700-Y Series of sources

, approved for this device. We are not aware of any requirement / guidance to

, label or make users aware of subtle changes in the design of inner components, nor do we see the advantage in doing so. The inner source

! holder could be removed and measured to determine which version was used

! in the event of an incident.

Response: - After considering IDNS comment, Appendix G, File No. 3 NRC comment (b)(3) was removed from the report.

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35. Appendix G, page G.2 File No.: 4 i Registry No.: ll-0412-D-123-B '

Manufacturer: Kay-Ray /Sensall, Inc.

SSD Type: Gamma Source Housing Date issued: 8/11/94 NRC 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."

IDNS Reply: Documents found in the licensing file were shown to the NRC reviewer. It was indicated that this was acceptable during the review. The NRC should delete this comment.

1 Response: Report modified. New text is as follows:

4 Registry file did not contain any documentation regarding approval of an additional source model. The information (applicant letter dated 5/6/96 and the reviewer's " Reviewer Notes" sheet dated 6/5/96) was found in the license file. The IMPEP review team suggests copies of this information be placed in the registry file. NOTE: IDNS comment i letter incorrectly refers to registry number IL-0412-D 123 B. It should j be IL-0353-D-101-G.

36. Appendix G, page G.2 I

File No.: 5

Registry No.

li-0422 D-101-S i Manufacturer: Lixi, Inc.

SSD Type: gamma gauge Date issued: 6/11/96 NRC 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."

IDNS Reply:

a) The attachments are correct. Attachments 2 and 3 are diagrams of the device and were listed under the " Diagram" section of the registry.

Attachment 1 is a description of the various models of Lixiscopes and is referenced in the " Description" section of the registry. The NRC should delete this comment.

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_ Response: After considering IDNS comment, Appendix G, File No. 5 NRC comment (a) 1 was removed from the report.

b) All of these documents are included with the license file for Lixi. Since many

• of the manufacturing and quality assurance issues were addressed with the

. license renewal these were filed in the license file accordingly. In fact, a majority of the license file deals with device manufacturing.

It was noted that the April 18,1994, letter was actually dated August 18, 1994. This will be corrected in the registry.

l - Response: Report modified.~ New text is as follows:

i Registry file did not contain 12/93 application or the letters dated 4/18/94 and 5/11/96. These letters were found in the license file.

. The IMPEP. team suggests copies of this information be placed in the

. registry file.

j 37. Appendix G, page G.2.

b File No.: 6 -

Registry No.: IL-0136-S-344-S Manufacturer: Amersham a SSD Type: Gamma Source  ;

Date issue: 9/27/95 l

NRC Comment:

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

IDNS Reply: This source was approved based on engineering analysis ,and comparison with a previously approved design. Therefore, bubble testing and void space concerns as part of prototype testing are not applicable. The NRC should delete this comment.

Response: Report modified. New text is as follows:

No documentation in registry file concerning void space and bubble testing. Information provided by State of Illinois staff subsequent to the IMPEP review indicated that this source was approved based on engineering analysis and comparison with a previously tested source, and therefore, the bubble testing and void space concerns as a part of prototype testing are not applicable. The IMPEP team suggests that all information which is used to reach a determination that the source (or device) under evaluation is acceptable for use, that is not represented in correspondence from the applicant, be clearly documented in a " Reviewer Note" in the registry file.

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38. Appendix G, page G.3 '

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

Manufacture: Amersham Corp.

SSD Type: Low Energy Gamma Point Source Date issued: 11/25/96 NRC Comment:

"a) Request was to change the manufacturing QA procedures for use of the charcoalleak 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 should be listed here in place of the wipe test."

IDNS Reply: This item was not discussed with the IDNS license reviewer during the l IMPEP review. The original amendment request was to add a charcoal test because the manufacturer suspected problems with some sources and wanted to add additional leak testing methods. The licensee had only two sources that it wanted to distribute, then it was no longer going to manufacture or distribute these sources. The approval of performing the charcoal tests was done by amending the license (i.e., tie down letter dated August 23,1995). Because the licensee was I adding a charcoal test, and not removing the wipe test, there was no need to list the charcoal test in place of the wipe test.

Although the original request was to add this charcoal testing method, the licensee later requested to inactivate the sheet (i.e., the charcoal test was only for the remaining two sources). Since the sheet was inactivated, the charcoal test would  !

not be applicable because inactivating the sheet means the licensee is no longer approved to manufacture or distribute the source; therefore, the charcoal test would not be applicable and was not added to the registry. The NRC should delete this comment.

Response: No action taken. Although the sheet has since been inactivated, the IMPEP review team believes that registration sheets should reflect accurate information.

39. Appendix G, page G.3 File No.: 8 Registry No.: IL-0599-D-801-G Manufacturer: Amersham SSD Type: Level Gauge Date issued: 11/94 and 2/14/95 NRC had no comments on this file.

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1 IDNS Comment: Either the referenced registry number is incorrect or the listed

^

manufacturer, Amersham, is incorrect. The original request of files from NRC's reviewer to our secretarial staff requested file IL-599-D-102-G, Heuft USA, Inc.

Model 100US. This registry had already been inactivated and was changed to IL-

• 599 D 801 G. Model 100US was added to the IL 599-D 101-G registry. Possibly, the actual file number listed is correct but the manufacturer should be changed to Heuf t USA, Inc.

Response: The proposed final report has been revised to reflect this correction.

40. Appendix G, page G.3 File No.: 9 Registry No.: IL-0136-S 215-S Manufacturer: Amersham SSD Type: Sealed source Date issued: 11/1/96 ,

4 NRC Comment:

"a) File did not contain documentation of either the QA commitments of the ,

second manufacturer, or a statement that the second manufacturer will abide '

by the QA commitments already in place."

IDNS Reply: This file was not discussed with the IDNS license reviewer. As a rule, all Quality Assurance matters are completed through licensing and tied down in the license document. This is why the documents were not found in the registry file.

The NRC should delete this comment.

Response: Report modified. New text is as follows:

Registry file did not contain documentation of either the QA commitments of the second manufacturer, or a statement that the second manufacturer will abide by the QA commitments already in place. Information provided by the State of Illinois staff subsequent to the IMPEP review indicated that this information is contained in the license file. The IMPEP team suggests copies of these be placed in the registry file.

41. Appendix G, page G.4 Fila No.: 10 Registry No: IL-0234-D-101-G Manufacturer: ESC Resources SSD Type: Gamma gauge Date issued: 2/15/96 20

c. ,

W NRC Comments:

"a) Application says that the user needs to use a mirror to view the mechanical onloff indicator. Suggest that this indicator should be in a location on the device that is easily visible to the user when mounted. ,

b) It was not apparent from the documentation in the file that a calculation of the estimated yearly dose to users we performed."

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IDf JS Reply: a) & b) This file was discussed with the IDNS reviewer but not for the two items noted in the report. The noted points were addressed in great detailin the application. The device has redundant on/off indicators and a consultant was hired to determine the estimated yearly dose. In fact, the dose was calculated j

using draft guidance prepared by the NRC's Steve Baggett for licensee's applying

] for general license distribution. The NRC should delete this comment.

Response

(a) Based on information provided by the State on 6/24/97, which is in the SS&D file, this comment has been deleted from the proposed final

report.

, Response: (b) These calculations were not found in the file at the time of the review. On 6/9/97 the State was asked to provide this information.

i Based on information provided by the State on 6/24/97, which is in the SS&D file, this comment has been deleted from the proposed final report.

42. The NRC revie wer also reviewed IL-412-D-129-B with Mary Burkhart but it does not appear in the report.

Response

No action taken. File IL-0412-D 129-B was not included in the IMPEP repc 1 because the rpplicant withdrew their request before the review was finished, and the certificate was issued. Therefore, this was not a completed case.

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