ML20134B452
| ML20134B452 | |
| Person / Time | |
|---|---|
| Issue date: | 01/13/1997 |
| From: | NRC |
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| NUDOCS 9701300106 | |
| Download: ML20134B452 (103) | |
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1 INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW OF NEBRASKA AGREE!AENT STATE PROGRAM JULY 15-19,1996 l
PROPOSED FINAL REPORT i
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i U. S. Nuclear Regulatory Commission l
01/13/97 ATTACHMENT 1 9701300106 970116 PDR STPRQ ESGNEP%
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1.0 INTRODUCTION
4 This report presents the results of the review of the Nebraska radiation control program.
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The review was conducted during the period July 15 19,1996, by a review team comprised of technical staff members from the Nuclear Regulatory Commission (NRC) and the Agreement State of Colorado. Team members are identified in Appendix A. The review was conducted in accordance with the " Interim implementation of the Integrated Materials Performance Evaluation Program Pending Final Commission Approval of the 1
Statement of Principles and Policy for the Agreement State Program and the Policy Statement on Adequacy and Compatibility of Agreement State Programs," published in the Federal Register on October 25,1995, and the September 12,1995, NRC Management Directive 5.6, " integrated Materials Performance Evaluation Program (IMPEP)." Preliminary results of the review, which covered the period June 25,1994-July 12,1996, were discussed with Nebraska management on July 19,1996.
(Paragraph on Results of MRB meeting will be included in final report. Attachment 1, l
State's response will be included in final report.)
The Nebraska Department of Health (NDOH) is the agency within the State of Nebraska government that regulates, among other public health issues, radiation hazards. The l
Director, NDOH, is appointed by, and reports directly to, the Governor. Within NDOH, the i
Nebraska radiation control program, excluding X ray, is administered by the Division of 4
Environmental Health, under the Environmental Health Protection Section (EHPS). The Department of Health and the Environmental Health Protection Section organization charts are included as Appendix B. During the review period the Nebraska program regulated 157 l
specific licenses, which includes four large irradiators, manufacturers, broad academic, broad medical, radiopharmocy, radiographers, and the program is in the process of j
conducting a licensing review of a low-level radioactive waste disposal site. The low level radioactive waste (LLRW) disposal regulatory program is jointly administered and managed by NDOH and the Nebraska Department of Environmental Quality (NDEO) through a i
Memorandum of Understanding. In addition to its radioactive materials and low-level radioactive waste disposal programs, NDOH is responsible for the control of machine j
produced radiation and radon, and emergency response planning for two nuclear power l
plants. The review focused on the materials program as it is carried out under the Section 274b. (of the Atomic Energy Act of 1954, as amended) Agreement between the NRC and the State of Nebraska.
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In preparation for the review, a questionnaire addressing the common and non-common indicators was sent to the State on May 17,1996. Nebraska provided its response to the questionnaire on June 17,1996. A copy of that response is included as Appendix C to this report.
The review team's general approach for conduct of this review consisted of:
(1) examination of Nebraska's response to the questionnaire, (2) review of applicable Nebraska statutes and regulations, (3) analysis of quantitative information from the radiation control program licensing and inspection database, (4) technical review of i
selected files, (5) field accompaniments of five Nebraska inspectors, and (6) interviews with staff and management to answer questions or clarify issues. The team evaluated the j-information that it gathered against the IMPEP performance criteria for each common and non-common indicator and made a preliminary assessment of the radiation control
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program's performance. As noted above, that preliminary assessment was discussed with program management before the team's departure.
2.0 STATUS OF PREVIOUS REVIEW The previous routine review concluded on June 23,1994, and there were no recommendations made following the previous review of the radiation control program.
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.
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3.0 COMMON PERFORMANCE INDICATORS The IMPEP process uses five common performance indicators in reviewing both NRC regional and Agreement State programs. These indicators are: (1) Status of Materials i
inspection Program; (2) Technical Staffing and Training; (3) Technical Quality of Licensing Actions; (4) Technical Quality of Inspections; and (5) Response to incidents and Allegations.
l 3.1 Status of Materials insoection Proaram The review 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.
Review of the State's inspection priorities showed that the State's inspection frequencies for the various types or groups of licenses are with few exceptions, at least as frequent as similar license types or groups listed in the frequency schedute in the NRC Inspection Manual Chapter (IMC) 2800. The State, in their response to the questionnaire, identified three types of licenses that were inspected at a frequency less than IMC 2800, as a result of not having yet incorporated the April 1995 revisions to IMC 2800 into their inspection Procedures Manual. Those categories for which NRC revisions to IMC 2800 were more conservative than the Nebraska frequencies are: (1) High-Dose Rate Remote Afterloaders (HDRs) were inspected on a three year basis in Nebraska vs. NRC's change to a one year frequency, (2) Mobile Nuclear Medicine Services were inspected on a three year frequency vs. NRC's change to a two year frequency, and (3) Instrument Calibration Services Only -
Other and Other Services were grouped together in Nebraska and inspected on a three or five year frequency vs. NRC's one-seven year frequency based on the type of service provided. Subsequently, the team found that the State does not have a service license requiring inspections at one or two year intervals, but they do have a service license for which IMC 2800 indicates a three year inspection frequency and the State was conducting inspections at a three year interval. Although the revised inspection frequencies had not 3
been incorporated into the Inspection Procedures Manual, the State indicated that they had i
completed incorporation of the new priorities into their inspection tracking system and, as a result, the State indicated that they planned to review all licenses and assign the proper priority and inspection frequency and inspect accordingly, but inspection schedules had not been completed. In discussions with the new program manager, the team found that the 4
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State intends to revise their inspection Manual to reflect the April 1995 revisions to IMC 2800 by January 1997. When these inspection priority findings were raised with the Nebraska staff, the staff indicated that the loss of three key personnel had prevented them from updating procedures.
In their response to the questionnaire, Nebraska indicated that as of July 12,1996, only nine licensees identified as core inspections in IMC 2800 were overdue by more than 25 i
percent of the NRC frequency. The State also indicated they planned to complete these overdue inspections by January 1997. It should be noted, that the staffing shortages j
created a considerable backlog of inspections and, in response, the State hired a contractor to conduct inspections, commencing on January 15,1996, and ending no later
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than June 30,1996. The contractor performed 27 inspections, of which 14 were overdue, during this period which helped to reduce the ba :klog of overdue inspections.
Although the State should be commended for this effort, the team noted that communication of the results of the inspections, (i.e. inspection report results, i
recommendations, noncompliance, etc.) have been provided to only 5 of the 27 licensees inspected. In discussions, the program manager stated that they retained a former staff member as a consultant to review the results of the contractor inspections, but they were
)j unsuccessful in their efforts to have the reviews completed in a timely fashion.
i The team reviewed the State's experience with overdue inspections during the entire 2
review period and found, based on 20 license files reviewed,8 out of 12 core inspections j
were conducted as overdue inspections exceeding the 25 percent window allowed in IMC 2800. Four of the 8 overdue core inspections with a one-year inspection frequency were i
between 10-24 months overdue (averaging 15 months overdue), and four of the 8 overdue core inspections with a three year inspection frequency were between 15-21 months overdue (averaging 17.3 months overdue). Non-core inspections were conducted as i
resources allowed.
With respect to initial inspections of new licensees, the team reviewed the inspections due i
by date in the numeric tracking system and the license files. Review of the tracking l
system identified 11 licenses, that required initial inspections. Of the 11 inspections due, i
identified from the tracking system,2 had been identified as overdue in the State's l
Questionnaire. Two of the 11 initial inspections due had been completed during the IMPEP j
review accompaniment process on July 16,1996, which leaves 9 inspections due.
Subsequent to the review, the State informed the team that 2 of the inspections due licenses are issued to nuclear power plants authorizing the use of radioactive material at temporary job sites in the event of an emergency situation, one is an out of state licensee from Wisconsin authorizing non-AEA material, and one other is an out-of-state service licensee for which no activity has occurred and is currently in a deferred status, which j
reduces the number of inspections due to 5.
Of the 20 files reviewed by the team,4 were initial inspections, and 2 of the 4 initial j
inspections were not inspected within the stated frequencies identified in IMC 2800. The i
2 overdue initialinspections were performed 16 and 13 months after issuance of the license. Subsequent to the review, the State informed the team that in response to su90estions made by the team, the State has implemented a condition for new licenses 4
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that requires the licenses to notify the Stats of receipt of materials and the beginning of licensed activities in addition to the telephone contacts now used by the program.
The timeliness of the issuance of inspection findings was also evaluated during the inspection file review. From the 20 files examined both in detail for quality of the inspection program and for issuance of inspection findings,14 (inspections performed in 1994 and 1995) had inspection correspondence sent to the licensee within 30 days after completion of the inspection. In the six remaining files (inspections performed in 1996 by the contractor), the inspection fidncs were in draft enforcement letters which had not been issued to the licensee. The six draft enforcement letters had been in the license file from 45 to 142 days. As previously indicated, the inspections findings of only 5 of the 27 inspections performed in 1E96 by the contractor, had been provided to the licensee after review by the State. Management was aware of the delays in getting these inspection reports issued. Delays in issuing inspection reports impair the effectiveness of getting prompt corrective action by the licensee to any violations. Late reports make it difficult for the program to require a prompt response from the licensee. Finally, late reports open the 1
program to criticism by licensees. The review team recommended that State management take immediate action to assure that the balance of the contractor completed inspection field notes and draft enforcement letters (22) are reviewed and issued to the appropriate licensees.
On examination of the major cause for the lack of timeliness in performing inspections at the stated frequency and the timely issuance of inspection findings, the IMPEP team noted the program lost three senior staff in the materials program and underwent two reorganizations during the review period. The team concluded that the failure to effectively manage the reduced level of program resources and performance and the lack of current, written, program procedures, are the primary root causes of the deficiencies found in the program.
A review of the fesults of previous program reviews of the Nebraska Radiation Control Program identified that similar problems were found in 1990 and 1992 that resulted in a withholding of findings of adequacy to protect public health and safety and compatibility l
for both reviews. During the 1992 review, significant problems were identified in the area of Status of Inspections and Staffing and Training. The 1992 review indicated that there had been no improvement in problem areas identified during the 1990 review. During the i
1990 review, significant problems were identified in the area of Status of the inspection Program, Staffing and Training, Status and Compatibility of Regulations, Enforcement Procedures, and Management. The 1990 review indicated a continuation of the same problems found during two previous reviews in 1988 and 1986. The 1994 review resulted in a finding of adequate and compatible based on the State filling four vacant positions that had remained open for over a year despite active recruiting, reduction of the inspection backlog, and expected continued reduction due to increased availability of staff.
In 1994, the State also indicated that efforts were underway to develop and implement revised procedures. The team found that the efforts begun in 1994 to maintain adequate staffing and control inspection backlogs were unsuccessful, and the efforts to implement new procedures were not completed.
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The State reported in its response to the questionnaire that 31 licensees filed 163 requests 1
for reciprocity during the review period; 20 of the 31 licensees were Priority 1,2, or 3 (7 industrial radiography,7 welllogging,1 mobile nuclear medicine service and 5 other service licensees). The State conducted 2 inr3pactions of reciprocity licensees (industrial radiography) during the review period. in its resp >nse to the questionnaire, the State reported that the program staff accompanied by an IMPEP team member performed one field inspection on a non-reciprocity industrial radiography licensee on May 26,1996. The review team recommends that the State follow the inspection frequency for conducting i
inspections of reciprocity licensees contained in IMC 1220, " Processing of NRC Forrn ?41, Report of Proposed Activities in Non-Agreement States, and Inspection of Agreement State Licensees Operating Under 10 CFR Part 150.20."
In addition to the recommendations stated above regarding the cr'ntractor performed inspections, the review team recommended that the Nebraska Radioactive Materials Program: (1) establish an action plan or procedure to assure inspections are completed at the required frequencies stated in the NRC's IMC 2800 and conduct reciprocity licensee inspections at the frequencies stated in IMC 1220; (2) establish an action plan or procedure for coordinating deviations from the schedule between staff and management based on the risk of license operations, past performance and need to temporarily defer the inspections to address more urgent or critical priorities; (3) organize a "get well" plan e
for rescheduling missed or deferred inspections, that takes into account unplanned loss of experienced staff; (4) establish a plan or methodology to assure initial inspections are performed within 6 months of receipt of licensed material,6 months of beginning licensed activities or within 1 year of license issuance, whichever comes first, in accordance with the Nebraska inspection Manual and NRC's IMC 2800; and (5) incorporate the inspection frequencies contained in NRC's IMC 2800 into the Nebraska inspection Manual.
Based on the IMPEP evaluation criteria, the review team recommends that Nebraska's performance with respect to the indicator, Status of Materials inspection Program, be found Satisfactory with Recommendations for improvement.
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3.2 Technical Staffina and Trainina i
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in reviewing this indicator, the review team considered the radioactive materials program and the NDOH low level radioactive waste program staffing levels, the technical qualifications of the staff, staff training, and staff turnover. To evaluate these issues, the review team examined the State's questionnaire responses regarding this indicator, interviewed program management and staff, and considered the identified backlogs in j
licensing and compliance actions.
Regulatory responsibility for the control of radiation in Nebraska is split into four separate organizational units, three in the NDOH, and one unit in NDEO, jointly administered by both NDOH and NDEO, with primary responsibility for regulating a proposed LLRW disposal site.
Since the last program review in 1994, there have been two reorganizations in the NDOH, the last of which was completed in mid 1995. Prior to the reorganizations, the NDOH radiation control program existed as a division with four subdivisions: radioactive l
materials (RAM), LLRW, machine produced radiation (X-ray) and emergency response. The
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RAM program was managed by the division director who also supervised the other three program managers. As a result of the reorganizations, two units (RAM and LLRW) are currently in the Division of Environmental Health, Environmental Health Protection Section (EHPS) (X ray was placed under another section). Emergency response activities, are now the responsibility of the NDOH LLRW program manager. The RAM and LLRW program managers report to e section administrator. Additionally, technical staffing and training for the organizational unit located in the Department of Environmental Quality, Low Level Radioactive Waste Disposal Program, consisting of both NDEO and NDOH LLRW staff,is addressed in Section 4.2.3 of this report. Organization Charts for NDOH and EHPS can be found in Appendix B.
in the second reorganization, fully implemented as of July 1,1995, the division director position was lost without naming a permanent RAM program manager. NRC received notification through letters from the State that an experienced RAM staff member had been designated program manager for Radioactive Materials on April 24,1995, and again in a letter dated June 13,1995, but this person left the program on June 23,1995. In a letter dated May 15,1995, the LLRW program manager, was given the additional responsibility for all radiological emergency response activities. A July 20,1995 internal memorandum that was providad to the IMPEP team during the review, designates the LLRW program manager as Acting RAM program manager, but based on statements made by program staff to the team,it was not clear to the RAM staff that the designated duties went beyond signature authority for licenses. In a March 25,1996 letter, NRC was notified that the Section Administrator for Environmental Health Protection would be handling matters related to radioactive materials. A permanent RAM program manager was not named until May 1996, a delay of nearly one year.
The current radioactive materials program technical staff consists of a program manager and three inspector / license reviewers while the LLRW program technical staff consists of a program manager and two professional positions. The two staff members of the LLRW program are cross trained to provide technical support to the RAM program on a short-term basis, as needed. Additionally, the RAM and LLRW programs supplemented staff effort during the review period with contractors. The review team found that the current i
staffing level, with contractor support, and establishment of effective management controls, is adequate to administer the regulatory program.
I With respect to RAM contract support, the State did not include a provision specifying personnel qualifications in their Statement of Work. The RAM program contractor, in bid documents, specified the use of individuals who possessed the education and experience to meet the requirements of this indicator, however, there was no specific provision concerning personnel qualifications included in the contract. This was noted by the program manager as a corrective action item for future contracts. The team concluded that the contractor (based on discussions with the RAM program manager), has adequate educational qualifications, but recommends that the qualifications of contractor personnel be tied to the contract as identified by the program manager or as accomplished by the Nebraska LLRW program. The program manager further stated that the contractor is an experienced consultant in the health physics area and personnel possessed appropriate technical qualifications.
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The team reviewed staff turn-over and qualifications, found that three experienced members of the RAM staff left during the review period, all at approximately the same time as the second reorganization. The review team found that although it appears that management was responsive in filling two of the vacant positions within a short period of time with cross-trained staff from the X-rsy and LLRW programs (with adequate educational background and experience), the fact that a key position that provides continuity, direction and support to the radioactive materials program staff, that of the Radioactive Materials program manager, was not permanently filled for almost a year, and was one of the root causes of the difficulties experienced in the program. The team observed that these difficulties, identified below, accelerated at the t me of the second i
reorganization and the nearly concurrent loss of three experienced staff members of the RAM program. Difficulties encountered during the review period include the following:
(1) a backlog of 8 core inspections, (2) 22 inspections pending supervisory review and notification of the findings to the licensee, of which one contained health and safety issues, (3) inspection reports were incomplete, (4) a backlog of 101 licensing actions of i
which 73 could have health and safety related issues; included in the backlog of 101 licensing actions were:
New RSO - 9 Add authorized user -9 Add or new location of use - 10 Terminate - 5 Renewal - 28 Delete location of use - 3 Short Form Renewal-9 Add new use - 2 Add RAM - 7 Other 2 (5) no incident reporting to NRC since June 1995, (6) incomplete documentation of incident response and response to allegations, (7) regulations required for compatibility not adopted in timely fashion, and (8) no "get-well" plan.
All of these factors considered collectively led the team to find that the performance with respect to the criteria for this indicator was inadequate. Details of these problems are discussed elsewhere in this report. The team found that the primary root causes for the deficiencies found in the program are (1) the failure of NDOH management to effectively i
address the reduced level of program performance, and (2) lack of current, written, program procedures or failure of staff to follow those procedures.
The Radioactive Materials program manager and all three full time staff perform duties in i
licensing, inspection, and event response. Although the staff did try to achieve a balance i
between the licensing and inspection functions, the significant backlog found in the area of inspections and licensing and other deficiencies found in the program demonstrate that the effort was not adequate to maintain the program. The team found it difficult to evaluate the training of the personnel involved with the materials control program, because there was no written program for staff qualification. According to the information provided in j
the questionnaire, all newly hired health physicists are required to attend the NRC core training courses outlined in the now suspended May 28,1992, Policy Statement (57 FR 224950), as well as the five week health physics course. However, there was no written documentation that stated this requirement had been met. The team found no program records to show that existing materials program staff members have taken the courses.
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The only records found were those maintained by individual staff members. Subsequent to the review, the team was informed that database records for a majority of the training i
received by program staff was available, but were unknown to the new program manager.
The radioactive materials program staff also described in house and on the-job training processes in their response ar.o during interviews. Briefly, new staff are assigned to i
review State regulations and procedures and to accompany senior license reviewers / inspectors, then are assigned increasingly complex licensing duties under the direction of senior staff and accompany experienced inspectors during increasingly complicated inspections. New staff are assigned independent inspections after demonstrating competence. The criteria for determining the progress of new staff have not been established. The team observed that the lack of criteria and the vacant radiation program manager position for almost one year resulted in an inspector (hired in July 1995) not yet considered trained to conduct even low priority inspections after one year on the j
job. The team recommends that a written program for staff qualification, including l
retaining training records, be developed.
The team recommends that the State develop comprehensive administrative procedures, sufficient to guide the day-to-day operation of the program in the event of another loss of senior staff. The procedures should include a formal process for bringing to the attention of upper management the increase of significant backlogs of licensing, inspection, or enforcement actions, or any other situation which increases the risk to public health and safety. Licensing procedures should include prioritization of licensing actions based upon identified factors, including health and safety significance for new and previously received applications. The team also notes that there is a legislative mandate to further reorganize by combining NDOH and four other Departments, to be completed by the end of calendar year 1996. The team recommends that NRC monitor the Nebraska program with increased attention to the effects of the further reorganization.
I As identified in Section 3.1 above, the team found that the problems encountered during j
the period represent continuing trends of deficiencies found in previous reviews of the Nebraska program. The exception was the 1994 review, wherein the previously identified staffing shortages were eliminated when the State filled four long vacant positions. But the team found that the State was unable to maintain adequate staffing beyond one year.
The team also concluded that the efforts begun in 1994, to maintain adequate staffing, j
reduce the inspection backlog, and implement revised procedures were unsuccessful.
Collectively considering the historical weaknesses of the program, the consistent significant staffing problems, the consequences of the loss of three key staff members, i
other deficiencies found throughout the program and lack of program management effectiveness to address these weaknesses, the review team concludes that the State's program relative to the criteria for this indicator was inadequate.
Based on the IMPEP evaluation criteria, the review team recommends that Nebraska's performance with respect to the indicator, Technical Staffing and Training, be found j
Unsatisfactory.
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3.3 Technical fhlity of Licensino Actions The review team examined casework and interviewed the reviewers for 12 licenses and 28 licensing actions completed during the review period covering June 25,1994 July 12, 1996. The review team was unable to review or evaluate statisticalinformation related to any backlog of cases prior to July 1995, due to the fact that the licensing program records for that time were contained in a handwritten logbook that did not easily allow for statistical review of pending actions. The team noted that the new RAM program manager has implemented a computerized tracking system, beginning with July 1995, to allow tracking of reviews, letters, replies, and license issue date. This tracking system is a great improvement over the handwritten sheets kept in the logbook and updated by individual reviewers prior to July 1995, and will allow staff to keep better track of the licensing backlog. Licensing actions were reviewed for completeness, consistency, proper isotopes and quantities used, qualifications of authorized users, adequate facilities and equipment, and operating and emergency procedures sufficient to establish the basis for licensing actions. Casework was reviewed for timeliness, adherence to good health physics practices, reference to appropriate regulations, documentation of sofety evaluation reports, product certification or other supporting documents, consideration of safety evaluation reports, product certification or other supporting documents, consideration of enforcement history on renewals, pre-licensing visits, peer or supervisory review, and proper signature authorities. Licenses were reviewed for accuracy, appropriateness of the license and its conditions and tie-down conditions, and overall technical quality. The files were checked for retention of necessary documents and supporting data.
The cases were selected to provide a representative sample of licensing actions which had been completed in the review period and to include work by all reviewers. The cross-section sampling included 12 licenses of the following types: medical / academic broad scope, medical-institution and medical-mobile, industrial radiography, research and development, and portable gauges. Licensing actions included three new licenses and 25 amendments. A list of these licenses with case-specific comments is included in Appendix D.
The review team found that the licensing actions completed were thorough, comp!ste, consistent, and of acceptable quality with health and safety issues properly addressed.
Special license tie-down conditions were stated clearly, backed by information contained in the file, and were inspectable. The team noted a few deviations in the files of minor significance such as the use of small yellow post it pad notes to attach pertinent information rather than a permanent form of documentation i.e., memorandum. All recent licensing actions included a peer review which was recorded on a License Action Review Record in the license file. No potentially significant health and safety issues were identified with completed licensing actions.
In response to the questionnaire, and discussions with the program manager, the State indicated that three staff perform both license reviews and inspections, and that Nebraska has approximately 157 specific licenses. Due to problems encountered by the team in trying to review the handwritten licensing logbook, we were unable to review or evaluate case backlog prior to July 1995. In the period from July - December 1995, 38 licensing w
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Nebraska Proposed Final Report Page 10 actions were completed. From January - June 21,1996,48 licensing actions were completed. Subsequent to the review, the State informed the team that they had completed 48 licensing actions from July - December 1995, and 70 licensing actions January 1 - June 21,1996. During the review, the t%m noted that the new radioactive materials program manager, appointed in May 1996, has implemented a computer listing of licensing actions, beginning with July 1995, to allow tracking of reviews, letters, replies, and license issue date. This tracking system is a great improvement over the handwritten sheets kept by individual reviewers, prior to July 1995, and will allow staff to keep better track of the licensing backlog.
In discussions with staff, priorities of licensing actions were stated to be based upon health and safety issues, and applicants need. The team noted, that the disruption caused by staff tumover has resulted in 101 licensing actions not having been acted upon in a timely manner, as indicated in Section 3.2, Technical Staffing and Training.
Based on the IMPEP evaluation criteria, the review team recommends that Nebraska's performance with respect to the indicator, Technical Quality of Licensing Actions, be found Satisfactory.
3.4 Technical Quality of Insoections The team reviewed enforcement documentation, inspection fieti notes, and data base information for 20 materials inspections conducted during the review period. The casework included inspections performed by the current program manageir. two health physicists who terminated their employment with the State during the review period and inspections performed by a contractor hireo to help with the inspection backlog created by the loss of three key staff and several reorganizations. The sampling included three nuclear medicine licensees, two each pool irradiator, service, fixed gauge, portable gauge and academic broad licensees and one each nuclear medicine / brachytherapy, mobile nuclear medicine, solf-shielded irradiator, radiography, academic / radiography, academic non-broad and teletherapy licensees. Appendix E provides a list of inspection cases reviewed in depth with case-specific comments.
The review team noted that the Nebraska program was adequate with respect to this l
indicator. Routine inspections usually covered all aspects of the licensee's radiation safety program. The team also noted that, during the accompaniment of State inspectors, the j
inspectors observed licensed operations or had operations demonstrated whenever
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possible. The observation of licensed activities provides the inspectors with an indication of the effectiveness of the licensee's radiation protection program. Finally, during the review period, the State conducted team inspections of larger licensees. Having multiple inspectors review a particular licensee's operations may lead to more thorough inspections and provide the opportunity for less experienced inspectors to observe experienced inspectors as an effective training technique.
l The team reviewed the inspection field notes and found them to be comparable with the l
types of information and data collected under NRC Inspection Procedure (IP) 87100. The j
inspection field notes provided documentation of inspection findings in a consistent l
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Nebraska Proposed Final Report Page 11 manner. The State uses separate inspection field notes for various classes of licensees, j
such as nuclear medicine, portable gauges, radiography, and industrial / academic. The State has not yet developed field notes specific for the inspection of HDRs or nuclear pharmacies. The State uses the nuclear medicine field notes for these type of licensees.
The inspection field notes provide documentation of the scope of the licensee's program including, posting; storage and use of radioactive material; receipt, transfer, and disposal of radioactive material; inventory; leak tests; radiation protection program; personnel monitoring, training; independent meest~ements; and inspection findings.
The team found several deficiencies during review of field notes in the compliance files, such as incomplete documentation of technical and administrative information, which are addressed in Appendix E,'and further clarified later in this section. The team noted that during the accompaniments of State inspectors, the State inspectors examined appropriate j
radiation health and safety issues at licensees' facilities. All the inspectors, who were i
accompanied by a team member, used the field notes to assure that all aspects of the program that could be reviewed were included in the scope of the inspection. The inspectors performed independent measurements whenever the licensee was using licensed material and also measured for radiation levels surrounding materials in storage.
Inspectors' written comments in the field notes and the team member's observations during accompaniments indicate that safety issues were discussed with licensee personnel. The field notes indicated that the licensees' operations were observed when licensed operations were being conducted by the licensee and interviews with the State inspectors and observation by the team member during accompaniments support that they routinely tour licensee areas such as laboratories, other locations of use and storage areas.
The inspectors emphasized the observation of licensed activities to determine the effectiveness of the licensee's radiation safety program and compliance to the requirements, a critically important inspection technique. The field notes indicated that the inspectors examined and, when appropriate, closed out previous violations. Also because health physicists serve both as inspectors and license reviewers, there was evidence that licensing issues were considered in the inspection process.
Four inspector accompaniments were performed by a review team member during the period of June 24 28,1996, and one accompaniment was performed during the review period on July 16,1996. The accompaniments included the following: (1) two inspections with two individuals from the LLRW program, the program manager and a health physicist, who are cross trained and qualified as inspectors in the RAM program during an inspection of a radiography program (including a field site visit) and a mobile nuclear medicine program, respectively, and a second health physicist from the LLRW j
program, who was being cross-trained in the Materials Program assisted on these inspections; (2) a third inspection with the Radioactive Materials program manager and a staff health physicist during inspections of a large nuclear medicine and a self-contained blood irradiator program at a major medical facility; and a fourth inspection with another staff health physicist during the initial inspections of two separate portable gauge programs, one of which also included a field site. These accompaniments are also identified in Appendix E. During the accompaniments the Nebraska lead inspectors demonstrated appropriate inspection techniques and knowledge of the regulations. The inspectors were well prepared and very thorough in their reviews of the licensee's i
Nebraska Proposed Final Report Page 12 radiation safety program. Each inspector emphasized observation of the licensee's activities and interviews with personnel to assess the effectiveness of the licensee's radiation safety program. Overall, the technical performance of the inspectors was satisfactory, and their inspections were adequate to assess radiological health and safety at the licensed facility. The technical quality of inspections and the knowledge of the inspectors is a strength in the Nebraska program. The review team noted that the State relies on the technical knowledge of the inspectors to identify root causes of non-compliance and poor licensee performance rather than having procedures in place which normally could be used to assist the inspectors in this identification.
f In response to the questionnaire, the State reported the number and type of supervisory accompaniments by senior program staff is not defined by a program procedure and they have not been documented in the past. However, in 1994, three inspectors were accompanied by a contract consultant who observed the inspector's performance. The consultant was performing a review of the program staff by accompaniment as part of his contract to develop an inspection and Enforcement Manual. Copies of the reports submitted for two of three staff evaluated were provided. There were no supervisory accompaniments of the Nebraska inspectois during 1995 and in the first six months of 1996. It should be noted that two of the three inspectors accompanied by the contractor in 1994 have since left the program and the third was promoted to program manager. The program manager indicated in discussions during the review that he was the lead inspector on several occasions and was accompanied by a staff health physicist for purposes of training, but had not performed an accompaniment in his capacity as the manager of the Radioactive Materials Program.
Therefore, the review team recommends that the State consider for adoption a policy of annual supervisory accompaniments of allindividuals who perform inspections for the Radioactive Materials Program.
In response to the questionnaire, the State indicated that a contractor was hired to develop an inspection and Enforcement Manual, which was completed in April 1994. The revised Enforcement Manual contains standardized text covering compliance issues for use in issuance of Notice of Violations (NOV) to licensees. Use of standardized text would enhance the efficiency of the compliance process, additionally, the Manual would prove very useful for training new staff. The program manager indicated that future plans included updating the Manual and implementing use of the Manual by the staff. Section 3.2 of this report covers procedures in greater detail.
It was noted that the State has available a variety of portable instruments for routine confirmatory surveys and use during incidents and emergency conditions. The instruments were a mix of low and high range Geiger-Mueller detectors and pancake probes, micro R meter, alpha detector, and available quantitative instruments in the Department of Health Laboratory. The portable instruments used during the inspector accompaniments were observed to be operational and calibrated. The team noted that the instruments are calibrated on an annual basis.
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j Nebraska Proposed Final Report Page 13 l
it was found that the State is generally performing unannounced inspections of materials licensees. Initialinspections and geographically-distant location inspections are usually announced.
A review was conducted of the procedures and documentation of inspector field notes or completed reports to determine that they are complete and reviewed promptly by supervisors or management. That review found that previous practice indicated that a supervisory review was conducted. The radiation program manager posit!on was vacant as of June 1995, and the person delegated responsibility for signing off on NOVs left the program on June 23,1995. Subsequently, the team was provided with a July 1,1995, internal memorandum designating the LLRW program manager as acting RAM program manager, but RAM program staff were not clear as to whether this went beyond signature authority for licensing actions. Therefore, it was not clear to the team or to the RAM staff that any one in the radioactive materials program had official supervisory signature responsibility prior to the announcement of a new program manager in May 1996. The normal practice of a supervisory review was not practiced during this time.
Inspection findings generally indicated that the State planned to take appropriate regulatory action with the following exceptions. As previously indicated, inspection J
findings, in the form of a letter to the licensee, had not been issued for 22 of the 27 inspections conducted by the contractor. Additionally, the team found that six of the 22 pending inspection findings resulted in a recommendation for enforcement action that had not yet been issued to the licensee, in one case, as indicated in Appendix E, the team found that the enforcement letter identified five violations to the licensee and the documentation in the field notes provided information for only two violations. The review team also found some other problems with the documentation of information on the field note reports as noted in the comments in Appendix E. The field notes on page one provide space for administrative information such as: inspection report no., license no., licensee (name and address), liennsee contact, telephone no., priority, date of last inspection, date of this inspection, type of inspection, summary of findings and action, next inspection date and whether next inspection is at a normal, reduced or extended frequency, signature and date the inspector signed, and signature and date supervisor approved the report. Eleven of the field note reports did not have all the administrative information required. Ten reports were not approved with a supervisor's signature and date; and a few of the typed inspection reports did not contain any signature. The team believes that supervisory approval of inspection findings documented in the field notes prior to issuance of an enforcement letter is necessary to assure that the field notes contain sufficient information to support any violations or recommendations in an enforcement letter. In addition, seven of the field note reports had no technical information documented in areas such as:
training of ancillary personnel; exit meeting attendees; pH, clarity and Cl or F concentrations in pool water; independent measurements, inventory of brachytherapy sources after retum to storage, and Radiation Safety Committee (RSC) minutes / committee composition. The team noted that Nebraska Code 10.03, effective May 30,1994,and compatible to 10 CFR 19.12, does not contain the August 1995 revisions to 10 CFR
. 19.12.
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Nebraska Proposed Final Report Page 14 In discussions with the program manager, the team was informed that the previous requirement for typewritten field notes to be used as the documentation of inspection findings delayed the supervisory review until the field notes were typed. The new program manager stated that handwritten field notes would be accepted during the interim time period, while the staff try to complete the backlog of inspections. The new program manager stated that future plans include standardizing and automating the boilerplate inspection information.
In addition to the recommendation stated above regarding annual supervisory accompaniments of allindividuals who perform inspections, the review team recommended that the program: (1) develop a plan or procedure to assure that field notes, as well as, reports, and enforcement letters are promptly reviewed, signed and dated by a supervisor within the recommended 30 day time frame for issuance of inspection findings; and (2) perform an immediate review of all contractor field notes and draft enforcement letters in order to finalize and issue the findings of the remaining 22 inspections to the licensees involved.
Based on the IMPEP evaluation criteria, the review team recommends that Nebraska's performance with respect to the indicator, Technical Quality of Inspections, be found Satisfactory with Recommendation for improvement, j
3.5 Resoonse to facidents 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 relative to this indicator and reviewed the incidents reported for Nebraska in the " Nuclear Material Events Database (NMED)" against those contained in the Nebraska casework and license files, and supporting documentation, as appropriate for six incidents. In addition the team interviewed the Radioactive Materials program manager. Due to recent staff turnover the team was unable to interview other staff for this indicator.
Responsibility for initial response and follow-up actions to material events rests with the Radioactive Materials Program and the Low-Level Radioactive Waste Program. Written procedures require a prompt response to incidents by the staff and provide additional procedural guidance. Written procedures for allegations also require prompt response, but contained no further procedural guidance. The review team found that allegations were handled as routine incidents and files contained incomplete or nc documentation of inspection results or State action. The team noted in one case that investigative techniques were insufficient to appropriately resolve alleged issues. The review team recommended revising the allegations procedures to incorporate key areas, i.e.,
documentation of any communications with the alleger, documentation of the inspection findings, interviewing techniques, etc., identified in NRC Management Directive 8.8, Management of Allegations.
The review team also noted that the staff did not have a procedure for tracking the status (i.e. identification, receipt, follow up, and closeout) of material events. The review team recommended that the staff use the draft " Handbook on Event Reporting in the Agreement J
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Nebraska Procosed Final Report Page 15 States (Handbook)," published March 1995, for review and reporting of material events to NRC. The Handbook identifies the NRC Operations Center, Office for Analysis and Evolution of Operational Data, as the proper group to receive voluntary notification of the occurrence of significant events in an Agreement State, and provides guidance on the identification, reporting, follow-up reporting, and closeout of material events.
The review team found, through discussions with the Radioactive Materials program manager, that the staff have been unable to voluntarily report to NRC the occurrence of any material events since June 1995, due to the loss of three experienced staff members.
Limited resources had to be redirected to other more critical areas. Therefore, the team was unable to evaluate whether or not the State provided information on all events that may have occurred during the period of review prior to June 1995. Two reportable events were found by the team during review of selected case files.
Through a review of information provided in the questionnaire and through review of selected case files, the team found that four reportable events had occurred, three of which had not been reported to NRC, and subsequently NMED. Two of the reportable events were identified in the State's response to the questionnaire as significant events that had occurred during 1995. Two of the reportable events examined by the team involved equipment malfunctions at an irradiator facility, and one involved loss of material.
Other case files reviewed included a 1994 event involving the loss of material, that had previously been reported to NRC, an event involving the unauthorized use of equipment, and an event involving loss of control of radioactive material, both of which had not been reported to NRC. The team noted several case file deficiencies,i.e., one file contained no documentation of inspection results, another indicated insufficient follow-up action by the State to the loss of control of radioactive material, and a third indicated lack of State
%n to a late notification of the occurrence of an svent by the licensee. With regard to the incidents that occurred at an irradiator facility, and one event involving equipment malfunction as a result of the unauthorized removal and replacement of equipment, the team discussed the need to report events involving equipment malfunction or possible defects of equipment with the program manager and the importance of documentation of contact with the alleger. The review team concluded that the State's documentation and in one instance response, to the occurrence of events involving the use of radioactive l
material and response to allegations needs improvement. They did not have a complete i
understanding of reporting requirements, and lacked proper procedures for handling allegations. A list of the incident reports examined is contained in Appendix F.
i in addition to the above recommendation that the Nebraska staff revise the allegations procedures and incorporate use of the " Event Reporting Handbook," the team recommends establishment of comprehensive procedures for tracking, follow up and close out of events 4
involving the use of radioactive material covered under the Atomic Energy Act. The I
review team also recommends that the State immediately begin reporting current material events to NRC and send in information on the three events identified during the review as reportable, to the State, but were not previously reported to NRC.
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Nebraska Proposed Final Report Page 16_
i Based on the IMPEP evaluation criteria, the review team recommends that Nebraska's performance with respect to this indicator, Response to incidents and Allegations, be
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found Satisfactory with Recommendations for improvement.
4.0 NON-COMMON PERFORMANCE INDICATORS 1
I 4.1 Lagislation and Regulations i
j 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 j
Evaluation Program, (3) Low Level Radioactive Waste Disposal Program, and (4) Uranium i
Recovery. Nebraska's agreement does not cover uranium recovery <, etions, so only the
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first three non-common performance indicators were applicable to thit. <iew.
i 4.1.1 Laoislative and Leoal Authority Along with their response to the questionnaire. Nebraska provided the review team with l
copies of legislation that affects the radiation control program. The Nebraska Department of Health regulates use of radioactive material. NDEO and NDOH have shared i
j responsibilities for regulation of the planned low-level radioactive waste site. Based on the response to the questionnaire, and on statements by the Director of the Department of Health that there had been no change to the Pste legislation that affected the duties or responsibilities of the materials programs, tho review team did not review the legislation j
but relied on previous reviews where State legislation was determined to be adequate, j
The team did note the legislative changes that will result in the reorganization of the i
Department.
l 4.1.2 Status and Comnatibility of Reaulations Nebraska's latest rules and amendments became effective May 30,1994. The equivalent i
NRC rules are: " Decommissioning," 10 CFR Parts 30,40, and 70; " Emergency Planning,"
10 CFR Parts 30,40, and 70; " Standards for Protection against Radiation," 10 CFR Part i
20; " Safety Requirements for Radiographic Equipment," 10 CFR Part 34; " Notification of Incidents," 10 CFR Parts 20, 30, 31, 34, 39, 40, and 70; and " Decommissioning i
Recordkeeping and License Termination: Documentation Additions," 10 CFR Parts 30,40, 1
70, and 72. Not all of these regulations were promulgated within the three year period following the adoption of the NRC regulation. The teara reviewed the final published j
Nebraska regulations equivalent to the above and found them to be compatible with the NRC regulations.
There are four irradiators in use in Nebraska which would be subject to the regulations in
" Licensing and Radiation Safety Requirement for Irradiators," 10 CFR Part 36. Equivalent i
tulos were in development when the reorganizations and personnel turn over discussed i
earlier in this report occurred. As a result of personnel reassignments, the rules were not adopted by their due date of July 1,1996. At the time of the review, the rules were scheduled for public hearing and adoption was expected by the end of the calendar year, i
Nebraska Proposed Final Report Page 17 Nebraska does not regulate uranium recovery operations, and does not have rules equivalent to NRC's regulations applicable to uranium recovery contained in 10 CFR Part
- 40. Therefore, it will not adopt the regulations equivalent to " Uranium Mill Tailings Regulations: Conforming NRC Requirements to EPA Standards," 10 CFR Part 40 amendments (59 FR 28220) that became effective on July 1,1994, and will need to be adopted by July 1,1997. Nebraska has assumed regulatory authority for a low level radioactive waste site, and has selected an enhanced technology for disposal. Therefore, the State does not need to adopt the land disposal definition part of the " Definition of Land Disposal and Weste Site QA Program," 10 CFR Part 61 amendments (58 FR 33886) that became effective on July 22,1993. The State has adopted the QA program portion of the amendment.
In addition to the above, the team found that work is in progress to develop equivalent rules to the following, which the program has scheduled for adoption in January 1997.
" Quality Management Program and Misadministration," 10 CFR Part 35 amendment (56 FR 34104) that became effective on January 27,1992. An NRC st6ff evaluation of whether this rule will be used to evaluate Agreement State compatibility continues.
"Self-Guarantee as an Additional Financial Mechanism," 10 CFR Parts 30,40,70 amendments (58 FR 68726,59 FR 1618) that became effective on January 28, 1994. Note, this rule is designated as a Division 2 matter of compatibility. Division s
2 compatibility allows the Agreement State flexibility to be more stringent (i.e., the State could choose not to adopt self-guarantee as a method of financial assurance.
if a State chooses not to adopt this regulation, the State's regulation, however must contain provisions for financial assurance that include at least a subset of those provided in NRC's regulations, e.g., prepayment, surety method (letter of credit or line of credit), insurance or other guarantee method (e.g., a parent company.)
" Timeliness in Decommissioning," 10 CFR Parts 30,40,70 amendments (59 FR 36026) that became effective on August 15,1994.
" Preparation, Transfer for Commercial Distribution and Use of Byproduct Material for Medical Use," 10 CFR Parts 30,32, and 35 amendments (59 FR 61767, 59 FR 65243,60 FR 322) that became effective on January 1,1995.
" Frequency of Medical Examinations for Use of Respiratory Protection Equipment,"
10 CFR Part 20 amendments (60 FR 7900) that became effective on March 13, 1995. Note, this rule is designated as a Division 2 matter of compatibility. Division 2 compatibility allows the Agreement States flexibility to be more stringent (i.e., the State could choose to continue to require annual medical examinations).
" Low Level Waste Shipment Manifest information and Reporting," 10 CFR Parts 20 and 61 amendments (60 FR 15649,60 FR 25983) that will become effective
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Nebraska Proposed Final Report Page 18 March 1,1998. Nebraska and the other Agreement States are expected to have an equivalent rule effective on the same date.
" Radiation Protection Requirements: Amended Definitions and Criteria, 10 CFR Parts 19 and 20 amendments (60 FR 36038) that became effective
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August 14,1995.
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" Medical Administration of Radiation and Radioactive Materials," 10 CFR Part 20 i
and 35 amendments (60 FR 48628) that became effective October 20,1995.
" Clarification of Decommissioning Funding Requirements," 10 CFR Parts 30,40, and 70 amendments (60 FR 38235) that became effective November 24,1995.
" Compatibility with the Intemational Atomic Energy Agency," 10 CFR Part 71 amendment (60 FR 50248) that became effective April 1,1996.
The review team examined the procedures used in the State's regulation promulgation process and found that the public is offered the opportunity to comment on proposed j
regulations during a comment period and in a public hearing that follows the comment period. According to the staff member responsible for rules development, NRC is provided
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with drafts for comment on the proposed regulations early in the promulgation process. A l
copy of the final regulation is submitted to NRC.
During discussions with the review team, the staff explained that they had begun the process of drafting revisions to the regulations which they expect to promulgate in g
4 January 1997 for new regulations due through 1998. The State is aware of the l
i importance of maintaining compatible regulations, and the State plans to update regulations yearly to maintain compatibility.
The review team identified a possible incompatibility in Section 012 of the Nebraska j
regulations, which are rules equivalent to NRC's 10 CFR Part 61. The Nebraska f
regulations, as written, apply the public dose limits in 180 NAC 1-012.22 (equivalent to J
10 CFR 61.41) to low-level radioactive waste facilities that process or store waste, as well as to disposal sites. Under NRC regulations, such facilities would not be subject to the equivalent public dose limits in 10 CFR 61.41, but rather to the public dose limit in 10 CFR l
Part 20. The Nebraska regulations may thus be more stringent than the equivalent NRC rules, however, both 10 CFR 61.41 and 10 CFR 20.1301 are Division 1 compatibility requirements. In response to the team's request for clarification regarding application of the public dose limits in the State's equivalent regulations to 10 CFR Part 61, the State responded in a letter dated December 13,1996. The State responded that they do not 4
currently have any brokers, treatment facilities, or storage facilities to which this regulation has been applied in accordance with the report that identified it as a Division 1 compatibility requirement which can only be applied te land disposal facilities, the Department intends to amend the regulation and anticipates this can be done by June 30, 1997. The State included a copy of the proposed amendment to 180 NAC 1-012.22 (equivalent to 10 CFR 61.41). Since there are no licensees to which the more stringent
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l Nebraska Proposed Final Repop Page 19 1
l standard is applicable and Nebraska has committed to revise 180 NAC 1-012.22, the i
review team believes this matter is not a significant issue.
I Based on the IMPEP evaluation criteria, at the time of the review, the team recommended I
that Nebraska's performance with respect to the indicator, Legislation and Regulations, be l
found unsatisfactory due to the failure to adopt regulations equivalent to 10 CFR Part 36 by July 1,1996. ' Subsequent to the review, the State informed the team that Section 019 3
of the Nebraska Code, " Licenses and Radiation Safety Requirements for Irradiators," was adopted effective October 30,1996, and inquired whether the team reviewed the area of other legally binding requirements. Note, the option of legally binding license conditions j
2 equivalent to the requirements contained in 10 CFR Part 36 had not been officially implemented at the time of the review, therefore, the reviewer did not look at this option.
l In response to the States adoption of 10 CFR Part 36 equivalent regulations, the team,
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based on additional information, is recommending that Nebraska's performance with respect to this indicator be found Satisfactory.
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4.2 Low Level Radioactive Wasta Disoosal Proaram In the rerocess of evaluating this performance indicator, the review team studied the Stat 9's response to the questionnaire, reviewed the terms of the Memorandum of l#,derstanding between NDEO and NDOH, compared Nebraska LLRW statutes and regulations with those of the NRC, evaluated the qualifications of the technical staff and contractors, reviewed the States written procedures and plans, reviewed or discussed
- parts of the safety analysis report (SAR), audits, and contractor reports, and any other supporting documentation, as necessary, and interviewed all staff and managers assigned to the LLRW program. In addition, the team evaluated the effectiveness of the shared responsibility for regulation of LLRW in Nebraska.
l 4.2.1 Introduction The State of Nebraska received a License Application from U.S. Ecology on July 27,1990, to operate a low level radioactive waste facility in the State. A site characterization plan was submitted to NDEO on June 6,1989. The State is presently reviewing the License i
Application submitted by U.S. Ecology, to develop a facility in the State; therefore, limited information may exist with respect to State activities for some of the performance indicators.
i in the shared responsibility for regulation of LLRW, the NDOH and the NDEO programs have agreed to procedures that are detailed in Section 1, Licensing Organization, of the Licensing Program Plan (LPP-01). As part of a commitment made in response to NRC recommendations following the 1990 program review, there are monthly meetings attended by the LLRW Program Manager and Director from each department. The meetings are not required as part of LPP-01. These meetings appear to be an effective means to keep management aware of program issues and progress, and to resolve issues that could be disruptive to the program, j
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l Nebraska Proposed Final Report Page 20 l
4.2.2 Status of Low-Level Radioactive Waste Disposal Proaram With the program in the pre-licensing non-operational phase, inspections are not applicable.
I 4.2.3 Technical Staffina and Trainino NDOH staff assigned principally to the LLRW program include a program manager (a health physicist), a health physicist with a specialty in environmental surveillance, a health physicist with a specialty in performance assessment, a radiation-health specialist, and
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three staff assistants (one in Lincoln, NE and two in Butte, NE). In addition, there is a vacant position for a health physicist with a specialty in nuclear engineering.
The NDEO LLRW program includes a program manager, an environmental specialist with specialties in health physics and performance assessment, an administrative assistant specializing in document preparation and public relations, a staff assistant specializing in i
document control, and a secretary. The LLRW program receives occasional support from l
technical specialists in other NDEO programs as short-term needs arise.
The LLRW program relies upon contractors for additional technical support and to provide i
additional technical specialists as needed for the SAR review (approximately 78 contractor staff). The NDEO LLRW program has continuing contracts with the University of l
Nebraska-Lincoln and a number of consulting-engineering firms. The engineering firms provide their in-house expertise as well as sub-contracting for national expertise in selected technical areas. These areas include:
i Hydrogeology Economics i
Surface Water Hydrology Seismology Geology Biology i
i Nuclear Engineering Climatology / Meteorology j
Geotechnical Engineering Sociology Structural Engineering Quality Assurance Operational / Construction Geochemistry Mechanical Engineering Performance Assessment i
Health Physics Financial Assurance Environmental Engineering Regulatory Analysis i
Materials Engineering Project Management Civil Engineering l
The team reviewed the documentation of qualifications and training of staff in both the NDOH and NDEO LLRW programs. In addition, the team reviewed the documentation of qualifications and Quality Assurance (OA) training that the program requires of review managers (8) and approximately 80 technical reviewers of the SAR. Staff and contractors are all highly qualified for their responsibilities in the LLRW program, easily meeting the guidance specified in NUREG/CR-4352, " Suggested State Requirements and Criteria for a Low Level Radioactive Waste Disposal Site Regulatory Program." The LLRW program has actively supported staff and contractor training in OA Procedures, Performance Assessment and other courses or workshops applicable to the program. The i
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l Nebraska Proposed Final Report Page 21 documentation to allow tracking or reporting of the status and history of staff and contractor training are not readily accessible and are not summarized. Training i
documentation is required and accessible during internal audits or surveillance of the contractors that are part of the program but is not accessible outside of the context of the audit / surveillance. Formalized tracking of NDEO and NDOH program staff training is apparently not required at the present time. The team suggests that the LLRW program j
assemble training documentation for individual staff and contractors and develop a consolidated training record to enable assessment of the progress of training across the entire program.
4.2.4 Technical rhlity of Licei gina Actions With current program emphasis on review of the applicant's SAR and documentation of Evaluation Findings prior to preparation of the Draft Safety Evaluation Report, the IMPEP s
teara examined the project's SAR review comments, comment tracking and reviewer qualification documentation. This involved tracing comments either through to closure resulting from subseguent SAR modifications, or as persistent open issues.
The program has a wall organized QA program to govern all program activities that might affect public health and safety. This OA program enabled the team to readily review and track the SAR review process.
A total of 195 comments in the subject areas of site characterization and performance assessment were tracked. Of these, the only questions arose due to seven comments submitted by a reviewer whose Technical-Review Qualification Statement was not on file.
This omission was corrected once it was brought to the attention of the program staff.
The team also reviewed a Quality Assurance Compliance Inspection Audit, performed by a LLRW audit team, of the U.S. Ecology's engineer of record for the project, Bechtel National Inc., Oak Ridge, Tennessee. This audit was selected because it examined the OA associated with performance assessment calculations. The applicant was informed of this audit on July 21,1995. The audit took place on August 10-11, 1995 at the Bechtel NationalInc. offices at Oak Ridge, Tennessee and was performed by three auditors and two technical specialists from the Nebraska LLRW program. The Quality Audit Checklist prepared prior to the audit contained 56 audit items; some were generic but many targeted directly at the applicant's program. The audit resulted in additional audit items, resulting in a total of 78 audit items. The audit resulted in 11 compliance nonconformances that were i
transmitted to the applicant on January 18,1996. The applicant responded on April 23, 1996 and is in the process of resolving the nonconformances.
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The team believes that the Nebraska LLRW program has a commendable OA program for
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auditing the applicant and for internal auditing within the Nebraska LLRW program.
4.2.5 Technical Quality of Insoections With the program in the license-application review phase, inspections are not applicable.
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i Nebraska Proposed Final Report Page 22 4.2.6 Pa*aanse to IreWnts and Alleastions There were no incidents or allegations reported.
Based on the IMPEP evaluation criteria, the review team recommends that Nebraska's f
performance with respect to the non-common indicator, Low Level Radioactive Weste l
i Disposal Program, be found Satisfactory, 4.3 saaled Source and Device Proaram The review team did not review the State's sealed source and device (SS&D) evaluation even though they currently have responsibility for this area because the State has indicated that it plans to formally relinquish its SS&D authority. The State has performed l
l only one SS&D review in the past 25 years and did not perform any SS&D evaluations during the period of review, i
5.0
SUMMARY
As noted in Sections 3 and 4 above, the review team found the State's performance with i
each of the performance indicators to be satisfactory or satisfactory with recommendations for improvement, with two exceptions. The team found the State's performance unsatisfactory in Section 3.2, Technical Staffing and Training, and Section 4.1.2, Status and Compatibility of Regulations. A review of previous program reviews between 19861992 indicated similar problems were found in, staffing, inspection program, compatibility of regulations, enforcement and management control. The team observed that the State experienced weaknesses and deficiencies throughout the program during the reporting period which were compounded by the loss of three key staff members and two reorganizations. Difficulties identified during the review include: (1) a backlog of 9 core inspections: (2) 22 inspections pending supervisory review and notification of the findings to the licensee; (3) inspection reports were incomplete; (4) a backlog of 101 licensing actions (5) no incident reporting to NRC since June 1995; (6) incomplete documentation of incident response and response to allegations; (7) regulations required for compatibility not a:fopted in timely fashion; and (8) no "get well" plan. All of these factors considered collectively led the team to find that State's response to Section 3.2, Technical Staffing and Training, was unsatisfactory at the time of the review. The team found Section 4.1.2, Status and Compatibility of Regulations, unsatisfactory due to l
the failure to adopt regulations equivalent to 10 CFR Part 36 by July 1,1996. However, 3
subsequently this regulation was promulgated on October 30,1996, with the minor i
l exception of the applicability of a more stringent radiation protection standard to a non-existent class of licensees, the Nebraska program is currently compatible. The team found
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i that the primary root causes for the deficiencies found in the program were directly attributable to (1) the need for management improvement to effectively assess and j
respond to the reduced level of performance in the Agreement State program, and (2) lack
' of current, written, program procedures or failure of staff to follow these procedures.
i Accordingly, the team recommends that the Management Review Board find the Nebraska program adequate to protect public health and safety but needs improvement, and i
compatible with NRC's program. Due to the significance and number of deficiencies found
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l Nebraska Proposed Final Report Page 23 in the Nebraska program that included unsatisfactory in one performance indicator, the team recommends a period of probation for a duration to be established after consultation
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i with Nebraska radiation control program management.
3 Recommendations 4
Below is a summary list of recommendations and suggestions, as stated in earlier parts of this report, for consideration and action by the State.
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1.
The review team recommends that the State follow the inspection frequency for l
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conducting inspections of reciprocity licensees contained in NRC Manual Chapter 1220, " Processing of NRC Form 241, Report of Proposed Activities in Non-s Agreement States, and inspection of Agreement State Licensees Operating Under j
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10 CFR Part 150.20." (Section 3.1)
I 2.
The review team recommends that the managers responsible for the Nebraska
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Radioactive Materials Program establish an action plan or procedure to assure inspections are completed at the frequencies stated in the Nebraska inspection i
Manual which is equal to the NRC's IMC 2800 and conduct reciprocity licensee
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inspections at the required frequencies stated in IMC 1220. (Section 3.1) 3.
The review team recommends that the managers establish an action plan or procedure for coordinating deviations from the inspection schedule between staff
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j and management based on the risk of license operations, past performance and need to temporarily defer the inspections to address more urgent or critical priorities. (Section 3.1) s l
4.
The review team recommends that the managers organize a "get well" plan for rescheduling missed or deferred inspections, especially due to loss of senior staff; and establish a plan or methodology to assure initial inspections are performed within 6 months of it..uance of the license in accordance with the Nebraska inspection Manual and NRC's IMC 2800. (Section 3.1) l 5.
The review team recommends the incorporation of the inspection frequencies i
contained in NRC's IMC 2800 into the Nebraska inspection Manual. (Section 3.1) 6.
The team recommends that the qualifications of contractor personnel be tied to the l
contract as identified by the program manager or as accomplished by the LLRW i
program in NDEO. (Section 3.2) 7.
The team recommends that a written program for staff qualification, including retaining training records, be developed. (Section 3.2)
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8.
The team recommends that the State develop comprehensive administrative procedures, sufficient to guide the day-to-day operation of the program in the event of another loss of senior staff. The procedures should include a formal process for bringing to the attention of upper management the increase of significant backlogs j
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0 Nebraska Proposed Final Report Page 24 of licensing, inspection, or enforcement actions, or any other situation which increases the risk to public health and safety. Licensing procedures should include prioritization of licensing actions based upon identified factors, including health and safety significance, for new and previously received applications. (Section 3.2) 9.
The team recommends that the program be observed with increased attention to the effects of the further reorganization. (Section 3.2) 10.
The team recommends that a written policy or procedure should be developed for prioritizing licensing actions based upon identified factors, including health and safety significance, for new and previously received applications. (Section 3.3) 11.
The team recommends that a written procedure and schedule should be developed for elimination or reduction of the backlog of existing licensing actions.
(Section 3.3) 12.
The review team recommends that the State consider for adoption a policy of annual supervisory accompaniments of allindividuals who perform inspections for the Radioactive Materials Program. (Section 3.4) 13.
The review team recommends that the State develop a plan or procedure to assure that field notes, as well as, reports, and enforcement letters are promptly reviewed, signed and dated by a supervisor within the recommended 30 day timo frame for issuance of inspection findings. (Section 3.4) 14.
The review team recommends that the State perform an immediate review of all contractor field notes and draft enforcement letters in order to finalize and issue the findiags of the remaining 22 inspections to the licensees involved. (Section 3.4) 15.
The review team recommends revising the allegations procedures to incorporate key areas,i.e. documentation of any communications with the alleger, documentation of the inspection findings, interviewing techniques, etc., identified in NRC Manual Directive 8.8, Management of Allegations. (Section 3.5) 16.
The review team recommends that the staff use the draft " Handbook on Event Reporting in the Agreement States (Handbook)," published March 1995, for review and reporting of material events to NRC. (Section 3.5) 17.
The review team recommends establishment of comprehensive procedures for tracking, follow up and close out of events involving the use of radioactive material covered under the Atomic Energy Act. (Section 3.5) 18.
The review team recommends that the State immediately begin reporting current material events to NRC and send in information on the three events identified during the review as reportable, that were not previously reported to NRC. (Section 3.5)
Nebraska Proposed Final Report Page 25 19.
In accordance with the State's commitment, the team recommends that Nebraska amend 180 NAC 1012.22 to remove its applicability to waste treatment and i
storage facilities.
i 20.
The team suggests that the LLRW program assemble training documentation for individual staff and contractors and develop a consolidated training record to enable assessment of the progress of training across the entire program. (Section 4.2.3) 1
-. =
4 e
LIST OF APPENDICES l
Appendix A IMPEP Review Team Members Appendix B NDOH and EHPS Organization Chart Appendix C Nebraska Questionnaire Response Appendix D License File Reviews Appendix E Inspection File Reviews Appendix F Incident File Reviews i
1 l
i 1
J f
4 4
4
'I 4
4
1 i
i APPENDIX A iMPEP REVIEW TEAM MEMBERS Name Area of Responsibility Patricia M. Larkins, OSP Team Leader Response to incidents and Allegations Jenny Johansen, RI Status of Materials inspe'ction Program Technical Quality of Inspections Richard Blanton, OSP Technical Staffing and Training Legislation and Regulations Charles Mattson, Colorado Technical Quality of Licensing Actions Ralph Cady, RES Low-Level Radioactive Waste Program i
- i -
i i
4 i
i APPENDIX B l
NEBRASKA DEPARTMENT OF HEALTH AND e
ENVIRONMENTAL HEALTH PROTECTION i
SECTION i
l ORGANIZATION CHART i
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Rev. 7/12/96 ENVIRONMENTAL llEALTil PROTECTION SECTION Jack L Daniel, Administrator Mary Hanneman, Admin. Asst.
Jo Ann Wagner, Admin. Asst. (Regulations)
AllERA Pronram Asbestos Control Procram Eneineerine Services Pronram Field Services Proeram Doug Gillespie, Program Manager Donald Madsen, Program Manager Subhash Jha, Program Manager Tom Michels, Program Manager Barb Eickmeier, Secretary Janell Miller, Staff Asst.
Dawn McFarland, StafTAsst.
Robert Donahue, HIHS Bob Lukowski, P.E.
Tom Flodman, WSS Steve Schlife, HIHS Steve Rowell, P.E.
Daryl Guest, WSS Larry Steele, EIT Rich Koenig, WSS Ralph Naber, WSS Roger Rhylander, WSS Mike Wentink, WSS Doug Woodbeck, WSS Low Level Radioactive Waste Procram Monitorine & Comoliance Pronram Radioactive Materials Pronram Water Well 9aad=eds Proeram Cheryl Rogers, Program Manager Scott Peterson, Program Manager Brian Hearty, Program Manager Rod Tremblay, Program Manager Bev Spang, Stali Asst.
Laura liardesty, WSS Joyce Davidson, IIP Pat Wilsey, Staff Asst.
John Fassell,11P Roger Lolley,ISA Jim DeFrain,llP Tom Christopherson, WSS Trudy 11i11, RilS Gale Stenberg, WSS Bryan, Miller, llP Dave Sizer, WSS Deb Larson, StafT Asst. (Butte)
Stephanie Vap, WSS Joe Milone, RilS Iloward Shuman,11P
APPENDIX C INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM (IMPEP) QUESTIONNAIRE 4
J I
1 4
e
'1 Approved by OMB No. 3150-0183 Expires 4/30/98 INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM QUESTIONNAIRE Nebraska Department of Health, Nebraska Department of Environmental Quality NDOH Radioactive Materials Program, Brian P. Hearty, Manager M 4 NDOH Low-Level Radioactive Waste Program, Cheryl K. Rogers, Manager NDEQ Low-Level Radioactive Waste Program, Jay D. Ringenberg, Manager Reporting Period: June 25,1994, to July 12,1996 A.
COMMON PERFORMANCE INDICATORS 1.
Status of Materials Inspection 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 initial inspections that are overdue.
Licensee Name Inspection License Number Frequency Due Months License Type (Years)
Date Overdue Type l
Stanley S. Jaeger 3
01-69-01 03/01/89 88 Other Services Jnitial Nebraska Methodist Hospital 1
01-07-02 09/01/94 22 l
HDR Afterloader Routine i
l l
2 Estimated burden per response to comply with this voluntary collection request: 60 hours6.944444e-4 days <br />0.0167 hours <br />9.920635e-5 weeks <br />2.283e-5 months <br />.
Forward comments regarding burden estimate to the Information and Records Management Branch (T-6 F33), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, and to the Paperwork Reduction Project (3150-0052), Office of Management and Budget, Washington, DC 20503.
NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
j.
l Lincoln General Hospital 1
i 02-06-03 05/01/95 14 i
HDR Afterloader Routine Nuclotron-Oldelft 3
Corporation 05/01/95 14 i
99-49-01 Routine j
Other Services i
Immanuel Medical Center 1
}
01-0441 01/01/96 6
j HDR Afterloader Routine Center for Metabolic imaging 1
1 01-72-01 01/01/96 6
l Manufacturing Routine Bergan Mercy Medical Center 1
01-09-02 04/01/96 3
l HDR Afterloader initial University of Nebraska 1
Medical Center 04/01/96 3
01-50-01 Routine MedicalInstitution Broad Thiele Geotech, Inc.
5 l
01-84-01 06/01/96 1
Industrial Gauge Initial 2.
Do you currently have an action plan for comp 6 ting overdue inspections?
If so, please describe the plan or provide a written copy with your l
response to this questionnaire.
License No. 01-69-01, Stanley S. Jaeger, expired 9/30/93 without an initial inspection having been performed. The Individual has submitted a renewal application, but has not responded to a subsequent deficiency letter. The application was not deemed timely filed. If the applicant is issued a license, an initial inspection will be performed within 6 months, otherwise a termination inspection will be performed in 1996 to confirm the transfer of the dose calibrator calibration sources authorized by the license.
Y I
2 4
Nebraska Methodist Hospital, Lincoln General Hospital, and immanuel Medical Center, were not assigned a Priority 1 when an HDR was added to each license. The licensees listed above will be inspected in 1996 and annually as described in A.I.3. below.
Center for Metabolic Imaging has requested that 01-72-01 he terminated since the operation of the cyclotron has been taken over by Syncor International Corp. under license 01-65-02, which was inspected 3/19/96. Since operations are ongoing under another license a termination inspection will not be required.
Bergan Mercy Medical Center, was authorized for an HDR in 8/95 and the license reviewer noted that an inspection should be performed within 6 months after start of HDR treatment. The licensee received their HDR in 10/95. The licensee will be inspected in 1996 and annually as described in A.I.3. below.
Nucletron-Oldelft Corporation was not assigned a Priority 3 when licensed in Nebraska. The licensee was inspected in 5/92 and 1
assigned a 5 year inspection frequency. Tha licensee will be inspected in 1996 and every 3 years as described in A.l.3. below.
2 i
l The University of Nebraska Medical Center was inspected during the j
spring semester of 1995. To provide variability in the research activities that may be directly observed during the inspection, the
)
licensee will be inspected during the fall semester of 1996.
l l
Thiele Geotech, Inc., will be inspected by program staff during the l
week of July 15-19,1996, with NRC accompaniment.
l l
3.
Please identify individual licensees or groups of licensees the l
State / Region is inspecting less frequently than called for in NRC j
Inspection Manual Chapter 2800 (issued 4/17/95) and state the reason for i
the change, t
Hiah-Dosh Rate Remote Afterloader: Licensees possessing an HDR have were previously inspected on a 3 year frequency. All licenses j
authorizing an HDR will be assigned a Priority 1 and inspected j
annually.
Mobile Nuclear Medicine Service: Licensees of this type were previously inspected on a 3 year frequency. Licensees providing i
IMPEP Questionnaire 3
State of Nebraska 4
l mobile nuclear raedicine services will be assigned a Priority 2 and be inspected every 2 years.
Instrument Calibration Services Only - Other: and Other Services:
Service licensees were previously grouped together and inspected on a 5 year frequency. All service licensees will be reviewed and assigned the proper priority and inspection frequency, either 3 or 5 years, and inspected accordingly.
Manual Chapter 2800 will be reviewed when revised and appropriate changes in the Program's inspection frequencies will be made if justified. A copy of 2800, Enclosure 1, will be placed in the Program Staff Inspection Manuals for reference.
4.
How many licensees filed reciprocity noticers in the reporting period?
31 licensecs filed 163 reciprocity notices.
a.
Of these, how many were industrial radiography, well-logging or other users with inspection frequencies of three years or less?
20 licensees of Priority 1,2, or 3. (7 industrial radiography,1 mobile nuclear medicine service,7 well logging, and 5 other services) b.
For those identified in 4a, how many reciprocity inspections were l
conducted?
l 2 licensees (industrial radiography) were inspected.
5.
Other than reciprocity licensees, how many field inspections of radiographers were performed?
l 1 field inspection will be performed. A field site (which the licensee hopes to add as a permanent radiographic facility) will be inspected i
on 6/26/96 by program staff with NRC accompaniment. Of the other 3 industrial radiographers licensed in Nebraska,2 are fixed facility, and 1 has not used their sources since 5/27/94.
j 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 IMPEP Questionnaire 4
State of Nebraska i
a 5
4 e-the reasons for any differences between the goals and the actual number j
of inspections performed.
J
)
N/A-i ll.
Technical Staffino and Trainina J
7.
Please provide a staffing plan, or complete a listing using the suggested i
format below, of the professional (technical) person-years of effort applied to the agreement or radioactive material program by individual. Include I
the name, position, and, for Agreement States, the fraction of time spent in the following areas: administration, materials licensing & compliance, i
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 l
materials program. Include all vacancies and identify all senior personnel assigned to monitor work of junior personnel. If consultants were used to carry out the program's radioactive materials responsibilities, include their i
efforts. The table heading should be:
RADIOACTIVE NAME MATERIALS AREA OF EFFORT PROGRAM l
POSITION Brian Hearty Program Manager Program Administration -40%
j Licensing / Compliance - 30%
i Regulations - 10%
]
Emergency Response - 10%
Jim DeFrain Health Physicist I Licensing / Compliance - 95%
i Emergency Response - 5%
i Vacant Health Physicist i Licensing / Compliance - 95%
Emergency Response - 5%
l Joyce Health Physicist i Regulations - 70%
l Davidson Licensing / Compliance - 25%
l Emergency Response - 5%
i' Cheryl Rogers Program Manager Licensing / Compliance - As j
LLRW Needed up 20%
i IMPEP Questionnaire 5
State of Nebraska i
i
l 1
e f.'
h Howard Health Physicist ll Compliance - As Needed up to Shuman LLRW 20%
Harold Radiological Regulations - As Needed j
Borchert Health Consultant Licensing / Compliance - As Stan A. Huber Contract p ance - Performance of j
Consultants, Consultant 27 inspections from 1/1/96 to Inc.
6/30/96.
i Brian Hearty, Cheryl Rogers, and Joyce Davidson have been I
identified ac senior personnel for reviewing work in materials licensing. Brian Hearty, Cheryl Rogers, and Howard Shuman have j
been identified as senior personnel for inspection accompaniments l
of junior personnel.
8.
Please provide a listing of all new professional personnel hired since the i
last review, indicate the degree (s) they received, if applicable, and additional training and years of experience in health physics, or other disciplines,if appropriate.
)
Jim DeFrain, was hired as a Health Physicist I in the Radioactive Materials Program on July 20,1995. Jim has MPA in Public Administration and has been with the Department of Health for 13 years. He has worked as a Radiological Health Specialist I and l
Health Physicist I in the X-ray Program, and a Radiological Health j
Specialist li and Health Physicist I in the Emergency Response and Environmental Surveillance Programs. Jim has attended the following training courses which directly relate to the Radioactive Materials Program: 6-Week Applied Health Physics, Radiological i
l Emergency Response Operations, Transportation of Radioactive Materials, inspection Procedures, Licensing Procedures, Medical l
Uses of Radionuclides, Safety Aspects of Industrial Radiography, j
Health Physics Technology, and Environmental Monitoring for Radioactive Materials.
l l
The vacant Health Physicist I will be hired in 6/96 and training and experience will be available at the time of the IMPEP review.
9.
Please list all professional staff who have not yet met the qualification l
requirements of license reviewer / materials inspection staff (for NRC, Inspection Manual Chapters 1245 and 1246; for Agreement States, l
lMPEP Questionnaire 6
State of Nebraska l
please describe your qualifications requirements for materials license
'l reviewers and inspectors). For each, list the courses or equivalent training / experience they need to attend and a tentative schedule for completion of these requirements.
The qualifications requirements for Radioactive Materials Program license reviewers and inspectors consists of intamal training, formal i
I coursework, and on-the job training.
)'
The intamal training consists of review of the program's inspection i
and Enforcement Manuals, review of all appropriate Nebraska and j
Federal Regulations and regulatory guides, and review of program policies.
i l
The formal coursework required has included the following NRC and j
FEMA sponsored courses: Radiological Emergency Response j
Operations, Applied Health Physics, Licensing Procedures, Inspection Procedures, Medical Uses of Radionuclides, Transportation of Radioactive Material, Health Physics Engineering, j
Safety Aspects of Industrial Radiography.
As more NRC sponsored courses become available to Agreement State inspectors, the above core coursework may be expanded to include coursewo* that would be beneficial to the Program.
j Courses that program staff have found beneficial include: Health i
Physics Technology, inspecting for Performance, Teletherapy and l
Brachytherapy, Irradiator Technology, Safety Aspects of Well Logging, and Environmental Monitoring for Radioactivity. The Diagnostic and Therapeutic Nuclear Medicine Course is also very appropriate for program staff.
1 j
The on-the-job training for materials licensing consists of the direct supervision of the trainee in the review and evaluation of j
increasingly complex licensing actions. On-the-job training for inspections consists of the trainee accompanying senior staff on l
various inspections, and then the trainee acting as lead inspector while accompanied by senior staff on increasingly complex l
inspections.
Brian Hearty has not yet attended the Safety Aspects of Industrial l
Radiography Course and plans to attend during 1996.
IMPEP Questionnaire 7
State of Nebraska i
.. +,
l
\\
Jim DeFrain has not yet attended the Health Physics Engineering Course and has submitted an application to attend the 8/12-16/96 i
offering. Jim is continuing to review increasinejy complex licensing actions under supervision. Jim has accompanied on several inspections, and has started to act lead inspector while accompanied by senior personnel.
i The vacant Health Physicist I will need to receive additional training dependent on the qualifications possessed at the time of hire.
10.
Please identify the technical staff who left the RCP/ Regional DNMS program during this period.
i NAME POSITION REASON FOR LEAVING Julie Peterson Health Physicist ll Accepted position as HP for U.S. Army Corps of Engineers on 6/23/95.
j Michael Beard Health Physicist I Accepted a position as NDOH Investigations Section Administrator i
on about 6/1/95.
l Subsequently, accepted l
a position as RSO at an l
i irradiator in Nebraska.
5 Ill.
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.
Crelohton University. 01-82-01: Combined 11 educational and 5 medical licenses into the broad scope license.
Bernan Mercy Medical Center. 01-09-02: Received authorization for an HDR, a PET Scanner to be used with a Rb-82/Sr-82 infusion system, and a redesign of the nuclear medicine area.
IMPEP Questionnaire 8
State of Nebraska
l.
Lincoln General Hospital. 02 06-03. and St. Elizabeth Community I
Health Center. 02-36-01: The licenses were transferred from the radiology group to the facilities, the 02-06-03 license combined a -
separate nuclear mediclL, and an HDR (brachytherapy) license.
\\
l Bryan Enterprises. : Combined two large mobile nuclear medicine j
services under one license. See also 13. below.
1 l
EndoTech. Inc. 01-76-01: This research and development licensee's requests resulted in the submission of financial surety for site reclamation, and a lowering of possession limits to avoid an j
emergency plan which was now being requested by the program.
l 12.
Please identify any new or amended licenses added or removed from the j
list of licensees requiring emergency plans?
l N/A. Currently, no licensees have been required to submit an i
i 13.
Discuss any variances in licensing policies and procedures or exemptions from the regulations granted during the review period.
Nebraska regulations require that an authorized user or on-site physician (40 hrs training in radiation safety) be at the facility during the performance of mobile nuclear medicine procedures. A policy was developed which allows a mobile nuclear medicine licensee to request an exemption allowing on-site physicians to be at their office, but available by phone and able to respond within 30 minutes in an emergency.
An exemption was granted to Bryan Enterprises,02-39-01, to allow delivery of licensed material to a client's address of use for receipt by the licensee's staff at the mobile van. The above exemptions allowed diagnostic health care services in parts of rural Nebraska that would not have been feasible before.
A variance in licensing practice was recently discovered regarding financial assurance for decommissioning with regards to the 3 commercial irradiator licensees in Nebraska. At the time the rule was adopted it was unclear if any Nebraska licensees would be rsquired to submit a decommissioning funding plan. It is now clear the irradiator licensees are required to submit a funding plan for IMPEP Questionnaire 9
State of Nebraska
$75,000. The licensees will be notified and the plans reviewed upon receipt.
14.
What, if any, changes were made in your written licensing procedures (new procedures, updates, policy memoranda, etc.) during the reporting period?
The standard license conditions have been revised.
Several policy memorandum have been superseded by implementation of the 5/31/94 revision of the rr,gulations.
The licensing procedure manual, review guidance, and checklists have not been updated to reflect current requirements. Currently, materials licensing reviewers use updated Regulatory Guides, NRC checklists, and NRC deficiency paragraphs for guidance. The generation of updated procedures, guidance, and checklists will be completed as soon as possible to ensure thorough and timely review of licensing actions.
15.
For NRC Regions, identify by licensee name, license number and type, any renewal applications that have been pending for one year or more.
N/A IV.
Technical Quality of Insoections 16.
What, if any, changes were made to your written inspection procedures during the reporting period?
An inspection Manual was developed and implemented in late 1994.
An Enforcement Manual containing boilerplate violations was developed and authorized for use as guidance in 2/95. The first use of the Enforcement Manual violations for actual drafting of a Notice of Violation has been by the contract inspector in 1996.
17.
Prepare a table showing the number and types of supervisory accompaniments made during the review period. Include:
i l
IMPEP Questionnaire 10 State of Nebraska
Supervisor inspector License Category Date Bill Schultz, Brian Hearty Medical Private 09/02/94 contract Practice consultant.
Bill Schultz, Julie Peterson MedicalInstitution 09/01/94 contract consultant.
Bill Schultz, Michael Board Industrial Radiography 08/31/94 contract
- Fixed consultant.
18 Describe intemal procedures for conducting supervisory accompaniments of inspectors in the field. If supervisory accompaniments were documented, please provide copies of the documentation for each accompaniment.
i Currently, the number and type of supervisory accompaniments by senior program staff is not defined by program procedure and they have not been documented in the past. A consultant was hired to develop the Inspection and Enforcement Manuals, and part of the contract was to review the program staff by accompaniment. Copies of the reports submitted for Julie Peterson and Brian Hearty are attached.
19.
Describe or provide an update on your instrumentation and methods of calibration. Are all instruments properly calibrated at the present time?
I Proaram Maintained Detection and Measurement Instrumentation:
Ludlum Model 5, dual intamal G-M detectors.
Ludlum Model 14C, intamal G-M and extemal 44-6 G-M detector.
j Ludlum Model 12S, intamal Nal detector, yR/hr meter.
1 The above instruments are calibrated annually by the manufacturer j
and are in calibration at this time.
Eberiine PAC-4S, AC-3-7 ZnS detector.
The above instrument was calibrated by the manufacturer in 8/93 and l
Is currently not calibrated for use.
IMPEP Questionnaire 11 State of Nebraska P
J e
i
- 1
)
i Available Detection and Measurement instrumentation:
Ludlum Model 3,44-38 energy compensated G-M detector and 44-3 i
j thin crystal Nat detector.
j The above instrument is calibrated annually by the manufacturer and j
is in calibration at this time.
1 Eberline RO-2, lonization chamber.
Eberline E-520, HP-210 or HP-210T G-M probe.
The above instruments are calibrated annually by the manufacturer i
or a calibration service and are in calibration at this time.
Confirmatory wipe tests and gamma isotopic measurements are l
performed by the Nebraska Department of Health Lab using various j
instruments.
4 V.
Responses to incidents and Alleastions i
j 20.
Please provide a list of the most sionificant incidents (i.e., medice:
misadministration, overexposuros, 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 l
Region / State during the review period. For Agreement States, information l
included in previous submittats to NRC need not be repeated. The list should be in the following format:
i Licensee License Date of Name Number incident /
Type of incident
{
Report 1
l Nebraska 02-02-02 incident Licensee discovered a l
Civil Defense O'1/93 missing Co-60 source (= 180 Agency (Assumed)
Cl on 1/93) which was i
most likely disposed of in 1
Reported the landfill. The NRC j
08/07/95 agreement states officer j
was notified by telephone l
on 08/07/95.
i l
1 IMPEP Questionnaire 12 State of Nebraska d
1
-l i
Sherwood 07-02-01 incident Irradiator licensee Medical 09/09/93 performing weekly maintenance check found j
Reported the low water switch not 09/12/95 functioning as intended.
The sources were raised without correcting the problem or notifying the Agency as required by license condition. the j
switch functioned properly when retested 09/11/95. The incident was not reported to NRC since 10 CFR 36 would allow the licensee to repair the switch without undue delay.
Sherwood 07-02-01 incident An employee of the licensee Medical 11/30/95 called to allege a possible violation involving barrier Reported doors malfunction. An l
12/1/95 inspection of the licensee confirmed that barrier doors were not functioning as intended when the licensee l
changed operation to index i
mode. It was determined by observation and interview I
that the barrier door or a tote was blocking the i
entrance at all times during the incident. The irradiator manufacturer checked and repaired the program logic.
This incident was not reported to NRC.
1 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?
IMPEP Questionnaire 13 State of Nebraska i
The equipment problems listed in A.V.20. above were reported by the
]
licensee to the manufacturer.
a.
For States, was timely notification made to the Office of State Programs?
I For Regions, was an appropriate and timely PN generated?
The OSP was not notified of any equipment or source failures, or deficient procedures, i
An attempt was made to use the interim Nuclear Materials Events i
Database and Report Preparation Program to generate reports of events. There were several problems with the implementation, and a decision to wait for the final Microsoft Access version of NMED was made.
22.
For incidents involving failure of equipment or sources, was information on the incident provided to the agency responsible for evaluation of the device for an assessment of possible generic design deficiency? Please provide details for each case.
No.
i 23.
In the period covered by this review, were there any cases involving possible wrongdoing that were reviewed or are presently undergoing review? If so, please describe the circumstances for each case.
4 1
No.
i 24.
Identify any changes to your procedures for handling allegations that occurred i
during the period of this review.
1 i
A procedure for response to allegations was drafted and implemented as part of the new Inspection Manual.
t a.
For Agreement States, please identify any allegations referred to your program by the NRC that have not been closed.
N/A 1
VI.
General i
- 25. Please prepare a summary of the status of the State's or Region's actions taken in response to the comments and recommendations following the last review.
IMPEP Questionnaire 14 State of Nebraska 4
The review completed June 24,1994, indicated that the Nebraska Program met the guidelines in all 30 indicators, and no recommendations or comments were identified.
- 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.
A strength of the Nebraska Radiation Control Program is its ability to obtain sufficient resources, such as qualified personnel, either internally or through contractual arrangements, to ensure that program activities are carried out at an adequate level to protect the public health and safety. The contract for inspection services and an increase in the allocation of time from LLRW Program Staff allowed the materials licensing backlog to be addressed during the staff shortage outlined in A.ll.10. above. However, it is a weakness of the Program that the frequency at which it is necessary to obtain outside resources has not decreased. A weakness of the Radioactive Materials Program is the time taken to review changes in NRC procedure for appropriateness to the program, such as the inspection frequencies in inspection Manual Chapter 2800. An example of this is the overdue inspections of HDR licensees as outlined in A.I.3.
Bo NON-COMMON PERFORMANCE INDICATORS 1.
Reaulations and Leaal Authority i
l
- 27. Please list all currently effective legislation that affects the radiation control j
program (RCP).
i Radiation Control Act 71-3501 to 71-3520 l
l Nebraska Disaster and Civil Defense Act, as amended 81-829.36 to 81-829.74.
(This #it was amended this past legislative session and will become the i
Emergency Management Act on 07/18/96).
Emergency, Governor, Civil Defense Assumption of Control of State i
Communications System 81-1120.25 i
j Administrative Procedures Act 84-920 i
I l
lMPEP Questionnaire 15 State of Nebraska i
Low-Level Radioactive Waste Disposal Act 81-1578, (This Act was amended this past legislative session an will become effective 07/19/96.).
Nebraska Partnership for Health and Human Services Act LB1044, Effective 01/01/97.
- 28. Are your regulations subject to a " Sunset" or equivalent law? If so, explain and include the next expiration date for your regulations.
No.
- 29. Please complete the enclosed table based on NRC chronology of amendments.
Identify those that have not been adopted by the State, explain why they were not adopted, and discuss any actions being taken to adopt them.
- 30. If you have not adopted all amendments within three years from the date of NRC l
rule promulgation, briefly describe your State's procedures for amending
)
regulations in order to maintain compatibility with the NRC, showing the normal length of time anticipated to complete each step.
Program staff drafts changes in regulations by using the Conference of Radiation Control Program Director's Suggested State Regulations, NRC Regulations, FDA, EPA, and DOT regulations. The drafts are then reviewed by the appropriate Program Manager, Health Department Legal staff, and the Nebraska Radiation Advisory Council. The Council may then give approval to go to Public Hearing. The drafts are then sent to the Governor's Policy i
I Research Office (PRO) for their approval to go to Public Hearing. Notice of Public Hearing is published (IN A NEWSPAPER WITH WIDE CIRCULATION THROUGHOUT NEBRASKA) at least 30-days prior [THIS IS LAW]
(SOMETIMES MORE TIME IS GIVEN DEPENDING ON THE PROPOSED l
DRAFTS).
l A copy of the Public Hearing notice is filed with the Nebraska Secretary of j
State's Office and copies of the Public Hearing notice are sent out to all i
licensees and registrants in Nebraska in addition to other interested parties.
Copies are also sent to the Nebraska Executive Board of the Legislature.
i Copies of the drafts are provided to all licensees and anyone who requests a copy. At this time all Federal Agencies are also sent copies of the Public l
Hearing Notice and a copy of the proposed draft regulations.
l l
lMPEP Questionnaire 16 State of Nebraska
l-After Public Hearing comments are reviewed and any necessary changes are i
l made, the final draft goes to the Attomey General's Office for their review, l
comments and approval. (USUALLY TAKES 30-DAYS, SOMETIMES LESS.)
i Upon approval by the Attomey General it then goes back to the Govemor's Office (PRO) for approval (USUALLY TAKES 30-DAYS SOMETIMES LESS.)
t t
Upon Govemor's approval and signature it is filed with the Nebraska Secretary of State's office. (EFFECTIVE DATE IS 5-DAYS LATER).
Printing and distribution takes about 30 additional days.
11.
Low-Level Waste Procram i
- 31. Please include information on the following questions in Section A, as they apply to the Low-level Waste Program:
Status of Materials Inspection Program - A.I.1-3, A.I.6 Technical Staffing and Training - A.ll.7-10 Technical Quality of Licensing Actions - A.lli.11, A.lli.13-14 Technical Quality of Inspections - A.IV.16-19 Responses to incidents and Allegations - A.V.20-23 The Nebraska Low-Level Radioactive Waste Program (LLRWP)is a joint effort by the Nebraska Department of Health (NDOH) and the Nebraska Department of Environmental Quality (NDEQ). The application for construction, operation and closure of the waste disposal facility is under review by the LLRWP; therefore, responses to the following questions are not appropriate:
Status of Materials inspection Program - A.I.1-3, A.I.6 Technical Quality of Licensing Actions - A.lll.11, A.Ill.13 Technical Quality of Inspections - A.IV.16-18 Responses to incidents and Allegations - A.V.20-23 The responses to the remaining questions follow:
ll.
Technical Staffina 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 j
agreement or radioactive material program by individual. Include the neme, position, and, for Agreement States, the fraction of time spent in the following areas: administration, materials licensing & compliance, emergency response, IMPEP Questionnaire 17 State of Nebraska
p LLRW, 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. blude all vacancies and identify all senior personnel assigned to monitor work of junior personnel. If consultants were used to carry out the program's radioactive materials responsibilities, include their i
efforts. The table heading should be:
l NAME LLRW PROGRAM AREA OF EFFORT l
POSITION J. D.
NDEQ LLRW Program LLRW program administration -
j Ringenberg Manager 100 %
Monitors work of LLRWP personnel.
C.K. Rogers NDOH L!.RW Program LLRW program administration-85%
Manager NDOH, ER-10%, NDOH Environmental-5%
Monitors work of LLRWP personnel
- H. Shuman NDOH HP ll -
LLRW program (application review I
Environmental and RESP) - 90%
Surveillance.
NDOH ER - 10%*
Reviews work of LLRWP personnel J. Fassell NDOH HP ll-LLRW program (application review l
Performance and IPA) - 90%
i Assessment NDOH ER - 10%
i l
G. Allen NDEQ LLRW program - 100%
Environmental Reviews work of LLRWP personnel.
Specialist
}
C. Felix NDEQ Administrative LLRW program - 100%
]
Assistant ll Reviews work of LLRWP personnel.
i 1
78 Expertise in various Names, resumes and areas of affort j
Contractors areas Have been or are on file and are available to the are involved in the NRC.
review of the application.
q
{
Vacant NDOH HP 11 -
LLRW program (source term, waste Nuclear Engineer form etc.) - 100%
i i
IMPEP Questionnaire 18 State of Nebraska l
l-
\\
l.
in addition to the foregoing the current LLRWP staff includes one NDEQ Staff Assistant II, one NDOH Secretary ll, one NDEQ Secretary ll, and one NDOH 1
Staff Assistant (part time).
l 8.
Please provide a listing of all new professional personnel hired since the last review, indicate the degree (s) they received, if applicable, and additional training and years of experience in health physics, or other disciplines, if appropriate.
John Fassell Joined the LLRW program in February 1996. He has a B.S. In Geology (minor-Geochemistry) and a MS in Atmospheric Sciences i
(Specializing in Space Physics) and completed the U.S. Air Force Institute of Technology Basic Meteorology Program. He is a Registered Radiation 4
Protection Technologist by the NRRPT. Courses that he has completed follow:
NB.Q l
Transportation of Radioactive Materials Course (1996)
EE.M8 Radiological Emergency Planners Course (1994)
Radiological Trainer 111 Train the Trainer) Course (1995)
Exercise Evaluators Course (1994) l Ingestion Pathway Gwrse (1993)
Radiological Emergency Response Operations Course (1993) f SCDAIFEMA j
Radiological Monitor Course (1993)
Radiological Responder Team Course (1993)
Radiological Officer Course (1993)
Radiolog! cal Monitor Instructor Course (1995)
Instructional Techniques Course (199ii)
.ld.QA Agricultural Pathway Course (1993)
Ef8 EPA-400 instructional Workshop (1993)
Radon Measurement Proficiency Course Employment History 4/1/95 to 3/1/96 NDOH Inspector X-raf Section j
IMPEP Questionnaire 19 State of Nebraska 1
i 1/4/93 to 41/95 NDOH HP Section Chief for the Emergency Response, i
Standards, Environmental Surveillance and Radon i
Section.
i 1983 to 1993 USAF Weather Officer serving in St Louis, MO, Okinawa,
[
Japan and Omaha, NE. Primary function was problem solving in electronics, physics and environmental l
applications.
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 need to attend and a tentative schedule for completion of these requirements.
i The review of the application for license is generally performed by j
consultants. There are 8 Review Managers assigned to specific technical areas of the application. Each Review Manager has several Technical Reviewers with expertise in specific areas reporting to him. The requirements for qualification as a Review Manager or as a Technical Reviewer are specified in LLRW Program Licensing Procedure LP-7.
}
- 10. Please identify the technical staff who left the RCP/ Regional DNMS program j
during this priod.
I l
NAME POSITION REASON FOR LEAVING i
Asish Banerjee NDOH HP 11 Transferred to NDOH X-Ray Radiological Analyst Program on 12/1/95.
Both Kernes-NDOH HP 11 Accepted a position as a l
Krause Nuclear Engineer Nuclear Engineer at Cooper NPS on 10/1/94.
Charles NDEQ Retired 2/28/94 and became a 1
Johnson Environmental part-time consultant to the Engineer LLRW Program.
6 lli. 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.
IMPEP Questionnaire 20 State of Nebraska
)
j.
i i
The application review process has not progressed to the point where this question is appropriate.
l
- 13. Discuss any variances in licensing policies and procedures or exemptions from the 1
regulations granted during the review period.
The application review process has not progressed to the point where this i
question is appropriate.
I i
14.
.What, if any, changes were made in your written licensing procedures (new
]
procedures, updates, policy memoranda, etc.) during the reporting period?
l i
Changes, Revisions and Additions to the Nebraska's LLRW Program's l
Licensing Program Plan Procedures from June 1994 to July 1996 j
j Section or Title Revision Date of
]
Procedure Number Revision Section 3 Review of the Safety analysis Report &
1 06/16/95 Preparation of Safety Evaluation Report Section 4 Review of Environmental Report &
2 06/30/95 l
Preparation of the EnvironmentalImpact Analysis l
Section 5 Preparation & Issuance or Denial of the 1
07/15/94 License Section 7 Non-Radiological Environmental 1
06/24/94
]
Surveillance Program 2
03/03/95 i
LP-5 Public Hearings 0
10/21/94 l
4 06/24/94 j
LP-8 Technical Review of the Safety Analysis Report 5
06/16/95 LP-11 Assembly and Availablii'y of the Draft 2
06/20/95 Safety Evaluation Report LP-15 Technical Review of the Environmental 4
06/24/94 l
Report 5
06/30/95 j
LP-17 Preparation & Distribution of the Draft 2
06/20/95 j
EnvironmentalImpact Analysis i
IMPEP Questionnaire 21 State of Nebraska l
r
l l-1 i
LP-19 Notification of Decision to issue Draft 0
07/15/94 a
License 1
LP-20 Preparation of Draft License 1
07/15/94 i
LP-22 Approval of LLRW Facility License 0
07/15/94 amendments i
LP-24 Notice of License Denial 0
07/15/94 i
LP-27 Changes Other than License 0
07/15/94 Amendments LP-36 Technical Review Comment Tracking &
1 06/24/94 i
Status 4
4 LP-58 Environmental Data Analysis 0
03/03/95 i
LP-59 Sampling Plan Preparation 0
06/24/94 1
03/03/95 LP-60 Health and Safety Plan Preparation 0
06/24/94 l
LP-61 Environmental Data Management 0
03/03/95 l
IV. Technical Quality of Inspections i
- 19. Describe or provide an update on your instrumentation and methods of calibration.
l Are all instruments properly calibrated at the present time?
l The foliowing fixed and portable instruments are currently in use by the j
LLRWP:
FIXED I
Genio PC Gamma Spectroscopy System Calibration procedure - NDOH-RAP-SOP-PR-17 Operation of the Genio PC Gamma Spectroscopy System l
References:
Canberra Genie PC Users Manual ANSI N42.12-1980 ANSI N42.14-1991
)
ANSI N323-1978 a
i.
Canberra Model 2404 Aloha / Beta System a
IMPEP Questionnaire 22 State of Nebraska i
4
l i.*
Calibration procedure - NDOH-RAP-SOP-PR-21 Operation of the Canberra
]
Model 2404 Alpha / Beta System i
l
References:
Canberra Model 2400 Alpha / Beta System Users Manual Model S394 Alpha / Beta / Gamma Control Software Users Manual ANSI N323-1978
)
l Packard 2500 TRIAB Llauld Scintillation Analyzer j
Calibration procedure-NDOH RAP-SOP 06 D6 termination of Tritium in Water l
References:
Packard 2500 Tri Carb TRIAS Operation and Reference Manual ANSI N42-15-1990 l
l_
PORTABLE i
Six Radeco Constant Flow (K-Flow) Air Samoler Calibration procedure - NDOH RESPP-09 Radiological Environmental s
Monitoring of Air l
References:
SAIC Radeco Operation and Maintenance Manual-
)
i Air Flow Calibrator l
Two Eberline Model ESP-2 portable Survey Meter j
l Calibrated by Commercial Vendor One Ludlum Model 177 Alarm Ratemeter Calibrated by Commercial Vendor One Alnor Tvoo 8500 Thermo-Anemometer i
j Calibrated by Commercial Vendor i
CALIBRATION All of the instruments are properly calibrated.
A i
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IMPEP Questionnaire 23 State of Nebraska i
J
TABLE FOR QUESTION 29.
OR DATE DATE 10 CFR RULE DUE ADOPTED CURRENT EXPECTED STATUS ADOPTION Any amendment due prior to 1991. Identify each regulation (refer to the Chronology of Amendments)
Decommissioning; 7/27/91 5/30/94 Parts 30, 40, 70 Emergency Planning; 4/7/93 5/30/94 Parts 30,40,70 Standards for Protection Against 1/1/94 5/30/94 Radiation; Part 20 Safety Requirements for 1/10/94 5/30/94 i
Radiographic Equipment; Part 34 Notification of incidents; 10/15/94 5/30/94 Parts 20, 30, 31, 34, 39, 40, 70 Quality Management Program 1/27/95 Draft copy to the Nebraska Radiation 1/97 and Misadministrations; Part 35 Advisory Council (Meeting September 6, 1996) for their approval to go to public hearing (October 1996) and adoption in January 1997 pending any NRC changes in compatibility or enforcement.
IMPEP Questionnaire 24 State of Nebraska
a OR
~
DATE DATE 10 CFR RULE DUE ADOPTED CURRENT EXPECTED STATUS ADOPTION Licensing and Radiation Safety 7/1/96 IN PROCESS: Draft copy went to the 11/96 Requirements br Irradiators; Part Nebraska Radiation Advisory Council for 36 their approval to go to public hearing (June 7,1996). Draft to Governor's Policy Research Office (PRO) week of (June 17,1996) to ask for approval to go to Public Hearing. Upon okay from the PRO, a public hearing will be set up (August 1996). Then on to the Attorney General's Office for h!s approval (September 1996) and back to the Governor for his approval (October 1996). Publication i
and out to licensees (November 1996).
Definition of Land Disposal 7/22/96 NDOH and Waste Site QA Program; Part 5/30/94 61 NDEQ 6/26/94 Decommissioning Recorokeeping:
10/25/96 5/30/94 Documentation Additions; Parts 30,40,70 Self-Guarantee as an Additional 1/28/97 Draft copy to the Nebraska Radiation 1/97 Financial Mechanism; Parts 30, Advisory Council (Meeting September 6, 40,70 1996) for their approval to go to public hearing (October 1996) and adoption in January 1997.
i Uranium Mill Tailings: Conforming 7/1/97 N/A Nebraska relinquished this part of the to EPA Standards; Part 40 Agreement to the NRC.
IMPEP Questionnaire 25 State of Nebraska
e,
[
OR DATE DATE 10 CFR RULE DUE ADOPTED
-CURRENT.
EXPECTED-STATUS ADOPTION Timeliness in Decsiinissioning 8/15/97 Draft copy to the Nebraska Radiation 1/97' Parts 30,40,70 Advisory Council (Meeting September 6, 1996) for their approval to go to public hearing (October 1996) and adoption in i
January 1997.
Preparation, Transfer for 1/1/98 Draft copy to the Nebraska Radiation 1/97 j
Commercial Distribution, and Use Advisory Council (Meeting September 6, of Byproduct Material for Medical 1996) for their approval to go to public Use; Parts 30,32, 35 hearing (October 1996) and adoption in January 1997.
Frequency of Medical 3/13/98 Draft copy to the Nebraska Radiation 1/97 Examinations for Use of Advisory Council (Meeting September 6, Respiratory Protection Equipment 1996) for their approval to go to public hearing (October 1996) and adoption in January 1997.
Low-level Waste Shipment 3/1/98 Draft copy to the Nebraska Radiation 1/97 Manifest Information and Advisory Council (Meeting September 6, Reporting 1996) for their approval to go to public hearing (October 1996) and adoption in i
January 1997.
Performance Requirements for 6/30/98 5/30/94 Radiography Equipment i
1 IMPEP Questionnaire 26 State of Nebraska
a.
OR DATE DATE 10 CFR RULE DUE ADOPTED CURRENT EXPECTED STATUS ADOPTION Radiation Protection 8/14/98 Draft copy to the Nebraska Radiation 1/97 Requirements: Amended Advisory Council (Meeting September 6, Definitions and Criteria 1996) for their approval to go to public i
hearing (October 1996) and adoption in 1
January 1997.
Clarification of Decommissioning 11/24/98 Draft copy to the Nebraska Radiation 1/97 Funding Requirements Advisory Council (Meeting September 6, 1996) for their approval to go to public hearing (October 1996) and adoption in l
January 1997.
10 CFR Part 71: Compatibility 4/1/99 Draft copy to the Nebraska Radiation 1/97 with the International Atomic Advisory Council (Meeting September 6, Energy Agency 1996) for their approval to go to public hearing (October 1996) and adoption in i
January 1997.
l l
Medical Administration of 10/20/98 Draft copy to the Nebraska Radiation 1/97 Radiation and Radioactive Advisory Council (Meeting September 6, Materials.
1996) for their approval to go to public hearing (October 1996) and adoption in January 1997.
i i
IMPEP Questionnaire 27 State of Nebraska I
4 APPENDIX D LICENSE FILE REVIEWS File No: 1 Licensee: University of Nebraska at Omaha License No: 01-48-01 Location: Omaha, NE Amendment: 9 License Type: R & D Reviewer: JD Date Amendment issued: 1/17/96 Comments:
a) Amendments are issued to include only the items which have been changed for that amendment and are not a rewrite of the entire document. The expiration date of the license is only included on the complete rewrite which was Amendment No. 5 issued i
11/15/90. The use of computerized sta xiard license formats for quicker processing, and for clarity both for the licensee and the Agency, was discussed with staff.
l b) A short form renewal was authorized by Brian Hearty since the licensee had stated there were no changes in the radioactive materials program since the previous renewal.
The calibration procedure for s/m had changed since the previous renewal.
File No: 2 Licensee: University of Nebraska, Biology License No: 01-48-02 Location: Omaha, NE Amendment: 5 License Type: R & D Reviewer: JD Date Amendment issued: 6/7/96 Comments:
a) A rewritten Radiation Safety Manual was submitted with the application, but was not included in the Amendment No. 5. It was still "pending" at the time of this inspection.
b) The previous inspection was completed on 4/13/93.
]
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i
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File No: 3 j
Licensee: Maxim Technologies License No: 01-22-01 i
Location: Omaha, NE Amendment: 21 and 22 i-License Type: Industrial Radiography Reviewer: BH l
Dates Amendments issued: 9/26/95 (renewal): 1/11/96 (amendment)
Comments:
a) The use condition allows use at temporary job sites of the licensee anywhere in Nebraska where the Agency maintains jurisdiction for regulating the use of radioactive i
materials.
b) There was no " reciprocal recognition of license" condition in the license. This was -
discussed with staff.
c) Amendment 22 was issued to delete Tech / Ops Model A 424-18, because of the
- implementation of the IR equipment regulations.
I J
.-w e
e Nebraska Proposed Final Report Page D 2 i
4
- File No: 4 Licensee: EndoTech, Inc.
License No: 01-76-01 Location: Spokane, WA Amendment: 5 License Type: R & D Reviewer: BH Dates Amendments issued: 6/12/96 Comments:
l a) A "line of credit" had been implemented for the company based upon 2 years rent for.
j their facility. The 5/29/96 letter did not appear adequate in terms of enforceability or retrievability by the Agency.
b) The place of use authorized on the Amendment 4 (previous to the IMPEP inspection) allowed use at Veterans Administration Hospital in Omaha, Nebraska, but this was recognized as inappropriate and was removed by Brian Hearty.
c) The request to " reactivate" the license was received on 9/8/94, a 15 item RFl was sent i
l by the Agency, a response was received from the licensee on 3/8/96, and an additional 6 j
j item RFI was sent on 3/29/96.
d) License includes a special condition for emergency contact when neither the RSO nor an authorized user is available.
e) Amendments issued only include the items mcdified.
i i
i I
l File No: 5 Licensee: Bryan Enterprises License No: 02-39-01 Location: Lincoln, NE Amendment: 2 through 10 l
License Type: Mobile Nuclear Medicine Reviewer: BH (9/10)
Date Amendment issued: 2 (7/20/94); 3(9/16/94); 4 (10/12/94); 5 (4/18/95); 6 (5/16/95); 7 (6/26/95); 8(12/12/95): 9(4/19/96); 10(5/14/96) i Comments:
I a) A computerized data base of physicians is available to the Agency to verify State l
licensure.
b) A letter was included in file regarding the Agency and the Advisory Committee developing a program for "on-site physicians" when an authorized user could not be 4
1 available. Allowed nuclear medicine in remote parts of Nebraska.
c) The 3/9/95 inspection included 2 items of non-compliance: Unauthorized user, and shipping papers not available.
d) Amendments issued only included the items modified. The expiration date, 11/30/98, was included only on Amendment 8.
d e) The "on-site physician" authorization changed from Condition 12.S,19, to 13 from amendment to amendment.
t i
2
Nebraska Proposed Final Report Page D 3 File No: 6 Licensee: Corning Clinical Laboratories License No: 02-08-01 Location: Lincoln, NE Amendments: 29, 30, and 31 License Type: Laboratory Reviewer: 29, signed by HBorchert: 30, signed by CRogers: 31, JDavidson.
Date Amendments issued: 29 (3/10/95); 30 (2/2/96); 31 (2/7/96) a) The license expired on 6/30/96; no renewal or timely filed letter was available in the file.
b) It was not possible to determine responsibility for this licensee and St. Elizabeth Community Health Center (02-35-01) which is licensed for same materials, with a different location within the same building. This was discussed with staff, and a note was made to review that in the renewal application.
c) The use locations were identified as " locations designated in the applicati,)ns dated i
l 5/23/91 and 5/4/92."
d) An inspection was completed on 2/7/96, with field notes in the file but not a cornpleted report. Four items were cited.
File No: 7 Licensee: Harris Laboratories License No: 02-10-01 Location: Lincoln, NE Amendment: 20 License Type: Gas Chromatograph Reviewer: BH Date Amendments issued: Renewal Applic. Rec'd 2/27/95; not yet completed.
a) Amendment request submitted 12/14/94; renewal application submitted 2/27/95; timely filed letter issued by Agency on 2/27/95 A 7 item RFIletter written on 2/15/96.
1 File No: 8 Licensee: Harris Laboratories Licenso No: 02-10-02 Location: Lincoln, NE Amendment: 15 License Type: R & D Reviewer: BH (RFI)
Date Amendment issued: Pending a) License expiration was extended to 11/30/94 due to delays in shipping new regulations 3
to licensees.
4 I
l i
4 i
l Nebraska Proposed Final Report Page D 4 File No: 9 j
Licensee: Omni Engineering, Inc.
License No: 01-83-01 Location: Omaha, NE Amendment: New License 4
License Type: Moisture / Density Gauge Reviewer: BH i
{
Date License issued: 11/17/95
)
a) A reciprocal recognition condition was not used in the license.
b) The standard license condition requires the attendance at a manufacturers training course. This could be changed to include "or a course in the safe use and handling of Artable gauges which has been accepted by the NRC or an Agreement State."
^
1 I
File No: 10 Licensee: Thiele Geotech, Inc.
License No: 01-84-01 L
Location: Omaha, NE Amendment: New,1, 1(Corr.)
License Type: Moisture / Density Gauge Reviewer: JD I
Date License issued: New (11/15/95): 1 (3/21/96): 1 (Corr.) (3/27/96) 4 l
a) A documented telephone call indicated that a Troxler Alert Detector would be worn and a description of storage location and security, which may not be inspectable.
l b) There were no limits on the number of gauges which were authorized, making it l
difficuit for license reviewers to determine compliance with 004.14 and 004.15 prior to issuance of the new license.
c) Ne close-out of a previous facility was included in the file.
d) A new location was requested on Amendment 1, but was not included in the licensed location of use. This was corrected in Amendment 1 (Corr.).
e) There was no reciprocal recognition condition in the license.
f) In this file and others, " yellow stickys" were used to include information that should have been part of the permanent record.
i File No: 11 l
Licensee: Bergan Mercy Medical Center License No: 01-09-02 Location: Omaha, NE Amendment: 85,86,87
(
License Type: Medical Reviewer: JP (85), BH (86, 1
87) l Date License issued. 85 (2/6/95); 86 (8/30/95); 87(1/26/96) a) License expired 2/29/96; renewal received 1/31/96, and TF letter sent 2/1/96. On 2/1/96, 2/6/96, and 3/7/96 requests were received to change information received on the renewal application. The renewalis pending.
b) License Condition 15.A. in Amendment 85 (tie down) included "A. The previous license applications which certified qualifications of authorized users." Not inspectable.
c) in writing amendments which were not complete rewrites, the tie down was Condition i
15, while there were 21 Conditions.
1 i
i 1
Nebraska Proposed Final Report Page D 5 File No: 12 Licensee: Creighton University License No: 01 82-01 Location: Omaha, NE Amendment: New,1 Ucense Type: Broad Reviewer: JP Date License issued: New (3/17/95); 1 (4/27/95) a) Authorization procedures for physicians, podiatrists, and dentists were identified by a license condition. Authorizations for non-medical users were included in the tie down.
b) An officiel higher than the RSO should sign the application for a broad license.
c) The chairmen of the RSC should be identified on the license. Membership of the RSC should be included in the license file.
d) This license combined 16 separate licenses into a broad license.
e) On this license and others, reviewers had made notes and crossed out items.
i i
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d i
9
.,,,.m..--.
se
. =, -.,
APPENDIX E INSPECTION FILE REVIEWS File No.: - 1 Licensee: Immanuel Medical Center License No: 01-04-01 Location: Omaha, Nebraska inspection Type: Routine, Unannounced License Type: Nuclear Medicine / Brachytherapy Priority: 11 (3 years) inspection Date: 12/7,28/94 Inspectors: JP, MB Comments:
a)
Overdue inspection, completed at a scheduled frequency outside the 25% window, b)
Enforcement letter issued and signed 1/27/95 by program manager, however, field notes report was not approved and signed by supervisor until 3/30/95, approximately 60 days after the enforcement letter issued.
c)
Field notes report indicates that inspection conducted in sufficient depth and scope to support findings of 3 violations.
File No.: 2 Licensee: Corning Clinical Labs License No: 02-08-02 Location: Lincoln, Nebraska inspection Type: Routine Announced License Type: Irradiator Self-Contained Priority: ll Inspection Date: 2/7/96 inspector: Contractor Comments:
a)
Overdue inspection, completed at a scheduled frequency outside the 25% window.
b)
Field notes report not approved and signed by supervisor as of 7/19/96.
c)
Draft enforcement letter dated 2/23/96 not reviewed and signed by supervisor or sent to licensee as of 7/19/96.
d)
Repeat violations identified in field notes report not indicated as such in draft enforcement letter.
e)
Field notes report does not contain all administrative information required on page one such as: inspection report no., next inspection date and whether next i
inspection is at a normal, reduced or extended frequency, etc.
j f)
No documentation provided in field notes report that ancillary workers such as secretarial, housekeeping or security personnel were interviewed as to training i
received from licensee per NE regulation 10.03 (equivalent to NRC 10 CFR 19.12) during the inspection.
i
l l
Nebraska Proposed Final Report Page E 2 l
File No.: 3 Licensee: Mary Lening Memorial Hospital License No: 14-03-02 l
Location: Hastings, Nebraska inspection Type: Routine Unannounced License Type: Teletherapy Priority: 11 l
Inspection Date: 11/21/94 Inspectors: MB, BH Comments:
i a)
Overdue inspection, completed at a scheduled frequency outside the 25% window, b)
No documentation in field notes report to support close-out violations found in previous inspection on 5/9/90. Enforcement letter dated 12/20/94 states that there l
were no further questions on corrective actions taken on findings from previous i
inspection.
l c)
No documentation in field notes report that RSC_ minutes and committee composition reviewed and that exit meeting was held at the appropriate management level.
d)
Field notes report does not contain all administrative information required on page one such as: inspection report no., license no., licensee (name and address),
4 licensee contact, telephone no., priority, date of last inspection, date of this inspection, type of inspection, summary of findings and action, next inspection date and whether next inspection is at a normal, reduced or extended frequency, 2
signature and date the inspector signed and signature and date supervisor approved i
the report.
i File No.: 4 Licensee: Memorial Hospital of Dodge County License No: 05-02-01 l
Location: Fremont, Nebraska inspection Type: Routine, Unannounced License Type: Nuclear Medicine Priority: 11 4
Inspection Date: 4/19/96 Inspector: Contractor Comments:
a)
Overdue inspection, completed at a scheduled frequency outside the 25% window.
b)
Field notes report not approved and signed by supervisor as of 7/19/96.
c)
Draft enforcement letter dated 5/8/96 not reviewed by supervisor or sent to licensee as of 7/19/96.
d)
Severity level not assigned to 2 of the 9 violations documented in the draft Notice of Violation of the draft enforcement letter.
I e)
Field notes report does not contain all administrative information required on page i
one.
f)
No documentation provided in field notes report that ancillary workers such as secretarial, housekeeping or security personnel were interviewed as to training received from licensee per NE regulation 10.03 (equivalent to NRC 10 CFR 19.12) during inspection.
J u
a r
.~..
Pobraska Proposed Final Report Page E 3 File No.: 5 Licensee: Becton Dickinson License No: 37-03-01 Location: Holdrege, Nebraska inspection Type: Routine, Unannounced License Type: Irradiator-pool Priority: 1 (1 year) inspection Date: 5/30/96 Inspector: Contractor Comments:
a)
Overdue inspection, completed at a scheduled frequency outside the 25% window.
b)
Field notes report not approved and signed by supervisor as of 7/19/96.
1 c)
Draft enforcement letter dated S/10/96 not reviewed by supervisor or sent to i
licensee as of 7/19/96.
d)
Field notes report does not contain all administrative information required on page l
one.
e)
No documentation in field notes report as to whether pH, pool clarity, or Cl or F concentration in pool water was reviewed during inspection.
- f)
No documentation provided in field notes report that ancillary workers such as secretarial, housekeeping or security personnel were interviewed as to training received from licensee per NE regulation 10.03 (equivalent to NRC 10 CFR 19.12) during inspection.
g)
No documentation in field notes report that any independent measurements were performed.
File No.: 6 Licensee: Nordian international License No: 99 37 01 Location: Kanata, Ontario, Canada inspection Type: Routine, Unannounced License Type: Service Priority: 111 (5 years)
Inspection Date:3/30/95 Inspector: MB Comments:
a)
Field notes report indicate a comprehensive inspection. Excellent b)
Field notes report approved by supervisor on 5/31/95 after enforcement letter dated 4/14/95 issued.
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i 4
Nebraska Proposed Final Report Page E 4 File No.: 7 Licensee: Bryan Enterprises License No:02 39-01 Location: Lincoln, Nebraska inspection Type: Initial, Unannounced License Type: Mobile Nuclear Medicine Priority: ll Inspection Date:
3/9/95 Inspector: BH Comments:
a)
Initial inspection did not occur until 16 months after license was issued on 11/22/93, which is not in accordance with IMC 2800.
b)
Field notes report and enforcement letter do not agree on the number of violations (field notes report documents 2 and enforcement letter 5).
c)
Letter from licensee dated May 8,1995 not in file.
(
d)
Field notes report does not contain all administrative information required on page j
one.
e)
Field notes report not approved and signed by supervisor.
i File No.: 8 i
Licensee: Maxim Technologies, Inc.
License No:01-22-01 Location: Omaha, Nebraska inspection Type: Routine, Unannounced License Type: Radiography Priority: 1 J
Inspection Date: 3/22/96 Inspector: Contractor Comments:
}
a)
Overdue inspection, completed at a scheduled frequency outside the 25% window.
b)
Field notes report not approved and signed by supervisor as of 7/19/96.
c)
Draft enforcement letter dated 4/5/96 not reviewed by supervisor or sent to
- licensee, d)
Field notes report does not contain all administrative information required on page one.
File No.: 9 l
Licensee: Southeast Community College License No:16-01-01 Location: Milford, Nebraska inspection Type: Routine, Announced 2
l License Type: Academic / Radiography Priority: I j
inspection Date: 2/6/96 Inspector: Contractor Comments:
a)
Overdue inspection, completed at a scheduled frequency outside the 25% window.
b)
Field notes report not approved and signed by supervisor as of 7/19/96.
c)
Draft enforcement letter not reviewed by supervisor or sent to licensee as of 7/19/96.
1 v'
Nebraska Proposed Final Report Page E 5 File No.: 10 Licensee: Arcedian Corp License No: 59-02-01 Location: Bellevue, Nebraska inspection Type: Routine, Unannounced License Type: Fixed Gauge Priority: lit inspection Date: 4/21/94 Inspectors: MB,BH Comments:
a)
Field notes report indicates a comprehensive inspection, all data present. Excellent b)
Field notes report reviewed and approved by supervisor on 5/27/94, 7 days after enforcement letter dated 5/18/94 issued.
c)
Field notes report identified need for change in name of RSO on license.
File No.: 11 Licensee: Wayne State College.
License No: 27-01-01 Location: Wayne, Nebraska inspection Type: Routine, Announced License Type: Academic (Non-Broad)
Priority: 111 Inspection Date: 2/2/94 Inspector: MB Comments:
a)
Overdue inspection, completed at a frequency outside the 25% window.
b)
Field notes report indicates a comprehensive inspection. Excellent File No.: 12 Licensee: Panhandle Drilling & Testing License No: 21-06-01 Location: Scottsbluff, Nebraska inspection Type: Initial, Announced License Type: Portable Gauge Priority: 111 Inspection Date: 3/1/94 Inspector: MB Comments:
a)
Initial inspection did not occur until 13 months after license was issued on 2/9/93, l
which is not in accordance with the requirements of IMC 2800.
b)
Field notes report indicates a comprehensive inspection. Excellent i
e 4 -
~_
Nebraska Proposed Final Report Page E 6 File No.: 13 Licensee: Kiewit Western Co.
License No: 01-80-01 Location: Omaha, Nebraska inspection Type: Initial, Announced License Type: Portable Gauge Priority: lli inspection Date: 8/3/95 Inspectors: BH, JD Comments:
a) initial inspection did not occur until 8/3/95, 9 months after license was issued on 12/5/94, outside the 6 month requirement.
b)
Acknowledgment letter for licensee's letter dated 8/3/95 containing corrective actions not issued until 11/25/95, greater than 30 days after receipt of licensee's
- letter, c)
Field notes report does not indicate who attended the exit meeting.
d)
Field notes report does not contain all administrative information required on page one.
e)
Field notes report not approved and signed by supervisor.
File No.: 14 Licensee: High Plains Corporation License No: 17-01-01 Location: Colwich, Nebraska inspection Type: Initial, Announced License Type: Fixed Gauge Priority: lli inspection Date: 3/13/95 Inspector: MB Comments:
a)
Field notes indicate a comprehensive inspection. Excellent File No.: 15 Licensee: University of Nebraska License No: 02-01-03 Location: Lincoln, Nebraska Inspection Type: Routine, Unannounced License Type: Academic Broad Priority: 1 Inspection Date: 2/8-16/95 Inspectors: JP, MB, BH Comments:
a)
Inspection close-out still pending as licensee's response dated 4/20/95 not reviewed and acknowledged as of 7/19/96. Enforcement letter dated 3/16/95 documented 9 violations and 10 recommendations.
b)
Field notes report does not contain all administrative information required on page one.
c)
Field notes report not approved and signed by supervisor.
d) incident report found in license file, but not in separate file kept for incidents.
t i
e i
Nebraska Proposed Final Report Page E 7 File No.: 16 i
Licensee: Sherwood Medical License No: 07-02-01 Location: Norfolk, Nebraska inspection Type: Routine Unannounced License Type: Irradiator pool Priority: 1 i
inspection Date: 4/16/96 Inspector: Contractor Comments:
a)
Field notes report not approved and signed by supervisor as of 7/19/96.
b)
Draft enforcement letter not reviewed by supervisor or sent to licensee as of j
7/19/96.
File No.: 17 Licensee: Beatrice Community Hospital License No: 03-02-01 Location: Beatrice, Nebraska inspection Type: Routine, Unannounced l
License Type: Nuclear Medicine Priority: 11 Inspection Date: 9/1/94 Inspector: JP Comments:
a)
Field notes report not approved and signed by supervisor, b)
Field notes report does not document evidence of observed operations, independent i
measurements, or that ancillary workers such as secretarial, housekeeping or security personnel were interviewed as to training received from licensee per NE regulation K.03 (equivalent to NRC 10 CFR 19.12) during inspection.
i File No.: 18 p
Licensee: University of Nebraska Medical Center License No: 01-50-01 Location: Omaha, Nebraska inspection Type: Routine, Unannounced License Type: Academic Broad Priority: I Inspection Date:
2/28-3/3/95 Inspectors:MB, JP, BH x-f Comments:
d)
Overdue inspection, completed at a frequency outside the 25% window.
2 b)
No field notes report in file documenting findings to support the 4 violations and 4 recommendations indicated in the enforcement letter.
c)
Could not determine whether supervisory review occurred.
File No.: 19 i
Licensee: Children's Memorial Hospital License No: 01-07-05 Location: Omaha, Nebraska inspection Type: Routine, Annoumed License Type: Nuclear Medicine Priority: 11 Inspection Date: 2/2/94 Inspector: JP Comments:
a)
Field notes report indicate a comprehensive inspection, all data present. Excellent 4
Nebraska Proposed Final Report Page E 8 File No.: 20 Licensee: Great Plains Nuclear Services License No: 01-59-01 Location: Omaha, Nebraska inspection Type: Routine, Announced License Type: Services-calibration Priority: ill inspection Date: 8/3/95 Inspectors: BH, JD Comments:
a)
Overdue inspection, completed at a frequency outside the 25% window.
b)
Field noies report does not contain all administrative information required on page one.
c)
Field notes report not approved, dated or signed by supervisor.
d)
Neither the handwritten or typed field notes report found in the file were signed by the inspector.
In addition the following inspection accompaniments were made as part of the on site IMPEP review:
Accompaniment No.: 1 Licensee: Bishop Clarkson Memorial Hospital License No: 01-12-05 Location: Omaha, Nebraska inspection Type: Routine, Unannounced License Type: Irradiator Priority: 11 (3 years)
Inspection Date: 6/24,25/96 Inspector: JD Comments:
a)
This was an accompaniment by J. Johansen, a team member.
Accompaniment No.: 2 Licensee: Bishop Clarkson Memorial Hospital License No: 01-22-01 Location: Omaha, Nebraska inspection Type: Routine, Unannounced License Type: Nuclear Medicine Priority: ll Inspection Date: 6/24,25/96 and 7/11/96 Inspector: BH Comments:
a)
This was an accompaniment by J. Johansen, a team member on 6/24-25/96.
b)
Inspection was completed by NE inspectors on 7/11/96.
Accompaniment No.: 3 Licensee: Professional Service Industries, Inc.
License No: 01-08-03 Location: Omaha, Nebraska inspection Type: Routine, Unannounced License Type: Radiography Priority: 1 (1 year) inspection Date: 6/26,28/96 Inspector: CR Comments:
a)
This was an accompaniment by J. Johansen, a team member.
b)
. The inspector is currently the program manager for the LLRW program.
Nebraska Proposed Final Report Page E 9 Accompaniment No.: 4 Licensee: Radiology Nuclear Medicine License No: 01-52-01 Location: Omaha, Nebraska inspection Type: Routine, Unannounced License Type: Mobil Nuclear Medicine Priority: ll Inspection Date: 6/27/96 Inspector: HS Comments:
a)
This was an accompaniment by J. Johansen, a team member.
b)
The inspector normally works in the LLRW program.
Accompaniment No.: 5 Licensee: Daniel J. Thiele License No: 01-84-01 Location: Omaha, Nebraska inspection Type: Initial, Announced License Type: Portable Gauge Priority: 111 (5 years)
Inspection Date: 7/16/96 Inspector: JD Comments:
a)
This was an accompaniment by J. Johansen, a team member.
j Accompaniment No.: 6 Licensee: Omni Fngineering License No: 01-83-01 Location: Omaha, Nebraska inspection Type: Initial, Unannounced License Type: Portable Gauge Priority: lli inspection Date: 7/16/36 Inspector: JD Comments:
a)
This was an accompaniment by J. Johansen, a team member.
d I
l
l l
APPENDIX F NEBRASKA INCIDENT FILES REVIEWED 4
File No.1 Licensee: Nebraska Civil Defense Agency Location: Norfolk, NE License #: 02-02-02 Date of Event: Unknown Type of Event: Loss of material Summary of incident: This event was identified as significant in response to the questionnaire. A Co 60 capsule used in training exercises conducted at the Norfolk Fire Department, was discovered missing during an inventory check. Licensee conducted extensive investigation and concluded the capsule was probably discarded to a local landfill. Event was not reported to NRC.
File No. 2 Licensee: Sherwood Medical Location: Norfolk, NE License #: 07-02-01 Date of Event: 09/09/95 Type of Event: Irradiator equipment failure Summary of incident: This event was identified as significant in response to the questionnaire. Licensee failc to report equipment failure event involving the failure of an irradiator pool level switch. State follow up resulted in issuance of NOV for failure to report within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> and operating with a failed component in violation of license condition.
NOV issued 10/17/95 referenced 9/22/95 inspect.an which was not documented in the file. Event was not reported to NRC.
File No. 3 Licensee: Sherwood Medical Location: Norfolk, NE License #: 07-02-01 Date of Event: 11/30/95 Typy, r4 Event: Irradiator equipment failure Summary of incident: This event was identified as significant in response to the questionnaire. Event involved equipment problem at irradiator facility--barrier door malfunctioned when changed to index mode. The team found, in discussions with the radiation program manager that, at State direction, licensee contacted manufacturer, Nor$an, who corrected faulty PLC logic rursg.
File containc j no documentation on State inspection, or follow up action. Documentation only included licensee letters and responses.
Nebraska Proposed Final Report Page F 2 File No. 4 Licensee: Univ. of Nebraska at Lincoln Location: Lincoln, NE License #: 02-01-03 Date of Event: Unknown Type of Event: Unauthorized transport of radioactive material, P-32 Summary of incident: Event involving loss of control of radioactive material, P-32.
Unauthorized transport of P-32 between U. of NE-Lincoln and the East Campus via public transportation. Through discussions with radiation program manager, State performed routine inspection on 2/8-10/95. NOV issued March 10,1995, cited 9 violations and j
contained 10 recommendations, appeared to support a detailed inspection.
The review team concluded that State response was not timely and documentation was inadequate, field notes were sporadically filled out in pencil--many areas not addressed.
No indication of supervisory review, and no notification to NRC in response to an inquiry to the States regarding events involving P-32.
File No. 5 Licensee: Ecova Corporation Location: Kimball, NE License #: 71-01-01 Date of Event: 08/15/94 Type of Event: Unauthorized removal of equipment Summary of Incident: Licensee failed to timely report unauthorized removal and 4
replacement of Ohmart SH-F1, Cs-137 level density gauge, Serial No. 66846, during routine maintenance on ellutriator to which gauge was attached, which resulted in stuck shutter. Licensee's nvent report to the State, after the fact, indicated that proper corrective actions were taken by notifying manufacturer who repaired, reinstalled, surveyed and leak tested gauge prior to notification to State, in discussions, State staff indicated no response to LER necessary due to fact licensee took proper corrective actions.
Any avant involving equipment required by reguiraion or license condition to prevent releases exceeding regulatory limits should be reported within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of occurrence.
This event was not reported to NRC.
File No. 6 Licensee: Cinemark-8 Stockyard Movie Theater Location: Omaha, NE License #: GLO336 Date of Event: 09/09/94 j
Type of Event: Stolen material Summary of Event: Vandals stole seven NRD Model T-4001 exit signs containing 8.4 Ci of H-3. Licensee advised to report theft to local police. No follow up action indicated by State.
d
J*.
STATE OF NEBRASKA t
9
@ffice of II e Attorneg Ceneral I
nEcavEo atis STATE CAPITOL BUILDMG DEPARTMENT OF HEALTH uncotm,as essee seso (402)471 3082 i
rooim2:471. ass 2 SEP 0 91996 i
CAPf70L FAX (402)4713397 1235 K ST. FAX (402)4714728 DON STENBERG STEVE GRASZ ATTORNEY GENERAL LAURIE SMITH CAMP DEPUTY ATTORNEYS GENERAL i
j September 6, 1996 Ms. Joyce Davidson, Health Physicist Radioactive Materials Program i
Nebraska Department of Health 301 Centennial Mall South l
Lincoln, NE 68509-5007
Dear Ms. Davidson:
At your request, I have conducted a brief, preliminary review i
of the draft reg.11ations for Title 180 NAC 1 and have found no j
obvious problems with statutory authority or constitutionality.
]
The materials which you sent for our review include the draft l
amendments to 180 NAC 1-004.21 and 180 NAC 1-015.26 and the new i
Section 019. As we discussed, the time constraints imposed by your request for a preliminary review of these regulations preclude a comprehensive review of these complex regulations. You should also be aware that, while I have reviewed the draft regulations, the Attorney General has not yet reviewed the regulations as he would review final regulations adopted by the Department..
Please feel free to call if you have any questions concerning this matter.
Sincerely, DON STENBERG Attorney General 8W Lynn A. Melson Assistant Attorney General
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' STATE OF NEBRASKA DEPARTMENT OF HEALTH I
Mad B. Horton, M.D., M.S.P.H.
Oswier November 1,1996 o
U.S. Nuclear Regulatory Commission Ma,T, Office of State Programs m
Mail Stop 3D23 3'
Washington, DC 20555 W
Attn: Richard L. Bangart, Director Office of State Programs
Dear Mr. Bangart:
This letter is in regards to the draft report provided to our office on October 18,1996 which details the findings and recommendations of the IMPEP team which conducted a review of our radiation control program during the period of July 15-19,1996. The draft report was rcviewed for factual correctness by the appropriate program managers and any corrections, clarifications, or proposed revisions are attached.
The interpretation and analysis of I 80 NAC 1-012.22 by our legal staffis currently in progress and is not addressed in this letter as requested. An accurate estimate of the date when analysis will be completed is being determined and will be indicated to you as soon as possible.
We are carrently addressing the recommendations identified in the report, and we will continue to keep you i'1 formed on our progress as in our August 6, September 10, and October 30,1996 letters. It is our hope that Nebraska's commitment to maintaining a radiation control program that ensures the public health and safety will be evident.
If you have any other questions prior to issuing the final report, please feel free to contact Brian Hearty at (402) 471-2168 or the LLRW Program at (402) 471-3380 as appropriate.
Sincerely, ms Mark B. Horton, M.D., M.S.P.H.
Director Nebraska Department of Health Enclosures k ' act ceni.nnai M. s ois. po. so. 95o07. tuoin. s i k. 6aso9.soo7 rax i.o2> 47 4> s 7Tv 4714 22 y
y, t ATTAcantn1 2 An Equal opportunny/Amomeeve Acean E&
.ac...p. m a
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t, STATE OF NEBRASKA DEPARTMENT OF HEALTH Mark B. Horton, M.D., M.S.P.H.
rheaar i
November 1,1996 U.S. Nuclear Regulatory Commission
"' """d"c,N Office of State Programs Mail Stop 3D23 Washington, DC 20555 Attn: Richard L. Bangart, Director Office of State Programs
Dear Mr. Bangart:
I have reviewed the draft report issued by the IMPEP review team with regard to factual correctness for the Radioactive Materials Program and have the following comments:
1.
3.1 Status of Materials insocction Program Refer to the second paragraph, eleventh line, (3): As stated in Question A.I.3. of the IMPEP questionnaire, all service licensees were previously assigned a five year inspection frequency. After review ofIMC 2800, the inspection frequencies of service licensees were revised to correspond to the appropriate three or five year frequency.
Refer to the second paragraph, fifteenth line: The presence of a service license for which IMC 2800 requires a two year inspection frequency is not documented in the report and is not readily clear from a review ofIMC 2800 and our licensees. IMC 2800 requires a two year inspection frequency for service licensees providing Decontamination Services and Waste Disposal Service Prepackaged Only and Nebraska does not have a licensee in either category. If you will indicate which service licensee you have determined requires a two year inspection frequency, the frequency will be revised.
Refer to the third paragraph, seventh line: The contractor performed 27 inspections, however,13 of the inspections were not yet overdue in accordance with IMC 2800. The contract was written to have performed all inspections that were identified as overdue at the time, and to have performed as many other ir/pections as financially possible.
Refer to the fifW paragraph, sixth line: The presence of 10 initial inspections which are due is not documented in the report and was not discussed at the time of the review. If the report is referring to all licensees that do not have an Last inspected date on our tracking system, there are explanations that may be provided. One license,02-20 01, is i
our program license. Two of the licenses,01-39-03 and 10-03-04, authorize the nuclear power plant to use radioactive material at temporary jobsites in the event of an 301 Ceniennial MaB South
- PO. Som 95007
- LJncoh. Netweeka 685o9 50c7 FAX (402) 4710383
- TTY 4716421
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An Eeunt oppo, sunny /Amrmeen Acoon Emphyer M# d Y /
paame.e so, en recycme new
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Richard L. Bangart, Director November 1,1996 Page 2 i
4 emergency situation, and material has not been used under these licenses. One license, L
99-46-01, is an out-of-state licensee from Wisconsin authorizing non-AEA material and has not yet entered the state. One license,99-43-01, is an out-of-state service licensee and has not entered the state since their license was placed in an deferred status October 10,1991. If any further guidance on this can be given, it would be appreciated.
j 4
Refer to the eleventh paragraph, eleventh line, (4): IMC 2800 04.03a. requires that initial inspections be performed within six months of receipt oflicensed material, within six months of beginning licensed activities, or within one year oflicense issuance. The use j
of a standard condition on new licenses to require notification of receipt of material and the beginning oflicensed activities in addition to the telephone contacts now used by the program is being explored.
2.
3.2 Technical Staffing and Training l
1 Regarding the third paragraph: The second reorganization was not fully implemented until July 1,1995. As stated in the report, a permanent program manager for the Radioactive Materials Program had already been designated on April 24,1995. An intemal memorandum, copy enclosed, dated July 20,1995, documents that the LLRW Program Manager was designated as the Acting Radioactive Materials Program Manager effective June 23,1995. This designation of an acting program manager was effective until a permanent manager was named on May 1,1996.
Refer to the sixth paragraph, eighth line: The Radioactive Materials Program Manager position was not permanentiv filled for almost a year.
Refer to the seventh paragraph, thirteenth line: A formalized training manual was not
)
available, but database records for a majority of the training received by program staff
)
were available but were unknown to the new Program Manager.
i Refer to the eighth paragraph, eighth line: A major factor not included in the reasons why
/,e I a newly hired staff member was not yet considered qualified to perform low priority inspections was that program staffwere limited to licensing activities while inspections
{
were performed by contract personnel.
3 i,
N
.'3 Richard L. Bangart, Director November 1,~ 1996 Page 3 3.
.3.3 Tachnien! Ouality of Licensing Actions
' Regarding the first paragraph, fourth line and fourth paragraph, third line: The Program.
Manager provided the review team with a licensing log book that covered the entire review period, but the handwritten logbook did not sasily. allow for statistical review of the pending acticas, and the program began using a computer based spreadsheet for tracking licensing actions in July 1995.
Refer to the fourth paragraph, fifth line: Our records indicate that 48 licensing actions were completed between July and December 1995, and that 70 licensing actions were completed between January and June 21,1996.
Refer to the fourth paragraph, tenth line: The handwritten sheets were kept in one logbook and updated by program support staff.
Regarding the seventh, eighth and ninths paragraphs: Does this statement indicate that the team intends to create a non-common performance indicator to be used to evaluate Agreement State Programs and not NRC Regions on the status of a licensing backlog?
The issue of a backlog oflicensing actions should be addressed in the report under 3.2 Technical Staffing and Training and any recommendations dealing with administrative procedures and get-well plans to eliminate backlogs included there. It is proposed that the finding for this indicator, as defined in NRC Management Directive 5.6, be
' Satisfactory since no recommendations were made regarding technical quality.
4.
3.4.
Technical Oualitv ofInsnections Refer to the fifth paragraph, ninth line: Delete Low-Level.
Refer to the eighth paragraph, third line: An indication that the Inspection Manual was,
used by program staff can be found in the draft report in paragraph three of this section which states that the State uses separate inspection field notes for various classes of licensees. These field note forms are a large part of the current Inspection Manual. The Enforcement Manual was written specifically into the contract for inspections and was used extensively by the contractor prior to being implemented by program staff.
,4,..
Ricnard L. Bangart, Director November 1,1996 Page 4 Refer to the eighth paragraph, fifth line: The Enforcement Manual contains boilerplate citations to be used in drafting an NOV.
Regarding the eleventh paragraph: A Program Manager for the Radioactive Materials Program was designated as indicated in item 2. of this letter. A delegation of authority dated June 20,1995, copy enclosed, was provided to the review team. It stated that inspection letters were to be signed by the lead inspector with peer review if a notice of violation was to be included. After discussions with the review team, the delegation of authority was revised to clearly indicate that a management review was required. See of draft report for a copy of the revision (the copy provided to the State did not include the Table which was printed on the back of the August 19,1996 memorandum).
Refer to the twelfth paragraph, ninteenth line, and Appendix E: Several references are made to not documenting the training provided to ancillary staff, such as secretarial, housekeeping or security personnel as required by 10 CFR 19.12. It is not clear if these comments take into account the revised Part 19 which requires training for only individuals likely to receive an occupational dose in excess than 100 mrem.
5.
3.5 Resnonse to incidents and Allegations Refer to the second paragraph, eleventh line (and other places): Revise reference to state NRC Management Directive 8.8," Management of Allegations."
6.
4.1.2 Status and Comnatibility of Regulations Refer to the second paragraph, seventh line: Has the review team made a determination that the conditions placed on each irradictor license are not legally binding or equivalent to or more stringent than the requirements in 10 CFR Part 36?
Richard L. Bangart, Director November 1,1996 Page5.
4 7.
5.0 Summary Recommendations 1,2 and 5: It is proposed that Recommendations 1 and 5 be removed since they reiterate what is already stated in Recommendation 2.
Recommendation 9: It is unclear if this recommendation is directed to the State or to the NRC as stated in Section 3.2 of the report. It is proposed that this recommendation be
)
removed under the assurance that the State will carefully consider the needs of the
- Agreement State Program during its reorganization.
Recommendations 10 and 11: As stated in item 3. of this letter, these recommendations reiterate what as already been stated in Recommendation 8. and should be removed, J
Recommendation 17: It is proposed that Recommendation 17 be removed since it reiterates what is already stated in Recommendation 8.
If you have any questions regarding the comments or proposed changes to the draft inspection report, please contact me at (402) 471-2168.
Sincerely, 9
L b,% W NEolk' Brian P. Hearty, Manager Radioactive Materials Program Enclosures 1
s.
.. STATE OF NEBRASKA
~
DEWtTMENT OF HEALTH Mark B. Horton, M.D., M.S.P.H.
D****'
MEMORANDUM s
E. Benkmh Ndman Date: June 20,1995 G"'"'
4
\\
From: Mark B. Horton, M.D., M.S.P.H. '
To:
Burke E. Casari, Director Environmental Health Division RE:
Delegation of authority to sign documents in the Radioactive Materials Program.
I have attached a table dated June 19,1995, showing the delegation of authority to sign licensing, inspection and other documents generated by the Radioactive Material Program.
XC:
Jack Daniel, Administrator Environmental Health and ToxicoloFy Section 4
4 s
ll
.j 301 Centennal Maa South
- Po. Box 95007
- L> cob. Nebreake 68509 5007 FAX (402) 4714383
- TTY 4714421 An Eeuel Opparnnwy/Nannaew Accan Empkser e
..w
Nebraska Dep:rtme:t of Heskh i.
E;5 fronmental Heahb Division Eosironmental Health and Tealeology Section Radioactise Materials Program June 19,1995 Document Signature Block Person whom may sign for the named indisidual New License
- Program Manager none License Renewal
- Propam Manager none License Amendment
- Program Manager Prt, gram Health Physicist (Author Only)
License Termination
- Propam Manager none RenewalRequest Indisidualresiewing thelicense to none required determine long or short form renewas (Propam Manager or Health Physicist)
Reciprocity Request Indnidualpronding the information none required (Propam Manager, Propam Health Physicist)
Reciprocity Renew Indisidual renewing mformation for none required completeness Timely Filed Lener Indisidual resiewmg the appheadon none required to assure it is valid (Propam Manager or Health Ph3 sicist)
Inspecdon tener Propam Health Physicist none
Enforcement Lener Propam Manager none irtspection Reply Lener Propam Health Phy sicist none
- If pamcipatory insp (lead Inspector)
Inspection Report
- Propam Health Phy sicist none (AllInspectors, Lead First)
Deficiency Lener Indnidual resiewtng licensing request or none required inspection reply (Author or Lead Inspector)
Pohey Statement Propam Manager or Rgher none Procedures Propam Manager none Event Database Update Individual prosidmg the information none required (Propam Manager, Propam Health Physicist)
Information Request Indnidualprosidmg theinformation none required (Propam Manager, Propam Health r
Ph> sicist or Support Staff)
- Peer res iew required for this document 1
STATE OF 3..EBRASKA l.
DDMTMENT OF HEALTH Mark B. Heston, M.D., M.S.P.H.
- Drecsor i
E. Benkman Nelson oo,nor MEMORANDUM DATE:
July 20,1995 TO:
Radioactive Materials Program Staff 1
Jack Daniel, Administrator f Id FROM:
Emironmental Health Protection Section RE:
Acting Program Manager for Radioactive Materials Program On June 23,1995, Cheryl K. Rogers was designated the Radioactive Materials Program Manager and assumed the responsibilities and signing privileges of the position until it is filled on a permanent basis. In the event of Cheryl's absence, Joyce K. Davidson is designated to have the signing privileges of the Radioactive Materials Program Manager.
l 4
4 301 Cornennial Mal South
- RO. Bam 95007
- IJncob, Nebraska 68509 5007 FAX (402) 4710383
- TTY 4714421 An EmmetC; ^ ;/Annmann Aeean E&
ww a, =.a.,.
ICC.13.1996 6 26Pf1 flis:H DN FEALTH # 402 471 0169 f r.'. 2'.:6 P.2 STATE OF NEBRASKA
~
9 DEPARTMENT OF HEA1.m Mark B. Horton, M.D., M.S.P.ll.
8**
- December 13,1996
[
h c-Richard L. Bangart F M* """ ** "
Director Offic: of State Programs Uniteil States Nuclear Regulatory Commission Washu.gton, D.C. 20555 0001 RE: October 16,1996 IMPEP report
Dear Mr. Bangart:
This is the response to issue 4.12 in the October 16,1996, IMPEP that you requested Under Nebraska law all regulations properly adopted at'd filed with the Nebraska Secreta 5y of State have the effect of statutory law. 180 NAC 1 012.22 was properly adopted and filed, as such it has the effect of law and therefore is a standard and not a goal or design objective. The Department at the time this regulation was adopted did not intend it to apply to storage and treatment facilitics that did not also do disposa! It only intended this regulation to apply to those disposal facilities which must be able to demonstrate that concentrations released to the general environment would not exceed the standard.
The state does not currently have any brokers. treatment facilities, or storage facilities to which this regulation has been applied. According to your letter this is a Division 1 compatibility requirement Much can only be apphed to land disposal facthties. The Department intends to amend the regulation and anticipates this can be donc by hme 30,1997 The process has been started and will be expedited as much as possible A copy of the proposed amendment is enclosed for your comment.
Sincerely, f
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Teresa M. Hampton.
Assistant Agency Counsel ka V
Cheryl R$gers 6
Program Manager Low-Level Radioactive Waste Program Enclosure cc.
Steve Moeller 301 Cemennial MaA South
- PO. Bos 95o07 e IJncoln. Netraska 68509 5007 FAX (402) 471-0383 e TTY 4716421 An taunt oppommetWMtrrrarne Accan Ewayer
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ATTACHMENT 3 (Q,-trz:rcruo ) u~
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ICC,13.1996. 6:2911 iIICH D f/ HU4.TH (402 i4;'1 0169 iO.296 P.3 i
h Title 180 Chapter 180 i
PERFORMANCE OBJECTIVES l
012.21 General Reaulrament. Management facilities shat! be sited, designed, operated, closed, and controlled after closure so that reasonable assurance exists that exposures to individuals are within i
the requirements established in the performance objectives in 012.22 through 012.25. Sgtgilictibra
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1 MM 1
012 22 Protection of the General Population from Releases of Radioactivity. Concentrations of radioactive material which may be released to the general environment in ground water, surface water, air, soil, plants, or animals shalt not result in an annual dose exceeding an equivalent of 0.25 Msv (25 millirems) to the whole body,0.75 Msv (75 millirems) to the thyroid, and 0.25 Msv (25 millirems) to any other organ of any member of the puble. Reasonable effort should be made to maintain releases of radioactivity in effluents to the general environment as low as is reasonably achievable.
012.23 Protection of Ind_ividuals from Inadverten_t Intrusjen Design, operation, and closure of the management facility shall ensure protection of any individual inadvertently intruding into the management site and occupying the site or contacting the waste at any time after active institutional
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controis over the management site are removed.
012.14 Protection of Individuals Durina Operat[gns., Operations at the management facility shall be conducted in compliance with the standards for radiation protection set out in Section 004 of these regulations, except for releases of radioactivity in effluents from the management facility, which shall be govemed by 012.22. Every reasonable effort should be made to maintain radiation exposures as low as is reasonably achievable.
912E Stability of the Mananement Site After Closurt The management facility shall be sited, designed, used. operated, and closed to achieve long-term stability of the management site and to eliminate, to the extent practicable, the need for ongoing active maintenance of the management site following closure so that only surveillar.ce, monitoring, or minor custodial care are required.
TECHNICAL REQUIREMENTS FOR MANAGEMENT FACILITIES i
0.12 2Lidangoement Site Su_ liability Recuirements.
01226A Management Site Suitability for Disposal. The primary emphasis in management site suitability is given to isolation of wastes and to management site features that ensure that the long term performance objectives are met.
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012 26A1 The management site shall be capable of being characterized, modeled, analyzed j
and monitored.
012 2sA2 Within the region where the facihty is to be located, a management site should be selected so that projected population growth and future developments are not likely to affect the ability of the management facility to meet the performance objectives of this section.
Q12 26A3 Areas shall be avoided having known natural resources which, if exploited, would result in failure to meet the performance objectives of this section.
12-14 DRAFT - DECEMBER,1996
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F ADDENDOM TO THE NEBRASKA IMPEP REPORT COVERING JULY 15-19,1996 IMPEP REVIEW n,
4
SUBJECT:
NRC RESPONSE TO COMMENTS PROVIDED BY THE STATE.OF NEBRASKA TO THE DRAFT IMPEP REPORT, TDATED OCTOBER 16,1996! -
2 d
COMMON PERFORMANCE INDICATORS 1.
3.1 Status of Materials inspection Program
- a.
State Comment: As stated in Question A.1.3. of the IMPEP Ouestionnaire, all service licensees were previously assigned a five year inspection frequency. After review of IMC 2800, the inspection frequencies of service licensees were revised to correspond to the appropriate three or five year frequency.
b.
State Comment: The presence of a service license for which IMC 2800 requires s two year inspection frequency is not documented in the report and is not readily clear from a review of IMC 2800 and our licensees. If you willindicate which service licensee you have determined requires a two year inspection frequency, the frequency will be revised.
NRC Response to a. and b.:
- a. The 10/16/96 Draft IMPEP Report already stated that "the State indicated that they had completed incorporation of the new priorities into their inspection tracking system prior to our review."
- b. The team revised the report to read as follows: Subsequently the team found that the State does not have a service license requiring inspections at one or two year intervals, but they do have a service license for which IMC 2800 indicate a three year inspection frequency and the State was conducting inspections at a j
l three year interval.
c.
State Comment: The contractor performed 27 inspections, however,13 of the j
4 inspections were not yet overdue in accordance with IMC 2800. The contract was l
written to perform all overdue inspections at the time, and to have performed as i
{
many other inspections as financially possible.
. NRC Response: Based on the computerized inspection tracking list provided by the F
State, the contractor performed 27 inspections of which 14 wers overdue. No i
change to report.
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l d.
State Comment: The presence of 10 initial inspections which are due is not documented in the report and was not discussed at the time of the review. The l
State provided clarification regarding severallicensees.
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ATTACHMENT 4 t
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Response to NE Comments 2
.i NRC Response: The team revised the report as follows: Subsequent to the review, the State informed the team that 2 of the inspections due licenses are issued to nuclear power plants authorizing the use of radioactive material at temporary jobs,ites in the event of an emergency situation, one is an out-of-state licensee from Wisconsin authorizing non-AEA material, and one is an out-of-state service licensee for which no activity has occurred and is currently in a deferred status, which reduces the number of inspections due to 5.
e.
State Comment: The State indicated that the report contained an incomplete statement regarding IMC 2800 as follows: The report stated: "Of the 20 files reviewed by the team... were not inspected within 6 months of issuance as required by IMC 2800." The State indicated that IMC 2800 states within 6 months j
of receipt of licensed material, or within one year of license issuance. The State also stated that in response to the team's suggestion the State added the use of a i
standard license condition on new licenses to require notification of receipt of material t
NRC Response: The report was revised to state: "were not inspected within the
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stated frequencies identified in IMC 2800."
l 2.
3.2 Technical Staffing and Training.
s.
State Comment: The State' clarified that the second reorganization was not fully i
implemented until July 1,'1995. Also an internal memorandum, dated July 20, 1995, documents that the LLRW Program Manager was designated as the Acting Radioactive Materials Program Manager effective June 23,1995, until a permanent manager was named on May 1,1996, which contradicts the statement in the report that "in the second reorganization the division director position was lost j
l' without naming a permanent RAM program manager."
- NRC Response: The report was revised as follows: "A July 20,1995 internal memorandum that was provided to the IMPEP team during the review, designates the LLRW program manager as Acting RAM Program Manager, but based on statements made by program staff to the team,it was not clear to the RAM staff that the designated duties went beyond signature authority for licenses. NOTE:
The LLRW program manager told the IMPEP team that she was not the Acting RAM l
manager during that time; that she was to spend up to 20% of her time in the RAM licensing area as needed.
1-b.
State Comment: The Stata responded to the team assessment that "a formalized training manual and formal training records for the staff were not available," by indicating that database records for a majority of the training received by program staff were available but were unknown to the new Program Manager.
I i
n Response to NE Comments 3
NRC Response: The report was revised as follows: " Subsequent to the review, the team was informed that database records for a majority of the training received by program staff was available, but were unknown to the new program manager."
c.
State Comment: The state responded to the statement in the report "that a newly hired staff member was not yet considered qualified to perform low priority inspections after one year on-the-job," with the fact that program staff were limited to licensing activities while inspections were performed by contract personnel.
NRC Response: This information does not address primary issue that the State lacked a written program for staff qualification, therefore, no change to report.
3.
3.3 Technical Quality of Licensing Actions a.
State Comment: The State provided clarification regarding team statement that "due to lack of records, the team was unable to review or evaluate case backlog prior to July 1995." The State commented that the Program Manager provided the review team with a licensing a log book that covered the entire review period, but the handwritten logbook did not easily allow for statistical review of the pending actions, and the program began using a computer based spreadsheet for tracking licensing actions in July 1995.
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NRC Response: NRC added the States clarifying information to the report. The team also revised the report to read "Due to problems encountered by the team in trying to review the handwritten licensing logbook, we were unable to review or evaluate the case backlog prior to July 1995."
b.
State Comment: The State commented that their records indicate that 48 licensing actions were completed between~ July and December 1995 versus the team statement of 38 completed, and that 70 licensing actions were completed between January and June 21,1996 versus the team" statement that 48 were completed.
NRC Response: The team reviewed the licensing log statistics provided to the team at the review and found that the statistics indicate 38 and 48 licensing actions, as i
cutained in the report. The team did not change the team results, but added that, subsequent to the review, the State indicated 70 and 48.
c.
State Comment: The State commented that the report reference to" handwritten sheets kept by individual reviewers," should be clarified to include "which were j
kept in one logbook."
l NRC Response: The team added the clarifying information to the report.
I d.
State Comment: The State questioned the team's inclusion of detailed information or: a backlog in licensing and indicated that it created an additional non-common i-performance indicator for the States which was not being applied to the NRC 5:
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Response to NE Comments 4
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j Regions. The State commented that the information should be included under 3.2, Technical Staffing and Training, with any recommendations dealing with administrative procedures and get woll plans to eliminate backlogs. Additionally the State proposed a Finding of Satisfactory for this indicator since no recommendation was made regarding technical quality.
NRC Response: The team revised the report and as recommended by the State, included the licensing backlog information and any recommendations under Section 3.2, Technical Staffing and Training. After removing the recommendations regarding the licensing backlog from this section, the finding was changed to j-
" Satisfactory."
4.
Technical Quality of Inspections a.
State Comment: The State commented in response to the team's statement in the report, "that their was no indication that staff were using and applying the inspection and Enforcement Manuals." The State responded that an indication that 1
the inspection Manual was used by program staff can be found in the draft report where it references that the State uses separate inspection field notes for various classes of licensees. The field note forms are a large part of the current inspection Manual. The Enforcement Manual was written specifically into the contract for inspections and was used extensively by the contractor prior to being implemented j
by program staff.
NRC Response: The team noted the inconsistency and deleted this statement from the report, b.
State Comment: The State,in response to the teams statement that "the normal practice of a supervisory review was not practiced during this time," commented that a June 20,1995 delegation of authority stated that inspection letters were to be signed by the lead inspector with peer review if a NOV was to be included.
Since the review, the statement has been revised to clearly indicate that a j
management review was required.
NRC Response: The modification was made after the IMPEP review, therefore, no change to report.
c.
State Comment: The State commented on several references in the report to not documenting the training provided to ancillary staff, such a secretarial,
' housekeeping, or security personnel as required by 10 CFR 19.12. It is not clear if these comments take into account the revised Part 19, which requires training only to individuals likely to receive an occupational dose in excess of 100 mrem.
NRC Response: The team reviewed the States equivalent Part 19 regulations and noted that the State has not adopted the 100 mrem amendment to Part 19, which
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i Response to NE Comments 5
E is due for adoption by Agreement State in 1998. The report was not changed, as the revised Part 19 does not currently apply to Nebraska.
5.
Status and Compatibility of Regulations State Comment: Has the review team made a determination that the conditions placed on each irradiator license are not legally binding or equivalent to or more stringent that the requirements in 10 CFR Part 36?
NRC Response: The option of legally binding license conditions equivalent to 10 CFR Part 36 had not been officially implemented at the time of review.
6.
Summary i
s.
State Comment: Recommendation 1,2,' and 5 are similar, proposed removal of 1 and 5 and maintain 2.
NRC Response: Recommendation accepted.
b.
State Comment: Unclear r<hether Recommendation 9 applies to State or NRC.
NRC Response: Recommendation 9 applied to NRC and was removed from the list of recommendations for the State, and placed in the report as a reminder for NRC action.
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c.
Stroto Comment: Recommendation 8,10, and 11 are similar, propose removal of 10 and 11, and maintain 8.
NRC Response: Recommendation accepted, d.
State Comment: Recommendation 17 reiterates what is stated in No. 8, and the State proposed that it be removed.
NRC Response: Recommendation number 8 did not include event reporting which is the area of concern indicated in recommendation No.17, therefore, no change to report.
NON-COMMON PERFORMANCE INDICATORS Low-Level Radioactive Waste The Low-Level Radioactive Waste Program steff provided five editorial comments to clarify the organizational structure and sharing of responsibilities between the RAM and LLRW program. All of their comments have been incorporated in the revised Nebraska Draft Final IMPEP Report.
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I 8 TATE OF NEBRASKA DEmHTMENT OF HEALTH
, ' Mark C. Norton, M.D., M.S.RH.
Donu-Sapwher 10,1996 E ame.Wn Nabon Gowrnor U.S. Nuclear Regulatory Commission j
Office ofState Programs Mail Stop 3D23 Washington, DC 20555 Patricia bl. Larkins, Health Physicist 4
Attn:
IMPEP Team Leader 4
i
Dear Ms. Larkins:
This letter is in regards to the IMPEP review conducted by your team the week ofJuly 15-19, l
1996. A preliminary finding identified for Performance Indicator I., Status of Materials Inspection Program, was the lack of a formal inspection plan. An inrpection schedule, copy enclosed, was created for 1996 which will allow all overdue inspections and those that are coming due to be completed by the end of the year. Two of the inspections identified as overdue j
in the questionnaire. have already been performed, Thiele Geotech, Inc., and Nucletron-Oldelft i
Corporation and are not included in the inspection schedule. The methodology tised in the scheduling process will be formalized and included in the Program's inspection manual to ensure that all inspections will be completed in a timely manner.
A preliminary finding identified for Performance Indicator III., Technical Quality ofInspections, was the lack of a management review of the inspection report prior to the Notice of Violation being issued. The delegation of authority to sign documents in the Radioactive Materials Program has been modified to require that the Program Manager sign all inspection repons, or field notes repons, if appropriate, prior to the inspector issuing the inspection letter. A copy of the revised delegation of authority is enclosed.
On August 19,1996, a public hearing on the proposed regulations regarding the licensing of irradiators was held and no comments were made. 'Ibe final proposed draft was brought before our Radiation Advisory Council on September 6,1996, and it was approved to go to the Board of Health. The Board meets on September 16,1996, a copy of the agenda for that meeting is enclosed. After approval by the Board, the draft regulations will be provided to the Attomey General, and with his approval offered for the Governor's signature. A preliminary review performed by the Assistant Attomey General found no obvious pmblems with statutoryauthority or constitutionality, a copy of the letter is enclosed.
ao: c nnnimes s.mh mo. ami seco7. m h.Nehw.essos.soo7 RUC leot) 4710BBs
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l Patricia M. Larkins September 10,1996 Page 2 t
it is our intention to quickly address the other preliminary findings identified in your exit interview, and we welcome the ongoing review process. It is our hope that Nebraka's commitment to maintaining a radiation control program that ensures the public health and safety will be evident.
Ifyou have any other questions prior to issuing the draft findings, please feel free so contact Brian Hearty or Cheryl Rogers at (402) 471-2168.
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Sincerely, j'
j.
. <.. ~.,
Jack L. Daniel, Administrator
)
Environmental Heath Protection Section JLD/bph i
i 1
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1 1
y
1996 RADIOACTIVE MATERIALS PROGRAM INSPECTION SCHEDULE INSPECTION LICENSE LEAD INSPECTION DATE(S)
No.
INSPECTOR TEAM 9/12/96 01-69 01 Brian Hearty 9/25/96 02-26-01 Jim DeFrain Brian Hearty 10/2-4/96 02-06-03 Brian Hearty Jim DeFrain, Bryan Miller 10/3-4/96.
01-04-01 Cheryl Rogers John Fassell 10/10/96 01-63-01 Brian Hearty Bryan Miller 10/11/96 02-43-01 Bryan Miller Brian Hearty 10/16/96 11-02-01 Jim DeFrain Brian Hearty 10/18/96 01-58-01 Jim DeFrain Brian Heany 10/21-22/96 01-07-02 Howard Shuman John Fassell 10/28-11/1/96 01-50-01 Brian Hearty Jim DeFrain, Bryan Miller, Joyce Davidson 11/5/96 02-10-03 Bryan Miller Brian Hearty 11/7/96 02-16 01 Joyce Davidson Bryan Miller 11/13-15/96 01-09-02 Brian Hearty Jim DeFrain, Bryan Miller 11/21/96 02-26-02 Bryan Miller Brian Hearty 11/25-26/96 01-12-04 Brian Hearty Jim DeFrain 12/9-13/96 02-01-03 Jim DeFrain Brian Hearty, Bryan Miller, Joyce Davidson 12/17/96 01-38-01 Bryan Miller Brian Hearty l
I R:\\RADIOUNSPSCHD.96 (Rev. September 3,1996)
ST TE OF NEBRASKA DE5NtTMENT OF HEALTH
' - Mark C. Harten, M.D., M.S.P.H.
maw E. Assimmin Nainen o wmar MEMORANDUM Date: August 19,1096 From: Mark B. Horton, M.D., MSPH To:
Burke E. Casari, Director Environmental Health Division RE:
Delegation of authority to sign documents in the Radioactive Materials Program.
I have attached a table dated August 19,1996, showing the delegation of authority to sign licensing, inspection and other documents generated by the Radioactive Material Program.
l XC:
Jack Daniel, Administrator Environmental Health Protection Section i
j Brian P. Hearty, Manager Radioactive Materials Program i
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l 301 Cemenmal Mal Sowh
- RO. Som 95007
- theoh. Nehreska 68509 5007 FAX Mom 4710383
- T1Y 4714421 An Ecumf ^.
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,2 Board of Health Education and Health Promotion Committee September 16,1996 - 9:00 a.m.
Conference Room 3A Aaenda Review Regulations 174 NAC 8, Report of Induced Termination of Pregnancy and Fetal Death Certificate - Jane Elliott, contact person 173 NAC 1, Rules and Regulations Concerning the Reporting and Control of Communicable Diseases and Poisonings - Adi Pour, contact person 178 NAC 10, Regulations Governing Licensure of Water Well and Pump Installation Contractors and Certification of Water Well Drilling, Pump Installation, and Water Well Monitoring Supervisors - Rod Tremblay, contact person 178 NAC 12, Regulations Governing Water Well Construction, Pump Installation and Water Well Decommissioning Standards - Rod Tremblay, contact person 178 NAC 13, Procedural Rules for Operation of Board - Rod Tremblay, contact person 180 NAC 1, Nebraska Regulations for Control of Radiation-lonizing -
Joyce Davidson, contact person Tobacco Resolution 1996 Board of Health Retreat Report 3
STATE OF NEBRASKA __
DenumswrOFltM0rH
. asea s. Hersen. Ep., M.s.P.H.
maner August 6,1996 U.S. Nuclear Regulatory Commisr oa Office ofState Fx,g-us EWO Mail Stop 3D23 Washington, DC 20555 i
l Atta: Patricia M. Larkins, Health Physicist IMPEP Team Leader
Dear Ms. Larkins:
This letter is in regards to the IMPEP review conducted by your team the w t
1996. A preliminary fmding identified for Performance Indicator L, Status ofMaterials inspection Program, was the lack of timely review of the inspection reports and iss enforcement letters for a group of 22 inspections perfonned by a contrac that was placed on this matter by the review team encouraged immediate a i
complete the review.
As of August 5,1996, all contractor performed inspections have received a mana and the appropriate enforcement letters have been issued. Concerns that the ir with the contractor draAed enforcement letters, such as the identification ofrepe noncompliance and the proper listing of severity level, were addressed in the re corrected prior to issuance of the fmal notice of violation.
lt is our intention to quickly address the other preliminary findings identified in i
interview, and we welcome the ongoing review process. It is our hope that Nebrask commitment to maintaining a radiation control program that ensures the s
will be evident.
Ifyou have any other questions prior to issuing the draft fiMiage, please feel f Brian Hearty or Cheryl Rogers at (402) 471-2168.
Sincerely,
-m f e./ ? ! h. f'
./
Jack L.' Daniel, Administrator Environmend Heath Protection Section JLD/bph
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f(/y]ubOS d'P 1 '
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Agenda f:r Managim:nt R:vi:w Bo:rd Mrcting Wednesday, January 22, 1997, 1:00 a.m., OWFN, 6-B-11 1.
Convention. MRS Chair convenes meeting. (HLThompson) 2.
Old Business - Approval of previous MRB Minutes - lowa (KSchneider) 3.
New Business - Caneideration of Nebraska IMPEP Report.
A.
InWeduction of Notweeka IMPEP Team Members. (PLarkins)
B.
Introduction of Nebraska Representative and Other State Representatives Participating. (PLarkins)
C.
Findmgs Regarding Nebraska Program. (IMPEP Team)
Technical Staffing / Training Status of Inspection Program i
l Technical Quality of Licensing Technical Qualit" of Inspections Response to incidents / Allegations Legislation and Regulations Low Level Radioactive Waste Program D.
Questions. (MRB Members)
E.
Comments from State of Nebraska. (Deb Thomas)
F.
MRB Consultation / Comments on issuance of Report. (HLThompson) 4.
Status of Upcoming Reviews. (KSchneider) 5.
Adjournment. (HLThompson)
Invitees:
Hugh L. Thompson, MRB Chair, DEDR Karen Cyr! MRB Member, OGC Carl Paperiello, MRB Member, NMSS Richard L. Bangart, MRB Member, OSP Denwood Ross, MRB Member, AEOD Roland Fletcher, Agreement State Liaison to MRB, State of Maryland Deb Thomas, State of Nebraska Brian Hearty, State of Nebraska Paul Lohaus, OSP Kathleen Schneider, OSP Patricia Larkins, IMPEP Team Leader, OSP Jenny Johansen, IMPEP Member, RI Richard Blanton, IMPEP Member, OSP Ralph Cady, IMPEP Member, RES Charles Mattson, IMPEP Member, State of Colorado ATTACHMENT 7 L -
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