ML20138E176
| ML20138E176 | |
| Person / Time | |
|---|---|
| Issue date: | 04/24/1997 |
| From: | Lohaus P NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | Bangart R, Paperiello C, Thompson H NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS), NRC OFFICE OF STATE PROGRAMS (OSP), NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| References | |
| NUDOCS 9705020096 | |
| Download: ML20138E176 (3) | |
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1 UNITED STATE 8 s
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NUCLEAR RECULATORY COMMISSION WASHINGTON, D.C. acess4001 l
April 24, 1997 MEMORANDUM TO:
Hugh L. Thompson, Jr.
Deputy Executive Director for l
Regulatory Programs i
Richard L. Bangart, Director Office of State Programs Carl J. Paperiello, Director Office of Nuclear Material Safety and Safeguards Karen D. Cyr, General Counsel i
l Denwood F. Ross, Director Office for Analysis and Evaluation pk of Operational Data
. FROM:
Paul H. Lohaus, Deputy Director Office of State Prograrr.s i
SUBJECT:
INTEGRATED MAT 6 RIALS PERFORMANCE EVALUATION PROGRAM (IMPEP) REVIEW OF TENNESSEE RADIATION CONTROL PROGRAM This memorandum transmits to the Management Review Board (MRB) a proposed final report (Attachment 1) documenting the IMPEP review of the Tennessee Radiation Control Program. The review of the Tennessee program was conducted by an interoffice team during the period December 2 6,1996. The team issued a draft report to Tennessee on f
March 11,1997, for factual comment. Tennessee's factual comments, received by letter I dated April 10,1997, from Mr. Eddie Nanney, Deputy Director, Division of Radiological Health, Tennessee Department of Environment and Conservation, (Attachment 2) have
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been incorporated into the proposed final report.
The review team found the State's performance with respect to the common and non-common indicators to be satisfactory. Based on these indicators, the review team recommends that the MRB find the Tennessee program to be adequate to protect public health and safety and compatible with the NRC's regulatory program.
l 9705020096 970424 PDR STPRG ESGTN
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I Multiple Addressees The MRB meeting to consider the Tennessee report is scheduled for Friday, May 2,1997, from 2:00 - 4:00 p.m. In One White Flint North, Room 4-B-6. In accordance with Management Directive 5.6, the meeting is open to the public. The agenda for that meeting is attached (Attachment 3).
If you have any questions prior to the meeting, please contact me at 415-2326 or James Myers at 301-415-2328.
Attachments:
As stated cc:
Michael H. Mobley, Director Division of Radiological Healtli, TN Ray D. Paris, Manager Radiation Protection Services, OR Distribution:
DlR RF DCD (SPO1)
RWoodruff, Ril CHaney, NMSS WPassetti, FL KSchneider DCool, NMSS SMoore, NMSS l
HNewsome, OGC l
FCameron, OGC Tennessee File DOCUMENT NAME: G:\\JHM\\TNMRBMEM.KNS G:\\JHM\\TNIMP96.PFN l
Ts exeive e copy of this document. indicate in the box: *c' - copy without attachment /enclosur,e "E" = Copy with attachment / enclosure
'N' - No copy OFFICE OSP.gnl OSP:DD OSP:Q)Q l
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NAME JMyers:nb i PHLohaus 475 RLBangart[ ' '
DATE 04/,y /97 04/2y /97 y 04/pt#97 fHj OSP FILE CODE: SP-AG-26
. _ _ ~... -.
i Multiple Addressees The MRB meeting to consider the Tennessee report is scheduled for Friday, May 2,1997, from 2:00 - 4:00 p.m. In One White Flint North, Room 4-B-6. In accordance with Management Directive 5.6, the meeting is open to the public. The agenda for that meeting is attached (Attachment 3).
if you have any questions prior to the meeting, please contact me at 415-2326 or James Myers at 301-415 2328.
Attachments:
As stated cc:
Michael H. Mobley, Director Division of Radiological Health, TN Ray D. Paris, Manager Radiation Protection Services, OR t
9
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW OF TENNESSEE AGREEMENT STATE PROGRAM DECEMBER 2-6,1996 PROPOSED FINAL REPORT U.S. Nuclear Regulatory Commission ATTACHMENT 1
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Proposed Final Report Page 1
1.0 INTRODUCTION
This report presents the results of the review of the Tennessee radiation control program.
The review was conducted during the period December 2-6,1996, by a review team comprised of technical staff members from the Nuclear Regulatory Commission (NRC) and the Agreement State of Florida. Team members are identified in Appendix A. The review was conducted in accordance with the " Interim implementation of the Integrated Materials Performance Evaluation Program Pending Final Commission Approval of the Statement of Principles and Policy for the Agreement State Program and the Policy Statement on Adequacy and Compatibility of Agreement State Programs," published in the Federal Reaister on October 25,1995, and the September 12,1995, NRC Management Directive 5.6, " Integrated Materials Performance Evaluation Program (IMPEP)." Preliminary results of the review, which covered the period February 4,1994 to December 6,1996, were discussed with Tennessee management on December 6,1996.
[ Paragraph on Results of MRB meeting will be included in final report. Attachment 1, State's response will be included in final report.]
The Tennessee Department of Environment and Conservation (DEC) is the agency within Tennessee State government that regulates environmental issues and radiation hazards.
The DEC Commissioner is appointed by and reports to the Governor of Tennessee. Within DEC, the radiation control program is administered by the Division of Radiological Health (DRH). The DRH organization chart is included as Appendix B. The Tennessee program regulated 563 specific licenses at the time of the review. In addition to the radioactive materials licenses, the DRH has also issued approximately 4500 registrations for machine-produced radiation which covers about 13,000 X-ray tubes used within the State. The j
DRH is also responsible for environmental surveillance, emergency planning and response.
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 Tennessee.
i in preparation for the review, a questionnaire addressing the common and non-common indicators was sent to the State on October 15,1996. Tennessee provided its response to the questionnaire on November 14,1996. 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 Tennessee's response to the questionnaire, (2) review of applicable Tennessee statutes and regulations, (3) analysis of quantitative information from the Division's licensing and inspection data base, (4) technical review of selected files, (5) field accompaniments of four Tennessee inspectors, and (6) interviews with staff and management to answer questions or clarify issues. The team evaluated the information that it gathered against the IMPEP performance criteria for each common and non-common indicator and made a preliminary assessment of the radiation control program's performance.
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Proposed Final Report Page 2 i
Section 2, below, discusses the State's actions in response to recommendations made following the previous review. Results of the current review for the IMPEP common performance indicators are presented in Section 3. Section 4 discusses results of the applicable non-common indicators, and Section 5 summarizes the review team's findings and recommendations.
2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS The previous routine review concluded on February 4,1994, and the results were transmitted to Mr. J. W. Luna, on July 28,1994. The DEC was informed that the NRC t
staff determined that at that time, the Tennessee program for regulation of Agreement Materials was adequate to protect public health and safety and was compatible with the regulatory program of the NRC. All of the recommendations were determined to be satisfactorily resolved and the issues were closed out as documented in the letter and r
follow-up report to Mr. J. W. Luna dated October 4,1994.
3.0 COMMON PERFORMANCE INDICATORS IMPEP identifies five common performance indicators to be used in reviewing both NRC Regional and Agreement State programs. These indicators are: (1) Status of Materials j
inspection Program, (2) Technical Staffing and Training, (3) Technical Quality of Licensing Actions, (4) Technical Quality of Inspections, and (5) Response to incidents and Allegations.
3.1 Status of Materials inspection Proaram The team focused on five factors in reviewing this indicator: inspection frequency, overdue inspections, initial inspection of new licenses, reciprocity and timely dispatch of inspection j
findings to licensees. This evaluation is based on Tennessee's questionnaire responses to j
this indicator, data gathered independently from the State's inspection data tracking systeni, and interviews with managers and staff.
Review of the State's inspection priorities showed that the State's inspection frequencies for i
various types, or groups of licenses are at least as frequent as similar license types, or groups, listed in the NRC inspection Manual Chapter (MC) 2800 frequency schedule.
Inspection frequencies under the State's system range from 6 months to five year intervals with two exceptions: generally licensed gauges / devices and in-vitro laboratories, possessing less than 200 microcuries of radioactive material, which are inspected initially and thereafter only for resolution of problems. NRC inspects these programs initially, and every five years thereafter, as resources allow. The State has six categories of licensees that are inspected on a six month frequency: nuclear laundries, disposal / processing facilities, incinerators, l
waste handlers (prepack and repack), and disposal facilities (burial). NRC inspects these i
categories of licensees on an annual basis.
l In its response to the questionnaire, Tennessee indicated that as of December 6,1996, only
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five core inspections of licensees located within the state were overdue by more than 25 j
percent of the State's established inspection frequency. Three of the licensees are inspected
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Proposed Final Report Page 3 i
a on a six-month frequency so, under NRC established frequency, these inspections would not have been considered overdue. As of the date of the IMPEP review, all five inspections were scheduled to be completed by March 1997. The State also indicated that three core and seven non-core licensees located outside the State were overdue by more than 25 percent.
The State indicated that the licensen had not performed work in the State and, therefore, the State was unable to perform the inspections. In addition, they indicated that license i
conditions had been placed on the out-of-State licenses that required the licensees to notify the State when work was scheouled to be performed within the State. Nevertheless, the team suggested that the State periodically remind licensees of the requirement to notify DRH before performing work within the State and verify that work has not been conducted within the State's jurisdiction. These numbers are well within the 10 percent criterion for overdue inspections of Management Directive 5.6.
The team reviewed the initial inspection dates for 11 of 32 new licenses that had been issued between March 1995 and February 1996. Ten of the 11 licensees were inspected within six-months of license issuance. One new licensee was inspected at seven months post issuance rather than at six months.
The timeliness of inspection result issuance was evaluated. The results of 19 inspections were reviewed. The typical procedure for issuing the results of an inspection is: (1) the inspector prepares a letter that is used to transmit the inspection results; (2) the transmittal letter is typically dated two weeks after the inspector finalizes the letter; (3) the letter is forwarded for supervisory review; and (4) the letter is transmitted to the licensee after at least two levels of supervisory review. The review indicated that of inspections reviewed, only 10 of the 19 letters transmitting inspection findings were dated within four weeks of the completion of the inspection, it was difficult to determine the dates the letters were issued due to the inspectors dating the letters prior to supervisory review. Twelve of the 19 inspection letters were issued between 6 to 18 weeks after the inspection; one inspection letter was dispatched within 4 weeks; and it was not possible to determine when the other five letters were dispatched. It is recommended that the State review the process for report issuance with the goal of increasing the timeliness of inspection report issuance.
The State reported in its response to the questionnaire that 139 requests for reciprocity were received between February 4,1994 and October 29,1996. The team was unable to determine how many of these reciprocity requests were received from the same licensee.
DRH performed 33 reciprocity inspections during the review period. This is a significant increase over the number of reciprocity inspections that had been performed during previous i
review cycles. The State's goalis to inspect at least ten percent of the licensees who are l
authorized to perform licensable activities under reciprocal recognition of a radioactive materials license issued by the NRC, an Agreement State, or a Licensing State. The State i
has met this goal. The review team was unable, however, to compare the number of reciprocity inspections by category of licensee to the goals established in NRC MC 1220,
" Processing of NRC Form 241," Report of Proposed Activities in Non-Agreement States," and inspection of agreement state licensees operating under 10 CFR Part 150.20," which is j
incorporated by reference into MC 2800. It is recommended that the State review the number of reciprocity inspections it is performing against the inspection goals established in MC 1220.
1 Proposed Final Report Page 4
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Based on the IMPEP evaluation criteria, the review team recommends that Tennessee's performance with respect to the indicator, Status of Materials inspection Program, be found satisfactory.
3.2 Technical Staffino and Trainino issues central to the evaluation of this indicator include the radioactive materials program staffing level, technical qualifications of the staff, training, and staff tumover. To evaluate these issues, the review team examined the State's questionnaire responses relative to this indicator, interviewed DRH management and staff, and considered any possible workload backlogs.
The organization chart shows that DRH has a total of 89 positions. Effectively about 50% of the staff works in whole, or in part, on matters related to Agreement materials. DRH was authorized to fill only 59 positions at the time of the review. Mr. Michael H. Mobley is the Division Director and he has a Deputy Director, Mr. Lawrence R. Nanney. The Office of the Director is supported by an Administrative Services Section (seven personnel) which provides general office services and accounts receivable support to the Division. The Technical Services Section (eleven personnel) provides personnel and environmental monitoring, low-level waste monitoring, standards development and processing, and emergency preparedness and training support to the Division. The Enforcement Section includes 24 staff members working out of four Area Offices. The distribution of the staffis as follows:
the Coordinator is located in the Nashville (Headquarters) Office; 4 persons are in the Nashville Area Office; 6 persons are in the Memphis Office; 3 persons-are in the Chattanooga Office; and 10 staff members are in the Knoxville Office.
The Licensing, Registration and Planning Section (12 personnel) license and register radioactive materials and radiation producing devices used within the State. Five individuals are directly involved in conducting the review of applications and issuing licenses for the radioactive materials used under the Agreement. Two individuals within the Radioactive Material Specific Licensing group also perform the reviews of sealed sources and devices (SS&D). A discussion of SS&D personnel training is covered in Section 4.2.2.
Four individuals are involved in machine and device permitting activities. Two individuals provide planning, policy and regulatory guidance to the Division.
The DRH has established qualifications for its technical classifications, including Health Physicist 1 (HP1) and Health Physicist 3 (HP3) Applicants at the entry level, HP1, are required to have a baccalaureate degree in a physical or (appropriate) life science. They are usually assigned basic responsibilities in the program until sufficient training experience is obtained. They receive training in health physics, nuclear medicine uses, materials licensing, inspection procedures for radioactive materials or radiation producing devices, industrial radiography, well logging, emergency response, environmental monitoring, low-level radioactive waste management, and standards / procedures development. Increased training warrants their assignment to more complex responsibilities. HP1 staff are required to qualify as HP3 staff after two years employment, one year for an individual with an MS in Health Physics, or their employment is terminated. Individuals with a MS have a shorter qualification
Proposed Final Report Page 5 time to reach the HP3 level because they are given constructive credit for their advanced training in Health Physics.
The higher technical classifications provide a career progression: from HP3, one may progress to HP Supervisor 1 or 2; from HP Supervisor 1 or 2, one may progress to HP Field Office Manager, HP Manager 1, HP Consultant, or HP Manager 2; from HP Manager 1 or 2, one may progress to HP Manager 3.
DRH has a pragmatic approach to training and qualification. The position description for new personnel, HP1, includes a description of several courses, including several " core" courses, which a new employee is expected to complete. DRH trains individuals on a case-by-case basis factoring in the individual's basic experience and program needs. An individual training program is developed to meet these needs. The DRH has an aggressive program for monitoring and scheduling individual training. DRH uses a data base for planning, scheduling and monitoring individual training. Because of the limited access to NRC sponsored " core" courses and other training opportunities, it may take several years for the person without a Health Physics background to complete all " core" training requirements.
The State has attempted to accelerate some individual training by sponsoring employee attendance at courses such as the five week health physics course. The DRH has worked very closely with the Office of State Programs (OSP) to fill any sudden vacancies in NRC sponsored courses, especially those given in Chattanooga and Oak Ridge, to maximize their training opportunities.
DRH re'ies heavily on an apprenticeship approach to training its personnel. All new l
personnel are carefully coached and observed while performing various activities related to their position. When supervisors determine that an individual is competent in a particular area, e.g., fixed gauges, nuclear medicine, or industrial radiography, the individual is permitted to work with less supervision in that area. This is a very subjective process and the length of time spent developing an employee varies with the individual. An individualis not considered fully qualified in any area until there is consensus on this point among the management team. Interestingly, the DRH may not limit a new employee's first experiences to less complex licensed activities. Depending on the need, the DRH may start training an individual on very complex activities as a team member. As an employee gains more on-the-job experience and training and completes the two ysars required in the HP1 class, they achieve the joumeyman (HP3) level of competency.
Personnel in the Licensing, Registration and Planning Section are assigned increasingly complex licensing case work under the direction of senior staff. They also accompany experienced inspectors during compliance inspections of complex licenses to gain field experience.
The inspection staff receives the same basic training as the licensing staff. Inspectors are required to demonstrate competence during accompaniments by the supervisor prior to being given permission to perform inspections independently. The DRH inspector accompaniment process and the team's findings are in Section 3.4. This information was verified through discussions with managers and staff, review of the questionnaire response, a review of
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I Proposed Final Report Page 6 m
t organizational charts and a review of the position descriptions. The team determined that all staff utilized for the agreement materials program were technically qualified by evidence of l-their training and experience.
The DRH reporf.ed that ten employees had left the Division since the 1994 review. One individual retired. Seven employees left DRH for promotion, better compensation or to i
continue their education. Two individuals were removed for cause. Retaining qualifed personnel is not believed to be a problem. The attrition noted in the State's response is considered to be normal given the size of the program. The DRH, however, is faced with the problem of filling vacc :t positions. All State govemment agencies are presently under a e
hiring freeze instituted in early 1995. Vacated positions cannot be filled. Strong justifications l
are necessary and the process is long and arduous. The State's response indicated that they are in the process of requesting freeze releases for six positions at the time of the review. The DRH is projecting the loss of two positions from their organization within the next six months. This will reduce the total number of DRH positions to 87.
in summary, the State has a balanced licensing and inspection program with approximately equal number of individuals involved in each area. Few vacancies exist at the senior level.
The DRH has developed a strategy for addressing the long term State-wide hiring freeze and is slowly filling vacant positions. DRH has enteria for hiring, training and developing i
members of the staff to assure a continued high level of performance. DRH management supports development and demonctrated a commitment to training during this review period.
Despite their commitment to training, the DRH has voiced a concem about the impact NRC's change in policy for funding Agreement State training will have on their program.
DRH is meeting all mission requirements through creative resource management. The i
replacement of personnellosses willincrease the size of the staff and provide more flexibility in meeting an unexpected, significant event.
Based on the IMPEP evaluation criteria, the review team recommends that Tennessee's
. performance with respect to the indicator, Technical Staffing and Training, be found satisfactory.
3.3 Technical Quality of Licensina Actions The review team examined completed licenses and casework for 78 license actions in 23 i
specific license files, representing the work of five license reviewers. The license reviewers and supervisor were interviewed when needed to supply additional information regarding licensing decisions or file contents.
The license casework was selected to provide a representative sample of licensing actions l
which had been completed in the review period and to include work by all reviewers. The l
cross sampling included eight of the State's major licenses and included the following types:
source and device manufacturing an.1 distribution, industrial radiography, nuclear medicine, gamma knife, high dose rate remoto afterloader, academic and nuclear pharmacy. Licensing actions reviewed included 3 new,3 renewals,69 amendments, and 3 terminations. Two of the new licenses, one renewal, and two of the terminations were major licenses. No major
Proposed Final Report Page 7 license termination involved decommissioning. The two terminations that were major licenses were commercial distributors of sealed sources. A list of these licenses with case specific comments can be found in Appendix D.
Licensing actions were reviewed for completeness, consistency, proper isotopes and quantities authorized, qualifications of authorized users, adequate facilities and equipment, and operating and emergency procedures sufficient to establish the basis for licensing actions. Licenses were reviewed for accuracy; appropriateness of the license and of its conditions and tie-down conditions; and overall technical quality. Casework was reviewed for timeliness; adherence to good health physics practices; reference to appropriate regulations; documentation of safety evaluation reports; product certifications or other supporting documents; consideration of enforcement history on renewals; pre-licensing visits; peer or supervisory review as indicated; and proper signature authorities. The files were checked for retention of necessary documents and supporting data.
j Two exemptions issued were reviewed. One exemption was from the "Very High Radiation Area" posting requirement on a gamma knife facility door to lessen patient apprehension and the other was to permit the preparation and distribution of I-123 MiGB (non-AEA material) which does not yet have an Investigational New Drug (IND) or New Drug Application (NDA) j from the Food and Drug Administration (FDA).
In general, the review team found that the licensing actions were thorough, complete, consistent, of acceptable or higher quality, and with health and safety issues properly i
addressed. Special license tie-down conditions were stated clearly, backed by information
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contained in the file, and inspectable. Two exemptions were reviewed for this review period.
3 Both of them had valid justifications. The licensee's compliance history was taken into i
account when reviewing renewal applications as determined from documentation in the license files and/or discussions with the license reviewers.
i The review team found that terminated licensing actions were well documented, showing appropriate transfer records and survey records. A review of the licensing actions over the review period showed that almost all terminations were for licensees possessing sealed sources. Thess files showed that documentation of proper disposal or transfer was available.
The team found that licensees have been notified of the need to file for reciprocity on sites which are exclusive Federal jurisdiction according to All Agreement States Letter SP-96-022.
All licenses which allow for temporary job sites have been amended to include a standard condition in accordance with the All Agreement States Letter SP-96-022.
Licenses were renewed on a five year frequency. Licensees are tied down to previously i
. submitted applications, supporting documentation and updated information. The State is considering extending the renewal period for certain licensees under specific conditions. The category of licensee and the specific conditions that would be required for the renewal extension is currently being studied. Licenses that are under timely renewal are amended as necessary to assure that public health and safety issues are addressed during the period that the license is undergoing the renewal process.
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1 Proposed Final Report Page 8 The license reviewer passed each licensing action up through the supervisory chain for review. Some of the licensing actions performed by the licensing manager do not receive a peer review. This was determined not to be of concem since the licensing actions which did i
not receive a peer review were of a minor nature. Major licensing actions receive multiple reviews and input from all levels up through the Director.
The review team found that the current staff is well trained and experienced in a broad range of licensing activities. The casework was reviewed for adequacy and consistency with the NRC procedures. The State does not have official, written administrative procedures for licensing reviews. They follow their licensing guides during the review process to ensure that l
licensees submit the information necessary to support the license. The licensing guides were j
very similar to the NRC guides.
1 Based on the IMPEP evaluation criteria, the review team recommends that Tennessee's performance with respect to the indicator, Technical Quality of Licensing Actions, be found satisfactory.
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l 3.4 Technical Quality of Inspections i
I The team reviewed the inspection reports and enforcement documentation for 19 inspections conducted during the review period. The casework included a review of the work of 13
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j materials inspectors from all field offices. The casework covered a range of license types to l
l include medical, academic, and industrial licensees. Appendix E provides a list of the j
inspection cases reviewed with case-specific comments.
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l The inspection procedures and techniques utilized by the State were reviewed and i
determined to be consistent with the inspectior guidance provided in MC 2800. It was found 2
that the majority of the inspections performed by the State were unannounced. The inspection reports provided documentation of inspection findings in a consistent manner. For the most part, the field offices were consistent in how they were documenting inspections.
The inspection form used by the inspectors provided documentation of the licensee's I
radiation safety organization, program scope, facilities, equipment, radiological safety procedures, personnel monitoring, exposure to radiation, receipts and disposal records, posting, labeling, independent measurements, general observations, and violations. The inspection form allowed inspectors to provide brief, clear, discussions of the inspection and i
relevant findings. The reports were sufficiently detailed to support escalated enforcement j
actions. The State's enforcement letters were formal in style, detail and language.
Inspectors cign all routine enforcement correspondence. All of the inspection results and i.
routine enforcament letters were verified as having been reviewed and approved in j
accordance witt applicable DRH policy before issuing the results to licensees.
Four inspector accompaniments were performed by a review team member during the period j
of October 31 and November 13-15, 1996. One inspector was accompanied during the early moming inspection of a nuclear pharmacy facility, and three other inspectors were accompanied to medical facilities. These accompaniments are also identified in Appendix E.
l All of the other fully qualified inspectors have been accompanied during previous reviews i
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Proposed Final Report Page 9 since 1990. On the accompaniments, the Tennessee inspectors demonstrated appropriate inspection techniques and knowledge of the regulations. The inspectors were well prepared and thorough in their reviews of the licensees' radiation safety programs. Overall, the technical performance of the inspectors was satisfactory, and their inspections were adequate to assess radiological health and safety at the licensed facilities.
In response to the questionnaire, the State reported that 9 out of 13 individuals who are qualified to perform inspections were accompanied by supervisors during the review period.
It was suggested that consideration be given to conducting accompaniments with the field l
office supervisors that are routinely performing inspections. The State's policy is to accompany each inspector at least once each calendar year.
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it was noted that the State had a variety of portable instruments for routine confirmatory j
surveys and for use during incidents and emergency conditions. Instruments were calibrated annually by a consthnt w by the instrument manufacturer. Laboratory samples are i
analyzed by Tennessee's Department of Health, Division of Laboratory Services, Radiochem%iry Laboratory. The laboratory participates in the Environmental Protection Agency's cross-check program. Approximately 400 samples are analyzed quarterly by the laboratory for the Division of Radiological Health.
Based on the IMPEP evaluation criteria, the review team recommends that Tenr.essee's performance with respect to the indicator, Technical Quality of Inspections, be found satisfactory.
3.5 Response to incidents and Alleaations I
In evaluating the effectiveness of the State's actions in responding to incidents and l
allegations, the review team examined the State's response to the questionnaire regarding i
this indicator, reviewed the incidents reported for Tennessee's " Nuclear Material Events Database" (NMED) against those contained in the Tennessee files and reviewed in detail the casework of 13 incident files and 7 allegation files. In addition, the review team interviewed the Deputy Director, the Manager of Inspection and Enforcement Section, the Supervisor of the Knoxville Area field office, and the two staff persons responsible for tracking incidents and allegations, and for providing the NMED summary data to NRC.
Responsibility for initial response and follow-up actions to incidents and allegations involving licensed materials rests with the inspection and Enforcement Section. Tennessee procedures require the prompt response by the Division of Radiological Health (DRH) to each incident or allegation. Each incoming notification is discussed with management and staff as appropriate and the response is coordinated with the appropriate field staff including an on-site inspection as appropriate. The managers related that all incidents, complaints, and allegations are evaluated by management, followed up with an inspection if possible, and l
recorded and tracked in the computerized tracking system. The updated NMED system was provided to the State on October 31,1996 and the State has designated one individual for entering the State's data onto the system. The State has begun submitting event information on diskettes, but the State did not have the modem installed and was unable to access the
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Proposed Final Report Page 10 i
on line event information at the time of the review. The State has plans for addition of the modem for on-line data input.
i The reviewer examined in detail the State's response and documentation to all 13 events listed in Appendix F and verbally discussed several other events with the Inspection and Enforcement Section Program Manager. This effort included the State's incident and allegation process, tracking system, file documentation, open records laws and policies, and notification of events to other Federal and State Agencies.
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The review team found that the State's responses generally were well within the performance criteria. Responses were prompt and well-coordinated, and the level of effort was commensurate with health and safety significance. Health Physicists were dispatched to the site when appropriate. In general, the State took suitable corrective and enforcement actions, notified the NRC, other States, and other Agencies as appropriate, and followed the 4
i progress of the investigation through until close out. The team noted a difference in the reporting threshold between State reporting procedures of significant events to NRC with respect to the definition of significant events. The State defines a "significant event" as an J
event that it an abnormal occurrence or one where media interest is involved. The NRC j
defines a "significant event" as one that is required to be reported by the licensee on an immediate or 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> basis. This threshold difference in reporting events to NRC resulted j
in two events not being reported to NRC as significant events. In the State's April 10,1997 response, the DRH provided additional perspective on their interpretation of the TN reporting I
procedures. Although the State believes the recommendation should be eliminated the j
review team disagrees. However, the events were reported to NRC later during the routine exchange of information. The review team recommends that the State revise their definition of "significant event" to be consistent with the definition provided in NRC guidance on reporting events, and which will provide uniformity in reporting events on a national basis.
i Allegations were responded to promptly with appropriate investigations and follow-up actions.
i Concemed individuals' (Cl) identity can be protected under the State's open record law to the l
extent that investigations can be protected while under investigation. Program management j
related that all confidential information is maintained in a file which is secured in a locked cabinet, and this was confirmed by the reviewer. In general, the State's response was determined by the review team to meet the indicator guidance. However, the State's i
procedures do not have specific details on how known allegers or Cls are notified conceming 1
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the actions taken by the State in response to the concems, specifically when the notification is needed and whether the notification should be verbal or in writing. All allegations, which had been referred by Region ll, were resolved. Although the State reportedly has j
experienced no problems with their current Cl notification procedures and policy, the team suggested that the State revisit their procedures and determine if more formal notification i
procedures are needed with respect to notification of the Cl of the actions taken and the results of the State's investigation.
Based on the IMPEP evaluation criteria, the review team recommends that Tennessee's l
performance with respect to the indicator, Response to incidents and Allegations, be found i
satisfactory.
(
l Proposed Final Report Page 11 4.0 NON-COMMON PERFORMANCE INDICATORS IMPEP identifies four non-common performance indicators to be used in reviewing l
Agreement State programs: (1) Legislation and Regulations, (2) Sealed Source and Device l
Evaluation Program, (3) Low-Level Radioactive Waste Disposal Program, and (4) Uranium l
Recovery. Tennessee is not authorized pursuant to its Agreement with NRC to regulate uranium recovery operations and the State does not have a low-level radioactive waste disposal site. Therefore, only the first two non-common performance indicators were applicable to this review.
t 1
4.1 Leaislation and Reaulations 4.1.1 Leaislative and Leaal Authority Based on previous reviews, the State's response to the questionnaire, and discussions with the staff and management, clear statutory authority exists which designates the Tennes7,ee DRH as the State radiation control agency with authority over agreement materials. The
(
State statute that provides this legal authority is Title 68, Chapter 202, of the Tennessee Code Annotated (TCA).
Along with their response to the questionnaire, the State provided the review team with copies of legislation that affects the radiation control program. The legislative authority has been reviewed during this, and previous reviews, and is considered adequate to protect public health and safety. Based upon discussions with staff, the management, and a review of the State's response to the questionnaire, the review team confirmed that there have been l
no changes that would negatively impact the regulation of agreement materials.
i 4.1.2 Status and Compatibility of Reaulations The Tennessee radiation control program's regulations are found in " Rules of the Department of Environment and Conservation," Chapters 1200-2-4 through 1200-2-i2. The questionnaire documented that DRH rules adopted during any calendar year are subject to the " sunset" l
l provisions on June 30 of the following calendar year, unless approved by the State -
l Legislature. Management indicated that the " sunset provision" has not been a problem since all DRH regulations must be approved by the Legislature's Govemment Operations Committee (GOC). Historically, all regulations approved by the GOC have been passed by the legislature. The list of regulations provided with the State's response to the questionnaire was evaluated to determine the status of the Tennessee regulations.
Four NRC regulation amendments became effective since the 1994 review and were adopted by the State:
a
" Notification of incidents," 10 CFR Parts 20,30,31,34,39,40,70 amendments (56 FR 64980) which became effective on October 15,1991. The State's rule became effective on December 28,1996. NRC has reviewed this rule and has found it to be j
compatible with NRC's regulations.
l l
4 l
Proposed Final Report Page 12 l
j
" Licensing and Radiation Safety Requirements for Irradiators," 10 CFR Part 36 i
amendment (58 FR 7715) which became effective on July 1,1993. The DRH does not have an irradiator licensee nor have they received an application for an irradiator license. Therefore, the State does not need to implement the requirement at this 4
time. DRH management has recognized the need to implement legally binding requirements should an application be received.
I j
- Definition of Land Disposal and Waste Site QA Programs," 10 CFR Part 61 j
amendment (58 FR 33886) which became effective on July 22,1993. The State
~
adopted this requirement on October 28,1996. NRC has reviewed this rule and has found it to be compatible with NRC's regulations.
"Self-Guarantee as an Additional Financial Mechanism," 10 CFR Parts 30,40, and 70 1
amendments (58 FR 68726 and 59 FR 1618) that became effective on January 28, j
1994. 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 not to adopt self-guarantee as a method of financial assurance).
5 If a State chooses not to adopt this regulation, the State's regulation, however, must l
contain provisions for financial assurance that include at least a subset of those provided in NRC's regulations, e.g., prepayment, surety method (letter of credit or line of credit), insurance or other guarantee method (e.g., a parent company guarantee).
)
It is noted that TRH has a "Self-Guarantee" provision in place since 1987. NRC has
]
reviewed this rule and has found it to be compatible with NRC's regulations.
)
The review team identified three regulations that have not been put into effect in the i
Tennessee program:
- Uranium Mill Tailings Regulations: Conforming NRC Requirements to EPA Standards," 10 CFR Part 40 amendment (59 FR 36026) that became effective on July 1,1994. The State of Tennessee does not have a uranium mill and this regulation is not required.
" Quality Management Program and Misadministrations," 10 CFR Part 35 amendment (56 FR 34104) which became effective bn January 27,1992. At the time of the February 1994 review, it was noted that the State's regulations should be amended to include this requirement. It has not been adopted. The team confirmed that this regulation has been submitted twice to the Commissioner, Tennessee Department of Environment and Conservation. It is presently at the Commissioner's Office. The expected date of adoption of the proposed rule cannot be predicted. NRC is currently deferring compatibility findings for Agreement States that have not yet adopted a compatible QM rule, pending resolution of the issue of Agreement State compatibility.
" Decommissioning Recordkeeping Documentation of Restricted Areas and Spill Sites,"
10 CFR Parts 30 and 40 (58 FR 39628) that became effective on October 25,1993.
The State has not adopted this regulation. Management asserted that DRH did not j
adopt NRC's rule believing the State has an effective combination of mechanisms in place that exceed NRC's requirement. DRH could not produce documentation
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Proposed Final Report Page 13 supporting their decision at the time of the review. The review team recommended that DRH document the rationale supporting their decision and what legally binding requirements are used in place of an amendment to the TRH regulations. In the State's response dated April 10,1997, the DRH submitted a rationale supporting their position on this rule and committed to use legally binding requirements. The review team recommended that DRH submit copies of sample license conditions used to implement the decommissioning recordkeeping requirement for NRC's review. The l
team finds that this is an acceptable practice.
The review team examined the procedures used in the State's regulatory process and found that the public is offered the opportunity to comment on proposed regulations and participate in public hearings that follow the comment period. The procedures also require the proposed regulations, proposed hearing date, hearing comments and analysis, and the final regulations to be placed on the Department's intemet home page. Draft copies of the proposed r3gulations are provided to NRC during the rule development process and the final regulations are submitted to NRC.
L i
l DRH uses a computerized system to follow future regulatory actions. It is the intention of the l
TRH management to address these regulations in a timely fashion. At the time of the review the following items are on the regulatory agenda:
" Timeliness in Decommissioning of Materials Facilities," 10 CFR Parts 30,40, and 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.
This rule is designated as a Division 2 matter of compatibility. Division 2 compatibility allows the Agreement State the flexibility to implement more stringent requirements if they so desire.
" Radiation Protection Requirements: Amended Definitions and Criteria,"
10 CFR Parts 19 and 20 amendments (60 FR 36038) that became effective August 14,1995.
" 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.
I l
i
Proposed Final Report Page 14
" Low-Level Waste Shipment Manifest Information and Reporting," 10 CFR Parts 20 l
and 61 amendments (60 FR 15649,60 FR 25983) that will become effective March 1, l
1998. Agreement States are expected to have an effective rule on the same date.
l l
Based on the IMPEP evaluation criteria, the review team recommends that Tennessee's j
performance with respect to the indicator, Legislation and Regulations, be found satisfactory.
4.2 Sealed Source and Device Evaluation Proaram in evaluating the State's SS&D evaluation program, the review team studied the information provided by the State relative to this indicator in their response to the questionnaire, reviewed the casework and background information of all certi%ates of registration issued since the February 1994 review, reviewed procedures and guidance, and interviewed the DRH staff t
l and managers responsible for SS&D evaluations.
4.2.1 Technical Quality of the Product Evaluation Proaram l
The review team reviewed the files of the seven new or revised SS&D registry sheets issued
(
since the February 1994 review. The SS&D registry sheets issued by the State and j
evaluated by the review team are listed with case-specific comments in Appendix G. The technical quality of the evaluations was good and there were no comments related to the i
technical quality.
The Tennessee Regulations for Radiation Protection provide a regulatory basis for the SS&D program. Tennessee regulations 1200-2-10.10 and 1200 2-10.13 define the approval criteria and the type of information to be submitted by the applicant for registration of sources and devices. During the review of one specific license authorizing the manufacture and distribution of a specific device, it was noted that the license required the devices to be manufactured in accordance with the " device model," rather than the approved " registration number." Since the registration is the regulatory basis for approval of the device by other States and NRC in their respective regulatory jurisdictions, we believe that the license should i
tie the manufacture and distribution to the " registration number" for the specific model(s) approved by the State. This would help ensure that all regulatory jurisdictions have the most t
i updated device information available through the SS&D registration system. The State l
indicated during the review that this license condition modification could be affected. The review team recommends that the standard license condition be revised as appropriate to tie the manufacture and distribution of devices to the approved registration number.
l i
4.2.2 Technical Staffino and Trainina The State reported that a three-person team with combined staff efforts equalling approximately 12 weeks per year are needed for performing safety evaluations. All persons performing safety evaluations have bachelor's degrees, and have been trained in health physics and have taken the NRC licensing course. The two senior reviewers have many
__~ _
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Proposed Final Report Page 15 years experience in performing safety evaluations and have attended the SS&D workshops i
for training. The reviewers demonstrated to the review team an ability to understand and interpret the information submitted by applicants as described in the performance criteria, i
The junior reviewer works under the supervision of the two senior members, and all evaluations receive at least one technical review by a supervisor and a second party I
concurrence by supervision.
4.2.3 Evaluation of Defects and incidents Reaardina SS&Ds There have been no reported incidents involving sources or devices approved by the State.
Based on the IMPEP evaluation criteria, the review team recommends that Tennessee's performance with respect to the indicator, Sealed Source and Device Evaluation Program, be found satisfactory.
4.3 Low-Level Radioactive Waste (LLRW) Disposal Proaram in 1981, the NRC amended its Policy Statement, " Criteria for Guidance of States and NRC in Discontinuance of NRC Authority and Assumption Thereof by States Through Agreement" to allow a State to seek an amendment for the regulation of LLRW as a separate category.
Those States with existing Agreements prior to 1981 were determined to have continued LLRW disposal authority without the need of an amendment. Although Tennessee has LLRW disposal authority, NRC has not required States to have a program for licensing a LLRW disposal facility until such time as the State has been designated as a host state for a LLRW disposal facility. When an Agreement State has been notified or becomes aware of the need to regulate a LLRW disposal facility, they are expected to put in place a regulatory program which will meet the criteria for an adequate and compatible LLRW disposal program. There are no plans for a LLRW disposal facility in Tennessee. Accordingly, the review team did not review this indicator.
5.0
SUMMARY
As noted in Sections 3 and 4 above, the review team tound the State's performance with respect to each of the performance indicators to be satisfactory. Accordingly, the team recommends the MRB find the Tennessee program to be adequate to protect public health and safety and compatible with NRC's program.
Below is a summary list of recommendations and suggestions, as mentioned in earlier sections of the report, for consideration by the State.
1.
The team suggested that the State periodically remind licensees of the requirement to notify DRH before performing work within the State and verify that work has not been conducted within the State's jurisdiction (Section 3.1).
i 2.
It is recommended that the State review the process for report issuance with the goal l
of increasing the timeliness of inspection report issuance (Section 3.1).
i l
l I
Proposed Final Report Page 16 3.
It is recommended that the State review the number of reciprocity inspections it is performing against the inspection goals established in MC 1220 (Section 3.1).
4.
It was suggested that consideration be given to conducting accompaniments with the field office supervisors that are routinely performing inspections (Section 3.4).
5.
The review team recommends that the State revise their definition of "significant event" to be consistent with the definition provided in NRC guidance on reporting events, and which will provide uniformity in reporting events on a national basis (Section 3.5).
6.
The team suggested that the State revisit their procedures and determine if more i
formal notification procedures are needed with respect to notification of the Cl of the actions taken and the results of the State's investigation (Section 3.5).
7.
The review team recommended that DRH submit copies of sample license conditions used to implement the decommission recordkeeping requirement for NRC's review (Section 4.1.2).
8.
" Quality Management Program and Misadministrations," 10 CFR Part 35 amendment l
(56 FR 34104) which became effective on January 27,1992. The team i
recommended that the DRH continue to closely follow the development of NRC's compatibility policy and the revision of 10 CFR Part 35 and, depending on the outcome, take appropriate action on this rule (Section 4.1.2).
9.
The review team recommends that the standard license condition be revised as appropriate to tie the manufacture and distribution of devices to the approved registration number (Section 4.2.1).
l
1 l
l LIST OF APPENDICES AND ATTACHMENTS i
l l
Appendix A iMPEP Review Team Members I
l Appendix B Tennessee DEC Organization Chart l
Appendix C Tennessee's Questionnaire Response i
Appendix D License File Reviews Appendix E Inspection File Reviews Appendix F Incident File Reviews i
i Appendix G Sealed Source and Device Evaluation Reviews l
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APPENDIX A iMPEP REVIEW TEAM MEMBERS Name Area of Responsibility James Myers, OSP Team Leader 1
Technical Staffing and Training Legislation and Regulations Richard L. Woodruff, Ril Response to incidents and Allegations Sealed Source and Device Evaluation Program Catherine Haney, NMSS Status of Materials inspection Program Technical Quality of Inspections William Passetti, Florida Technical Quality of Licensing Actions l
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i APPENDIX C l
l lNTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM l
QUESTIONNAIRE - RESPONSE 1
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Approved by OMB' l
No. 3150-0183 Expires 4/30/98 JNTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM QUESTIONNAIRE Tennessee Agreement State Program Reporting Penod: February 4,1994 to December 6,1996 A. COMMON PERFORMANCE INDICATORS 1.
Status of Materials Insoection Proaram 1.
Please prepare a table identifying the licenses with inspections that are overdue by more than 25% of the scheduled frequency set out in NRC Inspection Manual Chapter 2800 (issued 4/17/95). The list should include initial inspections that are overdue, l
insp. Frequency t
Licensee Name (Years)
Due Date Months O/D l
l Plaza Radiology 3.0 12/95 11 SEG, Inc./ Central Vol.
0.5 07/96 4
Reduction Facility SEG, Inc./ incinerator Fac 0.5 07/96 4
l Diversified Scientific Services, Inc. 0.5 08/96 3
l ATEC Assoc., Inc.
3.0 10/95 13 Out of State Licensees:
Tenn. Gas Pipeline 1.0 03/96 8
Meritus PLS, Inc.
2.0 05/96 6
Honeywell, Inc.
3.0 11/95 12 Troxler Electronic Lab 5.0 03/94 32 Diagnostic Technology Cons.
5.0 01/95 22 Golder Construction Ser.
5.0 04/95 19 Bhate Engineering Corp.
5.0 09/95 14 American Engineers, Inc.
5.0 09/95 14 Boart Longyear Co.
5.0 10/95 13 Rust Environment 5.0 11/95 12 l
l 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.
APPENDIX C
l l
l 2.
Do you currently have an action plan for completing overdue inspections? If so, please describe the plan or provide a written copy with your response to this l
questionnaire.
Plaza Radiology inspection planned for 12/96.
SEG, inc) Central Vol. Reduction Facility; SEG, Inc./ incinerator Fac; and l
Diversified Scientific Services, Inc., inspection planned for 3/97. Note that l
these three would not be due inspection until 3/97 by the NRC inspection l
frequency.
~
l ATEC Assoc., Inc., inspection planned for 1/97.
l Tenn. Gas Pipeline; Meritus PLS, Inc.; Honeywell, Inc.; Troxler Electronic l
Lab; Diagnostic Technology Cons.; Golder Construction Ser.; Shate l
Engineering Corp.; American Engineers, Inc.; Boart Longyear Co.; and Rust l
Environment are out-of state licensees. Arrangements have been made to j
alert the Manager of Inspection and Enforcement at the next notification of l
state entry for these licensees, and plans will be made for an inspection during that next entry.
3.
Please identify individual licensees or groups of licensees the State / Region is inspecting less frequently than called for in NRC Inspection Manual Chapter 200 (issued 4/17/95) and state the reason for the change.
none 4.
How many licensees filed reciprocity notices in the reporting period?
139(2/4/94 - 10/29/96) a.
Of these, how many were indutrial radiography, well-lo ng or other users with inspection frequencies of three years or l
lR - 49 WL/ Tracer - 181 b.
For those identified in da, how many reciprocity inspections were conducted?
33 5.
Other than reciprocity licensees, how many field inspections of radiographers were performed?
1 4
4 6.
For NRC Regions, did you establish numerical inspections to be performed during this review period? goals for the number of If so, please describe 1
your goals, the number of inspections actually performed, and the reasons for 1
any differences between the goals and the actual number of inspections performed.
d
d 1
11.
Technical Stamina and Trainino i
7.
Please provide a staWing plan, or complete siisting using the suggested i
format below, of the professional (technical) person-years of e# ort applied to th agreement or radioactive material program by individual. Include the name, position, and, for Agreement States, the fraction of time spent in the following areas: administration, materials licensing & compliance, emergency response, LLW, U-mills, other. If these regulatory responsibilities are divided between oMices, the table shouldbe consofidated to include all personnel contributing to i
the radioactive materials program. Include all vacancies and identify all senior 1
personnel assigned to monitor work of junior personnel. If consultants were used to carry out the program's radioactive materials responsibilities, include their efforts. The table heading should be:
NAME POSITION AREA OF EFFORT TOTAL EMER U-6DM L1C GQME BESE LLW M!LLS DIdEB M. Mobley Div. Director 25.0 10.0 N/A 35 0 L.Nanney Dep. Director 40.0 10.0 N/A 50 0 J. Sullivan*
HP Mgr2 40.0 10 0 N/A 50 0 J. Lisle HP3 90.0 5.0 N/A 95.0 l
J. Graves
- HP Mgr 2 40.0 10.0 N/A 50 0 C. Amott*
HP Mgr 1 90.0 5.0 N/A 95 0 R. Wynn HP3 14.0 53.0 N/A 67.0 C. Montgomery HP3 90 0 N/A 90 0 R. Parsons HP3 90.0 N/A 90.0 R. Young
- HP SPV2 20.0 5.0 N/A 25 0 G. Bacon HP3 1.7 N/A 1.7 M.Page HP3 50.0 10.0 N/A 20 0 pp 80.0 B. Shrader*
HP Supv2 40.0 10.0 N/A 50 0 D. Shults*
HP Mgr2 10.0 N/A 10.0 j
R. Crosshn*
HP Mgri 10.0 N/A 10 0 i
R. Wolford HP3 29.0 N/A 29 0 M. Hammon*
HP Supvi 10.0 N/A 10.0
)
R. Perry HP3 25.0 10.0 N/A 35.0 e B. Davis
- HP SPV2 40.0 10.0 N/A 50.0 J. Key
- HP SPV1
.8 N/A
.8 A. Grewe*
HPFO Mgr 40.0 10 0 N/A 50 0 G. Stevens' HP SPV1 40.0 10.0 N/A 53 0
- 8. Freeman
- HPFO Mgr 40.0 10.0 N/A SO O M. Andrews*
HP SPV2 40.0 10 0 N/A 50 0 C. Johnson HP3 40.0 10.0 N/A 50.0 A.Ho9an HP3 40.0 10.0 N/A 50.0 R. Mackhn HP3 40.0 10.0 N/A 50.0 C. Millsaps HP3 40.0 10.0 N/A 50.0 D. N Whitmil!* HP SPV1 20.0 10.0 N/A 30 0 R. Schaeffer HP3 16.0 N/A 16.0 M. Wofford HP1 2.0
.7 N/A 27 J. Pohtte HP3 1.3
.7 N/A 2.0 T. Papura HP3 21.0 N/A 21.0 j
l l
l Totalthed posibons 119.8 463.7 675.3 216 4 9 1395.2
- $erwor technice! staff assigned to monitor work of junior technical staff i
8.
Please provide a listin review, indicate the degee(s) g of all new professional personnel hired since the l they received, if applicable, and additional training and i
years of axperience in health physics, or other disciplines, if appropriate.
Melissa Wolford - 1/8/95 - TTU, BS, Biology, 94 Licensing until July,96 transfer to Chattanooga Field Office (Compliance) i Tom Papura - 4/1/96 - State U, NY, BS, Natural Sciences, 89 i
Prior experience - TN DOE Oversight Division, Red Monite ing, etc. / NY Radon, j
Radiation Emergency, etc.
i Titus Berry - 4/2/96 - TSU, BS, Physics, 8/95 Prior experience - U.S. Navy nuclear power student l
i John Politte - 8/2/96 - Henderson State College, BS, Chemistry / Biology,65 - U.
ARK, MS, Radiological Health,67 3
3 Prior experience - TVA HP,72 94 J
Rod Hartwig - 9/1/96 - APSU, BS Chemistry / Math, 95 Shawn Drake - 9/16/96 - MSU, BS, Physics / Math, 92 Sasikala Krishnasarma - 9/23/96 - U. of Kerala (India), BS, Botany,1970; U. of Calicut (India), MS, Botany Prior experience - ARRT/CNMT NWestem U Hospital /Ressurection Hospital, i
Chicago j
Roger Fenner - 11/25/96, MTSU, BS, Science / Physics, 82 Prior experience - DRH Compliance / Licensing,82-87 / VU Radiation Safety Office, j
88 10/96 l
J j
9.
Please list all professional staff who have not yet met the qualification i
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 i
tentative schedule for completion of these requirements.
j Licensing:
License reviewers are trained as junior reviewers under the direct supervision of eittre the Radioactive Materials Licensing Section Manager or the Licensing /
Registration /Plannhg Manager. As soon as possible millicense reviewers attend the 1
five week basic health pPysics course and the radioactive materials licensing course.
One staff member who was previously a license reviewer now works in the Planning a
l 4
Section assisting the Licensing / Registration /Plannin#anager in technical topics and specialized review of some amendments for some of the complex licenses. He has attended the five week basic health physics course and has worked for 4.5 years unde i
the direct supervision of the Licensing / Registration / Planning Manager to review i
license for delivery applications and provide technical research tihe manager on the more complex facility licenses.
inspection:
Name Needs Time Expected Approval l
Ron Hartwig 5-wk HP / Insp. Procedures CY 97 Shawr. Drake 5-wk HP / insp. Procedures CY 97 Travis Barber More OJT CY 97 i
Kristi Lewis More OJT CY 97 Lawrence Helveston Supervisor's Approval CY 97 Missy Wolford More OJT CY 97 Requirements:
5-wk HP Course and inspection Procedures Course (or equivalent experience) and sufficient OJT.to be capable to adequately perform independent inspections (as judged by their supervisor).
10.
Please identify the technical staff who left the RCP/ Regional DNMS program during this period.
Eric Miller; Alishia Parks; Janice Harkins; Robert Schaeffer; Keith Henshaw; Michele Barrett Taylor; Paul McCoy; Laura Phillips; Roger Van Blarcom; Dean Baker Ill.
Technical Quality of Licensino Actions 11.
Please identify any major, unusual, or complex licenses which were issued.
received a major amendment, terminated or renewed in this period.
New Licensti Manufacturing Sciences Corporation R-01078 Scientific Ecology Group R-73018 Scientific Ecology Group R-73020 M-4 Environmental. L.P.
R-01077 IT Corporation R-47152 Radiosurgical Center of Memphis, L.P.
R-79245
American Technologies, Inc R 01081 Amendments Scientific Ecology Group R-73006 Scientific Ecology Group R-73008 l
Scientific Ecology Group R 73013 Scientific Ecology Group R 73016 Scientific Ecology Group R 73018 Scientific Ecology Group R-73020 M 4 Environmental, L.P.
R-01077 Aerojet Ordnance Tennessee S-90009 Nuclear Fuel Services S-86001 Nuclear Fuel Services S-86007 American Ecology Recycle Center R-01037 American Ecology Recycle Center R-01068 Diversified Scientific Services, Inc.
R-73014 W.R. Grace S-33006 Baptist Hospital R-19044 l
Frank W. Hake Associates R-79171 Terminations HNU R-01051 l
l
1 HNU R-01055 Renewals Manufacturing Sciences Corporation S-01046 Frank W. Hake Associates R 79171 12.
Please identify any new or amended licenses added or removed from the list of licensees requiring emergency plans?
None 13.
Discuss any variances in licensing policies and procedureer exemptions fran the regulations granted during the review period.
Exemotions in 1996 an up-to-date list was compiled of exemptions and variances granted by the Division from 1966-10 the present. Below is a list of the exemptions and vunnces that were granted by the Division from 1994 to 1996.
122.4 DATE LICENSEE OR REGULATION BRIEF DESCRIPTION j
REGISTRANT 3/10/94 World Testing, Inc.
1200-2 5-allows use of radioactive R 95009-H96
.80(1) materialin a high radiation area that does not have the specified controls 9/1/94 Syncor international 1200-2 doesn't require the removal of Corp.
.113(2) individual containers that are R-47080-197 disposed of in a Sharps container
9/2/94 Syncor intemational-1200-2 doesn't require the removal of Corp.
.113(2) individual containers that are R-33111-197 disposed of in a Sharps container 9/2/94 Syr.cor International 1200 2 5-doesn't require the removal of Corp.
.113(2) individual containers that are R-19149-A98 disposed of in a Sharps container l
l e
i j
d
l I
l 111!i DATE LICENSEE OR REGULATION BRIEF DESCRIPTION REGISTRANT Regional Medical 1200-2 allows a particular doctor to 5/1/95 Center at Memphis
.33(3) perform diagnostic and R-79159-98 therapy procedures who didn't meet the specified training requirements i
7/10/95 Saint Francis 1200 2-5.60 management of patients with Hospital Cesium 107 and Radium 226 R-79104-G00 implants in the hospital 9/18/95 Memorial Hospital 1200-2 allows a particular doctor to R 33013-897
.33(3) perform diagnostic and therapy procedures who didn't meet the specified training requirements 10/27/95 Memorial Hospital 1200-2 7-waives the leak test R-33120-J00
.03(2)(a) requirement of sealed sources placed in storage for decay until removal from storage and/or ultimate disposal 9
0 1
..a J
-A 4
.kW 4~w--
A
,a
---+--Ju
- = -w eaJ W-u<+ - -
L a.La Fd
- h-a-ih---*mau-
.ai
- a....
m--l,a a.-A---
4 12H l
DATE LICENSEE OR REGUI.ATION BRIEF DESCRIPTION REGISTRANT 1/17/96 Lockheed Martin 1200-2 compgny meets the Energy Systems, 06(1) exemption requirements for Inc.
DOE contractors or subcontractors as defined in SRPAR 3/7/96 Goodax 1200-2 doesn't require the removal of Technology, Inc.
113(2) individual containers that are dba Phoenix disposed of in a Sharps Nuclear container R-47157-C01 l
3/29/96 Eastman Chemical 1200-2 allows use of radiographic Company
.04(10)(a) and equipment that doesn't R-82012-C01 1200-2-4.08 comply with a certain ANSI standard i
7//25/96 Alpha Nuclear 1200-2 5-doesn't require the removal of
)
Pharmacy, Inc.
113(2) individual containers that are R-83013-G01 disposed of in a Sharps l
container 1
i l
9/13/96 Syncor 1200 2 exempt from requirements of l
International, Inc.
.13(10)(b)1 having an IND, NDA, or a R-79174-L96 biologic product license issued by the FDA Variance to Resuhlil9DA Adopted an indemnification certificate for federal agencis that apply for a Tennessee Radioactive Waste License for Delivery.
14.
What, if any, changes were made in your written licensing procedures (new procedures, updates, policy memoranda, etc.) during the reporting period?
i
l POLICY Determination of Exclusive Federal Jurisdiction (completed - modifed temporary job sites licenses by condition to contain criteria concoming determining exclusive federal jurisdiction established by NRC)
Biologic Products with Product License Application (completed - modifed nuclear medicine (Groups 11 and lli) and radiopharmacy licenses by condition to recognize the new FDA approval methodology) l Definition of Broker as Applied to Tennessee Radioactive Waste License for Delivery (completed)
Inspection Procedures for Area Offices (ongoing) l Policy for Handling Expired Licenses (ongoing)
Notice to Pregnant Workers (ongoing)
Division Policy Conceming Transfer of Licenses From One Party to Another (ongoing) 1 REGULATORY. GUIDES l
l Radiography Guide (updated)
Guide for Qualifying as a Radiation Safety Officer for Disposal /Proceseg Facilities or Similar Facilities (completed)
Minimum Qualifications for Radiography RSO (completed) l White Paper on Reindustrialization and Privatization of Former DOE Sites White Pape j
(completed)
Decontamination and Decommissioning License Guide (completed)
Medical Guide (ongoing) i 15.
For NRC Regions, identify by licensee name, license number and type, any renewal applications that have been pending for one year or more.
IV.
Technical Quality of Inamections 16.
What, if any, changes were made to your written inspectiorprocedures during the reporting period?
None 17.
Prepare a table showing thenumber and types of supervisory accompanimers made during the review period. Include:
Suoervisor Insoectat License Cat-Qatt AEG JEH 03225 03/08/95 AEG GAS 03310 10/29/96 JRS AEG 03121 09/05/96 l
JRS AEG 03121 09/05/96 JRS JTL 02500 10/21/96 BHF CNM 03234 06/5-7/96 BHF CNM 03234 10/17/96 BHF AWH 03234 10/96 BHF AWH 03121 01/09/95 BHF RLM 03121 11/94 BHF CAJ 03233 10/25/94 i
BHF MVA 11300 9/96 i
i 18.
Describe intemal procedures for conducting supervisory accompaniments of inspectors in the field. If supervisory accompaniments were documented, please i
provide copies of the documentation for each accompaniment.
1 Accompaniments now should be made by all supervisory staff. Each supervisor will attempt to accompany each inspector supervised et least once each calendar year.
Documentation of inspections including supervisory me.companiment are inspection reports / notices of non-compliance (these can be made available during program review),
19.
Describe or provide an update on your instrumentation and methods of l
calibration. Are allinstruments properly calibrated at the present time?
j DRH procedure for catibration includes annual calibration of each instrument, under contract with K & S Associates, Inc., Nashville, except the 12-4 Ludlum neutron detector, which is sent to Ludlum for calibration each year.
All gamma detectors are calibrated to a Cs-137 source.
All alpha detectors are calibrated to a Pu 239 set.
When an instrument nears its calibration date, arrangements are made for that l
instrument to be sent for calibration. If the instrument is in a field office, a meter swap is made so the field office is not left without the proper instrument during the l
calibration time.
l
l The following is an updated instrument calibration list.
l l
CAL DATE MANUFACT.
MODEL SER.#
DET. TYPE MODW SER8 LOC.
10 3
96 LUDLUM 12-4 44437 BF3 REM NASH.
BALL 9
25 96 LUDLUM 12 S 5808 INTERNAL MEMP Nal 2
19 96 LUDLUM 12 S 5817 INTERNAL NASH Nat 6
5 96 LUDLUM 12 S 25107 INTERNAL NASH.
Nal 6
5 96 LUDLUM 12 S 92488 INTERNAL NASH.
Nal 12 12 95 LUDLUM 12-S 92491 INTERNAL KNOX Nal 1
15 96 LUDLUM 12 S 92495 INTERNAL NASH Nel 2
19 96 LUDLUM 12 S 92500 INTERNAL NASH Nel 12 18 95 LUDLUM 12 S 92502 INTERNAL NASH Nal 2
19 96 LUDLUM 12-S 92507 INTERNAL NASH.
Nal 11 9
95 LUDLUM 14 A 799 END 44-4 B13301 MEMP WINDOW G.M.
2 21 96 LUDLUM 14 A 13275 END 44-4 3006 NASH.
WINDOW G.M.
12 11 95 LUDLUM 14 B 1430 INTERNAL CHATT G.M.
7 10 96 VICTOREE 470-A 716 ION NASH.
N CHAMBER 2
19 96 BICRON MCR R B108G ORGANIC KNOX.
SCINTILL.
6 27 96 BICRON MCR-R B110G ORGANIC KNOX.
SCINTILL.
APTEC ODYSSE 9404-2' X 2' NAI 930712 6 NASH Y4 10 12 27 95 EBERLINE RO-2A 1677 ION MEMP l
CHAMBER l
8 20 96 EBERLINE RO 2A 1680 lON NASH.
l CHAMBER
l 6
27 96 EBERLINE RO-2A 1743 ION NASH.
CHAMBER 8
13 96 EBERLINE RO-2A 1770 ION NASH CHAMBER 2
21 96 EBERLINE RO-2A 1791 ION KNOX CHAMBER 10 7
96 EBERl.INE RO-2A 1803 ION KNOX CHAMBER 6
5 96 T.ASt,0C.
TBM-3P2 84173 ENER NASH.
COMP GM 8
13 96 LUDLUM 3
1877 END 44-4 PR26680 MEMP.
WINDOW G.M.
10 27 95 LUDLUM 3
2150 END 44-4 PR03175 CHATT WINDOW G.M.
3 18 96 LUDLUM 3
39206 PANCAKE 44-9 PR24447 NASH G.M.
2 21 96 LUDLUM 3
39240 END 44-7 PR33303 NASH.
WINDOW G.M 7
10 96 LUDLUM 3
39265 END 444 PR39265 NASH WINDOW G.M.
3 18 96 LUDLUM S
-3809 INTERNAL NASH G.M.
8 9
96 LUDLUM 5
3811 INTERNAL NASH.
G.M.
3 6
96 LUDLUM S
3824 INTERNAL NASH G.M.
10 7
96 LUDLUM S
6221 INTERNAL KNOX G.M.
4 16 96 LUDLUM 12 KIT 18348 PANCAKE 44-9 PR6046 NASH G.M.
4 16 96 LUDLUM 12 18348 SIDE HP-KIT 6 NASH WINDOW 270 G.M.
4 16 96 LUDLUM 12 18348 Naf SCINT.
44-2 PR6253 NASH 4
17 96 LUDLUM 12 18348 ZnS 452 PR7528 NASH SCINT.
2-24 96 LUDLUM 12 KIT 20040 PANCAKE 44 9 PR6047 CHATT G.M.
2 24 96 LUDLUM 12 20040 SIDE HP-N/A CHATT WINDOW 270 1
G.M.
l 2
26 96 LUDLUM 12 20040 ZnS 43-2 PR7531 CHATT SCINT.
2 26 96 LUDLUM 12 20040 Nal SCINT. 44 2 G1-03175 CHATT
'l
-~
l l
5 13 96 LUDLUM 12 KIT 20096 SIDE HP-KIT 2 NASH WINDOW 270 G.M.
5 13 96 LUDLUM 12 20096 ' PANCAKE 44-9 PR6048 NASH G.M.
5 13 96 LUDLUM 12 20096 ZnS 43 2 PR7530 NASH SCINT.
5 13 96 LUDLUM 12 20096 Nat SCINT.- 44-2 PR6256 NASH 10 7
96 LUDLUM 12 KIT 21665 SIDE HP-KIT 5 KNOX WINDOW 270 G.M.
10 7
96 LUDLUM 12 21665 Nel SCINT. 42 PR6255 KNOX i
10 7
96 LUDLUM 12 21665 PANCAKE
- 9 PR6044 KNOX G.M.
10 7
96 LUDLUM 12 21665 ZnS 432 PR7527 KNOX SCINT.
6 5
96
- .UDLUM 12 KIT 21688 PANCAKE 44 9 PR6045 MEMP G.M.
6 5
Pi LUDLUM 12 21688 SIDE HP-KIT 3 MEMP WINDOW 270 G.M.
6 5
96 LUDLUM 12 21688 Nel SCINT.
44-2 PR6254 MEMP 6
5 96 LUDLUM 12 21688 Zns 43-2 PR7526 MEMP SCINT.
2 23 96 LUDLUM 12 KIT 105701 PANCAKE
- 9 PR106665 KNOX G.M.
2 24 96 LUDLUM 12 105701 ZnS 43-2 PR085751 KNOX
- SCINT, 2
24 96 LUDLUM 12 105701 SIDE 44-PR106666 KNOX WINDOW 38 G.M.
2 24 96 LUDLUM 12 105701 Nat SCINT.
44-2 PR107144 KNOX 1
18 96 LUDLUM 12 KIT 105721 SIDE 44-PR106664 NASH WINDOW 38 G M.
1 18 96 LUDLUM 12 105721 Zns 43 2 PROB 5752 NASH SCINT.
1 18 96 LUDLUM 12 105721 Nal SCINT.
44-2 PR107148 NASH 1
18 96 LUDLUM 12 105721 PANCAKE 44-9 PR106634 NASH G.M.
10 30 95 LUDLUM 16 KIT 2650 END 44-4 2650 NASH.
WINDOW G.M.
10 30 95 LUDLUM 16 2650 PANCAKE 44-9 13680 NAEH.
G.M.
10 30 95 LUDLUM 16 2650 Nel SCINT.
44-2 G 2650 NASH.
i i
11 2
95 LUDLUM 16 2650 Zns 43-5 P59 NASH.
SCINT.
8 13 96 LUDLUM 16 KIT 2651 PANCAKE
- 9 2651 NASH G.M.
8 13 96 LUDLUM 16 2651 END 44-4 200295 NASH.
WINDOW G.M.
8 13 96 LUDLUM 16 2651 Nat SCINT.
44-3 G-2651 NASH.
1 19 96 LUDLUM 16 KIT 3006 Nat SCINT. 44 2 A-3006 KNOX 1
19 96 LUDLUM 16 3006 PANCAKE 44-9 24795 KNOX G.M.
1 19 96 LUDLUM 16 3006 END 44-4 B13294 KNOX WINDOW G.M.
1 19 96 LUDLUM 16 3006 ZnS 43 5 A 3006 KNOX 1
SCINT.
6 26 96 LUDLUM 16 KIT 3007 PANCAKE
- 9 PR077190 KNOX G.M.
6 28 96 LUDLUM 16 3007 END 44-4 3007 KNOX WINDOW G.M.
6 28 96 LUDLUM 16 3007 ZnS 43-5 A 3007 KNOX SClNT.
6 28 96 LUDLUM 16 3007 Nel SClNT.
44-2 A-3007 KNOX 10 8
96 LUDLUM 16 KIT 7319 Nel SCINT. 42 P444 MEMP 10 8
96 LUDLUM 16 7319 ZnS 43 5 P448 MEMP.
SCINT.
10 8
96 LUDLUM 16 7319 PANCAKE
- 9 PR33813 MEMP.
G.M.
10 8
96 LUDLUM 16 7319 END 44-4 7319 MEMP.
WINDOW G.M.
4 18 96 H.P.l.
4083 501 PIN DIODE CHATT 3
6 96 H.P.I.
4083 '
502 PIN DIODE NASH 12 8
95 H.P.I.
4083 503 PIN DIODE NASH 3
6 96 H P.I.
4083 504 PIN DIODE KNOX 2
22 96 H.P.I.
4083 505 PIN DIODE NASH.
12 8
95 H.P.I.
4083 506 PIN DIODE MEMP 12 8
95 H.P.I.
4083 509 PIN DIODE MEMP l
8 13 96 H.P.I.
4083 510 PlN DIODE 4593 CHATT NOTE:
- IN LAST COLUMN INDICATES THESE INSTRUMENTS ARE BEING CAllBRATED
$ IN LAST COLUMN INDICATES THIS INSTRUMENT IS OUT FOR REPAIRS
1 l
V.
Resoonses to incidents and Alleantions 20.
Please provide a list of the most sianificant incidents (i.e., medical misadministration, overexposures, lost and abandoned sources, incidents requiring i
24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> or less notification, etc.) that occurred in the Region / State during the review period. For Agreement States, information included in previous submittals to NRC need not be repeated. The list should be in the following format:
LICENSEE NAME LICENSE #
DATE OF INCIDENT / REPORT TYPE OF INCIDENT Summaries of allincidents have periodically been submitted to NRC.
)
21.
During this review period, did any incidents occur that involved equipment o r source failure or approved operating procedures that were deficient? If so, how and when were other State /NRC licensees who might be affected notified?
N/A a.
For States, was timely notification made to the Office of State Programs? For Regions, was an appropriate and timely PN generated?
N/A 22.
For incidents involving failure of equipment or sourceswas 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.
N/A 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 desenbe the circumstances for each case.
None Identify any changes to 24.
during the period of this review.your procedures for handlingillegations that occ There are no changes to our procedures.
s.
For Agreement States, please identify any illegations referred to your program by the NRC that have not been closed.
Complaint regarding public notice relative to Studsvik licensing referred by NRC to State on October 25,1996.
VI.
GsDatal i
25.
Please prepare a summary of thestatus of the State's or Region's actions taken in response to the comments and recommendations following the last review.
l The last full review of the Tennessee Division of Radiological Health (TN DRH) was concluded on February 4,1994, and the results formally transmitted to TN DRH by letter of July 28,1994. Accompanying that letter were three technical recommendations for program enhancement. In our response to that letter, we acknowledged actions to effect Recommendations One and Two. We also noted we would make efforts to increase our inspection of reciprocity licensees. As can be determined from our informal mid-cycle review of January 23-26,1995, and this report, TN DRH has increased its reciprocity inspections. A review of the resutts of those inspections is now being condixted.
26.
Provide a brief description of your program's strengths ad weaknesses. These strengths and weaknesses should be supported by examples of succames, problems or l
difficulties which occurred during this review period.
The major strength of TN DRH is the commitment of its staff to assuring the protectio n of the public and environment from the hazards of radiation. While having varied l
assignments, all Division staff understand our focus is to assathe adequate protection i
l of the public from radiation. TN DRH also has a core staff group that has significant I
training and experience in regulatory health physics, and a strong administrative core ttia effectivelysupports ouractivity. The senior technical staff is also very effective in workg with new staff to develop their skills.
Evidence of our strengths is the ability to quickly respond to numerous incidents or situations involving non-routine activities, e.g., molten metal spills at SEG, package crushings at Federal Express, lost or abadoned source actions. An additional strength is the high recognition factor for TN DRH within state govemment. We know rediation!
TN DRH weaknesses are staffingdifficulties and training difficulties. There is a desperat need for additional new technical staff in the training pipeline. In addition, without the NRC training and possibly no other outside training, it is going to become increasingly l
difficult to develop trained staff.
l B.
NON COMMON PERFORMANCE INDICATORS 1.
Reculations and Local Authority 27.
Please list all currently effective legislation that affects the radiation control program (RCP).
TennesseeCode Annotated 68 202101 through 68-202 508 an$8 202-705 through 6S j
202 70g 28.
Are your regulations subject to a " Sunset" or equivalent law? If so, explain and include the next expiration date for your regulations.
Rules adopted during any calendar year are subject to sunset June 30 of the following calendar year, unless approval by the legislature. Historically, all regulations approved by the (Legislature's) Govemment Operations Committee (GOC) are then approved by the Legislature by passage of a bill. All DRH regulations must have approval die GOC.
l.
2g.
Please complete the e1 closed 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.
]
l l
l See last 5 pages of report 30.
If you have not adopted all amendments within three years frorthe date of NRC l
rule promulgation, briefly describe your State's procedures for amending regulations in l
order to maintain compatibility with the NRC, showing the normal length of time enticipated to complete each step.
Description of procedures not applicable at this time.
l!.
Sealed Source and Device Proaram l
l 31.
Prepare a table listing new and revised SS&D registrations of sealed sources ad l
devices issued during the review period. The table heading should be:
l SS&D Manufacturer, Type of l
Registry Distributor or Device l
Number Custom User or Source SS&D Manufacturer, Type of i
Registry Distributor of Device l
Number Custom User or source l
TN-0241-S-101 S Sanders Medical Products Inc.
calibration and transmission sources TN-0241-S 102-S Sanders Medical Products, Inc.
calibration source TN-0241-S-103 S Sanders Medical Products, Inc.
calibration source TN-314-S-101-S ETRAC Laboratories, Inc.
reference source TN-628-D-200-S Eastman Chemical Company gauging device 1
l TN 7gg D-101-S Energy Technologies, Inc. (ETI) gauge l
TN-1004 D-101-S Bristol-Myers Squibb Company isotope generator 32.
What guides, standards and procedures are used to evaluate registry applications?
The Division makes appropriate use of the guidesstandards, and procedures currentt j
incorporated in the Course Notebook from the Sealed Source and Device Workshop l
conducted by the NRC on September 12-15,1995.
l 33.
Please include information on the following questions in Section A, as they apply to the Sealed Source and Device Program:
Technical Staffing and Training - A.ll.7-10 Technical Quality of Licensing Actions - A.lil.11, A.lll.13-14 l
Responses to incidents and Allegations - A.V.20-23
l Since the last NRC review, registry evaluations have beerperformed by Charles Arnot i
and Chestine " Der Montgomery. Mr Arnott has worked for the Division for seventee years and has attended a Sealed Source and Device Workshop. He has provided l
guidance and supervision in this enort for Ms. Montgomery who has worked for the Division of 3.5 years. There were no reported incidets involving failure of sources or devices evaluated by the Division.
Or 10 CFR Rule 10 CFR Date Date Current Expecte Part(s)
Due Adopted Status d
Adoption Addition of an exempt quantity for Be-133 20,30 9/2494 Addihon and modificabon of transport and packaging 20,30, 3/26/74 procedures 40,70, 71 Changes in values of radionuchdes of all concentrations in 20 11/2n5 air and water Requirements for notices, instruction and reports by lican-19 9/1796 sees to workers, and options available to workers with re.
gard to inspechons Change to abbreviations for
- curie
- and
- microcurie,* and 20,30, 10/24/76 addeon of definthon for *milheune' 32 Authorustion to use C-14 in m vrtro chnical or laboratory 31,32 1/10/77 tests Requirement that supphers must venfy that customers are 30,31, 3/11/77 suthorned to receive the matenal shipped 40,70, 150 l
Special curie definitions and concentration values for U 20 7/29/77 l
and Th Andeben of H-3 and Fe-59 to in vrtro tests and extension of 31,32.
8/16/77 Medical Group licensing 35 Modification of requirements for distribution of 31.5 GL 31,32 1/15/78 devices Cienfication of AEC contractors exempt pursuant to Energy 1/19/75 Reorganization Act Requirements for control of licensed material in unre-20 6/25/78 j
stncted areas and Datin storage l
Addeon of I-125 seeds for interstitial treatment of cancer 35 6/25/78 f
to Group VI l
Incorporation of *As Low As is Reasonabty Achievable 20 1/19/79 l
(ALARA)* wording Modt6 cation of occupational exposure limit for Rr>222 20 1/29/79 Addibon of Sn-113/in-113m generators to Group til 35 2/23/79 N
Addlbon of Yb-169 DTPA for cistemography to Group 11 35 4/19/79 i
Requirements for preservations of certain records required 20.31, 6/2/79 by the regulations 32,35, 40,70, 150 l
t l
Personnel monitonng requirements for industrial radiogra-34 8/4/79 phers Add.%n of I-125 fibrinogen for detection of deep vein 35 8/16/79 8
throntesis to Group ll Autterizes use of respirators. Bases intomat exposure 20 12/29/79 limits on intake into the body Estabbshes GL for depleted uranium products 40 1/5/80 Exemphon for personnel neutron dosimeters containing 40 3/7/80 thonum Additon of Se-75 to in v#ro GL 31,32 5/31/80 Addition of Mock lodme-125 calibration sources to in vrtro 31,32 6/27/80 GL Modificehon of requirements for individual physic an use of 35 8/15/B0 redcactive matenal for human use Extends small quantrry source matenal GL to Federal, state 40 1/6/81 and local governments for operational purposes Addttion of Tc-99m human serum albumin for heart blood 35 1/16/81 poolimaging to Group Ill Additon of Tc-99m medronate sodium for bone imaging to 35 2/7/81 Group ill Exempbon for spark gap irradiators containing Co-60 30 2/16/81
@g Addttonal requirements for controlling areas in which 20 3/14/81 radiaton levels m excess of 500 rems /hr exist Addrbon of Tc-99m gluceptate sodium for brain and rena!
35 6/16/81 perfusion imaging to Group 111 Removal or defacing of radioactive matenallabels on 20 6/23/81 empty containers Addrbon of Tc-99m human serum microspheres for venog-35 9/7/81 raphy to Group til Requirement to perform survey of patients to confirm that 35 12/28/81 implants have been removed Deleton of diagnostic procedures from medical groups 35 3/22/82 Notice of discontinued beensed operatens 30,40, 6/5/82 8
70 Teletherapy calibrations 35 7/9/82 Control of radiaton to transient workers 19,20 8/20/82 Modification of transportation requirements 71 9/27/82 TN has modi.
fled its regu-lation, but the wording is not i
identical to the NRC's Amendments to industrial radiography regulations 71 3/28/83 Correction to reference to Postal Service regulations 71 W28/83 g@
Testing of radioisotope generators 35 9/2/83 Deletion of GL for source material medicinals 40 9/16/83 Medical misadministration reporting 35 11/10/83 Requirements to implement the Uranium Mill Tellings Act 40 11/17/83 N/A
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Reference to 40 CFR 190 for uranium fuel cycic operatons 20 12/1/83 N/A
)
Deletion of weste burief authornaten 20 1/28/81 Adebon of Tc-99m oxidronate sodium to Group til 35 3 4/84 Desposalof doswnster records 34 3/13/84 Bomescalwaele nde 20 3/31/84 Exemphon for survey metrument calibration sources 30 5/13/84 A& hon of Am-241 to axempbon for i.urvey instrument 30 9/23/84
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cabbrebon sources j
j Radiation protection survey requirement 20 11/30/84 Clartncetson of exempbon for uranium shielding in shipping 40 12/24/84 contamers Adebon of Tc-99m laboied $sofonin to Group til 35 3/26/85 l
Plecement of provisions of Reg Guide 8.15 in regulations 20 4/15/85 Addrtion of Tc-99m isbeled succimer to Group lli 35 6/29/85 Advance notification of transport of waste 71 7/6/85 Change medicalisotope commrttee to radiation safety 35 9/13/85 committee Licensing requirements for land disposal of radioactive 61 1/26/87 weste, and waste classification Transfer for disposal and manrfests 20 12/27/87 Teletherapy room monitors and servicing of source expo-35 3/4/86 l
sure mechanisms Ex:rnption from requirements for use of approved radio-35 3/7/86 pharmaceuticals for unapproved procedures Addition of I-125 sealed source in portable device to 35 6/28/86 Group V1 Expiration and termination of licenses 30,40, 8/15/86 70 Transportation rogs compatib9 sty with LAEA 71 9 4/87 l
irretnevable welllogging source 30,70, 9/28/86 i
150 Ehmination of exemption for glass enamel and glass 40 9/11/87 l
enamelfnt Addition of Tc-99m labeled pharmaceuticals for gastroeso-35 9/10/88 phegealimaging and other clinical procedures Uranium Mill Tailings (proposed) EPA Standards 40, 11/15/88 N/A l
Appendix A,150 Industrial radiography storage surveys and quarterty audits 34 7/16/89 g@
Bankruptcy notification 30.40, 2/11/90 61.70 Exemption for use of aerosols 35 3/24/90 1
Revtion for medicaluse 35 4/1/90 Medical misadministration reporting 6/26/90 Requirements for welllogging 39 7/14/90 11/23/92 NVLAp certification of dosimetry processors; 20 2/12/91 Part 20 8/29/88
C+z, t : - ii 30,40, 7G7/91 70 12/6/87 Greater than Class C 61 606S2 Exempbon-Authonred to use sealed sources in well log-39 7/17/g2 ging Addition of palladiurr>-103 for interstitel treatment of can.
35 10/12/92 cor Emergency Plannmg 30,40, 40/93 70
$/15f92 Use of redopharmaceuti::als for therapy 35 8/23S 3 Safety Requirements for Radographic Equipment 34 1/1044 1/10S4 ASNT certtncebon of radographers 34 4/18 S4 Standards for Protection Against Radiation 20 1/1S4 1 /21/9 4 Notification of incidents 20,30, 10/15S4 31, 39-12/28/96 40,70 Quality Management Program and Misadministrations 35 1G7/95 Has been Adoption i
submrtted Date to Com-Unknown missioner of TDEC Licensing and Radiation Safety Requirements for irretta-36 7/1/96 N/A tors Definiten of Land Disposal and Weste Site QA Program 61 7/22/96 10/28/96 Decommissioning Recordkeeping; Documentation Addi-30,40, 10/25/96 N/A tons 70 Self Guarantee as an Additional Financial Mechanism 30,40, 1/28/97 70 12/6/87 Uranium Mill Taihngs; conforming to EPA Standards 40 7/1/97 N/A Tunelinessin Decommissioning 30,40, 8/15S7 70 Preparation, Transfer for Commercial Distribution, and Use 30,32, 1/1/98 of Byptoduct Material for Medical Use 35 Frequency of Medical Examinations for Use of Respiratory 3/13/98 Protodion Equipment Low-leve! Waste Shipment Manifest information and Re-3/1/98 portmg Performance Requirements for Radiography Equipment 6/30 S8 Radiation Protecbon Requirements; Added Definitions and 8/1448 Criteria Clartf' cation of Decommissioning Funding Requirements 11/24 S8 i
10 CFR Part 71: Compatibility with the intemational Atomic 4/1/99 Energy Agency Medical Administration of Radiation and Radioactive Mate-10/20/98 rials
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I APPENDIX D 4
LICENSE FILE REVIEWS 4
File No: 1 Licensee: Radiosurgical Center of Memphis, L.P.
License #: R-79245 Location: Memphis, TN New, Amendments No.1,2, and 3 License Type: Gamma Knife Reviewer: CWA, MW, CLM Date issued: June 1,1995; December 8,1995 February 21,1996; June 24,1996 1
i Comments:
a)
Clearly identified the ownership, responsible party and relationship with Methodist
)
Hospital and the licensee.
b)
Amendment #2 - exemption from posting of Very High Radiation Area due to patient apprehension.
l File No: 2 l
Licensee: Mallinckrodt Medical, Inc.
License No: R M7002 l
Location: Maryland Heights, MO New License Type: Calibration / Leak Testing Reviewer: CLM Date issued: October 4,1996 I
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File No: 3 i
Licensee: M4 Environmental, L.P.
License No: R-01077 Location: Oak Ridge, TN Amendments No. 6,7,8,9, and 10 Licensee Type: Brokerage Reviewer: MAP Date issued: April 23,1996; June 14,1996 September 13,1996; September 17,1996 l
October 10,1996 File No: 4 Licensee: HNU Systems, Inc.
License No: R-01051 Location: Oak Ridge, TN Termination l
License Type: Possession / Calibration Reviewer: CWA Date issued: September 25,1995 Comment:
a)
This termination involved escalated enforcement action. Sources transferee to HNU MA. HNU in MA has an NRC license but there was no evidence that they have a MA license for the cobalt 57. The State of MA was notified of the situation.
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i Tennessee Proposed Final Report Page D.2 License File Reviews File No: 5 Licensee: HNU Systems, Inc.
License No: R-01055 Location: Oak Ridge, TN Termination i
License Type: Commercial Distribution Reviewer: CWA Date issued: September 25,1995 Comment:
a)
See comment in File No. 4 above.
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i File No: 6 Licensee: Chattanooga Outpatient Center License No: R-33096 Location: Chattanooga, TN Amendments 14,15,16, and 17 License Type: Private Medical - Diagnostic Reviewer: RJP, CLW, CWA, CLW Date 1:: sued: December 8,1994; April 4,1995 December 21,1995; July 31,1996 File No: 7 Licensee: Tennessee Asphalt Company License N' : R-47132 o
Location: Knoxville, TN Renewal License Type: Portable Gauge Reviewer: MW Date issued: May 23,1996 File No: 8 Licensee: Columbia River Park Hospital License No: R-89003 Location: McMinnville, Tn Amendments 14,15,16, and 17 License Type: Medical - Hospital Reviewer: MD, MW, RJP, REW Date issued: May 16,1995; May 1,1996 August 28,1996; September 26,1996 Comment:
a)
Amendment #17 - Waste storage area and sealed source storage area was not identified on licensees new facility diagram.
File No: 9 Licensee: Radiation Oncology Associates, Inc.
License No: R-57027 Location: Jackson, TN Amendments 1, 2, 3, 4, 5, and 6 License Type: Medical - HDR Reviewer: CLM, CWA, RJP, MD, RJP Date issued: July 12,1994; November 14,1994 February 8,1995; April 6,1995 August 16,1995; August 8,1996 I
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Tennessee Proposed Final Report Page D.3 l
License File Reviews File No: 10 Licensee: Carson-Newman College License No: N-45001 Location: Jefferson City, TN Amendments 18 and 19 License Type: Academic Reviewer: REW, RJP Date issued: April 6,1995; October 25,1996 Comment:
a)
It was not clear that the model and serial number of a gas chromatograph that was requested to be removed from the license was the same as that listed on the license.
File No: 11 Licensee: Jackson Utility Division License No: R-57012 l
Location: Jackson, TN Amendments 10,11, and 12 License Type: Portable Gauge Reviewer: RJP Date issued: August 29,1994; April 5,1995 April 2,1996 File No: 12 i
Licensee: Outpatient Diagnostic Center License No: R-19140 Location: Nashville, TN Amendments 39, 40, 41, 42, 43, 44, 45, 46, and 47 License Type: Medical - Private Practice Reviewers: CWA, ROW, MJD, REW Date issued: April 21,1994; August 2,1994 October 13,1994; November 9,1994 March 13,1995; April 7,1995 June 27,1995; July 31,1995 File No: 13 Licensee: Professional Services Insustries, Inc.
License No: R-19014 Location: Nrashville, TN Amendments 40, 41, 42, 43, 44, 45, 46, and 47 License Type: Industrial Radiography Reviewers: CWA, ROW, MJD, RJP Date issued: June 6,1994; November 30,1994 April 10,1995; January 11,1996 l
January 18,1996; February 16,1996 i
April 3,1996; July 17,1996 Comments:
l a)
State amended license la mendment #43 to place equipment that did not meet I
new equipment standards to a " storage only" status.
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l Tennessee Proposed Final Report Page D.4 License File Reviews File N o: 14 Licensee: Vulcan Materials Company License No: R-33114 Location: Chattanooga, Tn Amendments 5,6,7, and 8 License Type: Portable Gauge Reviewer: CLM Date issued: May 27,1994; April 6,1995 April 8,1996; August 27,1996 File No: 15 Licensee: Middle Tennessee State University License No: R-75004 Location: Murfreesboro, TN Renewal License Type: Academic Reviewer: CLM
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Date issued: July 19,1996 Comments:
a) ltem 10 of license states " Storage Only" but does not identify the devices that are in storage.
b)
Licensee made reference in correspondence dated July 9,1996 that they had discovered old radioactive materialin their radiation room, it appears this was not l
followed up on or included on license.
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l File No: 16 Licensee: Syncor International Corp.
License No: R-79174 Location: Memphis, TN Amendments 68, 69, 70, 71, 72, 73, 74, and 75 i
License Type: Radiopharmacy Reviewers: CLM, RJP, MDW l
Date issued: January 3,1996 February 20,1996 l
May 23,1996; June 27,1996 l
July 31,1996: August 21,1996 i
September 5,1996; September 13,1996 i
Comment:
a)
Amendment #75 granted an exemption to regulations granted to allow the preparation and distribution of l-123 mlBG that does not have an IND or NDA.
File No: 17 Li::ensee: Law Engineering License No: R-19123 Location: Nashville, TN Amendments 19, 20, 21, 22, and 23 License Type: Portable Gauge Reviewers: RJP,MJD,CLM Date issued: March 4,1994; April 6,1995 November 17,1995; April 3,1996 September 12,1996 i
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Tennessee Proposed Final Report Page D.5 l
License File Reviews l
l File No: 18 Licensee: Harton Regional Medical Center License No: R-16014 l
Location: Tullahoma, TN Amendments 20, 21, 22, and 23 License Type: Institutional Medical with Radiopharmaceutical
)
l Therapy Reviewers: MJD, REW, RJP Date issued: April 5,1995; March 18,1996 July 2,1996; September 20,1996 File No: 19 Licensee: Manufacturing Sciences Corp.
License No: R-01078 Location: Oak Ridge, TN New License Type: Brokerage Reviewer: REW
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Date issued: December 5,1996 File No: 20 Licensee: Frank W. Hake Associates License No: R-79171 Location: Memphis, TN Renewal License Type: Brokerage / Storage / Decontamination Reviewer: CWA Date issued: September 23,1996 File No: 21 Licensee: Scientific Ecology Group, Inc.
Location: Oak Ridge, TN License No: R-73006 License Type: Storage / Decontamination Amendment No. 49 Date issued: November 22,1996 Reviewer: REW File No: 22 Licensee: Diversified Scientific Services, Inc.
License No: R-73014 Location: Kingston, TN Amendments 32 and 33 License Type: Brokerage Reviewer: CWA j
Date issued: September 12,1996; October 8,1996 l
Tennessee Proposed Final Report Page D.6 License File Reviews File No: 23 Licensee: Physicians Medical Laboratory License No: l-3205 Location: Morristown, TN Termination License Type: In Vitro Clinical Lab.
Reviewer: RJP Termination issued: May 1,1996 i
l Comment:
l a)
Closecut survey was performed by a third party with an instrument that was last calibrated two years prior to the survey. The instrument used was not appropriate for the isotope used at the facility (iodine 125).
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APPENDIX E l
INSPECTION FILE REVIEWS File No.: 1 Licensae: Syncor Int'l Corp., Inc.
License No.: R 47091-C99 l
Location: Knoxville, TN Inspection Type: Unannounced, routine I
License Type: Calibration / Leak Tests Priority: 5 l
Inspection Date: 11/1/95 Inspector: AH File No.: 2 Licensee: Syncor int'l Corp., Inc.
License Type: R-47080-197 l
Location: Knoxville, TN Inspection Type: Unannounced, routine License Type: Pharmacy Priority: 1 l
Inspection Date: 7/2/95 Inspector: AH Comments:
a)
Significant radiation levels in the area of the generator were noted in the inspection report but there was no mention of action taken by the inspector to investigate the levels.
File No.: 3 Licensee: Eastman Chemical Company License No.: R-82038-H98 Location: Kingsport, TN Inspection Type: Announced, routine License Type: Research Priority: 1 Inspection Date: 7/2/96 Inspector: TP File No.: 4 Licensee: Methodist Medical Center l
Of Oak Ridge License No.: R-01029-G97 Location: Oak Ridge, TN Inspection Type: Unannounced, Routine License Type: Hospital Priority: 3 Inspection Date: 7/12-15/96 Inspector: RM File No.: 5 Licensee: Sanders Medical Products, Inc.
License No.: R-47154-DOO Location: Knoxville, TN Inspection Type: Announced, initial License Type: R&D Priority: 4 Inspection Date: 9/27/95 Inspector: CM l
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Tennessee Proposed Final Report Page E.2 Inspection File Reviews File No.: 6 Licensee: Laughlin Memorial Hospital License No.: R-3003-B98 Location: Greeneville, TN Inspection Type: Announced, routine l
License Type: Hospital Priority: 1 inspection Date: 3/9/95 Inspector: DW Comment:
a)
Independent measurements (radiation levels) should be reported as a measured reading rather than a meter reading times the scale factor.
File No.: 7 Licensee: Eye Clinic, Inc.
License No.: R-57010-E98 Location: Jackson, TN Inspection Type: Unannounced, routine License Type: Eye applicator Priority: 4 l
Inspection Date: 3/13/96 Inspector: AG l
File No.: 8 Licensee: Vanderbilt University License No.:
Location: Nashville, TN Inspection Type: Unannounced, routine License Type: Broad, Academic Priority: 1 Inspection Date: 6/11-13/96 Inspector: JL Comment:
a)
The inspection report indicated that security was slack but did not indicate any follow-up action taken by the inspector.
File No.: 9 Licensee: Blount Memorial Hospital License No.: R-05007-D98 Location: Maryville, TN Inspection Type: Unannounced, routine
]
License Type: Pathology Lab Priority: 3 Inspection Date: 10/9/96 inspector: CJ 1
File No.: 10 Licensee: Engineering and Testing Svc.
License No.: R-79200-197 Location: Memphis, TN Inspection Type: Unannounced, routine License Type: Portable Gauge Priority: 4 Inspection Date: 5-8-95 Inspector: GS i
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I Tennessee Proposed Final Report Page E.3 Inspection File Reviews File No.: 11 Licensee: ABB CE Nuclear Power License No.: R-33113 Location: Chattanooga, TN Inspection Type: Unannounced, routine License Type: Decon Service Priority: 1 Inspection Date: 8/28-30/95 Inspector: BS&BS l
File No.: 12 j
Licensee: Rad. Oncology Assoc., Inc.
License No.: R-57927-A99 I
Location: Jackson, TN Inspection Type: Unannounced, routine License Type: HDR Priority: 1 Inspection Date: 7/12/95
!nspector: JH File No.: 13 l
Licensee: Thompson Metal Serv., Inc.
License No.: R-82049 J99 l
Location: Piney Flats, TN Inspection Type: Unannounced, initial License Type: Gauge Priority: 7 1
Inspection Date: 6/22/95 inspecter: CJ File No.: 14 Licensee: IT Corporation License No.: R-01060-J01 Location: Kingston, TN Inspection Type: Unannounced, routine License Type: R&D, Analytic Test Priority: 4 Inspection Date: 3/1-5/96 Inspector: MA Comment:
a)
Licensed activities extend across three categories of licenses with different frequencies. The license should be inspected at the most restrictive frequency.
File No.: 15 Licensee: Rust Env. and Infra.
License No.: NRC-48-18608-02 Location: Sheboygon, WI Inspection Type: Announced License Type: Portable Gauge Priority: Reciprocity inspection Date: 2/23/95 Inspector: CM Comment:
a)
Independent measurements (radiation levels) should be reported as a measured reading rather than a meter reading times the scale factor.
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Tennessee Proposed Final Report Page E.4 i
inspection File Reviews
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l File No.: 16 l
Licensee: Atlanta Testing & Eng.
License No.: Florida 1641-1 Location: Tampa, FL Inspection Type: Unannounced License Type: Portable Gauge Priority: Reciprocity inspection Date: 5/31/96 Inspector: MA l
File No.: 17 Licensee: E.1. Dupont License No.: R-33018-G97 Location: Chattanooga, TN inspection Type: Unannounced, routine License Type: Gauge Priority: 5 inspection Date: 8/14/96 Inspector: BS File No.: 18 Licensee: Univ. of Memphis License No.: R-79219-E00 Location: Memphis, TN inspection Type: Una inounced, routine License Type: Gauge Priority: 4 Inspection Date: 11/21/95 Inspector: GS File No.: 19 Licensee: Testing & Tech., Inc.
License No.: R-47144-K98 Location: Hixson, TN Inspection Type: Unannounced, routine License Type: Radiography Priority: 1 Inspection Date: 5/8/96 Inspector: BS in addition, the following inspection accompaniments were made as part of the on-site IMPEP review:
1 Accompaniment No.: 1 Licensee: Baptist Hospital License No.: R 190-44 Location:, Nashville, TN Inspection Type: Routine, unannounced License Type: Institutional Medical Priority: 3 Inspection Date: October 31,1996 Inspector: JL Accompaniment No.: 2 Licensee: Abercrombe Radiological Consultants License No: R-47094 Location: Knoxville, TN Inspection Type: Routine, Unannounced i
License Type: Private Medical Priority 3 Inspection Date: November 13,1996 inspector: CJ
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l Tennessee Proposed Final Report Page E.5 Inspection File Reviews Accompaniment No.: 3 Licensee: Syncor International Corp.
License No.: R-47080 Location: Knoxville, TN Type inspection: Routine, Unannounced i
License Type: Nuclear Pharmacy Priority 1 Inspection Date: November 14,1996 Inspector: AH l
Accompaniment No.: 4 Licensee: Ft. Sanders Regional Medical Center License No: R-47003 Location: Knoxville, TN Inspection Type: Routine, Unannounced License Type: Institutional Medical Priority: 3 Inspection Date: November 15,1996 Inspector: DN l
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APPENDIX F INCIDENT FILE REVIEWS File No: 1 Licensee: Scientific Ecology Group License No. R-73-008-H94 Site: Oak Ridge Date of Event: 8-8-96 Type of Event: Molten Metal Spill Summary of Incident:
The licensee reported that a furnace located in tho molten metal facility developed a leak and spilled metal onto the facility floor. No excessive personnel exposures occurred, and no contamination was released outside the facility. The fire and leak developed due to a crack in the furnace shell, and the shell was removed from service and sent out for repair on 8-13-96.
File No: 2 Licensee: AmeriSteel Corporation License No: R-57015-K97 Site: Jackson, TN Date of Events: 8-09-96 Type of Event: Potential Overexposure Summary of incident:
The Licensee removed a defective fixed gauge from operation and found that the gauge's j
shutter was stuck in the open position. A contractor secured the device, performed radiation measurements and removed the source for disposal. No excessive exposures occurred.
Comment:
a)
This event was not reported to NRC because the potential exposure was determined l
at the time to not likely exceed Licensee reporting requirements. However, additional follow up is needed to determine if the cause for the incident was generic to the device in that specific environment or caused by other actions.
File No. 3 Licensee: Federal Express (A general license)
License No: N/A Site: Memphis Air Terminal Date of Event: 10-19-95 Type of Event: Misplaced RAM Summary of Incident:
FedEX reported the loss of three packages containing 20 millicuries of Xe-133 at the Memphis facility. The RSO consultant responded and notified the National Response Center and the State. Packages were found and determined to be undamaged.
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l Tennessee Proposed Final Report Page F.2 incident File Reviews File No: 4 Licensee: Frank W. Hake and Associates License No: R-78171 K95 Site: Memphis, TN Date of Event: 5-31-95 l
Type of Event: RAM Shipment exceeded Radiation Limits Summary of incident:
A RAM shipment was received by Alaron Corporation in Wampum, PA that exceeded the i
external radiation limits for transportation of limited quantities shipped by the Licensee. An investigation revealed that a " hot Co-60 particle" had dislodged inside the container and caused the high reading upon receipt at Alaron. The particle was returned to Hake for disposal.
File No: 5 i
Licensee: Science Applications International Corporation (SAIC)
License No: R-01069-F98 Site: Oak Ridge, TN Date of Event: 8-19-94 Type of Event: Loss of Material l
Summary of incident:
l The Licensee reported the theft of a 5 microcurie Cs-137 source and a 3 microcurie Am-241 source. Later the same day, the Licensee reported that the sources were not lost, but had been transferred to a Maryland licensee (Patriot Coal Company) and one to a Kentucky licensee (Riverton Coal Co.).
Comments:
a)
No records were found in the files to verify that sources actually had been transferred to specifically licensed facilities as described by the TN Licensee.
b)
No records were found in the files to indicate that the States of Maryland and 1
Kentucky were notified of the source transfers.
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Tennessee Proposed Final Report Page F.3 incident File Reviews File No: 6 Licensee: Tennessee Department of Transportation (DOT)
License No: R-19017-J96 Site: Gainesboro, TN Date of Event: 8-30-94 Type of Event:. Portable gauge involved in traffic accident Summary of incident:
Licensee reported that a Troxler moisture density gauge had been run over by a passenger vehicle. The State responded and determined that the device source was not leaking and that no excessive exposure had occurred. The source and device were returned to the manufacturer.
File No: 7 Licensee: University of Tennessee License No: R-47005-197 Site: Knoxville, TN Date of Event: 12-19-94 Type of Event: Lost RAM Summary of incident:
The Licensee reported that a package containing 250 microcuries of P-32 had been lost or stolen. Licensee RSO and staff performed a survey but could not find the source.
Comment:
a)
Incident should have been reported to NRC as a significant reporting event (lost RAM as an AO).
File No: 8 Licensee: Jackson-Madison County General Hospital License No: R-57002 C98 Site: Jackson, TN Date of Event: 12-22-94 Type of Event: Contamination from therapy patient i
Summary of Incident:
The Licensee RSO notified the State concerning 1-131 contamination from patient urine during a therapy procedure. RSO provided report describing the clean up actions taken, radiation surveys, and personnel bioassays. No contamination was released outside the licensee's facility and no personnel contamination occurred.
l Tennessee Proposed Final Report Page F.4 incident File Reviews File No: 9 Licensee: Diversified Scientific Services Corp. (DSSI)
License No: R 73014-K98 Site: Kingston, TN l
Date of Event: 12-21-95 Type of Event: RAM shipment with excessive radiation levels Summary of incident:
l The Licensee shipped RAM (2 drums) to the Cooper Nuclear Station in Nebraska that was determined to have radiation levels in excess of DOT limits, and liquid inside the drums.
The Licensee revised their procedures for shipping RAM, and provided the State with a report of the actions taken to prevent a reoccurrence.
File No: 10 Licensee: Baptist Memorial Hospital Medical Center License No: R-79032-F97 Site: Memphis, TN Date of Event: 9-23-94 Type of Event: Diagnostic Misadministration Summary of incident:
The Licensee reported giving a patient 5.1 millicuries of Tc-99m choletec instead of the prescribed 25 millicuries of To-99m HDP. The Licensee revised their hot lab procedures to prevent future incidents of this nature. No patient adverse effects were projected.
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File No: 11 Licensee: Florida Steel Corporation License No: (a non-Licensee)
Site: Jackson, TN Date of Event: 9-20-94 Type of Event: Contaminated Scrap metal Summary of incident:
The scrap metal processor received a shipment of metal from the Culp Iron & Metal facility located in Atella, Alabama. The material was returned to the Alabama f acility. The State issued an exemption for the shipment and coordinated the action with the Alabama Division of Radiation Control.
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i Tennessee Proposed Final Report Page F.5 l
Incident File Reviews l
l File N o: 12 l
Licensee: Federal Express l
Licerise No: (not a specific licensee) l Site: University of Tennessee campus Date of Event: 6-7 96 Type of Event: Transportation event Summary of Incident:
The University of Tennessee RSO notified the State concerning an event where 3 packages l
of P-32 fell from the FedEx truck while making a delivery on the University campus. The University RSO determined that the packages were not damaged, performed radiation surveys and smears, and the packages were allowed to continue to their destination.
Notifications were made to the isotope manufacturer and the FedEx shipper concerning the j
event.
File No: 13 Licensee: David Joseph Co.
License No: (None)
Site: Knoxville facility of Florida Steel Corp.
Date of Event: 6-4 95 Type of Event: RAM detected in scrap metal Summary of incident:
The Scrap Metal facility contacted the State concerning a truck of scrap metal that activated the radiation alarm at the facility. The State investigated and determined that the radiation level was only 10 microrem per hour of an unknown isotope. The material was returned to the scrap dealer located in Kentucky. The State of Kentucky, Radioactive Materials Unit, was notified and helped coordinate the return shipment and source disposition.
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APPENDIX G SEALED SOURCE AND DEVICE EVALUATION REVIEWS i
File No: 1 Registry No.: TN-0241-S-101-S Manufacturcr:
Sanders Medical Products, Inc.
SS&D Type: Calibration source Date of Registration:
July 7,1995 File No: 2 Registry No.: TN-0241-S-102-S Manufacturer:
Sanders Medical Products, Inc.
SS&D Type: Calibration source Date of Registration:
October 18,1996 f
l File No: 3 l
Registry No.: TN-0241-S-103-S l
Manufacturer:
Sanders Medical Products, Inc.
SS&D Type: Calibration source Date of Registration:
October 18,1996 File No: 4 Registry No.: TN-314-S-101-S Manufacturer:
ETRAC Laboratories, Inc.
i SS&D Type: Reference source Date of Registration:
June 13,1996 Comments:
a)
Noted that this source is not required to be evaluated under the NRC Policy &
Guidance Directive 84-22, revision 1, dated June 27,1995; however, the State elected to perform the source evaluation for quality control purposes and in accordance with standard source evaluation procedures..
File No: 5 Registry No.: TN-628-D-200-S Manufacturer: Eastman Chemical Company SS&D Type: Gauging device Date of Registration:
October 26,1995 l
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4
APPENDIX F lNCIDENT FILE REVIEWS File No: 1 Licensee: Scientific Ecology Group License No. R-73-008-H94 Site: Oak Ridge Date of Event: 8-8-96 Type of Event: Molten Metal Spill Summary of incident:
The licensee reported that a furnace located in the molten metal f acility developed a leak and spilled metal onto the f acility floor. No excessive personnel exposures occurred, and no contamination was released outside the facility. The fire and leak developed due to a crack in the furnace shell, and the shell was removed from service and sent out for repair on 8-13-96.
File No: 2 Licensee: AmeriSteel Corporation License No: R-57015-K97 Site: Jackson, TN Date of Events: 8-09-96 Type of Event: Potential Overexposure Summary of incident:
The Licensee removed a defective fixed gauge from operation and found that the gauge's shutter was stuck in the open position. A contractor secured the device, performed radiation measurements and removed the source for disposal. No excessive exposures occurred.
Comment:
a)
This event was not reported to NRC because the potential exposure was determined at the time to not likely exceed Licensee reporting requirements. However, additional follow up is needed to determine if the cause for the incident was generic to the device in that specific environment or caused by other actions.
File No. 3 Licensee: Federal Express (A general license)
License No: N/A Site: Memphis Air Terminal Date of Event: 10-19-95 Type of Event: Misplaced RAM Summary of incident:
FedEX reported the loss of three packages containing 20 millicuries of Xe-133 at the Memphis facility. The RSO consultant responded and notified the National Response Center and the State. Packages were found and determined to be undamaged.
~_. __ _.__..._ _.__._ ___ _. _ _.__..__._.
i Tennessee Proposed Final Report Page F.2 Incident File Reviews i
File No: 4 Licensee: Frank W. Hake and Associates License No: R 78171-K95 Site: Memphis, TN Date of Event: 5-31-95 Type of Event: RAM Shipment exceeded Radiation Limits i
Summary of incident:
A RAM shipment was received by Alaron Corporation in Wampum, PA that exceeded the external radiation limits for transportation of limited quantities shipped by the Licensee. An investigation revealed that a " hot Co-60 particle" had dislodged inside the container and I
caused the high reading upon receipt at Alaron. The particle was returned to Hake for disposal.
File No: 5 Licensee: Science Applications International Corporation (SAIC)
)
License No: R-01069 F98 Site: Oak Ridge, TN Date of Event: 8-19-94 Type of Event: Loss of Material Summary of incident:
The Licensee reported the theft of a 5 microcurie Cs-137 source and a 3 microcurie Am-241 source. Later the same day, the Licensee reported that the sources were not lost, but had been transferred to a Maryland licensee (Patriot Coal Company) and one to a Kentucky licensee (Riverton Coal Co.).
Comments:
a)
No records we're found in the files to verify that sources actually had been transferred to specifically licensed facilities as described by the TN Licensee.
b)
No records were found in the files to indicate that the States of Maryland and Kentucky were notified of the source transfers.
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idgatsxc<. >Ec< is re. :t.st.-s.Te-79i.i
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c,r 30 9:
3 2 :t.:
s,ce MEMORANDUM TENNESSEE DEPARTMENT OF ENVIRONMENT AND CONSERVATION DIVISION OF RADIOLOGICAL HEALTH i
i DATE:
April 10,1997 TO-Jim Myers (NRC, OSP) l FROM: uwLawrence E. Nanney, for Michael H Mobley, Director 4
$UBJECT:
Comments on draft review repon (letter dated March 11,1997) i Thank you for the opponuruty to provide the following specific comments and suggestions for i
revision of the subject document. If we may provide any additional clarification, please feel free to give us a call.
10 t3 L 10 delete "and radon control" 2.0 t1 L. 2 following ".. Environment", add "and Conservation "
3I T2 L5 This four-line description may be somewhat difficult to read, but we bebeve we understand it.
sho' ld read ".after at least two levels of supervisory review."
31 15 L5 u
32 12 L4 incorrect spelling of "Nanney" 3.2 1 11 L. I1 delete "..and reduce the number of staff to 57" 3.4 T3 L2 should read ". and approved in accordance with applicable DRH policy before. "
I 3.5 t2 L1 should read "..to incidents and allegations involvmg beensed materials rests. "
3.5 14 L. 6 The repon states that two events meeting the NRC's definition of "significant", i e., requiring immediate or 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> notification to DRH, were not reponed immediately to NRC, but rather were reponed later during the routine exchange ofinformation.
Notes from the closeout meeting reveal that the reviewer brought only one event to our attention.
specifically, the gauge removal by unauthorized personnel at the Ameristeel (Jackson, TN) facility Our assessment of that event indicated that it did not meet the criteria requiring immediate or 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> reporting Even though unauthorized. that activity was not conducted in a manner which could have caused an overexposure. We do not know to which other event the reviewer refers. Regardless of the above, the issue here is how we define a "significant event" The reviewer interpreted that our definition was as described in this repon, i e., inclusive only of events meeting the Abnormal Occurrence criteria, or those likely to attract media attention That ATTACHMENT 2
TN F43CL.C6 Kid. Ei4.TH Fe. :QS-5?.2-79 >
vpr M '97 p:9 s..i.
Jim Myers April 10,1997
)
is not in fact the case, and Mr. Nanney attempted to explain how we interpret the wording in our Procedure, acknowledging that it might not be perfectly clear as currently written. We would l
propose to eliminate any possible connasion by changmg the wording in our procedure to the following " Events which meet the NRC's Abnormal Occurrence (AO) criteria (copy attached),
other significant events, or those that may attract media attention, should be promptly reported ". It remains our intent, as expressed previously (letter dated April 4,1996, Nanney to larkins), to cooperate to the Adlest extent possible in providing the NRC with the information it wants, in the timeframe which it prefers, in addition to reponing all incident information appropriate for a national database Ifyou accept this proposal, we would suggest that the remaining twelve lines of this paragraph be eliminated, or rewritten to reflect the above agreement 3.5 16 L. 3 The two anomalies referred to here were brought to our attention by the reviewer, but we had no specific knowledge of them at that time. We were asked to look into these and report back, which we did. We do not believe that either of these events involved a l
Tennessee licensee or material licensed in Tennessee This information was communicated by telephone to the reviewer by Mr. Nanney. Perhaps this information reached the reviewer too late l
to allow for deletion of this discussion from the draA report, but we suggest that such would be I
appropriate prior to issuance of the final repon l
l 4.11 1i L4 The reference to " Chapter 23" should be updated to " Chapter 202" to reflect the fa:t that the statutes have been re-codified.
l 4.1.2 11 L1 The reference to TCA sections (applicable to legislation) should be i
replaced by a reference to " Rules of the Department of Environment and Conservation. Chapters 1200 2 4 through 1200 2-12"(applicable to regulations) l 4.1.2 12 e3 L. 4 Here and at four other locations in this section the Division (DRH) l or the Department (TDEC) are referred to by different acronyms than those used in the remainder l
of the report These are either "TRH" or "TDH".
I 4 L2 13 e2 L6 The correct name of the Department is ".. Environment and Conservation" l
l 4.1.2 13
- 3 L. 6 Attached please find the requested rationale relevant to the l
Decommissioning Recordkeeping Documentation rule l
l 4.1.2 15 e7 L. 3 There appears to be a word missing adjacent to " effective" 1
i 2
lti f @3Ct.DiKit. Eit.TH Fe. :M5-5?2-79?.i for 10 '97 15:00 f. 0.1 0
Decommissioning Recordkeeping Documentation of Restricted Areas and Spill Sises As you requested in your review visit, the Tennesen Division of Radiological Health has reviewed its decision not to adopt the " Decommissioning Re.ordkeeping Documentation of Raetricted Areae and spill Sites
- regulatson.
%e decommissioning recordkeeping reguistion identifies records considered important to decommu,*ioning and requires that a licensee keep them unti! the facihty is decommissioned. The I
Division achieves an equivalent result by regulat.iune. license or amendment review actions, beense conditiins, inspectums, investigations and enforcement actions Those legally binding requiremente result in the retention of records and other relevant information, usuntly in the files of both the licensee and the Division An appropriate, the Division uses licenee commitments or license conddions requiring a beenece to outvey oE.eite stress potentially affected by his use of radiosetive material, as well as on site areas both withm and outside of entablished restricted areas Licensees must submit these surveys for Division review. Records of these surveys are required to be kept indefinitely. The only authorized means of disposition of these records is by transfer to the Division.
In fecihties with higher potential for problems with decommissioning, financial assurance requirement 4 give added control of and information about on-site processing and storage areas and puneible oE site consequencea
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l Aaenda for Manaaement Review Board Meetina Fridav, May 2,1997.2:00 o.m., One White Flint North - Rm. 4-86 l
I 1.
Convention. MRB Chair convenes meeting. (HThompson) 2.
Old Business - Approval of the past MRB Minutes. (KSchneider) 3.
New Business - Consideration of Tennessee IMPEP Report.
A.
Introduction of Tennessee IMPEP Team Members. (J. Myers) l B.
Introduction of Tennessee representative and other State representatives participating through telephone bridge. (KSchneider) l l
C.
Findings regarding Tennessee Program. (IMPEP Team)
Status of Inspection Program Technical Staffing / Training Technical Quality of Licensing Technical Quality of Inspections Response to incidents / Allegations l
Legislation and Regulations Sealed Source and Device Evaluation Program i
D.
Questions. (MRB Members) l l
E.
Comments from State of Tennessee. (MMobley)
F.
MRB Consultation / Comments on issuance of Report. (HThompson)
Recommendation for next IMPEP review 4.
Status of Upcoming Reviews. (KSchneider) l l
)
5.
Adjournment. (HThompson) invitees:
Hugh Thompson, MRB Chair, DEDR Karen Cyr, MRB Member, OGC j
Carl Paperiello, MRB Member, NMSS i
Richard Bangart, MRB Member, OSP Denwood Ross, MRB Member, AEOD Ray Paris, Oregon, Agreement State Liaison to MRB Michael Mobley, Tennessee Paul Lohaus, OSP Don Cool, NMSS James Myers, IMPEP Team Leader, OSP William Passetti, IMPEP Member, Florida Cathy Haney, IMPEP Member, NMSS 1
Richard Woodruff, IMPEP Member, Rll Kathleen Schneider, OSP Lance Rakovan, OSP ATTACHMENT 3
.