ML20140B419

Forwards Intergrated Materials Performance Evaluation Program Rept on Tennessee Agreement State Program.Response to Recommendations Requested

ML20140B419
Person / Time
Issue date:	05/21/1997
From:	Thompson H NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To:	Scharber W TENNESSEE, STATE OF
References
NUDOCS 9706060206
Download: ML20140B419 (3)

Text

_ _ . . _ _ . . . . _ _ . _ _ _ _ __ _ _ _.

t ., Mr. W:yna K. Sch;rber Deputy Commission:r May 21, 1997 Tenn::ss::a Dep rtmsnt of  ;

Environment and Conservation i L & C Tower, 21st Floor 401 Church Street

, Nashville, TN 37243-1532 1 i

Dear Mr. Scharber l On May 2,1997, the Management Review Board (MRB) met to consider the proposed final Integrated Materials Performance Evaluation Program (IMPEP) report on the Tennessee Agreement State Program. The MRB found the Tennessee program adequate to protect public health and safety and compatible with NRC's program.

l Section 5, page 16, of the enclosed final report presents the IMPEP team's  ;

recommendations. We request your evaluation and respense to those recommendations f within 30 days from receipt of this letter.

Based on the results of the current IMPEP review, the next review will be scheduled in four

i years, unless program concerns develop that require an earlier evaluation. l l  !

I appreciate the courtesy and cooperation extended to the IMPEP team during the review and

, your support of the Radiation Controi Program. I look forward to working with you in the '

) future.

Sincerely, Originai Sig::c;J by Hugh L. Thcmpson .ir.  !

Hugh L. Thompson, Jr. ,

1 Deputy Executive Director  !

j for Regulatory Programs l

Enclosure:

As stated

{ cc: Kenneth W. Bunting, Director bec: Chairman Jackson q Division of Superfund {mmissioner Rogers

Commissioner Dieus i

Michael H. Mobley, Director Commissioner Diaz Division of Radiological Health Commissioner McGaffigan Lawrence E. Nanney, Deputy Director Division of Radiological Health 4 Distribution:

! DlR RF DCD (SP01)

! SDroggitis, OSP PDR (YES_X_ NO )

RWoodruff, Ril CHaney, NMSS CPaperiello, NMSS j RTrojanowski, Rll WPassetti, FL MKnapp, NMSS KSchneider, OSP GDeegan, NMSS KCyr, OGC FCameron, OGC RParis, OR Dross, AEOD t

1 HNewsome, OGC LRakovan, OSP TCombs, OCA  !

Tennessee File DOCUMENT NAME: G:\JHM\96FINTR.TN G:\JHM\TN\TNIMP96. FIN *See Previous Concurrence.

T ec.iv. . copy of thi. oocum.nt, indic.i. in th. box: c - copy witnout ett. chm.nt/ nciosur. E - Copy with ett.chment!.nclosur. *N - No copy j OFFICE OSP lE OSP:DD l OSP:D//1 DEDff y

'NAME JMyers:nb PHLohausl{V) RLBangartMD HThomp!Idk DATE 05/16/97

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l 9706060206 970521 PDR STPRC EEGTN PDR __

. . Mr. W;yn3 K. Schcrber Deputy Commission:r

ltnn:sse] Dep:Mment of l Environment and Conservation L & C Tower, 21st Floor 401 Church Street Nashville, TN 37243-1532 /

Dear Mr. Scharber. j/

On May 2,1997, the Management Review Board (MRB) met to consid,er the proposed final Integrated Materials Performance Evaluation Program (IMPEP) repo,rt'on the Tennessee Agreement State Program. The MRB found the Tennessee program adequate to protect public health and safety and compatible with NRC's program.

Section 5, page 16, of the enclosed final report presents the)MPEP team's recommendations. We request your evaluation and respons'e to those recommendations within 30 days from receipt of this letter. j Based on the results of the current IMPEP review, the 'next review will be scheduled in four years, unless program concerns develop that require'an earlier evaluation.

I appreciate the courtesy and cooperation extend [d to the IMPEP team during the review and your support of the Radiation Control Program / I look forward '.o working with you in the future. /

r

/ Sincerely,

/ Hugh L. Thompson, Jr.

Deputy Executive Director

/

/ for Regulatory Programs

Enclosure:

As stated

/

/

cc: Kenneth W. Bunting / Administrator bec: Chairman Jackson i Land and Radiation Programs Commissioner Rogers  !

/ Commissioner Dicus i Michael H. Mobley, Director Commissioner Diaz Division of Radiological Health Commissioner McGaffigan i

/

Lawrence h. Nanney, Deputy Director Division of Radiological Health i Distribution:

DIR RF DCD (SP01)

SDroggitis, OSP .

PDR (YES._X__ NO )

RWoodruff, Rll t 0M CHaney, NMSS CPaperiello, NMSS

'JHomor,-RIVMh U SIL WPassetti, FL MKnapp, NMSS KSchneider GDeegan, NMSS KCyr, OGC FCameron, OGC -CHackneyrRir Dross, AEOD

~/HNewsome, OGC RParis, OR TCombs, OCA g Tennessee File LRakoyarLOSP/TN DOCOMENT NAME: G:UHM\96FINTR.TN G:UHM\TNIMP96. FIN n ,.c.iv. . copy of ini. oocum.nt. ing. in in. bo : c - copy without .ti. chm.nt>.ncio.ur. s - copy wiin .ti.cnm.ni/.nciosur. n - no copy OFFICE OSP % lE OSP:DD l OSP:D l DEDR l NAME JMyers:nb PHLohaus RLBangart HThompson DATE 05/ W /97 05/ /97 05/ /97 05/ /97 QSP FILE CODE: SP-AG-12

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NUCLEAR REGULATORY COMMISSION WASHINGTON, D.c. 20555 0001

• • • • +4 May 21, 1997 j l

Mr. Wayne K. Scharber )

Deputy Commissioner I Tennessee Department of l

~ Environment and Conservation j L & C Tower, 21st Floor 401 Church Street Nashville, TN 37243-1532 i

Dear Mr. Scharber:

On May 2,1997, the Management Review Board (MRB) met to consider the proposed final j Integrated Materials Performance Evaluation Program (IMPEP) report on the Tennessee Agreement State Program. The MRB found the Tennessee program adequate to protect public health and safety and compatible with NRC's program.

Section 5, page 16, of the enclosed final report presents the IMPEP team's recommendations. We request your evaluation and response to those recommendations within 30 days from receipt of this letter.

Based on the results of the current IMPEP review, the next review will be scheduled in four years, unless program concerns develop that require an earlier evaluation.

I appreciate the courtesy and cooperation extended to the IMPEP team during the review and your support of the Radiation Control Program. Ilook forward to working with you in the future.

Since ly,

1. 7 71  !

H 'h 'L. Thompson, r. j D pu:y Executive irec r  :

o Regulatory Progra

Enclosure:

As stated  !

cc: Kenneth W. Bunting, Director j Division of Superfund l Michael H. Mobley, Director Division of Radiological Health Lawrence E. Nanney, Deputy Director Division of Radiological Health l

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

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l INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM l J

REVIEW OF TENNESSEE AGREEMENT STATE PROGRAM DECEMBER 2-6,1996 l-I i

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FINAL REPORT 1

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! U.S. Nuclear Regulatory Commission i

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Tennessee Final Report Page 1 l

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 i

comprised of technical staff members from the Nuclear Regulatory Commission (NRC) and l the Agreement State of Florida. Team members are identified in Appendix A. The review I was conducted in accordance with the " Interim implementation of the Integrated Materials l Performance Evaluation Program Pending Final Commission Approval of the Statement of l 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.

A draft of this report was issued to Tennessee for factual comment on March 11,1997.

The State of Tennessee responded in a letter dated April 10,1997 (Attachment 1). The j State's comments were incorporated into the final report. The Management Review Board (MRB) met on May 2,1997, to consider the proposed final report. The MRB found the Tennessee radiation control program was adequate' to protect public health and safety and compatible with NRC's program.

The Tennessee Department of Environment and Conservation (DEC) is the agency within Tennessee State government that regulates environmental issues and radiation hazards. j The DEC Commissioner is appointed by and reports to the Governor of Tennessee. Within l DEC, the radiation control program is administered by the Division of Radiological Health j (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 DRH is also responsible for environmental surveillance, emergency planning, and response to emergencies. 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, 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) fielo accompaniments of four Tennessee inspectors, and (6) interviews with staff and management to answer questions or clarify issues. The team evaluated the information

Tennessee Final Report - Page 2  ;

1 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.

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 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 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 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 findings to licensees. This evaluation is based on Tennessee's questionnaire responses to ,

this indicator, data gathered independently from the State's inspection data tracking system, and interviews with managers and staff.

Review of the State's inspection priorities showed that the State's inspection frequencies for 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, waste handlers (prepack and repack), and disposal facilities (burial). NRC inspects these categories of licensees on an annual basis.

L Tennessee Final Report Page 3 ;

In its response to the questionnaire, Tennessee indicated that as of December 6,1996, only ,

five core inspections of licensees located within the state were overdue by more than 25 percent of the State's established inspection frequency. Three of the licensees are inspected on a cix-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 licensees had not performed work in the State and, therefore, the State was unable to perform the inspections. In addition, they indicated that license conditions had been placed on the out-of-State licenses that required the licensees to notify the State when work was scheduled 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 initialinspection 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 dx-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. Twelvo 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 4 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 numb,er of reciprocity inspections that had been performed during previous review cycles. The State's goal is to inspect at least ten percent of the licensees who are 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 1 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

Tennessee Final Report Page 4 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 estab!ished in MC 1220.

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 S'taffino and Trainina Issues central to the evaluation of this indicator include the radioactive materials program staffing level, technical qualifications of the staff, training, and staff turnover. To evaluate these issues, the review team examined the State's questionnaire responses relative to this indicator, interviewed DRH management and st aff, and considered any possible workload backlogs.

The organization chart shows that DRH has a :otal of 89 positions. Effectively about 50% of <

the staff works in whole, or in part, on matters reidied 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 distnbution of the staff is 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) licenses and registers 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 soLrces 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. Twc 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 trair:ing 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

Tennessee Final Report Page 5 i warrants their assignment to more complex responsibilities. HP1 staff are required to qualify l as HP3 staff after two years employment, one year for an individual with an MS in Health l Physics, or their employment is terminated. Individuals with a MS have a shorter qualification time to reach the HP3 level because they are given constructive credit for their advanced-training in Health Physics. j 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. I 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" coursos, 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. l 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 relies heavily on an apprenticeship approach to training its personnel. All new 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 individual is 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 years required in the HP1 class, they achieve the journeyman (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 l experienced inspectors during compliance inspections of complex licenses to gain field I 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

Tennessee Final Report Page 6 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 '

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 i their training and experience.

The DRH reported that ten employees had left the Division since the 1994 review. One ,

individual retired. Seven employees left DRH for promotion, better compensation or to continue their education. Two individuals were removed for cause. Retaining qualified j personnel is not believed to be a problem. The attrition noted in the State's response is l considered to be normal given the size of the program. The DRH, however, is faced with the l problem of filling vacant positions. All State govemment agencies are presently under a hiring freeze instituted in early 1995. Vacated positions cannot be filled. Strong justifications 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 i

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 j equal number of individuals involved in each area. Few vacancies exist at the senior level. l The DRH has developed a strategy for addressing the long term State-wide hiring freeze and l i

is slowly filling vacant positions. DRH has criteria for hiring, training and developing members of the staff to assure a continued high level of performance. DRH management supports development and demonstrated 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.

ORH is meeting all mission requirements through creative resource management. The l teplacement 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 -

1 -

! The review team examined completed licenses and casework for 78 license actions in 23 l specific license files, representing the work of five license reviewers. The license reviewers l and supervisor were interviewed when needed to supply additionalinformation regarding licensing decisions or file contents.

The license casework was selected to provide a representative sample of licensing actions which had been completed in the review period and to include work by all reviewers. The cross sampling included eight of the State's major licenses and included the following types:

source and device manufacturing and distribution, industrial radiography, nuclear medicine, I

l l

l l l Tennessee Final Report Page 7 )

gamma knife, high dose rate remote afterloader, academic and nuclear pharmacy. Licensing i 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 license termination involved decommissioning. The two terminations that were major licenses I were commercial distributors of sealed sources. A list of these licenses with case specific  ;

l comments can be found in Appendix D.

l l J Licensing actions were reviewed for completeness, consistency, proper isotopes and l' quantities authorized, qualifications of authorized users, adequate facilities and equipment, l

and operating and emergency procedures sufficient to establish the basis for licensing l 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  !

tirneliness; adherence to good health physics practices; reference to appropriate regulations;  ;

documentation of safety evaluation reports; product certifications or other supporting i 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 i retention of necessary docurnents and supporting data.  :

l Two exemptions issued were reviewed. One exemption was from the "Very High Radiation i 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) l from the Food and Drug Administration (FDA). I 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  !

addressed. Special 1; cense tie-down conditions were stated clearly, backed by information contained in the file, and inspectable. Two exemptions were reviewed for this review period.

Both of them had valid justifications. The licensee's compliance history was taken into  ;

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 i 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. These files showed that documentation of proper disposal or transfer was available.

t 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.

Alllicenses 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 .

submitted applications, supporting documentation and updated information. The State is  !

considering extending the renewal period for certain licensees under specific conditions. The i 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

i 1

Tennessee Final Report Page 8 necessary to assure that public health and safety issues are addressed during the period that )

the license is undergoing the renewal process. l l

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 concern since the licensing actions which did 3 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 j licensees submit the information necessary to support the license. The licensing guides were i

very similar to the NRC guides.

Based on the IMPEP evaluation criteria, the review team recommends that Tennessee's r

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

l 3.4 Technical Quality of Inspections The team reviewed the inspection reports and enforcement documentation for 19 inspections I

conducted during the review period. The casework included a review of the work of 13 1

' materials inspectors from all field offices. The casework covered a range of license types to include medical, academic, and industrial licensees. Appendix E provides a list of the i inspection cases reviewed with case-specific comments.

4 ,

The inspection procedures and techniques utilized by the State were reviewed and . i determined to be consistent with the inspection guidance provided in MC 2800. It was found I 4

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.

i The inspection form used by the inspectors provided documentation of the licensee's i

radiation safety organization, program scope, facilities, equipment, radiological safety i procedures, personnel monitoring, exposure to radiation, receipts and disposal records, posting, labeling, independent measurements, general observathns, and violations. The inspection form allowed inspectors to provide brief, clear, discussions of the inspection and relevant findings. The reports were sufficiently detailed to support escalated enforcement actions. The State's enforcement letters were formal in style, detail and languaga.

Inspectors sign all routine enforcement correspondence. All of the inspection results and routine enforcement letters were verified as having been reviewed and approved in accordance with applicable DRH policy before issuing the results to licensees.

Four inspector accompaniments were performed by a review team member during the period of October 31 and November 13-15,1996. One inspector was accompanied during the early

a ,

Tennessee Final Report Page 9 morning inspection of a nuclear pharmacy facility, and three other inspectors were accompanied to medical facilities. These accompaniments are also identified in Appendix E.

All of the other fully qualified inspectors have been accompanied during previous reviews 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, arid 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 office supervisors that are routinely performing inspections. The State's policy is to 1 accompany each inspector at least once each calenaar year.

It was noted that the State had a variety of portable instruments for routine confirmatory surveys and for use during incidents and emergency conditions. Instruments were calibrated annually by a consultant or by the instrument manufacturer, Laboratory samples are analyzed by Tennessee's Department of Health, Division of Laboratory Services, Radiochemistry 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 Tennessee's performance with respect to the indicator, Technical Quality of Inspections, be found satisfactory.

3.5 Response to incidents and Alleaations in evaluating the effectiveness of the State's actions in responding to incidents and allegations, the review team examined the State's response to the questionnaire regarding this indicator, reviewed the incidents reported for 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 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 allincidents, complaints, and allegations are evaluated by management, followed up with an inspection if possible, and 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 I

i

Tennessee Final Report Page 10 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 on

line event information at the time of the review. The State has plans for addition of the modem for on-line data input.

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.

The review team found that the State's responses generally were well within the performance l 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 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 event that is an abnormal occurrence or one where media interest is involved. The NRC 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 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 procedures. However, the events were reported to NRC later during the routine exchange of information. The review team suggests 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.

Allegations were responded to promptly with appropriate investigations and follow-up actions.

Concerned individuals' (Cl) identity can be protected under the State's open record law to the extent that investigations can be protected while underway. Program management related that all confidentialinformation 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 procedures do not have specific details on how known allegers or Cls are notified concerning the actions taken by the State in response to the concerns, specifically when the notification is needed and whether the notification should be verbal or in writing. All allegations, which had been referred by Region 11, were resolved. Although the State reportedly has 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 procedures are needed with respect to notification of the Cl of the actions taken and the results of the State's investigation.

i

, ,c Tennessee Final Report Page 11 Based on the IMPEP evaluation criteria, the review team recommends that Tennessee's  !

performance with respect to the indicator, Response to incidents and Allegations, be found '

- satisfactory.

4.0 NON-COMMON PERFORMANCE INDICATORS IMPEP identifies four non-common performance indicators to be used in reviewing .

Agreement State programs: (1) Legislation and Regulations, (2) Sealed Source and Device Evaluation Program, (3) Low-Level Radioactive Waste Disposal Program, and (4) Uranium i Recovery. Tennessee is not authorized pursuant to its Agreement with NRC to regulate 7 uranium recovery operations and the State does not have a low-level radioactive waste i disposal site. Therefore, only the first two non-common performance indicators were applicable to this review. '

4.1 Lecislation and Reculations 4

4.1.1 Lecislative and Leaal Authori.ty 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 Tennessee 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 l

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 no changes that would negatively impact the regulation of agreement materials.

4.1.2 Status and Compatibility of Reculations The Tennessee radiation control program's regulations are found in " Rules of the Department l of Environment and Conservation," Chapters 1200-2-4 through 1200-2-12. The questionnaire I documented that DRH rules adopted during any calendar year are subject to the " sunset" l provisions on June 30 of the following calendar year, unless approved by the State  !

Legislature. Management indicated that the " sunset provision" has not been a problem since l all DRH regulations rnust be approved by the Legislature's Government Operations i 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: l 4

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i Tennessee Final Report Page 12 !

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" 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 l

- it to be compatible with NRC's regulations. l l

=

" Licensing and Radiation Safety Requirements for Irradiators," 10 CFR Part 36 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 time. DRH management has recognized the need to implement legally binding requirements should an application be received.

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" Definition of Land Disposal and Waste Site QA Programs," 10 CFR Part 61 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

( amendments (58 FR 68726 and 59 FR 1618) that became effective on January 28,

1994. Note, this rule is designated as a Division 2 matter of compatibiliiy, 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).

!- If a State chooses not to adopt this regulation, the State's regulation, however, must contain provisions for financial assurance that include at least a subset of those provided in NRC's regulations, e.g., prepayment, surety method (letter of credit or line

of credit), insurance or other guarantee method (e.g., a parent company guarantee).

, it is noted that TRH had a "Self-Guarantee" provision in place since 1987. NRC has l reviewed this rule and has found it to be compatible with NRC's regulations.

I The review team identified three regulations that have not been put into effect in the Tennessee program:

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" Uranium Mill Tailings Regulations: Conforming NRC Requirements to EPA Standards," 10 CFR Part 40 amendment (59 FR 36026) that became effective on 1

July 1,1994. The State of Tennessee does not have a uraniurn mill and this

regulation is not required.

1 i.

- " Quality Management Program and Misadministrations," 10 CFR Part 35 amendment (56 FR 34104) which became effective on 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 i 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.

. ,. l l

I Tennessee Final Report Page 13 1

1 The team 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.

+

" Decommissioning Recordkeeping Documentation of Restricted Areas and Spill Sites," l 10 CFR Parts 30 and 40 (58 FR 39628) that became effective on October 25,1993.

Under this requirement a licensee must maintain records of spills or contamination events in or around their site or facility where they cannot remove radioactive material or may have spread to inaccessible areas. Licensees must maintain as-built drawings and modifications of structures and equipment, or records containing the relevant information, within their restricted areas where radioactive materials are used l

or stored. The drawings or records should include information about normally l inaccessible areas such as buried pipes that may become contaminated. l Agreement States generally adopt regulations or impose legally binding requirements l similar to NRC's to maintain compatibility. DRH management asserted that they did not adopt NRC's rule believing the State has an effective combination of mechanisms i in place that exceeds NRC's requirement. Additionally, the team could not show that l DRH had imposed a consistent, legally binding requirement equivalent to NRC's upon I its licensees. Despite the lack of a regulation and the inability to specifically identify a l legally binding equivalent the team did not find the State's performance lacking in "t, )

area. The review team recommended that DRH document the rationale supporting i their decision and what legally binding requirements are used in place of an amendment to the DRH regulations. Pursuant to the team's request, DRH examined its procedures and practices and submitted an explanation of their position.  ;

Additionally, in the State's response dated April 10,1997 the DRH committed to use legally binding requirements. The review team and the MRB believe that the rationale explains that DRH's license application, application review, inspection, license termination process, environmental monitoring procedures and record retention requirements provide a performance-based equivalent to NRC's requirement. In particular, provisions in other sections of Tennessee's regetations and in license conditions imposed on licensees contain requirements that satisfy the essential objectives of the NRC regulation.

Based on information DRH submitted and further explanation provided by the Division Director at the MRB meeting, a need does not exist for DRH to adopt a requirement similar to NRC's 10 CFR Part 30.35 (g) (1) and (2). The MRB's determination is that the State's procedures give adequate assurance that the intent of NRC's requirement will be met in this area. The review team agrees with the MRB's decision.

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

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Tennessee Final Report Page 14 i

final regulations to be placed on the Department's intemet home page. Draft copies of the j proposed regulations are provided to NRC during the rule development process and the final  ;

regulations are submitted to NRC. I DRH uses a computerized system to follow future regulatory actions. It is the intention of the DRH 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 I Medical Use," 10 CFR Parts 30,32 and 35 amendments (59 FR 61767,59 FR 65243, I 60 FR 322) that became effective on January 1,1995.

" Frequency of Medical Examinations for Use of Respiratory Protection Equipment," 10 CFR Part 20 amendmerits (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 I 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.

" Low-Level Waste Shipment Manifest Information and Reporting," 10 CFR Parts 20 and 61 amendments (60 FR 15649,60 FR 25983) that will become effective March 1, 1998. Agreement States are expected to have an effective rule on the same date.

Based on the IMPEP evaluation criteria, the review team recommends that Tennessee's 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 certificates of registration issued since the February 1994 review, reviewed procedures and guidance, and interviewed the DRH staff and managers responsible for SS&D evaluations.

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Tennessee Final Report Page 15 I 4.2.1 Technical Quality of the Product Evaluation Proaram The review team reviewed the files of the seven new or revised SS&D registry sheets issued l since the February 1994 review. The SS&D registry sheets issued by the State and l 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. l l

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.

l 4.2.2 Technical Staffino and Trainina  !

l 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 years experience in performing safety evaluations and have attended the SS&D workshops 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.

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 concurrence by supervision.

J 4.2.3 Evaluation of Defects and Incidents Recardina SS&Ds 2

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

i 1

Tennessee Final Report Page 16 I

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 found the State's performance with respect to each of the performance indicators to be satisfactory. Accordingly, the team I recommended, and the MRB concurred in finding the Tennessee program to be adequate to

, protect public health and safety and compatible with NRC's program.

I 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 I notify DRH before performing work within the State and verify that work has not been  :

conducted within the State's jurisdiction (Section 3.1). l

2. It is recommended that the State review the process for report issuance with the goal j of increasing the timeliness of inspection report issuance (Section 3.1).

l

3. It is recommended that the State review the number of reciprocity inspections it is j 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 I field office supervisors that are routinely performing inspections (Section 3.4).

5. The review team suggests 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 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. " Quality Management Program and Misadministrations," 10 CFR Part 35 amendment (56 FR 34104) which became effective on January 27,1992. The team recommended that the DRH continue to closely follow the development of NRC's j 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).

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j APPENDIX A IMPEP REVIEW TEAM MEMBERS i Name Area of Responsibility -

James Myers, OSP Team Leader Technical Staffing and Training Legislation and Regulations

]

1 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 1

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i e

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LIST OF APPENDICES AND ATTACHMENTS Apper. dix A iMPEP Review Team Membars I Appendix B Tennessee DEC Organization Chart j Appendix C Tennessee's Questionnaire Response Appendix D License File Reviews l

Appendix E Inspection File Reviews ,

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Appendix F Incident File Reviews

]

Appendix G Sealed Source and Device Eval ation Reviews Attachment 1 Tennessee's Response to Review Findings

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APPENDIX B ORGANIZATIONAL CHARTS 9

I

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TENNESSEE DEPARTMENT OF ENVIRONMENT AND CONSERVATION FunClional Organization .

COMMISSIONER JUSTIN P. WILSON OFFICE OF GENERAL COUNSEL Greer Tkfwet, fr.

INTERNAL AUDIT Director Gay Ouver OFFICE OF PUBlic INFORMATION Director Metissa Meer l

I I I I l ADM. SERVICES ADM. SERVICES COMPLtANCE EMNNT PARKS CONSERVATION Asst. Commisskmer Asst. Commissioner Director Director g,[ _

Deputy Commisshmer Weiter Butler Ome Keger Tom Casery Chuck Amohl pieg sw Wayne K Scherber l i 1 l 1 w--.-e- ----

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tmd Water Pro 9ecten Foster Ewa ng Greer TMvret. Jr' ******

s or, Justin P. WRson arv3 Das Hem

• Ormughtet (515) 532 4131 e Wm thynes ogws - * - * .. (S15) 5324104

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er u.n.ge.nore neer. smci.= cc.w.m __ Director Gay Cever slowaw Finante Smetatt Oraham (615) 532 4512

= ou etycor*d navnes oavis Smas Business Advocate WayRO K. Scharber '

Ernest C. Blankenship DeptAy Commissioner OFFICE OF PtJOLIC I ' " " *" ~

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5 53242 COMPLIANCE ASSISTANCE (61 ) 32 0743 FAX (s15) 5324120 Rd E-mar: vrscharber@ man state tn us (615) 532 6 Enforcement Coordmator Jm Haynes, Kenneth Dunting. Executive Assrstant Ken Pornter Lyn Robertson. Administrators Sany impey (615) 532 4225 (615) 532-0230 POLLtJTION PREVENDON! ENVIRONMENTAL AWARENESS F 1 O I ^ ^

O! VISION OF AIR POLLifTION CONTROL A E E Dueetw John W. Wafton - -

Director.J. Tom Tiester DIVISION OF CONSTRUCTION GRANTS (615) 5324554 AND LOANS (615) 532-0780

~

Director, Ron Graham (615) 532 4445 DIVISION OF GROtMD WATER PROTECTION DtV1stON OF SUPERFUND DIVISION OF SOLID WASTE ASSISTANCE Dwector. Kent Topor - -

Director. Vacant Director. Paul Evan Davis (615) 532 4761 (SIS) 5324900 I

(615) 532 4070 FIELD OFFICE SUPPORT OtVtSION OF WATER SUPPLY DfVISION OF UNDERGROUND Director Dwector. W. David Droughon STORAGE TANKS I

(615) 532 4191 , Director. Chtd Head (615) 532 4 945 OfVISION OF NATURAL HERITAGE

_ Dweetor. Reggie Reeves (615) 53244M OfVISION OF WATER POLLtfT1CN CONTROL DtVistON OF RADIOLOGICAL HEALTH Director Peta E. Davts _ _

Director. Micheet H. Mobley ENVIRONMENTAL POLICY Coordmator. Dodd Galbreath (G15) 532-8545 FLEMING TTIAINING CENTER D! VISION OF D 0 E. OVERSIGHT WEDMASTER Dwector. Drent Opes - - Director. Earl C. L eming

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- _ - - _ _ _ _ _ _ . . _ _ _ _ _ _ _ _ . _ _ _ _ _ , _ __ 1Wv- , , , , _ _

4 g O

APPENDlX C INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM QUESTIONNAIRE - RESPONSE I

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Approved by OMB'  !

No. 3150 0183 i Expires 4/30/98 INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM OUESTIONNAIRE l

I Tennessee Agreement State Program i l Reporting Penod: February 4,1994 to December 6,1996 l l l l

A. COMMON PERFORMANCE INDICATORS 1

\

l. 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, insp. Frequency Licensee Name (Years) Due Date Months O/D 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 Diversified Scientific Services, Inc. 0.5 08/96 3 ATEC Assoc.,Inc. 3.0 10/95 13 Out of State Licensees: 1 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 l

' 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

' 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, i

l l . APPENDIX C i

i 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 questonnaire.

Plaza Radiology inspection planned for 12/96.

• SEG, inelCentral Vol. R' eduction Facility; SEG, Inc./ Incinerator Fac; and 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 frequency.

ATEC Assoc., Inc., inspection planned for 1/97.

l Tenn. Gas Pipeline; Meritus PLS, Inc.; Honeywell, Inc.; Troxier Electronic i

Lab; Diagnostic Technology Cons.; Golder Construction Ser.; Bhate Engineering Corp.; American Egineers, Inc.; Boart Longyear Co.; and Rust Environment are out-of state licensees. Arrangements have been made to alert the Manager of inspection and Enforcement at the next notification of 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 indusrial radi raphy, well-ng or other users with inspection frequencies of t roe years or IR - 49 -

WL/ Tracer - 181 j

b. For those identified in da, how many reciprocity inspections were conducted? l l

33

5. Other than recipt licensees, how many field inspections of radiographers were perio  ?

1

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

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

I s

i w - w - w --- - e p ---

1 a

e

!!. Technical Staffino and Trainino j 7. Please provide a staffing plan, or complete disting using the suggested format below, of the professional (technical) person-years of effort apphed to e, i -

agreement or radioactive material program by individual, include the name, i 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 i

offices, the table shouldbe consolidated to include all personnel contributing to the radioactive materials program. Include all vacances and identify all senior personnel assigned to monitor work of junior personnel. If consultants were used to carry out the program's radioactive materials responsibilities, include l their efforts. The table heading should be:

bl&ME POSITION AREA OF EFFORT TOTAL

! EMER U-

M. Mobley am Dev. Dweetor uc 25.0 cae sue un un.ui mins 10.0 N/A 35.0

t Nanney Dep. Director 40.0 10.0 N/A $0.0

! J. Suthvan* HP Mgr2 40.0 10.0 N/A 50 0

{ J. Lisle HP3 90.0 5.0 N/A l

95 0 J. Groves

• HP Mgr 2 40.0 10.0 N/A 60 0 i C. Amott' HP Mgr 1 90.0 5.0 N/A 95.0

} R. Wynn HP3 14.0 63.0 N/A 67.0 j C. Montgomery HP3 90.0 N/A 90.0

R, Persons HP3 90.0 N/A 90.0 R. Young

• HP SPV2 20.0 6.0 N/A 25.0 i G. Bacon HP3 1.7 N/A 1.7

! M.Page HP3 80.0 10.0 N/A j

20.0 pp 80.0 B. Shrader* HP Supv2 40.0 10.0 N/A 60 0

' D. Shutts* HP Mgr2 10.0 N/A 10.0 R. Crosshn* HP Mgr1 10.0 N/A 10.0 R. Wolford HP3 29.0 N/A 2g 0 M. Hammon* HP Supvi 10.0 N/A 10.0 R. Perry HP3 25.0 10.0 N/A , 35.0 i S. Davis' HP SPV2 40.0 10.0 N/A 60.0 J. Key' HP SPV1 .8 N/A .8 A. Growe' HPFO Mgr 40.0 10.0 N/A 50 0 G. Stevens' HP SPV1 40.0 10.0 N/A 50.0 B. Freemen

• HPFO Mgr 40.0 10.0 N/A 50.0 M. Andrews' HP SPV2 40.0 10.0 N/A 50.0 C. Johnson HP3 40.0 10.0 N/A 60.0 A. Hogan 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.'WNtmit!' HP SPV1 20.0 10.0 N/A 30 0 R. Scheeffer HP3 16.0 N/A 16 0 M. Wotford HP1 2.0 .7 N/A 2.7 J. Potrete HP3 1.3 .7 N/A 2.0 T. Papura MP3 21.0 N/A 21.0

i 4 j  !

s TasalMed posibons 119.4 463.7 575.3 216.4 20.0 1395.2 l *serwar technical stan assigned to monitor work of Junior techniest sten I -

8. Please provide a listin of all new professional personnel hired since the last review, indicate the degee(s) received, if applicable, and addi:ional training and

) years of experience in health ysics, or other disciplines, if appropriate.

• Melissa Wolford - 1/8/95 - TTU, BS, Biology, 94 Licensing until July,96 transfer to Chattanooga Field Office (Compliance)

Tom Papurs - 4/1/96 - State U, NY, BS, Natural Sciences, 89  ;

i Prior experience - TN DOE Oversight Division, Red Monitoring, etc. / NY Radon, )

i Radiation Emergency, etc. l Titus Berry 4/2/96 - TSU, BS, Physics,8/95 Prior experience - U.S. Navy nuclear power student u

John Politte 8/2/95 - Henderson State College, BS, Chemistry / Biology,65 - U.

ARK, MS, Radiological Hestth,67 Prior experience -TVA HP,72 94 Rod Hartwig - 9/1/96 - APSU, BS Chemistry / Math,95 l

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, Chicago Roger Fenner - 11/25/96, MTSU, BS, Science / Physics,82 '

Prior experience - DRH Compliance / Licensing,82-87 / VU Radiation Safety Office, 88 10/96

9. Please list all professional staff who have not yet met the qualification requirements of license reviewer / materials inspection staff (for NRC, inspection Manual Chapters 1245 and 1246; for Agreement States, please describe your qualifications requirements for materials license reviewers and inspectors). For each, list the courses or equivalent training / experience they need to attend and a tentative schedule for completion of these requirements.

Licensing:

License reviewers are trained as junior reviewers under the direct supervision of eithe the Radioactive Materials Licensing Section Manager or the Licensing /

Registration /Plannhg Manager. As soon as possible alllicense reviewers attend the five week basic health ptysics course and the radioactive materials licensing course.

One staff member who was previously a license reviewer now works in the Planning

i i Section assisting the Licensing / Registration /Plannin$Aanager in technical topics an 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 the direct supervision of the Licensing / Registration / Planning Manager to review license-for delivery applications and provide technical research tihe manager on the more complex facility licenses.

Inspection:

Name Needs . Time Expected Approval Ron Hartwig 5-wk HP / insp. Procedures CY 97 Shawn Drake 5-wk HP /Insp. Procedures CY 97 '

Travis Barber More OJT CY 97 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 Mi!ler; Alishia Parks; Janice Harkins; Robert Schaeffer; Keith Henshaw; i

Michele Barrett Taylor; Paul McCoy; Laura Phillips; Roger Van Blarcom; Dean Baker lit. Technical Quality of Licensing Actions

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

New Licentes Manufacturing Sciences Corporation R-01078 Scientific Ecology Group R 7301B Scientific Ecology Group R 73020 M-4 Environmental, L.P. R-01077 IT Corporation R-47152 i

Radiosurgical Center of Memphis, L.P. R 79245

.= .<

l American Technologies, Inc. R-01081 l

l l Amendments Scientific Ecology Group R 73006 Scientific Ecology Group . R-73008 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 I

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 1

FrankW. Hake Associates R-79171 e

i Teminations HNU R-01051

l l

HNU R-01055 Renewals i

Manufacturing Sciences Corporation S-01046 l

l l 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?

o None

13. Discuss any variances in licensing policies and proceduremt exemptions frcrn the regulations granted during the review period.

Exemotions i

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 vences that were granted by the Division from 1994 to 1996.  !

D.9.4 DATE LICENSEE OR REGULATION BRIEF DESCRIPTION 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 Intemational 1200 2 doesn1 require the removal of  ;

Corp. .113(2) individual containers that are 1 R 47080-197 disposed ofin a Sharps container 4

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

1 9/2/94 Syncor intemational- 1200 2 5- doesn1 require the removal of Corp. .113(2) individual containers that are l R-33111-197 disposed ofin a Sharps '

container 9/2/94 Syncor intemational 1200-2 5- doesn1 require the removal of {

Corp. .113(2) individual containers that are  :

R 19149-A98 disposed ofin a Sharps  !

container  !

1 I

1 l

1 1

e i

l l

. l l

l I

it9ft

~

DATE LICENSEE OR REGULATION BRIEF DESCRIPTION {

REGISTRANT l Regional M9 dical 1200-2 10- allows a part;cular doctor to 5/1/95 Center at Memphis .33(3) perform diagnostic and R-79tS9 98 therapy procedures who didn't meet the specified training l requirements l 7/10/95 Saint Francis 1200 2 5.60 management of patients with Hospital Cesium 137 and Radium 226 R-79104-G00 implants in the hospital 9/18/95 Memorial Hospital 1200 2 10- 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 waives the leak test R 33120-J00 .03(2)(a) requirement of sealed sources placed in storage for decay until removalfrom storage and/or ultimate disposal 8

.1Dit DATE LICENSEE OR REGULATION 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 1 3/7/96 Geodax 1200 2 5- doesn't require the removal of 4 Technology, Inc. .113(2) individual containers that are l dba Phoenix disposed ofin a Sharps Nuclear -

container R 47157-C01 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 l 7//25/96 Alpha Nuclear 1200 2 5- doesn1 require the removal of Pharmacy, Inc. .113(2) individual containers that are l R-83013-G01 disposed ofin a Sharps i container 9/13/96 Syncor 1200-2 10- exempt from requirements of Intemational, Inc. .13(10)(b)1 having an IND, NDA, or a R-79174 L96 biologic product license issued by the FDA Variance to Regulations

. Adopted an indemnification certificate for federal agencia that apply for a Tennessee Radioactive Waste License for Delivery.

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

}

1 i

a POLICY Determination of Exclusive Federal Jurisdiction (completed - modified temporary job 1 sites licenses by condition to contain criteria concoming determining exclusive l federaljurisdiction established by NRC) i i Biologic Products with Product License Application (completed - modifed nuclear

medicine (Groups il and lil) and radiopharmacy licenses by condition to recognize

the new FDA approval methodology)

} Definition of Broker as Applied to Tennessee Radioactive Waste License for

Delivery (completed) j j inspection Procedures for Area Offices (ongoing) l Policy for Handling Expired Licenses (ongoing) i l Notice to Pregnant Workers (ongoing) I j

Division Policy Concoming Transfer of Licenses From One Party to Another j (ongoing)

) REGULATORY GUIDES l Radiography Guide (updated) l j Guide for Qualifying as a Radiation Safety Officer for Disposal /Procesag Facilities or ,

Similar Facilities (completed) i l Minimum Qualifications for Radiography RSO (completed)

White Paper on Reindustrialization and Privatization of Former DOE Sites White Pape l (completed)

Decontamination and Decommissioning License Guide (completed)

Medical Guide (ongoing)

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

i

} IV. Technical Quality of Inanections

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

l

None

17. Prepare a table showin thenumber and types of supervisory accompanimert made during the review perioc;. Include

Supervisor insoector License Cat. Dait AEG JEH 03225 03/08/95 '

AEG GAS 03310 10/29/96

JRS AEG 03121 09/05/96

! 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 BHF MVA 11300 9/96

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

Accompaniments now should be made by all supervisory staff. Each supervisor will I attempt to accompany each inspector supervised at least once each calendar year.

Documentation of inspections including supervisory accompaniment 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 calibration. Are allinstruments properfy calibrated at the present time? {

DRH procedure for calibration includes annual calibration of each instrument, under i contract with K & S Associates, Inc., Nashville, except the 12 4 Ludlum neutron detector, which is sent to Ludium for calibration each year.

All gamma detectors are calibrated to a Cs-137 source.

All alpha detectors are calibrated to a Pu 239 set. j When an instrument nears its calibration date, arrangements are made for that 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 calibration time.

4 6

I 1

The following is an updated instrument calibration list.

CAL DATE MANUFACT. M.ODEL SER.# DET. TYPE MODS SER# LOC.

10 3 96 LUDLUM 12-4 44437 BF3 REM NASH.

BALL 9 25 96 LUDLUM 12-S 5808 INTERNAL MEMP Nel 2 19 96 LUDLUM 12 S 6817 INTERNAL NASH.

Nel 6 5 96 LUDLUM 12 S 25107 INTERNAL NASH.

Nat 6 5 96 LUDLUM 12 S 92488 INTERNAL NASH.

Nat 12 12 95 LUDLUM 12 S 92491 INTERNAL KNOX Nel 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 Nel 2 19 96 LUDLUM 12 S 92507 INTERNAL NASH. l Nel l 11 9 95 LUDLUM 14-A 799 END 444 813301 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 8108G ORGANIC KNOX.

SCINTILL. I 6 27 96 BICRON MCR-R 8110G ORGANIC KNOX.

SCINTILL. .

APTEC ODYSSE B404- 2' X 2' NAl 930712 6 NASH.

Y4 10 '

12 27 95 EBERLINE RO 2A 1677 ION MEMP j CHAMBER 8 20 96 EBERLINE RO-2A 1680 ION NASH.

CHAMBER i I

p. ..

6 27 96 EBERLINE RO-2A 1743 ION NASH.

CHAMBER 8 13 96 EBERLINE RO-2A 1770 ION NASH.

j

' CHAMBER 2 21 96 EBERLINE RO 2A 1791 lON KNOX CHAMBER i 10 7 96 EBERLINE RO 2A 1803 ION KNOX CHAMBER 4

6 5 96 T. ASSOC. TBM 3P2 84173 ENER NASH.

{ COMP GM j 8 13 96 LUDLUM 3 1877 END 44 PR26680 MEMP.

WINDOW

. G.M.

10 27 95 LUDLUM 3 2150 END 44 PR03175 CHATT

• l WINDOW *

! G.M.

! 3 18 96 LUDLUM 3 39206 PANCAKE #9 PR24447 NASH l G.M.

2 21 96 LUDLUM 3 39240 END #7 PR33303 NASH.

WINDOW

) G.M.

i 7 10 96 LUDLUM 3 39265 END 44 PR39265 NASH WINDDW G.M.

3 18 96 LUDLUM $ 3809 INTERNAL NASH G.M.

l 8 9 96 LUDLUM 5 3811 INTERNAL NASH.

G.M.

3 6 96 LUDLUM 5 3824 INTERNAL NASH 4

G.M.

! 10 7 96 LUDLUM 6 6221 INTERNAL KNOX 4

G.M.

4 16 96 LUDLUM 12 KIT 18348 PANCAKE #9 PR6046 NASH

G.M.

4 16 96 LUDLUM 12 18348 SIDE HP. KIT 6 NASH i

WINDOW 270 j G.M.

4 16 96 LUDLUM 12 18348 Nel SCINT. 44-2 PR6253 NASH

' 4- 17 96 LUDLUM 12 18348 ZnS 43-2 PR7528 NASH SCINT.

2 24 96 LUDLUM 12 KIT 20040 PANCAKE 44-9 PR6047 CHATT i G.M.

p 2 24 96 LUDLUM 12 20040 SIDE HP. N/A CHATT i

WINDOW 270 G.M.

2 26 96 LUDLUM 12 20040 ZnS 432 PR7531 CHATT

{ SClNT.

2 26 96 LUDLUM 12 20040 Nat SCINT. #2 G1-03175 CHATT

l v* .- 3

! 1

!' I t l t 1

5 13 96 LUDLUM 12 KIT 20096 SIDE HP- KIT 2 NASH NNDOW 270

. G.M.

5 13 96 LUDLUM 12 20096

• PANCAKE 44 9 PR6048 NASH t

G.M.

j 5. 13 96 LUDLUM 12 20096 ZnS 43 2 PR7530 NASH j SCINT.

l 5 13 96 LUDLUM 12 20096 Nel SClNT. 44 2 PR6256 NASH 10 7 96 LUDLUM 12 KIT 21665 SIDE HP- KIT 5 KNOX l WINDOW 270 G.M.

l 10 7 96 LUDLUM 12 21665 Nel SCIN"". #2 PR6255 KNOX

.10 7 96 LUDLUM 12 21665 PANCAKE 44-9 PR6044 KNOX 4

G.M.

10 7 96 LUDLUM 12 21665 ZnS 43-2 PR7527 KNOX l, SCINT.

t 6 5 96 LUDLUM 12 KIT 21688 PANCAKE 44-9 PR6045 MEMP G.M.

6 5 96 LUDLUM 12 21688 SIDE HP- KIT 3 MEMP

! WINDOW 270

G.M.

j 6 5 96 LUDLUM 12 21688 Nel SCINT. 44 2 PR6254 MEMP

j. 6 5 96 LUDLUM 12 21688 Zns 43-2 MEMP PR7526 i

SCINT.

f 2 23 96 LUDLUM 12 KIT 105701 PANCAKE 44 2 PR106665 KNOX G.M.

i 2 24 96 LUDLUM 12 105701 ZnS 43 2 PR085751 KNOX 1 SCINT.

l 2 24 96 LUDLUM 12 105701 SIDE # PR106666 KNOX I l

WINDOW 38 l

} G.M.  ;

j 2 24 96 LUDLUM 12 105701 Nel SCINT. 44-2 PR107144 KNOX l 1 18 96 LUDLUM 12 KIT 165721 SIDE 44- PR106664 NASH j WINDOW 38 l

G.M.  !

1 18 96 LUDLUM 12 105721 ZnS 43 2 PR085752 NASH SCINT.

1 18 96 LUDLUM 12 105721 Nel SCINT. 44-2 PR107148 NASH 1 18 96 LUDLUM 12 105721 PANCAKE 44 9 PR106634 NASH l 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 NASH.

• G.M.

10 30 95 LUDLUM 16 2650 Nel SCINT. 44 2 G-2650 NASH.

• v* ,

• a 1

?

4 l

{ 11 2 95 LUDLUM 16 2650 Zns 43-5 P59 NASH.

• SCINT.

• l

O 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 Nel SCINT. 44-3 G-2651 NASH.

1 19 96 LUDLUM 16 KIT 3006 Nel SCINT. 44 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 $

. SCINT. 8 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 ZLS 43 5 A-3007 KNOX SCiNT. I 6 28 96 LUDLUM 16 3007 Nel SCINT. 44 2 A 3007 KNOX  !

10 8 96 LUDLUM 16 KIT 7319 Na! SCINT. 44 2 P444 MEMP.

10 8 96 LUDLUM 16 7319 ZnS 43-5 P448 MEMP.

SCINT.

10 8 96 LUDLUM 16 7319 PANCAKE 44 9 PR33813 MEMP.

G.M.

10 8 96 LUDLUM 16 7319 END 44-4 7319 MEMP.

WINDOW G.M.

4 18 96 H.P.I. 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 8 13 96 H.P.I. 4083 510 PIN DIODE 4593 chart

' NOTE:

• IN LAST COLUMN INDICATES THESE INSTRUMENTS ARE BEING CALIBRATED

$ IN LAST COLUMN INDICATES THIS INSTRUMENT IS OUT FOR REPA!RS

o. ..

V. Resoonses to incidents and Afloomtions

20. Pieese provide a list of the most sinnificant incidents (i.e., medical

.i misadministration, overexposures, lost and abandoned sources, incidents requiring 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> or less notification, etc.) that occun'ed 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 d

1.NCIDENT i

g Summaries of allincidents have periodically been submitted to NRC.

i 21. During this review period,' did any incidents occur that involved equipment o r i . 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 l

! 22. For incidents involving failure of equipment or sourceswas information on the l Incident provided to the agency responsible for evaluation of the device for an l assessment of possible generic design deficiency? Please provide details for each case.

i i N/A i

j 23. In the period covered by this review, were there any cases involving possible 4

wrongdoing that were reviewed or are presently undergoing review? if so, please desenbe the circumstances for each case.

I

~

None l 24. Identify any changes to your procedures for handlingillegations that occurred i during the period of this review.

! There are no changes to our procedures. ,

)

a. For A poement States, please identify any allegations referred

! to your program by tw NRC that have not been closed.

Complaint regarding public notice relative to Studsvik licensing referred by NRC to State on October 25,1996.

, VI. General -

1 3 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.

i i

e. ..

I l The isst 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 j letter of July 28,1994. Accompanying that letter were three technical i 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 limnsees. As can be determined from our informal mid-cycle review of January 23 26,19g5, and this

! report, TN DRH has increased its reciprocity inspections. A review of the results of i those inspections is now being conducted.

26. Previde a brief description of your program's strengths ad weaknesses. These

strengths and weaknesses should be supported by examples of sucesses, problems or L

difficulties which occurred during this review period.

j 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

! assignments, all Division staff understand our focus is to assurthe adequate protection

! . of the public from radiation. TN DRH also has a core staff group that has significant

[ training and experience in regulatory health physics, and a strong administrative core tfia j

effectivelysupports ouractivity. The senior technical staffis 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 j situations involving non-routine activities, e.g., molten metal spills at SEG, package j 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 radiation!

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 difficult to develop trained staff.

! 8. NON COMMON PERFORMANCE INDICATORS 4

j l. Reoufations and Lenal Authority t

i 27. Please list all currently effective legislation that affects the radiation contro!

program (RCP).

j

' 7ennessee Code Annotated 68-202101 through 68-202 508 arwSS-202 705 through 66 202-70g i

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

] Rules adopted during any calendar year are subject to sunset June 30 of the followin g j

calendar year, unless approval by the legislature. Historically, all regulations approved  ;

i by the (Legislature's) Govemment Operations Committee (GOC) are then approved by  !

j the Legislature by passage of a bill. All DRH regulations must have approval me GOC.

4 j 2g. Please complete the e1 closed table based on NRC chronology of amendments.

1 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.

I l

i c. ..

I l l 4

See last 5 pages of report

{

30. If you have not adopted all amendments within three years frorehe date of NRC 4

rule promulgation, briefly describe your Stpte's procedures for amending regulations in l order to maintain compatibility with the NRC, showing the normal length of time

] anticipated to complete each step.

l 1

Description of procedures not applicable at this time.

4

!!. Sealed Source and Device Pisurem l

31. Prepare a table listing new and revised SS&D registrations of sealed sources ad

devices issued during the review period. The table heading should be

l . SS&D Manufacturer, Type of j Registry Distributor or Device j Number Custom User or Source i SS&D Manufacturer, Type of. I

Registry Distributor of Device {

Number Custom User or source i

! TN-0241-S-101 S Sanders Medical Products Inc. calibration and i transmission source i TN-0241-S 102-S Sanders Medical Products, Inc. calibration source I TN-0241-S-103-S Sanders Medical Products, Inc. calibration source i

i. I

TN-314-S-101 S ETRAC Laboratories, Inc. reference source  !

TN-628 D-200-S Eastman Chemical Company gauging device l TN 799-D-101 S Energy Technologies, Inc. (ETI) gauge l

i TN 1004-D-101-S Bristol-Myers Squibb Company isotope generator j 32. What guides, standards and procedures are used to evaluate registry applications? ,

i The Division makes appropriate use of the guidesstandards, and procedures currentt

! incorporated in the Course Notebook from the Scaled Source and Device Workshop 1 conducted by the NRC on September 1215,1995.

33. Please include information on the following questions in Section A, as they

} spply to the Sealed Source and Device Program:

, Technical Staffing and Training - A.ll.7-10 Technical Quality of Licensing Actions - A.lli.11 A.lli.13-14 i Responses to incidents and Allegations - A.V.20-23 l

. . l I

i .

4 l

i Since the last NRC review, registry evaluations have beerperformed by Charles Arnot j and Chestine " Del!* Montgomery. Mr. Arnott has worked for the Division for seventee j

years and has attended a Sealed Source and Device Workshop. He has provided j

guidance and supervision in this effort for Ms. Montgomery who has worked for the l Division of 3.5 years. There were no reported incidets involving failure of sources or j devices evaluated by the Division. l 1

Or

! 10 CPR Rule 10 CFR Date Date Cunent Expecte l Port (s) Due Adopted Status 8 Adoption i Addhon of en esempt quantNy for Be-133 20,30 9/24/74 @@

f Adaten and modficaten of transport and packaging 20,30, 3/2634 @@

i. precedures 40,70, ,

i

{- 71

! Changes in values of redenuclides of o!! concentrations in 20 11/2n5 @@

j eir and water s

, Requirements for notices, instruction and reports by licon- 19 9/1706 @@

sees to workers, and optens available to workers with re-l Sonitoinspedons

! Change to abbronstens for ' curie" and " microcurie,* and i 20,30, 10f2406 @@ i j addeon of defituten for *milicurie" 32 j

f Authortasion to use C-14 in in v#ro clinice! or laboratory 31,32 1/1077 s  !

i tests l Requirement that supplers must venfy that customers are 30,31, sulhorned to receive the meteriel shipped 40.70, 3/11/77 @@

l

150 l Spacef curie definstens and concentreten values for U 20 7/2977 j

andTh @@

! Adeten of H-3 and Fe-59 to in ydro tests and extension of 31,32, S/1647 s

} MetcalGrouplicensing 35 l Medficaten of requirements for detributen of 31.5 GL 31,32 1/1508 i

donces @@

l Chvthcotion of AEC contractors exempt pursuant to Energy

> R;.irgensaten Act 1/19/75 @@

R$^e.L.. for control of licensed materiet in unre- 20 6/2578 @@

j esisted stees and D9.1in storage Addhon of M25 seeds for interstitief treatment of concer 35 6/2508 8

) O GroupVI

! incorporaten of *As Low As is Reasonably Achevable 20 1/10a9 i (ALARA)* woreno l Modacoton of occupatenel exposure limit for Rr 222 20 1/29n9 @@

j Adamon of Str113/Irw113m generators to Group 111 35 2/23&9 s

! Addbon of Yb-169 DTPA for cistemography to Group II 35 4/10/79 s Requirements for preservations of certain records required 20,31, 6/2#9 8 4 by the regulations 32,35.

40,70, i 150 j

e e

i , ..  ;

I i

1

Personnelmentionng requwements forindustrief radiogre- 34 t/4/79 #

Ph85

! Addiben of 8-125 fibnnogen for detecton of deep vein 35 4/16/19 8

! thromboes to Group 11 5

i Aulhortres use of resprotors Bases intemel exposure 20 12/29/79 @@

f limits onintoke into the body l Esteldehes GL ter depleted uranium products 40 1440 #

} Exempeen for personnel neutron doornsters containing 40 3/740 @@

! versen i Addibon of So-75 to M waro GL 31,32 5/3140 8 5

Addiben of* Mock loshne.-125 onlibraten sources to h vdiru 31,32 8/2740 8 i OL i

i Modellcaten of requirements for individuet physician use of 35 8/1540 #

} redesebve meterolfor human use

} Estends emelf quantity source material GL to Federal, state 40 12/81 #

i and local govemments for operatonal purposes l Addeon of Tc-99m human serum albumin for heeft blood 35 1/16/81 #

poolimagmg to Group 111

{

Addeon of To-99m medronate sodium for bone imaging to 35 2/7/81 8 j Groupill J

l Exempton for spark pop irradiators containing Co-40 30 2/1641 @@

Additenet requirements for controlling eroes in which 20 3/1441 @@

i

. redebon levels in excess of 500 rems /hr exist l Addeon of Tc-99m gluceptete sodium for brain and renal 35 6/16/81 s j perfusenimaging to Group til I Removal or defecing of radioactive meteriellebels on 20 j empty containers 6/23/81 @@

Addeon of Tc-99m human serum microspheres for venog- 35 9/741 #

< rephy to Group til j Requirement to perform survey of patients to con 6rm that 35 12/2841 e i implants have been removed i

j Doisten of diagnostic procedures from rnedice! groups 35 3/2242 #

Notee of descontmuod licensed operatens 30,40, 6/5/82 s 10 l Teletherapy celibretons 35 7/942 3 1

Control of redation to transient workers 19,20 4/2042 @@

4 8

Modeliceben of transportation requwements 71 t/2742 TN has modi-

, hed its regu-toten, but the wording is not j identicalto

f. the NRC's

{s Amendments to industrial radiography regulatons 71 3/2643 8

! Correction to reference to Postaf Service regulations 71 3/2643 @@

! Testing of redoisotope generators 35 9/243 s

! Deleton of GL for source meterief medicinals 40 9/16/83 s Medical misedministration reporting 35 11/1043 #

Requirements to implement the Uranium Mill Tellings Act 40 11/1743 N/A 4

__ ~ __ _. -

. r ..

1

Reference to 40 CFR 190 for urenium fuel cycle opersbons 20 12/1/83 N/A i i Denebon of waste burialauthorsebon 20 1/2841 @@

j Addthon of To-89m oxidronate sodium to Group til 35 3444 #

{ Deposalof dosenster recor.ts 34 3/1344 #

{ Bemodest weste rule 20 3/31/84 #

l Exemphon for sunny instrument celibration sources 30 6/1344

', Addibon of Am-2411o exempton for survey instrument 30 9/2344 onlibtshon sources Radebon protechen survey requwement -

20 11/3044 @@  ;

ciertacebon of exempton for uranium shielding in shipping 40 12/2444 @@ l i **""'8

Addibon of To-89m isbeled theofemn to Group ll1 35 3/26/85 # j Piscoment of provisens of Reg Guide 8.15 in reguletions 20 4/1545 W 1

Addition of To-89m isbeled succimer to Group 111 3f 6/2fv85 #

Advance retf6cebon of transport of waste l

{ 71 7#/85 @@ l l Change medicalisotope comnwttee to rediation safety 35 9/13/85 #

committee Licensing sequwoments for lend disposal of radioactive 1/2647

waste, and waste classt6cetion 61 @@

Transfer for disposaland manifests 20 12/27/87 @@

l Teletherapy room monitors and servicing of source expo- 35 3/4/86 #

sure mectorpsms '

i Exempton from requirements for use of approved radio- 35 3/746 s  ;

pharmaceutcals for unapproved procedures

! Addition of I-125 saaled source in portable device to 35 IV2846 #

} Group VI

Expreten and termmabon oflicenses 30,40, 8/15/86 s l

1 70 4

Transportation regs compatibilrty wtth IAEA 9447 71 @@

Instrievable welllogging source 30,70, 9/2846 8 150 Elimination of exemption for glass enamel and glass 40 9/1147 @@

, enamelfrit Addition of Tc-99m isbeled pharmaceuticals for gestroeso- 35 9/1048 s phegealimaging and other cimical procedures

! Uranium Mill Taihnps (proposed) EPA Standards 40, 11/1548 N/A

, Appendix

. A,150 industrief radiography storage surveys and quartetty audits 34 7/164g gg Bankruptcy notf6cabon 30,40. 2/1140 @@

, . 61,70 ,

i Esempton for use of serosois 35 3/2440 s a

1 Revision for medicat use 35 4/1/90 @@

Medical misadministration reporting 6/26/90

, Requirements for welllogging 3g 7/1440 @@

~

I 11/23/g2 NVLAP certification of dosimetry processors; 20 2/1241 @@

Part 20 8/2948

.S ,,

4 i

! C + z ... - ,,

30,40, j

7/27/91 @@

70 124/87 i

i Greater then Ciess C 61 6/26/92 #

Enea,~e . ^m.r. feed to use sealed sources in welllog. 39 7/17/92 #

Sin 0

, Addthon of patodium 103 for irserstitial treatment of con- 35 10/12/92 #

I cor i Emergency PlanninD 30,40. 4/743 i

70 5/15/92

, Use of redopharmeceubcels for therapy 35 8/23/93 #

l Safety Requwoments for Raf,.e v repNc Equement 34 1/1044 @@

1/1044 4 ASNT certineshon of radiographers 34 4/1844 # i

. Standards for Protection A9ainst Radiation 20 1/144 @@  !

1/2//94 l Notification ofincidents 20,30, 10/1544 @@

31,39-

- 12/28/96 40,70 Quality Management Program and Misadministrations 35 1/27/95 - Has been Adopten submrtted Date to Com- Unknown I

}l missioner i ofTDEC Licensing and Radiation Safety Requirements for Irradia. 36 7/1/96 N/A tors Definiten of Land Disposer and Waste Srte QA Program 61 7/22/96 @@

10/2846 Decommessening Recordkeeping; Documentation Addi- 30,40, 10/25/96 WA tons 70 Self Guarantee as an Addrtonal' Financial Mechanism 30,40, 1/28/97 @@

70 12 4/87 Uranium Min Tailings; conforming to EPA Standants 40 7/1/97 N/A Tameliness h Decommissioning 30.40, 4/15/97 70 '

Preparation. Transfer for Commercial Distribution, and Use 30,32, 1/148 of Byproduct Material for Medice! Use 35 Frequency of Medice! Examinations for Use of Respiratory 3/13/98 Protecten Equipment Low-leve!Weste Shapment Manifest information and Re- 3/1/98 porting Performance Requirements for Radiography Equpment 8/3048 Radiation Protection Requirements; Added Definitions and 8/14/98 Crtieria Clarification of Decommissioning Funding Requirements 11/24/98 10 CFR Part 71: Compatibility with the intemational Atomic 4/1/99 Energy Agency Medical Administration of Radiation and Radioactive Mate- 10/2048 fiels

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

4s . . , i i 1 l l l  :

4 APPENDIX D  :

LICENSE FILE REVIEWS

. File No: 1- f

- Licensee

Radiosurgical Center of Memphis, L.P. License #: R-79245 l j . Location: Memphis,- TN New, Amendments No.1,2, and 3 i 2 License Type: Gamma Knife Reviewer: CWA, MW, CLM l

. Date issued: June 1,1995 December 8,1995 1 February 21,1996; June 24,1996 Comments:

- a) Clearly identified the ownership, responsible party and relationship with Methodist  :

Hospital and the licensee.

i b) Amendment #2 - exemption from posting of Very High Radiation Area due to patient l apprehension. l l  !

File No: 2

. Licensee: Mallinck'rodt Medical, Inc. License No: R-M7002 l Location: Maryland Heights, MO .

New  !

l License Type: Calibration / Leak Testing Reviewer: CLM  !

Date issued: October 4,1996 1 i

i s-File No: 3 Licensee: M4 Environmental, L.P. License No: R-01077 l 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 j September 13,1996: September 17,1996 i

October 10,1996 i

I- -

File No: 4 L Licensee: HNU Systems, Inc. License No: R-01051  !

l Location: Oak Ridge, TN Termination i

License Type

Possession / Calibration Reviewer: CWA l Date issued: September 25,1995

Comment.  ;

4 a) This termination involved escalated enforcement action. Sources transferee to HNU 2 MA. HNU in MA has an NRC license but there was no evidence that they have a ~ l MA license for the cobalt 57. The State of MA was notified of the situation. ,

i i

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! l r i r--- , - -e

4 > .

l Tennessee Final Report Page D.2 License File Reviews File No: 5 i Licensee: HNU Systems, Inc. License No: R-01055  !

Location: Oak Ridge, TN Termination !

License Type: Commercial Distribution Reviewer: CWA I Date issued: September 25,1995 Comment:

a) See comment in File No. 4 above.

1 l

1 File No: 6 I Licensee: Chattanooga Outpatient Center License No: R-33096 I Location: Chattanooga, TN Amendments 14,15,16, and 17 License Type: Private Medical - Diagnostic Reviewer: RJP, CLW, CWA, CLW Date issued: December 8,1994; April 4,1995 l December 21,1995; July 31,1996 I I

File N o: 7 l Licensee: Tennessee Asphalt Company License No: R-47132 l Location: Knoxville, TN Renewal l License Type: Portable Gauge Reviewer: MW  !

Date issued: May 23,1996 l l

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 issuedi 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 l Date issued: July 12,1994; November 14,1994 February 8,1995: April 6,1995 August 16,1995; August 8,1996

4 ,<

t Tennessee Final Report Page D.3 l License File Reviews l File No: 10 Licensee: Carson-Newman College License No: N-45001 Location: ' Jefferson City, TN Amendments 18 and 19 License Type: Academic l Reviewer: REW, RJP l

Date issued: April 6,1995; October 25,1996 1 l

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 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 i File No: 12 Licensee: Outpatient Oiagnostic Center License No: R 19140 Location: Nashville, Ti! Amendments 39, 40, 41, 42, 43, 44, 45, 46, and 47 License Type: Medical - Private Practice Reviewers: CWA, ROW, MJD, REW i Date issued: April 21,1994; August 2,1994 ,

October 13,1994; November 9,1994 l

March 13,1995; April 7,1995 l

June 27,1995; July 31,1995 l

J File No: 13 Licensee: Professional Services Insustries, Inc. License No: R-19014 Location: Nashville, TN Amendments 40, 41, 42, 43, 44, 45, 46, and 47 i License Type: Industrial Radiography Reviewers: CWA, ROW, MJD, RJP )

Date issued: June 6,1994; November 30,1994 '

~

April 10,1995; January 11,1996 January 18,1996; February 16,1996 i April 3,1996; July 17,1996 Comments:

a) State amended license in amendment #43 to place equipment that did not meet new equipment standards to a " storage only" status.

l Tennessee Final Report Page D.4 License File Reviews File No: 14 Licensee: Vulcan Materials Company I.icense 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 i April 8,1996; August 27,1996 l File No: 15 l Licensee: Middle Tennessee State University License No: R-75004 Location: Murfreesboro, TN )

Renewal License Type: Academic Reviewer: CLM j Date issued: July 19,1996 4

Comments:

a) Item 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 followed up on or included on license.

i i

File No: 16 Licensee: Syncor International Corp. License No: R-79174 Location: Memphis, TN Amendments 68, 69, 70, 71, 72, 73, 74, and 75 License Type: Radiopharmacy Reviewers: CLM, RJP, MDW Date issued: January 3,1996; February 20,1996 May 23,1996; June 27,1996 July 31,1996; August 21,1996 September 5,1996; September 13,1996 Comment:

a) Amendment #75 granted an exemption to regulations granted to allow the preparation and distribution of I-123 mlBG that does not have an IND or NDA.

File No: 17 Licensee: 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 l 1

t a

Tennessee Final Report Page D.5 ,

License File Reviews i 1

File No: 18

. Licensee: Harton Regional Medical Center License No: R-16014 Location: Tullahoma, TN Amendments 20, 21, 22, and 23 License Type: Institutional Medical with Radiopharmaceutical Therapy Reviewers: MJD, REW, RJP Date issued: April 5,1995; March 18,1996 July 2,1996; September 20,1996 j i

File No: 19 Licensee: Manufacturing Sciences Corp. License No: R-01078  ;

Location: Oak Ridge, TN New License Type: Brokerage Reviewer: REW Date issued: December 5,1996

'l i File No: 20 Licensee: Frank W. Hake Associates License No: R-79171 Location: Memphis, TN Renewal  !

l License Type: Brokerage / Storage / Decontamination Reviewer: CWA {

)- Date issued: September 23,1996 l

i i File No: 21 Licensee: Scientific Ecology Group, Inc.  :

Location: Oak Ridge, TN License No: R-73006  ;

License Type: Storage / Decontamination Amendment No. 49 i

! Date issued: November 22,1996 Reviewer: REW-i 1

j j File No: 22  !

Licensee: Diversified Scientific Services, Inc. License No: R-73014

, Location: Kingston, TN Amendments 32 and 33 ,

i License Type: Brokerage Reviewer: CWA I

Date issued: September 12,1996; October 8,1996 i

r i

l

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i. 1 4

3-

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

4 . .

l t

t i

Tennessee Final Report Page D.6 l License File Reviews  !

File No: 23 i Licensee: Physi::ians Medical Laboratory License No: 1-3205 i Location: Morristown, TN Termination  !

License Type: In Vitro Clinical Lab. Reviewer: RJP l Termination issued: May 1,1996 '

i r

Comment:

a) Closeout 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).

• h l

I i

i I

i i

t I

I s

I i

1

, i h

! J l

l h

I i

I

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

i 1  !

I

) ,

4 APPENDIX E i INSPECTION FILE REVIEWS  !

I j File No.: 1 i Licensee: Syncor Int'l Corp., Inc.

License No.: R-47091-C99 .

Location: Knoxville, TN Inspection Type: Unannounced, routine

[

l License Type: Calibration / Leak Tests Priority: 5 l/ Inspection Date: 11/1/95 Inspector: AH '

i  !

File No.: 2 i Licensee: Syncor int'i Corp., Inc. License Type: R-47080-197 I Location: Knoxville, TN Inspection Type: Unannounced, routine i l License Type: Pharmacy Priority: 1 l

Inspection Date: 7/2/95 Inspector: AH )

4

!- 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 l levels. .

i i

j File No.: 3 .

l

Licensee: Eastman Chemical Company License No.: R-82038-H98 l I Location: Kingsport, TN . Inspection Type: Announced, routine l l License Type: Research Priority: 1  !

! Inspection Date: 7/2/96 Inspector: TP l t

I File No.: 4 i Licensee: Methodist Medical Center i

! Of Oak Ridge License No.: R-01029-G97  !

, Location: Oak Ridge, TN Inspection Type. Unannounced, Routine License Type: Hospital Priority: 3 t j inspection Date: 7/12-15/96 Inspector: RM

{

i i l File No.: 5 i Licensee: Sanders Medical Products, Inc. License No.: R-47154-DOO I Location: Knoxville, TN Inspection Type: Announced, initial License Type: R&D Priority: 4 Inspection Date: 9/27/95 Inspector: CM

) i I  ;

4 0

_.. _ . - _ - . _ ._-.._ _ _ _.- _ - _ ...._.._ ._ ..-- _ _m- _ _ . _ _ ._ ._.

.4 . . .

j h

i i

Tennessee Final Report Page E.2 I

i inspection File Reviews  !

File No.: 6 }'

Licensee: Laughlin Memorial Hospital License No.: R-3003-B98 i

! Location: Greeneville, TN Inspection Type: Announced, routine '

l License Type: Hospital Priority: 1  ;

Inspection Date: 3/9/95 Inspector: DW l

l Comment-a) Independent measurements (radiation levels) should be reported as a measured '

j reading rather than a meter reading times the scale factor. }

File No.: 7 t 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 i I

File No.: 8 l Licensee: Vanderbilt University License No.. i Location: Nashville, TN Inspection Type: Unannounced, routine [

License Type: Broad, Academic Priority:.1 Inspection Date: 6/11-13/96 Inspector: JL l J

Comment *  !

a) The inspection report indicated that security was slack but did not indicate any  !

follow-up action taken by the inspector.  ;

I i

File No.: 9 l Licensee: Blount Memorial Hospital License No.: R-05007-D98 Location: Maryville, TN Inspection Type: Unannounced, re,utine License Type: Pathology Lab Priority: 3 Inspection Date: 10/9/96 - Inspector: CJ File No.: 10 Licensee: Engineering and Testing Sve. 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

)

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

t Tennessee Final Report Page E.3  ;

inspection File Reviews (

I File No.: 11 l Licensee: ABB CE Nuclear Power License No.: R-33113

• Location: Chattanooga, TN Inspection Type: Unannounced, routine i License Type: Decon Service Priority: 1 i inspection Date: 8/28-30/95 Inspector: BS&BS  !

I File No.: 12 Licensee: Rad. Oncology Assoc., Inc. License No.: R-57927-A99 Location: Jackson, TN Inspection Type: Unannounced, routine j l License Type: HDR Priority: 1  !

! Inspection Date: 7/12/95 Inspector: JH  !

l

' t i

r l File No.: 13 ,

l Licensee: Thompson Metal Serv., Inc. License No.: R-82049-J99  !

Location: Piney Flats, TN Inspection Type: Unannounced, initial l License Type: Gauge Priority: 7 i

inspection Date

6/22/95 Inspector: CJ l

1 File No.: 14 '

Licensee: IT Corporation License No.: R-01060-J01 -

Location: Kingston, TN . Inspection Type: Unannounced, routine i License Type: R&D, Analytic Test Priority: 4 Inspection Date: 3/1-5/96 Inspector: MA l<

l l 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 l Location: Sheboygon, WI Inspection Type: Announced License Type: Portable Gauge Priority: Reciprocity l Inspection Date: 2/23/95 Inspector: CM Comment:

l_ a) Independent measurements (radiation levels) should be reported as a measured l rea.iing rather than a mete reading times the scale factor.

l i

l I

_ _ _ _ . .. _ _ _ . . _ _ _ _ _ _ _ _.._____.__.____._m._ _

i Tennessee Final Report Page E.4  :

Inspection File Reviews ,

[

j File No.: 16 i Licensee: Atlanta Testing & Eng. License No.: Florida 1641-1 4

Location: Tampa, FL Inspection Type: Unannounced  ;

License Type: Portable Gauge Priority: Reciprocity inspection Date: 5/31/96 Inspector: MA t

File No.: 17 Licensee: E.1. Dupont License No.: R-33018-G97 Location: Chattanooga, TN Inspection Type: Unannounced, routine i License Type: Gauge Priority: 5 2

Inspection Date: 8/14/96 Inspector: BS i

File No.: 18 Licensee: Univ. of Memphis License No.: R-79219-E00 Location: Memphis, TN Inspection Type: Unannounced, routine j License Type: Gauge Priority: 4 l Inspection Date: 11/21/95 Inspector: GS 4

File No.: 19 l Licensee: Testing & Tech., Inc. License No.: R-47144-K98 Location: Hixson, TN Inspection Type: Unannounced, routine j License Type: Radiography Priority: 1 l Inspection Date: 5/8/96 Inspector: BS in addition, the following inspection accompaniments were made as part of the on-site IMPEP review:

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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

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Accompaniment No.: 2 '

Licensee: Abercrombe Radiological Consultants License No: R-47094

Location: Knoxville, TN Inspection Type: Routine, Unannounced I i License Type: Private Medical Priority 3 l Inspection Date: November 13,1996 Inspector: CJ

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i Tennessee Final Report Page E.5 l inspection File Reviews

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l Accompaniment No.: 3 Licensee: Syncor International Corp. License No.: R-47080 i Location: Knoxville, TN Type inspection: Routine, Unannounced l License Type: Nuclear Pharmacy Priority 1 I Inspection Date: November 14,1996 Inspector: AH )

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1 Accompaniment No.: 4 l Licensee: Ft. Sanders Regional Medical Center License No: R-47003 J Location: Knoxville, TN Inspection Type: Routine, Unannounced 1 License Type: Institutional Medical Priority: 3 Inspection Date: November 15,1996 Inspector: DN .

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I APPENDIX F

, INCIDENT FILE REVIEWS File No: 1 5

Licensee: Scientific Ecology Group j License No. R-73-008-H94 Site: Oak Ridge Date of Event: 8-8-96

Type of Event: Molten Metal Spill l

Summary of incident:

I The licensee reported that a furnace located in the 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 i crack in the furnace shell, and the shell was removed from service and sent out for repair

. on 8-13-96.

i 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 4 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 j to the device in that specific environment or caused by other actions. j i

File No. 3 Licensee: Federal Express (A general license) i License No: N/A  ;

Site: Memphis Air Terminal ,

Date of Event: 10-19 95 Type of Event: Misplaced RAM l l

Summary of incident- l FedEX reported the loss of three packages containing 20 millicuries of Xe-133 at the j Memphis facility. The RSO consultant responded and notified the National Response  !

Center and the State. Packages were found and determined to be undamaged. l l

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Tennessee 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 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 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 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 net 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 founri 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 l Kentucky were notified of the source transfers.

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Tennessee Final Report Page F.3 1 Incident File Reviews J 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 l manufacturer.

File No: 7 Licensee: University of Tennessee License No: R-47005-197 l Site: Knoxville, TN l Date of Event: 12-19-94 Type of Event: Lost RAM -

Summary of Incident:

l The Licensee reported that a package containing 250 microcuries of P-32 had been lost or j stolen. Licensee RSO and staff performed a survey but could not find the source, j 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 i Type of Event: Contamination from therapy patient i Summary of incident:

The Licensee RSO notified +he 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.

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Tennessee Final Report Page F.4 l Incident File Reviews I

File No: 9 Licensee: Diversified Scientific Services Corp. (DSSI)

License No: R-73014-K98 Site: Kingston, TN Date of Event: 12-21-95 Type of Event: RAM shipment with excessive radiation levels l

Summary of incident:

The Licensee shipped RAM (2 drums) to the Cooper Nuclear Station in Nebraska that was l ' 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 l

Summary of incident: j l 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 I prevent future incidents of this nature No patient adverse effects were projected.

l File No: 11 Licensee: Florida Steel Corporation License No: (a non-Licensee)

Site: Jackson, TN Date of Event: 9-20-94 l 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 facility. The State i issued an exemption for the shipment and coordinated the action with the Alabama i Division of Radiation Control. ,

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Tennessee Final Report Page F.5 Incident File Reviews File No: ~ 12 Licensee: Federal Express License No: (not a specific licensee)

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 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 event.

i Filo No: 13 Licensee: David Joseph Co.

License No: (None)

Site: Knoxville facility of Florida Steel Corp.

Date of Event: 6-4-95 l Type of Event: RAM detected in scrap metal l

Summary of incident:

! The Scrap Metal facility contacted the State concerning a truck of scrap metal that l 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 ,d source

' disposition.

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APPENDIX G s

SEALED SOURCE AND DEVICE EVALUATION REVIEWS i

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File No: 1  ;

. Registry No.: TN-0241-S-101-S i j Manufacturer: Sanders Medical Products, Inc.

[ SS&D Type: Calibration source j Date of Registration: July 7,1995 '

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File No: 2

• l 4 Registry No.: TN-0241-S-102-S  !

Manufacturer: Sanders Medical Products, Inc. '!

SS&D Type: Calibration source i Date of Registration: October 18,1996 i

j . File No: 3 l 3

Registry No.: TN-0241-S-103-S j Manufacturer: Sanders Medical Products, Inc. l

} SS&D Type: Calibration source I

.Date of Registration: October 18,1996 j

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i File No: 4  !

Registry No.: TN-314-S-101-S Manufacturer: ETRAC Laboratories, Inc. l SS&D Type: Reference source {

I Date of Registration: June 13,1996 '

l- Comments:

a) Noted that this source is not required to be evaluated under the NRC Poliuy &

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 j accordance with standard source evaluation procedures..

i File No: 5  ;

Registry No.: TN-628-D-200-S I Manufacturer: Eastman Chemical Company {

SS&D Type: Gauging device  !

!- Date of Registration: October 26,1995 I i

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Tennessee Final Report Page G.2 Sealed Source and Device Reviews File No: 6 Registry No.: TN-799-D-101-S Manufacturer: Energy Technologies, Inc. (ETI)

SS&D Type: Gauge Date of Registration: October 5,1994 File No: 7 Registry No.: TN-1004-D-101-S Manufacturer: Bristol-Myers Squibb Company SS&D Type: Isotope generator Date of Registration: February 6,1996 l

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l TN F@ICLC61Cid. FEft.TH Fe. :615-5?.2-MT.i Apr JO *K 1.1 :Li F.02 MEMORANDUM l l'

TENNESSEE DEPARTMENT OF ENVIRONMENT AND CONSERVATION DIVISION OF RADIOLOGICAL HEALTH

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DATE: April 10.1997 TO: Tun Myers (NRC, OSP)

FROM: Lawrence E. Nanney, for Michael H Mobley, Director

SUBJECT:

Comments on draA review repon (letter dated March 11,1997)

Thank you for the opportunity to provide the following specific comments and suggestions for

' revision of the subject document. If we may provide any additional clarification, please feel free to give us a call. -

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1.0 13 L lo delete"and radon control" l 2.0 11 L. 2 following " .. Environment", add "and Conservation "

l 3.1 12 L5 This four line description may be somewhat difficuh to read, but we believe l we understand it.

31 15 L. 5 sho'uld read ". .aRer at least two levels of supenisory review."

l 3.2 12 L4 incorrect spelling of "Nanney" 3.2 1 11 L.11 delete " ..and reduce the number of staff to 57".

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. 3.4 53 L2 should read " ..and approved in accordance with applicable DRH policy before . "

3.5 12 L. I should read "...to incidents and allegations involving beensed materials rests .."

3.5 14 L. 6 The repon states that two events meeting the NRC's definition of "signi6 cant", 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 closcout meeting reveal that the reviewer brousht 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 dit 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 /> reponing. Even though unauthorized. that activity was not conducted in a snanner 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 medis attention That ATTACHMENT 1

IN Fi('lCR.C6 Kit Eid.TH FO :(45-!32-79?' (pr 10 '97 11:!9 F . 0?.

! TunMyers L . April 10,1997 .i '

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is not in fact the case, and,Mr. Nanney attempted to explain how we interpret the wording in our j

procedure, acknowledging that it might not be perfectly clear as currently written. We would propose to climinate any possible confbaion by changing the wording in our procedure tc the

{ '-L' i,: *Tvents which meet the NRC's Abnormal Occurrence (AO) criteria (copy setached),

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other significant evema, or those that may attract media attention, should be promptly  !

reponed.. ". k remains our intent, as expressed previously (letter dated April 4,1996, Nanney to i 1.arkins), to cooperste to the Adleat ament possible in providing the NRC with the information it  !

j- wanta, in the timefranw which it prefers, in addition to reporting all incident information j .

appropriate for a national database Ifyou accept this proposal, we would suggest that the ,

i remaining twelve lines of this paragraph be eliminated, or rewrmen to reflect the above l 1 agreement 1

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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 i these and repon back, which we did. We do not believe that either of these events involved a i Tennessee licensee or material licensed in Tennessee. This information was communicated by j telephone to the reviewer by Mr. Nanney. Perhaps this information reached the reviewer ioo late to allow for deletion of this discussion from the draA repon, but we suggest that such would be appropriate prior to issuance of the final repon l

4.11 11 L4 The reference to -Chapter 23" should be updated to " Chapter 202" to j reflect the fact that the statutes have been re-codified. 4 i i 4.1.2 11 L1 The reference to TCA sections (applicable to legislation) should be 1

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' replaced by a reference to " Rules of the Department ofEnvironment and Conservation. Chapters J 1200 2 4 through 1200 212"(applicable to regulations).

4.1.2 12 e3 L. 4 Here and at four other locations in this section the Division (DRH)

{ or the Depanment (TDEC) are referred to by different acronyms than those used in the remainder j- of the repon These are either "TRH" or "TDH".

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} 41.2'13 e2 L6 The correct name of the Depanment is "... Environment and Conservation

1 4.1.2 13 *3 L. 6 Attached please And the requested rationale relevant to the Decommissioning Recordkeeping Documentation rule, 1-

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l 4.1.2 15 *7 L. 3 There appears to be a word missing adjacent to

• effective".

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