DATED: MAY 21, 1997 SIGNED BY: HUGH L. THOMPSON, JR.

Mr. Wayne K. Scharber

Deputy Commissioner

Tennessee Department of 

 Environment and Conservation

L & C Tower, 21st Floor

401 Church Street

Nashville, TN 37243-1532

Dear Mr. Scharber:

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. 

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. I look forward

to working with you in the future.

Sincerely, /RA/

Hugh L. Thompson, Jr.

Deputy Executive Director

 for Regulatory Programs

Enclosure:

As stated

cc: Kenneth W. Bunting, Director

Division of Superfund

Michael H. Mobley, Director

Division of Radiological Health

Lawrence E. Nanney, Deputy Director

Division of Radiological Health
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM

REVIEW OF TENNESSEE AGREEMENT STATE PROGRAM

DECEMBER 2-6, 1996

FINAL REPORT

U.S. Nuclear Regulatory Commission
Tennessee Final Report Page 1

1.0 INTRODUCTION

This report presents the results of the review of the Tennessee radiation

control program. The review was conducted during the period December 2-6,

1996, by a review team comprised of technical staff members from the Nuclear

Regulatory Commission (NRC) and the Agreement State of Florida. Team members

are identified in Appendix A. The review was conducted in accordance with the

"Interim Implementation of the Integrated Materials Performance Evaluation

Program Pending Final Commission Approval of the Statement of Principles and

Policy for the Agreement State Program and the Policy Statement on Adequacy

and Compatibility of Agreement State Programs," published in the Federal

Register on October 25, 1995, and the September 12, 1995, NRC Management

Directive 5.6, "Integrated Materials Performance Evaluation Program (IMPEP)." 

Preliminary results of the review, which covered the period 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 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. The DEC Commissioner is appointed by and reports to the

Governor of Tennessee. Within DEC, the radiation control program is

administered by the Division of Radiological Health (DRH). The DRH

organization chart is included as Appendix B. The Tennessee program regulated

563 specific licenses at the time of the review. In addition to the

radioactive materials licenses, the DRH has also issued approximately 4500

registrations for machine-produced radiation which covers about 13,000 X-ray

tubes used within the State. The 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 noncommon indicators was sent to the State on October 15, 1996. Tennessee

provided its response to the questionnaire on November 14, 1996. A copy of

that response is included as Appendix C to this report. 

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

(1) examination of Tennessee's response to the questionnaire, (2) review of

applicable Tennessee statutes and regulations, (3) analysis of quantitative

information from the Division's licensing and inspection data base,

(4) technical review of selected files, (5) field accompaniments of four

Tennessee inspectors, and (6) interviews with staff and management to answer

questions or clarify issues. The team evaluated the information 
Tennessee Final Report Page 2

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 Program

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. 

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 six-month frequency so,

under NRC established frequency, these inspections would not have been

considered overdue. As of the date of the IMPEP review, all five inspections

were scheduled to be completed by March 1997. The State also indicated that
Tennessee Final Report Page 3

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 initial inspection dates for 11 of 32 new licenses that

had been issued between March 1995 and February 1996. Ten of the 11 licensees

were inspected within six-months of license issuance. One new licensee was

inspected at seven months post issuance rather than at six months.

The timeliness of inspection result issuance was evaluated. The results of 19

inspections were reviewed. The typical procedure for issuing the results of

an inspection is: (1) the inspector prepares a letter that is used to

transmit the inspection results; (2) the transmittal letter is typically dated

two weeks after the inspector finalizes the letter; (3) the letter is

forwarded for supervisory review; and (4) the letter is transmitted to the

licensee after at least two levels of supervisory review. The review

indicated that of inspections reviewed, only 10 of the 19 letters transmitting

inspection findings were dated within four weeks of the completion of the

inspection. It was difficult to determine the dates the letters were issued

due to the inspectors dating the letters prior to supervisory review. Twelve

of the 19 inspection letters were issued between 6 to 18 weeks after the

inspection; one inspection letter was dispatched within 4 weeks; and it was

not possible to determine when the other five letters were dispatched. It is

recommended that the State review the process for report issuance with the

goal of increasing the timeliness of inspection report issuance. 

The State reported in its response to the questionnaire that 139 requests for

reciprocity were received between February 4, 1994 and October 29, 1996. The

team was unable to determine how many of these reciprocity requests were

received from the same licensee. DRH performed 33 reciprocity inspections

during the review period. This is a significant increase over the number of

reciprocity inspections that had been performed during previous 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 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

incorporated by reference into MC 2800. It is recommended that the State

review the number of reciprocity inspections it is performing against the

inspection goals established in MC 1220.

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.
Tennessee Final Report Page 4

3.2 Technical Staffing and Training

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 staff, and considered any possible workload

backlogs.

The organization chart shows that DRH has a total of 89 positions. 

Effectively about 50% of the staff works in whole, or in part, on matters

related to Agreement materials. DRH was authorized to fill only 59 positions

at the time of the review. Mr. Michael H. Mobley is the Division Director and

he has a Deputy Director, Mr. Lawrence R. Nanney. The Office of the Director

is supported by an Administrative Services Section (seven personnel) which

provides general office services and accounts receivable support to the

Division. The Technical Services Section (eleven personnel) provides

personnel and environmental monitoring, low-level waste monitoring, standards

development and processing, and emergency preparedness and training support to

the Division. The Enforcement Section includes 24 staff members working out

of four Area Offices. The distribution of the 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 sources and devices (SS&D). A

discussion of SS&D personnel training is covered in Section 4.2.2. Four

individuals are involved in machine and device permitting activities. Two

individuals provide planning, policy and regulatory guidance to the Division. 

The DRH has established qualifications for its technical classifications,

including Health Physicist 1 (HP1) and Health Physicist 3 (HP3). Applicants

at the entry level, HP1, are required to have a baccalaureate degree in a

physical or (appropriate) life science. They are usually assigned basic

responsibilities in the program until sufficient training experience is

obtained. They receive training in health physics, nuclear medicine uses,

materials licensing, inspection procedures for radioactive materials or

radiation producing devices, industrial radiography, well logging, emergency

response, environmental monitoring, low-level radioactive waste management,

and standards/procedures development. Increased training warrants their

assignment to more complex responsibilities. HP1 staff are required to

qualify as HP3 staff after two years employment, one year for an individual 

with an MS in Health Physics, or their employment is terminated. Individuals

with a MS have a shorter qualification time to reach the HP3 level because

they are given constructive credit for their advanced training in Health

Physics. 

The higher technical classifications provide a career progression: from HP3,

one may progress to HP Supervisor 1 or 2; from HP Supervisor 1 or 2, one may

progress to HP Field Office Manager, HP Manager 1, HP Consultant, or HP

Manager 2; from HP Manager 1 or 2, one may progress to HP Manager 3. 
Tennessee Final Report Page 5

DRH has a pragmatic approach to training and qualification. The position

description for new personnel, HP1, includes a description of several courses,

including several "core" courses, which a new employee is expected to

complete. DRH trains individuals on a case-by-case basis factoring in the

individual's basic experience and program needs. An individual training

program is developed to meet these needs. The DRH has an aggressive program

for monitoring and scheduling individual training. DRH uses a data base for

planning, scheduling and monitoring individual training. Because of the

limited access to NRC sponsored "core" courses and other training

opportunities, it may take several years for the person without a Health

Physics background to complete all “core” training requirements. 

The State has attempted to accelerate some individual training by sponsoring

employee attendance at courses such as the five week health physics course. 

The DRH has worked very closely with the Office of State Programs (OSP) to

fill any sudden vacancies in NRC sponsored courses, especially those given in

Chattanooga and Oak Ridge, to maximize their training opportunities.

DRH 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 onthe-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 experienced inspectors during compliance inspections of

complex licenses to gain field experience. 

The inspection staff receives the same basic training as the licensing staff. 

Inspectors are required to demonstrate competence during accompaniments by the

supervisor prior to being given permission to perform inspections

independently. The DRH inspector accompaniment process and the team’s

findings are in Section 3.4. This information was verified through

discussions with managers and staff, review of the questionnaire response, a

review of 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 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 personnel is not believed to be a

problem. The attrition noted in the State's response is considered to be

normal given the size of the program. The DRH, however, is faced with the

problem of filling vacant positions. All State government 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
Tennessee Final Report Page 6

requesting freeze releases for six positions at the time of the review. The

DRH is projecting the loss of two positions from their organization within the

next six months. This will reduce the total number of DRH positions to 87.

In summary, the State has a balanced licensing and inspection program with

approximately equal number of individuals involved in each area. Few

vacancies exist at the senior level. The DRH has developed a strategy for

addressing the long term State-wide hiring freeze and is slowly filling vacant

positions. DRH has 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 concern about the

impact NRC's change in policy for funding Agreement State training will have

on their program. 

DRH is meeting all mission requirements through creative resource management. 

The replacement of personnel losses will increase 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 Licensing Actions

The review team examined completed licenses and casework for 78 license

actions in 23 specific license files, representing the work of five license

reviewers. The license reviewers and supervisor were interviewed when needed

to supply additional information regarding licensing decisions or file

contents. 

The license casework was selected to provide a representative sample of

licensing actions 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, gamma knife, high

dose rate remote afterloader, academic and nuclear pharmacy. Licensing

actions reviewed included 3 new, 3 renewals, 69 amendments, and 3

terminations. Two of the new licenses, one renewal, and two of the

terminations were major licenses. No major license termination involved

decommissioning. The two terminations that were major licenses were

commercial distributors of sealed sources. A list of these licenses with case

specific comments can be found in Appendix D.

Licensing actions were reviewed for completeness, consistency, proper isotopes

and quantities authorized, qualifications of authorized users, adequate

facilities and equipment, and operating and emergency procedures sufficient to

establish the basis for licensing actions. Licenses were reviewed for

accuracy; appropriateness of the license and of its conditions and tie-down

conditions; and overall technical quality. Casework was reviewed for

timeliness; adherence to good health physics practices; reference to

appropriate regulations; documentation of safety evaluation reports; product

certifications or other supporting documents; consideration of enforcement

history on renewals; pre-licensing visits; peer or supervisory review as

indicated; and proper signature authorities. The files were checked for

retention of necessary documents and supporting data.
Tennessee Final Report Page 7

Two exemptions issued were reviewed. One exemption was from the “Very High

Radiation Area” posting requirement on a gamma knife facility door to lessen

patient apprehension and the other was to permit the preparation and

distribution of I-123 MIGB (non-AEA material) which does not yet have an

Investigational New Drug (IND) or New Drug Application (NDA) from the Food and

Drug Administration (FDA). 

 

In general, the review team found that the licensing actions were thorough,

complete, consistent, of acceptable or higher quality, and with health and

safety issues properly addressed. Special license 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. 

 

The review team found that terminated licensing actions were well documented,

showing appropriate transfer records and survey records. A review of the

licensing actions over the review period showed that almost all terminations

were for licensees possessing sealed sources. These files showed that

documentation of proper disposal or transfer was available.

 

The team found that licensees have been notified of the need to file for

reciprocity on sites which are exclusive Federal jurisdiction according to All

Agreement States Letter SP-96-022. All licenses which allow for temporary job

sites have been amended to include a standard condition in accordance with the

All Agreement States Letter SP-96-022. 

Licenses were renewed on a five year frequency. Licensees are tied down to

previously submitted applications, supporting documentation and updated

information. The State is considering extending the renewal period for

certain licensees under specific conditions. The category of licensee and the

specific conditions that would be required for the renewal extension is

currently being studied. Licenses that are under timely renewal are amended

as necessary to assure that public health and safety issues are addressed

during the period that the license is undergoing the renewal process. 

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 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

licensees submit the information necessary to support the license. The

licensing guides were very similar to the NRC guides. 

Based on the IMPEP evaluation criteria, the review team recommends that

Tennessee's performance with respect to the indicator, Technical Quality of

Licensing Actions, be found satisfactory.
Tennessee Final Report Page 8

3.4 Technical Quality of Inspections

The team reviewed the inspection reports and enforcement documentation for 19

inspections conducted during the review period. The casework included a

review of the work of 13 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 inspection cases

reviewed with case-specific comments.

The inspection procedures and techniques utilized by the State were reviewed

and determined to be consistent with the inspection guidance provided in

MC 2800. It was found that the majority of the inspections performed by the

State were unannounced. The inspection reports provided documentation of

inspection findings in a consistent manner. For the most part, the field

offices were consistent in how they were documenting inspections. The

inspection form used by the inspectors provided documentation of the

licensee's radiation safety organization, program scope, facilities,

equipment, radiological safety procedures, personnel monitoring, exposure to

radiation, receipts and disposal records, posting, labeling, independent

measurements, general observations, and violations. The inspection form

allowed inspectors to provide brief, clear, discussions of the inspection and

relevant findings. The reports were sufficiently detailed to support

escalated enforcement actions. The State's enforcement letters were formal in

style, detail and language. 

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 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, and their inspections were adequate to assess

radiological health and safety at the licensed facilities.

In response to the questionnaire, the State reported that 9 out of 13

individuals who are qualified to perform inspections were accompanied by

supervisors during the review period. It was suggested that consideration be

given to conducting accompaniments with the field office supervisors that are

routinely performing inspections. The State's policy is to accompany each

inspector at least once each calendar 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.
Tennessee Final Report Page 9

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 Allegations

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 all incidents, 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 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 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

hours 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
Tennessee Final Report Page 10

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' (CI) 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 confidential

information is maintained in a file which is secured in a locked cabinet, and

this was confirmed by the reviewer. In general, the State's response was

determined by the review team to meet the indicator guidance. However, the

State's procedures do not have specific details on how known allegers or CIs

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 II, were resolved. Although the State reportedly has

experienced no problems with their current CI 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 CI of the actions taken and the results of the State's

investigation. 

Based on the IMPEP evaluation criteria, the review team recommends that

Tennessee's 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 Recovery. Tennessee is not authorized

pursuant to its Agreement with NRC to regulate uranium recovery operations and

the State does not have a low-level radioactive waste disposal site. 

Therefore, only the first two non-common performance indicators were

applicable to this review.

4.1 Legislation and Regulations

4.1.1 Legislative and Legal Authority

Based on previous reviews, the State’s response to the questionnaire, and

discussions with the staff and management, clear statutory authority exists

which designates the 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 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 Regulations

The Tennessee radiation control program’s regulations are found in "Rules of

the Department of Environment and Conservation," Chapters 1200-2-4 through
Tennessee Final Report Page 11

1200-2-12. The questionnaire documented that DRH rules adopted during any

calendar year are subject to the “sunset” 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 all DRH

regulations must be approved by the Legislature’s Government Operations

Committee (GOC). Historically, all regulations approved by the GOC have been

passed by the legislature. The list of regulations provided with the State’s

response to the questionnaire was evaluated to determine the status of the

Tennessee regulations. 

Four NRC regulation amendments became effective since the 1994 review and were

adopted by the State: 

! “Notification of Incidents,” 10 CFR Parts 20, 30, 31, 34, 39, 40,

70 amendments (56 FR 64980) which became effective on October 15,

1991. The State’s rule became effective on December 28, 1996. 

NRC has reviewed this rule and has found it to be compatible with

NRC's regulations. 

! “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. 

! “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 compatibility. Division 2 compatibility allows the Agreement

States flexibility to be more stringent (i.e., the State could choose

not to adopt self-guarantee as a method of financial assurance). 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

reviewed this rule and has found it to be compatible with NRC's

regulations.

The review team identified three regulations that have not been put into

effect in the Tennessee program:

! “Uranium Mill Tailings Regulations: Conforming NRC Requirements to EPA

Standards,” 10 CFR Part 40 amendment (59 FR 36026) that became effective

on July 1, 1994. The State of Tennessee does not have a uranium mill

and this regulation is not required.

! "Quality Management Program and Misadministrations," 10 CFR Part 35

amendment (56 FR 34104) which became effective on January 27, 1992. At

the time of the February 1994 review, it was noted that the State's
Tennessee Final Report Page 12

regulations should be amended to include this requirement. It has not

been adopted. The team confirmed that this regulation has been

submitted twice to the Commissioner, Tennessee Department of Environment

and Conservation. It is presently at the Commissioner’s Office. The

expected date of adoption of the proposed rule cannot be predicted. NRC

is currently deferring compatibility findings for Agreement States that

have not yet adopted a compatible QM rule, pending resolution of the

issue of Agreement State compatibility. 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," 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 or stored. The drawings or records

should include information about normally inaccessible areas such as

buried pipes that may become contaminated. 

Agreement States generally adopt regulations or impose legally binding

requirements 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 in place that exceeds NRC’s

requirement. Additionally, the team could not show that DRH had imposed

a consistent, legally binding requirement equivalent to NRC’s upon its

licensees. Despite the lack of a regulation and the inability to

specifically identify a legally binding equivalent the team did not find

the State’s performance lacking in this area. The review team

recommended that DRH document the rationale supporting their decision

and what legally binding requirements are used in place of an amendment

to the 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

regulations 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,
Tennessee Final Report Page 13

hearing comments and analysis, and the final regulations to be placed on the

Department's internet home page. Draft copies of the proposed regulations are

provided to NRC during the rule development process and the final regulations

are submitted to NRC. 

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 Medical Use," 10 CFR Parts 30, 32 and 35 amendments (59 FR

61767, 59 FR 65243, 60 FR 322) that became effective on January 1, 1995.

! "Frequency of Medical Examinations for Use of Respiratory Protection

Equipment," 10 CFR Part 20 amendments (60 FR 7900) that became effective

on March 13, 1995. This rule is designated as a Division 2 matter of

compatibility. Division 2 compatibility allows the Agreement State the

flexibility to implement more stringent requirements if they so desire.

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

10 CFR Parts 19 and 20 amendments (60 FR 36038) that became effective

August 14, 1995.

! "Clarification of Decommissioning Funding Requirements," 10 CFR Parts

30, 40, and 70 amendments (60 FR 38235) that became effective

November 24, 1995.

! "Compatibility with the International 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 Program

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.
Tennessee Final Report Page 14

4.2.1 Technical Quality of the Product Evaluation Program

The review team reviewed the files of the seven new or revised SS&D registry

sheets issued since the February 1994 review. The SS&D registry sheets issued

by the State and 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 technical quality.

The Tennessee Regulations for Radiation Protection provide a regulatory basis

for the SS&D program. Tennessee regulations 1200-2-10-.10 and 1200-2-10-.13

define the approval criteria and the type of information to be submitted by

the applicant for registration of sources and devices. 

4.2.2 Technical Staffing and Training

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. 

4.2.3 Evaluation of Defects and Incidents Regarding SS&Ds

There have been no reported incidents involving sources or devices approved by

the State.

Based on the IMPEP evaluation criteria, the review team recommends that

Tennessee's performance with respect to the indicator, Sealed Source and

Device Evaluation Program, be found satisfactory.

4.3 Low-Level Radioactive Waste (LLRW) Disposal Program

In 1981, the NRC amended its Policy Statement, "Criteria for Guidance of

States and NRC in Discontinuance of NRC Authority and Assumption Thereof by

States Through Agreement" to allow a State to seek an amendment for the

regulation of LLRW as a separate category. Those States with existing

Agreements prior to 1981 were determined to have continued LLRW disposal

authority without the need of an amendment. Although Tennessee has LLRW 

disposal authority, NRC has not required States to have a program for

licensing a LLRW disposal facility until such time as the State has been

designated as a host state for a LLRW disposal facility. When an Agreement

State has been notified or becomes aware of the need to regulate a LLRW

disposal facility, they are expected to put in place a regulatory program

which will meet the criteria for an adequate and compatible LLRW disposal

program. There are no plans for a LLRW disposal facility in Tennessee. 

Accordingly, the review team did not review this indicator.
Tennessee Final Report Page 15

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 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. 

Below is a summary list of recommendations and suggestions, as mentioned in

earlier sections of the report, for consideration by the State. 

1. The team suggested that the State periodically remind licensees of the

requirement to notify DRH before performing work within the State and

verify that work has not been conducted within the State’s jurisdiction

(Section 3.1).

2. It is recommended that the State review the process for report issuance

with the goal of increasing the timeliness of inspection report issuance

(Section 3.1). 

3. It is recommended that the State review the number of reciprocity

inspections it is performing against the inspection goals established in

MC 1220 (Section 3.1).

4. It was suggested that consideration be given to conducting

accompaniments with the field office supervisors that are routinely

performing inspections (Section 3.4). 

5. The review team 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 CI 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 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).
LIST OF APPENDICES AND ATTACHMENTS

Appendix A IMPEP Review Team Members

Appendix B Tennessee DEC Organization Chart

Appendix C Tennessee's Questionnaire Response

Appendix D License File Reviews

Appendix E Inspection File Reviews

Appendix F Incident File Reviews

Appendix G Sealed Source and Device Evaluation Reviews

Attachment 1 Tennessee's Response to Review Findings
APPENDIX A

IMPEP REVIEW TEAM MEMBERS

Name Area of Responsibility

James Myers, OSP Team Leader

Technical Staffing and Training

Legislation and Regulations 

Richard L. Woodruff, RII 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
APPENDIX B

ORGANIZATIONAL CHARTS
APPENDIX C

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM

QUESTIONNAIRE - RESPONSE