August 6, 2008 

Mr. Paul Sloan 

Deputy Commissioner 

Bureau of Environment 

Tennessee Department of Environment 

 and Conservation 

401 Church Street 

First Floor, L & C Tower 

Nashville, TN 37243-0435 

Dear Mr. Sloan: 

On July 15, 2008, 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 Agreement State Program 

adequate, but needs improvement, to protect public health and safety and compatible with the 

U.S. Nuclear Regulatory Commission=s program. 

Section 5.0, page 18, of the enclosed final report contains a summary of the IMPEP review 

team=s findings and recommendations. We request your evaluation and response to the 

recommendations within 30 days from receipt of this letter. 

Based on the results of the current IMPEP review, the next full review of the Tennessee 

Agreement State Program will take place in approximately 4 years, with a periodic meeting 

tentatively scheduled for April 2010. 

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

I also wish to acknowledge your continued support for the Agreement State Program. I look 

forward to our agencies continuing to work cooperatively in the future. 

Sincerely, 

 

/RA/ 

Martin J. Virgilio 

Deputy Executive Director for Materials, Waste, 

Research, State, Tribal, and Compliance Programs 

Office of the Executive Director for Operations 

Enclosure: 

Tennessee Final IMPEP Report 

cc w/encl.: Lawrence E. Nanney, Director 

 Tennessee Division of 

 Radiological Health 

 John Parker, New Mexico 

 Organization of Agreement States 

 Liaison to the MRB 
August 6, 2008 

Mr. Paul Sloan 

Deputy Commissioner 

Bureau of Environment 

Tennessee Department of Environment 

 and Conservation 

401 Church Street 

First Floor, L & C Tower 

Nashville, TN 37243-0435 

Dear Mr. Sloan: 

On July 15, 2008, 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 Agreement State Program adequate, 

but needs improvement, to protect public health and safety and compatible with the U.S. Nuclear 

Regulatory Commission=s program. 

Section 5.0, page 18, of the enclosed final report contains a summary of the IMPEP review 

team=s findings and recommendations. We request your evaluation and response to the 

recommendations within 30 days from receipt of this letter. 

Based on the results of the current IMPEP review, the next full review of the Tennessee 

Agreement State Program will take place in approximately 4 years, with a periodic meeting 

tentatively scheduled for April 2010. 

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

I also wish to acknowledge your continued support for the Agreement State Program. I look 

forward to our agencies continuing to work cooperatively in the future. 

Sincerely, 

 /RA/ 

 

Martin J. Virgilio 

Deputy Executive Director for Materials, Waste, 

Research, State, Tribal, and Compliance Programs 

Office of the Executive Director for Operations 

Enclosure: 

Tennessee Final IMPEP Report 

cc w/encl.: Lawrence E. Nanney, Director 

 Tennessee Division of 

 Radiological Health 

 John Parker, New Mexico 

 Organization of Agreement States 

 Liaison to the MRB 

Distribution: EDATS: FSME-2008-0030

See next page. 

 ML082040245 

OFFICE FSME/DMSSA FSME/DMSSA FSME/DMSSA Tech Editor 

NAME KLukes:km ADWhite RJLewis CPoland 

DATE 07/22/08 07/23/08 07/23/08 07/24/08 

OFFICE FSME DEDMRT 

NAME CLMiller (GP for) MJVirgilio 

DATE 07/29/08 08/06/08 

 OFFICIAL RECORD COPY
LETTER TO PAUL SLOAN FROM MARTIN J. VIRGILIO DATED:

Distribution: EDATS : FSME-2008-0030 

DMSSA RF DCD (SP01) 

EDO RF 

RidsEdoMailCenter 

RidsFsmeOd 

RidsSecyCorrespondenceMailCenter Chairman Klein 

AMcCraw, FSME/DMSSA Commissioner Jaczko 

RBlanton, FSME/DMSSA Commissioner Lyons 

DJanda, RI/RSAO Commissioner Svinicki 

JPalotay, NSIR SECY 

BParker, RI 

RBrowder, RIV 

Karl Von Ahn, OH 

KSchneider, FSME/DMSSA 

MOrendi, FSME/DMSSA 

SCampbell, OEDO 

BJones, OGC 

SReynolds, RIII 

JGray, OGC 

RLewis, FSME 

APowell, OCA (2 copies) 
Enclosure 

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM 

REVIEW OF THE TENNESSEE AGREEMENT STATE PROGRAM 

April 21-25, 2008 

FINAL REPORT
Tennessee Final Report Page 1 

1.0 INTRODUCTION 

This report presents the results of the review of the Tennessee Agreement State Program. The 

review was conducted during the period of April 21-25, 2008, by a review team comprised of 

technical staff members from the U.S. Nuclear Regulatory Commission (NRC) and the State of 

Ohio. Team members are identified in Appendix A. The review was conducted in accordance 

with the “Implementation of the Integrated Materials Performance Evaluation Program and 

Rescission of Final General Statement of Policy,” published in the Federal Register on 

October 16, 1997, and the February 26, 2004, NRC Management Directive 5.6, “Integrated 

Materials Performance Evaluation Program (IMPEP).” Preliminary results of the review, which 

covered the period of February 27, 2004, to April 25, 2008, were discussed with Tennessee 

managers on the last day of the review. 

A draft of this report was issued to Tennessee for factual comment on May 29, 2008. The State 

responded by letter on June 25, 2008, from Lawrence E. Nanney, Director, Division of 

Radiological Health (the Division). A copy of the State’s response is included as an attachment 

to this report. The Management Review Board (MRB) met on July 15, 2008, to consider the 

proposed final report. The MRB found the Tennessee Agreement State Program to be 

adequate, but needs improvement, to protect public health and safety and compatible with 

NRC’s program. 

The Tennessee Agreement State Program is administered by the Division. The Division is 

located in the Bureau of Environment, which is in the Department of Environment and 

Conservation (the Department). The Division Director reports to the Senior Director of Air 

Programs, who reports to the Deputy Commissioner for Environment, who in turn reports to the 

Commissioner of the Department. Organization charts for the Department and the Division are 

included as Appendix B. 

At the time of the review, the Tennessee program regulated 591 specific licenses. The review 

focused on the 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 

performance indicators was sent to the Division on January 22, 2008. The Division provided a 

response to the questionnaire on April 8, 2008, and an updated response to the questionnaire 

on April 18, 2008. Copies of the questionnaire responses can be found in the NRC’s 

Agencywide Document Access and Management System using the Accession Number 

ML081490544. 

The review team's general approach for conduct of this review consisted of: (1) examination of 

the Division’s response to the questionnaire; (2) review of applicable Tennessee statutes and 

regulations; (3) analysis of quantitative information from the Division’s database; (4) technical 

review of selected regulatory actions; (5) field accompaniments of five of the Division’s 

inspectors; and (6) interviews with staff and managers to answer questions or clarify issues. 

The review team evaluated the information gathered against the established criteria for each 

common and applicable non-common performance indicator and made a preliminary 

assessment of the Agreement State program’s performance. 
Tennessee Final Report Page 2 

Section 2.0 of this report covers the State’s actions in response to recommendations made 

during the previous review. Results of the current review for the common performance 

indicators are presented in Section 3.0. Section 4.0 details the results of the review of the 

applicable non-common performance indicators, and Section 5.0 summarizes the review team's 

findings and recommendations. Recommendations made by the review team are comments 

that relate directly to program performance by the State. A response is requested from the State 

to all recommendations in the final report. 

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS 

During the previous IMPEP review, which concluded on February 26, 2004, the team made three 

recommendations in regard to program performance that were transmitted to Ms. Karen 

Stachowski, Deputy Commissioner for Environment, on June 9, 2004. The current status of the 

recommendations is as follows: 

1. The review team recommends that the Division promptly adopt the current version 

10 CFR 20.2003. (Section 4.1.2 of the 2004 IMPEP review report) 

Current Status: The Division adopted a rule equivalent to 10 CFR Part 20.2003 that 

became effective July 7, 2006. The Division submitted the rule to the NRC for a 

compatibility review on July 27, 2006. On September 1, 2006, the NRC responded 

without comment. This recommendation is closed. 

2. The review team recommends that the Division acquire or provide a mechanism for staff 

to have access to expertise commensurate with the complexity of SS&D casework. 

(Section 4.2.2 of the 2004 IMPEP review report) 

Current Status: The Division adopted a procedure for accessing expertise as outlined in 

a letter to the NRC dated July 14, 2004. During the review period, the Division generally 

resolved questions about sealed source and device (SS&D) reviews internally. The 

Division utilized the procedure to acquire technical assistance from the NRC concerning 

a device evaluation in 2004. This recommendation is closed. 

3. The review team recommends that the Division prepare registration certificates 

consistent with the current version of NUREG-1556, Volume 3. (Section 4.2.2 of the 

2004 IMPEP review report) 

Current Status: The Division incorporated changes in its preparation of registration 

certificates such that they are consistent with the format and style of NUREG-1556, 

Volume 3, “Consolidated Guidance About Materials Licenses – Applications for Sealed 

Source and Device Evaluation and Registration.” This recommendation is closed; 

however, a new related recommendation is opened in Section 4.2.2 of this report. 

In addition to the above, the 2004 review team made one recommendation to the NRC. 

Consistent with current practice, NRC’s Office of Federal and State Materials and Environmental 

Management Programs (FSME) will track and address this recommendation separately from this 

report. 
Tennessee Final Report Page 3 

3.0 COMMON PERFORMANCE INDICATORS 

IMPEP identifies five common performance indicators to be used in reviewing NRC Regional 

and Agreement State radioactive materials programs. These indicators are: (1) Technical 

Staffing and Training, (2) Status of Materials Inspection Program, (3) Technical Quality of 

Inspections, (4) Technical Quality of Licensing Actions, and (5) Technical Quality of Incident and 

Allegation Activities. 

3.1 Technical Staffing and Training

Issues central to the evaluation of this indicator include the Division’s staffing level and staff 

turnover, as well as the technical qualifications and training histories of the staff. To evaluate 

these issues, the review team examined the Division’s questionnaire responses relative to this 

indicator, organizational chart and staffing plan, interviewed Division management and staff, 

reviewed job descriptions, the training policy, and training records. The review team also 

considered any possible workload backlogs in evaluating this indicator. 

The Division is comprised of Office of the Director and four Sections: the Administrative 

Services Section, the Inspection and Enforcement Section, the Licensing/Registration/Policy

Section, and the Technical Services Section. The Office of the Director, the Administrative 

Services Section, the Licensing/Registration/Policy Section and the Technical Services Section 

are located at the Central Office in Nashville. Inspection, enforcement and incident response 

activities are conducted primarily through four field offices located in Nashville, Chattanooga, 

Memphis, and Knoxville. Inspection and enforcement activities are coordinated by the 

Inspection and Enforcement Section Manager, located at the Knoxville Field Office. 

At the time of the review, there were 38 individuals with various degrees of involvement in the 

radioactive materials program, totaling 20.4 full time equivalents (FTE). This staffing level does 

include administration; however, excludes clerical support. The review team noted that 

inspection and licensing staff may also be involved with x-ray or other regulatory activities. At 

the time of the review, the Division had five vacancies. The vacancies included two staff 

positions at the Central Office, one staff position at the Nashville Field Office, one supervisory 

position at the Memphis Field Office, and one supervisory position at the Knoxville Field Office. 

The five vacancies account for an additional 1.95 FTE, bringing the full staffing total to 

approximately 22.4 FTE for radioactive materials activities. 

The five vacant positions are currently frozen. At the time of the review, the Division was 

preparing to petition the Department to fill one position at the Central Office. A portion of the 

FTE for this position would be allotted to compatibility activities. The Division was not seeking to 

fill the remaining four frozen positions which include three slots for inspectors at the Field Offices 

and one staff position at the Central Office. The review team discussed with Division 

management the prospect of filling currently vacant positions. 

During the review period, 11 staff members left the Division and 11 staff members were hired. 

At the time of the review, two staff members had been with the Division for less than 1 year, and 

a total of eight had been with the Division for 2 years or less. An additional four individuals were 

hired and then left the Division within the review period. Although these individuals were 

primarily assigned to x-ray duties, Division managers stated that the loss of these individuals 
Tennessee Final Report Page 4 

affected the materials program because personnel performing materials-related duties are used 

to balance the workload. The Division’s turnover can be primarily attributed to competition with 

local industry and other agencies for qualified staff. Low starting salary and limited opportunities 

for advancement appear to be contributing factors to the turnover, according to Division 

managers. 

The high turnover rate has been a historic problem within the Department. Division managers 

are concerned that the current economic situation may result in additional staff losses. The 

review team determined that the staff turnover and unfilled positions likely contributed to 

weaknesses observed in the inspection program and the adoption of regulations, as discussed 

later in this report. An insufficient number of staff members who were formerly approved to 

perform specific tasks by the Department in the areas of inspection and regulatory review 

appears to be the root cause for late inspections and the untimely adoption of regulations 

needed for compatibility. Increased security and emergency response activities have been 

putting additional strain on the Division’s available resources. The review team discussed the 

high turnover rate with Division staff and managers, as well as potential solutions such as 

employee recruitment and retention incentives. 

Subsequent to the review, the Division Director informed the NRC of the direct impact to the 

Division resulting from a Statewide initiative to reduce operating costs. The initiative calls for a 

Statewide reduction of 2,000 filled positions, primarily by means of voluntary buyouts, to be 

followed by a reduction in force, if necessary, to meet that goal. For the Division, the goal is to 

eliminate four currently filled positions; however, the five currently frozen vacant positions have 

not been affected by the Statewide initiative. At the time of the review, the review team 

determined that the Division's staffing level was adequate to achieve the Division's mission of 

protecting public health, safety, and security; however, in light of these staffing cuts and potential 

additional staff losses, the Division's performance with respect to inspections, licensing actions, 

and response to incidents and allegations could be adversely impacted. The review team 

recommends that the State evaluate the Division's projected staffing level and take appropriate 

action to ensure that the Division has adequate resources to achieve its primary objective of 

protecting public health, safety, and security. 

The Division has a written training program that is consistent with the guidance in the 

NRC/Organization of Agreement States Training Working Group Recommendations for 

Agreement State Training Programs, dated 1997; however, the training program was put in 

place in July 2001 and has not been revised or reviewed since. The review team found that the 

training program does not specify minimum training and qualification requirements. The review 

team also found that qualification practices and documentation are not consistent throughout the 

Division. The review team looked at 14 staff training files, including managers and staff from the 

Central Office and the Field Offices. Training and qualification information was either missing or 

incomplete in most files. The review team found that some files from the Knoxville Field Office 

were complete, with detailed notes and other documentation demonstrating training, and 

included a qualification journal, which indicates what types of licenses the inspector is qualified 

to perform. The review team observed that this documentation is not part of the training 

program; therefore, it is not used in the other offices. The review team determined that the 

Division’s written training program does not meet the current needs of the Division. The review 

team recommends that the State develop a method to document clearly that an inspector or 
Tennessee Final Report Page 5 

license reviewer is qualified or approved to perform inspections or licensing actions of the 

different license types upon completion of specified training. 

Discussion with Division managers and staff revealed that no specific training was defined for 

license reviewers except the courses listed in Appendix B of the training program and on-the-job 

training of reviewing progressively more complex licenses with the approval of more senior 

license reviewers. Staff stated that some courses which could contribute to the training of 

license reviewers and inspectors were not listed on the Appendix B form. The review team 

noted that the training program does not include the radioactive material security training course. 

The review team recommends that the State review the training policy to ensure that it meets 

current and future needs of the staff and revise the policy, as appropriate, to include on-the-job 

training and security training. 

Overall, the staff is well qualified from an education and experience standpoint. All new staff 

members have at least a Bachelor’s degree in a science. Experienced technical staff members 

have taken the NRC courses or equivalent; however, as discussed above, the documentation 

was not complete in all cases. Division managers indicated that training of staff is no longer the 

challenge it had been in previous years due to the State more readily approving out-of-State 

travel and the NRC’s revised policy on funding Agreement State training. On-the-job training 

has also been used to supplement formal course work so that individuals may broaden their 

work experience. The Division Director supports staff training opportunities, as well as 

participation in Federal and State working groups. 

Division management indicated that approximately 90 percent of the Division’s funding is 

dedicated revenue from licensee and x-ray registrant fees with the balance from appropriated 

funds. In 2001, the Division increased fees to materials licensees by approximately 50 percent. 

Fees have not been increased since that time. 

Tennessee does not have a radiation oversight board. 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that Tennessee’s performance with respect to the indicator, Technical Staffing and Training, was 

satisfactory, but needs improvement. 

3.2 Status of Materials Inspection Program

The review team focused on five factors while reviewing this indicator: inspection frequency, 

overdue inspections, initial inspections of new licenses, timely dispatch of inspection findings to 

licensees, and performance of reciprocity inspections. The review team’s evaluation was based 

on the Division’s questionnaire response relative to this indicator, data gathered from the 

Division’s database, examination of completed inspection casework, and interviews with 

managers and staff. 

The review team verified that the Division’s inspection priorities for various license types were at 

least as frequent as similar license types listed in NRC’s Inspection Manual Chapter (IMC) 2800, 

“Materials Inspection Program.” The Division does not extend or compress inspection 

frequencies based on compliance history. 
Tennessee Final Report Page 6 

The review team determined that the Division conducted approximately 397 routine inspections 

of Priority 1, 2, and 3 licensees and 161 initial inspections during the review period. The Division 

performed 36 of these inspections overdue by more than 25 percent of the inspection priorities 

listed in IMC 2800, ranging from 1 month to 107 months overdue. Fourteen Priority 1, 2, and 3 

or initial inspections were overdue at the time of this review, ranging from 1 month to 65 months 

overdue. Based on this data, the review team calculated that approximately 9 percent of the 

Priority 1, 2, and 3 and initial inspections were either completed overdue or were overdue at the 

time of the review. 

The review team was concerned about the length of time some of the inspections were overdue. 

The review team discussed this issue with the Deputy Division Director and the Inspection and 

Enforcement Section Manager and determined that the major factors that contributed to the 

length of time some of these inspections were overdue included frequent staff turnover, 

especially at one field office, and the amount of time needed to train new staff. Other 

contributing factors included changing to a new inspection tracking system, which was not 

completely utilized by all regional inspection staff until recently; inadvertent mischaracterization 

of some inspection priority codes (e.g., some Priority 3 licensees were coded as Priority 5 

licensees and were not inspected at the correct interval); and initial inspections of new program 

codes for existing licensees were not identified as due within 12 months. In addition, a few of 

the inspections were counted as overdue even though the inspections were completed. The 

inspection documentation could not be located so the Division considered these inspections to 

be overdue and committed to reinspect those licensees where the findings have not yet been 

issued. This issue was identified during the previous review in 2004. Division managers 

committed to using their electronic inspection tracking system, DRH Track, to monitor the 

inspection due dates for upcoming inspections to ensure that the inspections are performed prior 

to their due date. The Division has assigned all of the overdue inspections and plans to 

schedule and conduct the inspections as soon as possible. 

The review team evaluated the timeliness in providing inspection findings to licensees by 

reviewing inspection data and files for 51 inspections, covering a cross-section of the staff and 

regional inspection offices. Twenty-two of the inspection reports were issued greater than 30 

days after the date of the inspection. Two of the regional offices account for 17 of these reports. 

The review team discussed this issue with the Deputy Division Director and the Inspection and 

Enforcement Section Manager and determined that the regional field office managers are 

responsible for ensuring inspection reports are issued in a timely manner. The review team 

determined that staffing turnover and competing priorities (e.g., incident response, non-materials 

inspections) affected the issuance of some of the reports. Division managers and the regional 

managers have committed to using DRH Track to monitor the due dates for inspection reports 

and ensure that the reports are issued to licensees in a timely manner. There is a strong 

management commitment by the Division to take action to improve the timely performance of 

inspections and timely issuance of inspection reports to licensees. The review team believes 

that the Division can successfully correct the weaknesses in the materials inspection program. 
Tennessee Final Report Page 7 

Over the review period, the Division granted 65 reciprocity permits that were candidates for 

inspection based on the criteria in IMC 1220, “Processing of NRC Form 241 and Inspection of 

Agreement State Licensees Operating under 10 CFR 150.20.” The review team determined that 

the Division met or exceeded the goal of inspecting 20 percent of all candidate licensees 

operating under reciprocity in each of the 4 years covered by the review period. The Division 

conducted 32 inspections of candidate reciprocity licensees during the review period. 

The review team determined that the Division adequately planned for the initial set of Increased 

Controls inspections of affected licensees. The review team evaluated the Division’s 

prioritization methodology and found it acceptable. The Division identified 44 licensees who are 

subject to the Increased Controls and had completed 51 Increased Controls inspections at the 

time of the review. 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that Tennessee’s performance with respect to the indicator, Status of Materials Inspection 

Program, was satisfactory. 

3.3 Technical Quality of Inspections

The review team evaluated inspection reports, enforcement documentation, inspection field 

notes, and interviewed inspectors for 15 radioactive materials inspections conducted during the 

review period. The casework examined included a cross-section of inspections conducted by 18 

Division inspectors and covered a wide variety of inspection types, including: broad scope 

academic, industrial radiography, waste disposal service providers, nuclear pharmacy, 

Increased Controls, mobile nuclear medicine, and limited scope medical programs. Appendix C 

lists the inspection casework files reviewed, with case-specific comments, as well as the results 

of the inspector accompaniments. 

Based on the evaluation of casework, the review team noted that inspections covered all 

aspects of the licensees’ radiation safety programs. The review team found that inspection 

reports were generally thorough, complete, consistent, and of high quality with sufficient 

documentation to ensure that licensees’ performances with respect to health, safety, and 

security were acceptable. Inspection report documentation supported violations, 

recommendations made to licensees, unresolved safety issues, and discussions held with 

licensees during exit interviews. 

The inspection procedures utilized by the Division are described in “Division of Radiological 

Health’s Inspection and Enforcement Policy and Procedures” and are generally consistent with 

the inspection guidance found in IMC 2800. After the inspectors complete inspection reports, 

the reports are previewed and signed by the respective Field Office Manager. Once signed, 

completed actions are sent to the licensee. The Division’s goal is to issue all inspection reports 

within 30 days of the inspections. 

All inspection correspondence is issued from the respective field office where the inspection was 

performed. For inspections conducted by Field Office Managers, the Inspection and 

Enforcement Manager will perform the second review on the inspection documentation and 

correspondence. Findings were clearly stated and documented. If any violations are identified, 

a draft notice of noncompliance is prepared by the inspector. The review team also noted that 
Tennessee Final Report Page 8 

inspection correspondence involving the Increased Controls was appropriately labeled as 

sensitive information and withheld from public disclosure. 

During the review period, supervisory accompaniments were conducted for all inspectors on an 

annual basis, including supervisory inspectors. 

The Division maintains an adequate supply of appropriately calibrated survey instrumentation to 

support its inspection program, as well as to respond to radioactive materials incidents and 

emergency conditions. The Division has commercial contractors who calibrate the majority of 

their survey instruments on an annual basis. The remaining instruments are sent to the 

manufacturer for calibration. The Division uses the Tennessee Department of Public Health’s 

radiochemistry laboratory in Nashville for analysis of media samples collected by Division 

inspectors. The laboratory is capable of a number of analyses, including gamma spectroscopy, 

liquid scintillation counting, and low background gross alpha and beta counting. The Division 

sends samples to private laboratories for any laboratory services that cannot be performed in the 

Department of Public Health laboratory. 

The review team accompanied five of the Division’s inspectors during the weeks of April 7 and 

April 14, 2008. The Division’s inspectors performed inspections at an industrial radiography 

facility and limited scope medical institutions. All inspectors demonstrated performance-based 

inspection techniques and knowledge of the regulations. The inspectors were well trained, 

prepared for the inspections, and thorough in their audits of the licensees’ radiation safety and 

security programs. The inspectors conducted interviews with appropriate personnel, observed 

licensed operations, conducted confirmatory measurements, and utilized good health physics 

practices. The review team determined that the inspections were adequate to assess 

radiological health, safety, and security at the licensed facilities. 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that Tennessee’s performance with respect to the indicator, Technical Quality of Inspections, 

was satisfactory. 

3.4 Technical Quality of Licensing Actions

The review team examined the completed licenses and casework for 21 materials licensing 

actions which represented the work of 5 license reviewers. The licensing actions were reviewed 

for completeness, consistency, proper radioisotopes and quantities, 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, license conditions and tie-down conditions, and overall technical quality. 

Casework was evaluated for adherence to good health physics practices, reference to 

appropriate regulations, supporting documents, peer or supervisory review and proper signature 

authorities. The files were checked for retention of necessary documents and supporting data. 

The licensing casework was selected to provide a representative sample of licensing actions 

that were completed during the review period. The sample focused on the State’s new licenses, 

amendments, renewals, terminations, and the incorporation of Increased Controls into licenses. 

The sample included the following types of licenses: industrial radiography, radioactive waste 

processing, decommissioning and decontamination service provider, broad scope 
Tennessee Final Report Page 9 

medical/research and development, medical institution - written directive required, well logging, 

fixed gauge, portable gauge, veterinary, nuclear pharmacy and medical institution - emerging 

technology. Licensing actions included 6 new licenses, 4 renewals, 1 termination, and 10 

amendments. A list of the casework licenses evaluated, with case-specific comments, can be 

found in Appendix D. 

Each of the five license reviewers tracked their licensing actions electronically. Due to the 

prompt assignment, review, and resolution of incoming licensing requests, the licensing staff 

effectively managed their casework. The review team identified no backlog of amendments or 

new applications during the review period. The Division issued license renewals associated with 

medical, industrial radiography, portable gauge and waste processors for a 10-year period under 

a timely renewal system. Other types of licenses were reviewed on a similar 10-year period; 

however, the license was extended without requiring the licensee to submit a complete renewal 

application. The Division was incorporating the extended licenses into the timely renewal 

process in a systematic method. 

All license reviewers have signature authority and sign their own licensing actions. The licensing 

staff generate licenses and correspondence with standardized conditions and formats. The 

review team noted that the licensing staff used the computer database effectively and efficiently 

to obtain needed information in order to complete licensing actions. The review team found that 

the licensing actions were thorough, complete, timely, consistent, and of high quality with health, 

safety and security issues properly addressed. License tie-down conditions were stated clearly 

and backed by information contained in the license or sealed source and device registry files. 

To obtain additional information from the licensees or applicants, the license reviewers primarily 

used formal deficiency letters that stated regulatory positions and referenced the established 

guidance document for the respective licensed activity and specifically identified the deficiencies 

in the licensee’s documents. 

The license reviewers followed standard procedures, guidance documents and checklists that 

are similar to those used by the NRC. During the review period, the Division revised a number 

of their licensing guides. The review team acknowledged that the Division authorizes a number 

of unique licenses, identified as waste processors. These activities are primarily regulated by 

the Division for the entire country. The Division has unique talents, experience and expertise 

associated with licensing these types of activities. The review team discussed with Division 

managers the possibility of developing a guidance document or checklist for licensing the unique 

activities associated with waste processors in an effort to capture the expertise and experience 

of the Division that could be used for knowledge management within the Division or by other 

regulatory agencies. 

During the review period, the Division implemented NRC’s recently revised pre-licensing 

guidance. The pre-licensing checklist and worksheets were adequately completed. The review 

team found that the Division had followed the guidance for the new licenses issued since it was 

adopted. Pre-licensing visits were not conducted, which was consistent with the guidance for 

these licensees. 

Because not all of the recent regulatory changes issued by the NRC had been adopted as 

Tennessee regulations, the Division had imposed a number of the regulations by license 

conditions. Some examples included the security requirements for portable gauges and 
Tennessee Final Report Page 10 

guidance for medical emerging technologies. In addition, the Division sent Radiological 

Information Notices to its licensees, similar to the NRC’s Regulatory Issues Summaries. One 

example included a Radiological Information Notice dated January 25, 2007, which addressed 

the change in the NRC regulations regarding medical physicists. The notice encouraged 

medical physicists to request an amendment so they may be named on the license as an 

authorized medical physicist under the State of Tennessee qualification requirements. The 

Increased Controls had been incorporated by license condition into each of the required 

licenses. Additionally, the Division had received notification on April 14, 2008, from FSME that 

the State of Tennessee’s proposed license condition for the fingerprinting order was compatible 

with the NRC’s license condition. The Division indicated that it would start implementing the 

revised license condition. 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that Tennessee’s performance with respect to the indicator, Technical Quality of Licensing 

Actions, was satisfactory. 

3.5 Technical Quality of Incident and Allegation Activities

In evaluating the effectiveness of the Division’s actions in responding to incidents and 

allegations, the review team examined the Division’s response to the questionnaire relative to 

this indicator, evaluated selected incidents reported for Tennessee in the Nuclear Material 

Events Database (NMED) against those contained in the Division’s files, and evaluated the 

casework for 10 radioactive materials incidents. The incidents selected for review included 

medical events, lost radioactive material, damaged equipment, reported overexposures, and 

equipment failures. A listing of the casework examined can be found in Appendix E. The review 

team also evaluated the Division’s response to eight allegations involving radioactive materials, 

including four allegations referred to the State by the NRC during the review period. 

When notification of an incident is received, the responding technical staff members, in 

consultation with their supervisor or manager, determine the appropriate level of initial response. 

Technical staff members are authorized to respond to the site of an incident without obtaining 

supervisor or manager approval if the incident requires notification to the Division in 24 hours or 

less. The review team determined that the Division’s response to incidents was complete and 

comprehensive. Initial responses were prompt and well coordinated, and the level of effort was 

commensurate with the health and safety significance. The Division dispatched inspectors for 

on-site investigations in appropriate situations and took suitable enforcement and followup 

actions when necessary. 

The review team identified 35 radioactive materials incidents in NMED for Tennessee during the 

review period of which 34 required reporting to the NRC’s Headquarters Operations Center. The 

review team evaluated the Division’s timeliness in reporting incidents and found that, following 

notification from the licensee, the Division reported 30 of the 34 incidents within the required 

time frame. Of the remaining four cases, two incident reports were delayed due to the delayed 

discovery of situations which required reporting; one was delayed during holidays; and the other 

was delayed due to the unusual circumstances of the incident. The review team noted that in 

responses to more significant incidents, the Division issued a simplified charter to guide the 

response activities. The charter document identified issues to be resolved and information to be 

collected. The Division’s response procedure does not address charters. The review team also 
Tennessee Final Report Page 11 

noted that the Division does not close incidents until all compliance issues are resolved and 

enforcement action, if required, is completed. 

The review team noted that the Tennessee incident files included events involving electronic 

radiation sources and other events to which staff respond but are not reportable under NRC 

regulations. The review team found that incident information in NMED for Tennessee was up to 

date and complete, with the exception of three recent incidents not yet closed. The Division’s 

Complaint/Allegation/Incident (CAI) Coordinator maintains the incident files. The Deputy 

Division Director provides information electronically to the NRC’s contractor responsible for 

maintaining NMED. The Division’s Event Investigation Procedure requires coordination of 

responses among the Deputy Division Director, the CAI Coordinator, the responding staff and 

the responding staff’s supervisor. The procedure addresses timely reporting of events to the 

NRC Headquarters Operations Center and entering event information into NMED. 

In evaluating the effectiveness of Tennessee's response to allegations, the review team 

evaluated the casework for four NRC-referred allegations, as well as four other allegations 

reported directly to the State during the review period. The review team determined that the 

Division took prompt and appropriate action in response to all concerns raised. All of the 

allegations reviewed were appropriately closed, and the affected individuals were notified of the 

actions taken. Although the Division makes every effort to protect an alleger’s identity, 

Tennessee law requires the allegation files to be public records, and made available to the 

public upon request. For this reason, the Division avoids recording the name of an alleger in the 

file records. 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that Tennessee’s performance with respect to the indicator, Technical Quality of Incident and 

Allegation Activities, was satisfactory. 

4.0 NON-COMMON PERFORMANCE INDICATORS 

IMPEP identifies four non-common performance indicators to be used in reviewing Agreement 

State Programs: (1) Compatibility Requirements; (2) Sealed Source and Device Evaluation 

Program; (3) Low-Level Radioactive Waste Disposal Program; and (4) Uranium Recovery 

Program. Tennessee’s Agreement does not relinquish NRC authority for a Uranium Recovery 

Program, so only the first three non-common performance indicators were applicable to this 

review. 

4.1 Compatibility Requirements

4.1.1 Legislation

Tennessee became an Agreement State on September 1, 1965. The statutory authority for the 

radiation control program is found in Title 68, Chapter 202-101 through 202-709 of the 

Tennessee Code Annotated. The Division is designated as the State’s radiation control agency 

in Title 68, Chapter 203-101 through 203-105. The review team verified with Division staff that 

no legislation affecting the radiation control program was passed during the review period. 
Tennessee Final Report Page 12 

4.1.2 Program Elements Required for Compatibility

Tennessee’s regulations for the control of radiation are found in the “Rules of the Department of 

Environment and Conservation,” Chapters 1200-2-4 through 1200-2-12, and apply to all ionizing 

radiation from radioactive materials and radiation-producing machines. Tennessee requires a 

license for possession and use of all radioactive material including naturally occurring materials 

(such as radium) and accelerator-produced radionuclides. 

During the 2004 review, the review team examined the procedures used in the Division’s 

regulatory process and found that the public and other interested parties are offered an 

opportunity to comment on proposed rules. During this review, the review team verified that no 

changes have been made to the procedures since the last review. Tennessee has procedures 

for amending four types of regulations: Rulemaking Hearing Rules, Proposed Rules (noncontroversial filed without a public hearing), Emergency Rules, and Public Necessity Rules. The 

Division generally uses the Rulemaking Hearing Rules procedures. Under these procedures, 

proposed rules are reviewed internally by the Department’s Office of the General Counsel (OGC) 

and by outside interested parties before a rulemaking hearing is established. The proposed 

rules are published in the Tennessee Administrative Register during the month prior to the public 

hearing. Comments are accepted at the hearing and for a 2-week period following the hearing. 

Changes are made to the rules, as needed; reviewed by the OGC; signed by the Department’s 

Commissioner; reviewed by the Attorney General’s Office; filed with the Secretary of State; and 

become effective 75 days after filing. After the rule becomes effective, representatives of the 

Division and OGC are scheduled to appear before the Government Operations Committee of the 

legislature for the Committee’s hearing and approval of the rules. Rules adopted during the year 

are subject to sunset on June 30 of the following calendar year, unless approved by the 

legislature. 

The review team evaluated the Division’s response to the questionnaire relative to this indicator, 

reviewed the status of regulations required to be adopted by the State under the Commission’s 

adequacy and compatibility policy, and verified the adoption of regulations with data obtained 

from the State Regulation Status sheet that FSME maintains. 

Current NRC policy requires that Agreement States adopt equivalent regulations or legally 

binding requirements no later than 3 years after an NRC amendment becomes effective. The 

following NRC amendments are overdue for adoption: 

• “Medical Use of Byproduct Material,” 10 CFR Parts 20, 32, and 35 amendment 

(67 FR 20249), that was due for Agreement State adoption by October 24, 2005. 

• “Financial Assurance for Materials Licensees,” 10 CFR Parts 30, 40, and 70 amendment 

(68 FR 57327), that was due for Agreement State adoption by December 3, 2006. 

• “Compatibility with IAEA Transportation Safety Standards and Other Transportation 

Safety Amendments,” 10 CFR Part 71 amendment (69 FR 3697), that was due for 

Agreement State adoption by October 1, 2007. 
Tennessee Final Report Page 13 

• “Medical Use of Byproduct Material - Recognition of Specialty Boards,” 10 CFR Part 35 

amendment (70 FR 16336), that was due for Agreement State adoption by April 29, 

2008. 

The Division developed a documented plan for adopting above regulations. As noted in Section 

3.4 of this report, the Division has used license conditions as legally binding alternatives to 

regulations to impose safety and security requirements on licensees for several of the 

requirements in these amendments; however, the Division has not submitted all of the license 

conditions to the NRC for a compatibility review. 

In addition, the following portions of NRC amendments are overdue for adoption: 

• The 30.35 portion of “Decommissioning Recordkeeping and License Termination: 

Documentation Additions [Restricted areas and spill sites],” 10 CFR Parts 30 and 40 

amendment (58 FR 39628), that was due for Agreement State adoption by October 25, 

1996. 

• The 30.35 portion of “Timeliness in Decommissioning Material Facilities,” 10 CRF Parts 

30, 40, and 70 amendment (59 FR 36026), that was due for Agreement State adoption 

by August 15, 1997. 

• The 30.35 portion of “Clarification of Decommissioning Funding Requirements,” 

10 CFR Parts 30, 40, and 70 amendment (60 FR 38235), that was due for Agreement 

State adoption by November 24, 1998. 

• The 30.35 portion of “Termination or Transfer of Licensed Activities: Recordkeeping 

Requirements,” 10 CFR Parts 20, 30, 40, 61, and 70 amendment (61 FR 24669), that 

was due for Agreement State adoption by June 17, 1999. 

During a previous MRB, there was a misunderstanding on the part of both the NRC and Division 

staff which resulted in the four rules above being omitted from the Tennessee regulations. The 

misunderstanding involved the MRB’s acceptance of Tennessee’s handling of another portion of 

the NRC rulemaking as compatible. It was later discovered that the portion accepted by the 

MRB did not include these sections. Because of the misunderstanding, the review team is not 

considering these as overdue in its evaluation of this indicator. The Division plans to include the 

rules in a package scheduled to be submitted to the NRC for review by the end of 2008. 

The review team identified the following NRC amendments that will need to be addressed in the 

future: 

• “National Source Tracking System,” 10 CFR Part 20 amendment (71 FR 65865; 

72 FR 59162), that is due for Agreement State adoption by January 31, 2009. 

• “Minor Amendments,” 10 CFR Parts 20, 30, 32, 35, 40, and 70 amendment 

(71 FR 15005), that is due for Agreement State adoption by March 27, 2009. 
Tennessee Final Report Page 14 

• “Medical Use of Byproduct Material – Minor Corrections and Clarifications,” 10 CFR 

Parts 32 and 35 amendment (72 FR 45147, 54207), that is due for Agreement State 

adoption by October 29, 2010. 

• “Requirements for Expanded Definition of Byproduct Material,” 10 CFR Parts 20, 30, 31, 

32, 33, 35, 61, and 150 amendment (72 FR 55864), that is due for Agreement State 

adoption by November 30, 2010. 

• “Exemptions From Licensing, General Licenses, and Distribution of Byproduct Material: 

Licensing and Reporting Requirements,” 10 CFR Parts 30, 31 32, and 150 amendment 

(72 FR 58473), that is due for Agreement State adoption by December 17, 2010. 

• “Occupational Dose Records, Labeling, Containers, and Total Effective Dose 

Equivalent,” 10 CFR Parts 19 and 20 amendment (72 FR 68043), that is due for 

Agreement State adoption by February 15, 2011. 

At the time of the review, the Division had two draft rulemaking packages at different stages in 

the process, as documented in the Division’s rulemaking plan. The first package will address 

two overdue amendments and two upcoming amendments. This package was with Department 

management for their review and was scheduled to be submitted to NRC for a compatibility 

review within a month of the IMPEP review. The second package was under development and 

was scheduled to be submitted to NRC by the end of 2008. The second package will address 

the remaining overdue amendments and one upcoming amendment. 

Division managers and staff were aware of the regulations that are overdue and those that need 

to be adopted in the near future. The Division appeared to have a well formulated plan to 

address rules that were late for adoption and those becoming due. The review team learned 

that one staff member is considered proficient in the maintenance of the regulations and 

legislation and dedicates 0.35 FTE to those tasks. Division managers and staff noted that the 

low FTE allotted to compatibility, with only one new individual with limited regulatory review 

experience assigned to the task, was the contributing factor to the backlog. The review team 

discussed with Division managers the prospect of dedicating additional FTE to compatibilityrelated tasks, and of establishing means to address the timely adoption of required rules and 

regulations. 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that Tennessee’s performance with respect to the indicator, Compatibility Requirements, was 

satisfactory, but needs improvement. 

4.2 Sealed Source and Device (SS&D) Evaluation Program

In reviewing this indicator, the review team used three subelements to evaluate the Division’s 

performance regarding the SS&D Evaluation Program. The subelements were: (1) Technical 

Staffing and Training; (2) Technical Quality of the Product Evaluation Program; and (3) 

Evaluation of Defects and Incidents Regarding SS&Ds. 

In assessing the Division’s SS&D Evaluation Program, the review team examined the 

information that the Division provided in response to the IMPEP questionnaire. The review team 
Tennessee Final Report Page 15 

conducted a review of selected new, amended SS&D evaluations, deficiency letters, interactions 

with the applicant, and supporting documents covering the review period. The review team 

noted the Division’s use of guidance documents and procedures, interviewed the staff involved 

in the evaluations, and verified the use of regulations and license conditions to enforcement 

commitments made in the applications. 

4.2.1 Technical Staffing and Training

The Division has five individuals who perform SS&D evaluations as secondary duties. During 

the review period, one new SS&D reviewer attended the NRC SS&D Workshop held in 2006. 

The individual is now fully qualified to perform SS&D evaluations after completing several 

reviews in collaboration with a senior reviewer. The individual has the proper training and 

qualifications in accordance with the Division’s Training Policy. The new SS&D reviewer has 

documented training and authorization in the training files. All five SS&D reviewers have 

attended the NRC SS&D Workshop. The current SS&D reviewers have extensive health 

physics experience for the performance of SS&D reviews. None of these individuals have 

formal engineering training. 

According to the Division’s response to the questionnaire, the Division expends approximately 

0.45 FTE on SS&D evaluations. The review team concluded that the current SS&D staffing 

level is adequate for the needs of the Division. 

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

performance with respect to the subelement, Technical Staffing and Training, was satisfactory. 

4.2.2 Technical Quality of the Product Evaluation Program

During the review period, the Division issued 50 SS&D certificates. The review team examined 

14 certificates and their supporting documentation including 3 new applications, and 11 

amendments. The review team’s casework evaluations covered 10 unique products (sources or 

devices) and all 5 of the Division’s SS&D reviewers. Appendix F contains a list of the SS&D 

registration certificates, with case specific comments, examined by the review team. 

Analysis of the files and interviews with the staff confirmed that the Division follows the 

recommended guidance from the NRC SS&D Workshop and NUREG-1556, Volume 3, Revision 

1, issued in April 2004. Appropriate standards, Regulatory Guides, and NRC SS&D training 

workshop references were available to staff when performing SS&D reviews. 

The review team concluded that the overall technical quality of the product evaluations varied. 

The team found that the reviewers did not consistently use the review checklist provided in 

NUREG-1556, Volume 3, Appendix A. The review team found that the use of the checklist 

resulted in a significant improvement in the overall evaluation of the applications. The overall 

technical quality of product evaluations for new applications that used a complete checklist was 

better than amendments that used only a single page of the checklist regarding the portion being 

amended, if it was used. 
Tennessee Final Report Page 16 

Through the casework evaluations, the review team identified repeated problems with respect to 

thoroughness; consistency with American National Standards Institute (ANSI) standards and 

NUREG-1556, Volume 3; and adherence to existing guidance in product evaluations. Specific 

examples include: 

• Failure to specify in measurable terms the temperature and vibration limits in certain 

devices that may have been a contributing factor to multiple device failures (four unique 

products); 

• Reporting of dose rate measurements that are not consistent with ANSI and NUREG1556, Volume 3, with respect to using maximum activity and scatter radiation for shutter 

closed measurements (seven unique products); 

• Use of product principal use codes that are outdated or inconsistent with NUREG-1556, 

Volume 3, Appendix C use codes (six unique products); 

• Lack of rule-required justifications on file for leak test frequencies greater than 6 months 

(six unique products); 

• Inadequately addressed label durability or content (two unique products); and 

• Omission of dose profile of radionuclide added to device (two amendments of one 

unique product). 

These issues were discussed with the Division managers and staff. The review team 

recommends the Division establish a means to ensure evaluations are conducted with 

thoroughness; consistency with ANSI standards and NUREG-1556, Volume 3; and adherence to 

existing guidance in product evaluations. 

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

performance with respect to the subelement, Technical Quality of the Product Evaluation 

Program, was satisfactory, but needs improvement. 

4.2.3 Evaluation of Defects and Incidents Regarding SS&Ds

Utilizing NMED and the Division’s response to the questionnaire, the review team examined a 

selected sample of incidents or failures regarding SS&D registered products that occurred 

during the review period. The review examined events that occurred within the State of 

Tennessee, as well as events nationwide that occurred within the review period involving 

equipment or sources registered by the Division. 

There were several incidents involving devices registered by the Division and one open 

investigation during the last IMPEP that was subsequently closed. 

During the last IMPEP, the Division was still evaluating a device failure regarding the Berthold 

Technologies LB 7400 series device. The Division sought technical assistance from the NRC 

regarding the device evaluation. The Division issued an amended SS&D registration on 

February 25, 2005. 
Tennessee Final Report Page 17 

In the response to the questionnaire, the Division reported that the State of Georgia notified the 

Division in 2006 of three occurrences of stuck shutters on Berthold Technologies LB 7400 series 

devices. These events were due to severe vibration leading to lead buildup on the shutter and 

one with environmental corrosion. The Division also reported in the questionnaire that Berthold 

Technologies informed them in August 2007 of an application where the Berthold Technologies 

LB 7400 series device that had stuck shutters due to lead powder buildup from vibration issues. 

During the IMPEP, the Division informed the review team that Berthold Technologies had just 

advised them there was another problem with the Berthold Technologies LB 7400 Series device 

with lead buildup due to vibration causing the shutter to stick in another specific use application 

and that the manufacturer is preparing to add another model to the device series as a corrective 

action. 

The review team noted that the Division reviewed the incidents and corrections as presented by 

the manufacturer in a timely manner. The review team determined that the Division adequately 

reviewed the root causes of the individual incidents within the scope of the individual usage 

applications at the time of failure; however, the review team concluded that the Division did not 

fully evaluate the root causes of these failures, which become apparent in the repeated nature of 

these device failures. The review team noted that the manufacturer had not specified the 

vibration limits in measurable terms that the devices would be expected to withstand for the 

entire expected life of the devices, and consequently the information was not identified in the 

limitations and normal conditions of use in the registration certificates. 

Based on the IMPEP evaluation criteria, the review team recommended that Tennessee’s 

performance with respect to the subelement, Evaluation of Defects and Incident Regarding 

SS&Ds, was satisfactory, but needs improvement. 

Based on the IMPEP evaluation criteria, the review team recommended, and the MRB agreed, 

that Tennessee’s performance with respect to the indicator, SS&D Evaluation Program, was 

satisfactory, but needs improvement. 

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 Regulatory 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 Agreements prior to 1981 were determined to have continued 

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

Agreement State Program 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. At this time, there are no plans for a commercial LLRW disposal facility in 

Tennessee. Accordingly, the review team did not review this indicator. 
Tennessee Final Report Page 18 

5.0 SUMMARY 

As noted in Sections 3.0 and 4.0, Tennessee’s performance was found satisfactory for four 

performance indicators and satisfactory, but needs improvement, for the following performance 

indicators: Technical Staffing and Training, Compatibility Requirements, and SS&D Evaluation 

Program. The review team made four recommendations regarding program performance. 

Accordingly, the review team recommended, and the MRB agreed, that the Tennessee 

Agreement State Program be found adequate, but needs improvement, to protect public health 

and safety and compatible with NRC's program. Based on the results of the current IMPEP 

review, the review team recommended, and the MRB agreed, that the next full IMPEP review 

take place in approximately 4 years. 

Below are the recommendations, as mentioned earlier in the report, for evaluation and 

implementation, as appropriate, by the State. 

1. The review team recommends that the State evaluate the Division's projected staffing 

level and take appropriate action to ensure that the Division has adequate resources to 

achieve its primary objective of protecting public health, safety, and security. (Section 

3.1) 

2. The review team recommends that the State develop a method to document clearly that 

an inspector or license reviewer is qualified or approved to perform inspections or 

licensing actions of the different license types upon completion of specified training. 

(Section 3.1) 

3. The review team recommends that the State review the training policy to ensure that it 

meets current and future needs of the staff and revise the policy, as appropriate, to 

include on-the-job training and security training. (Section 3.1) 

4. The review team recommends the State establish a means to ensure evaluations are 

conducted with thoroughness; consistency with ANSI standards and NUREG-1556, 

Volume 3; and adherence to existing guidance in product evaluations. (Section 4.2.2) 
LIST OF APPENDIXES AND ATTACHMENT 

Appendix A IMPEP Review Team Members 

Appendix B Tennessee Organization Charts 

Appendix C Inspection Casework Reviews 

Appendix D License Casework Reviews 

Appendix E Incident Casework Reviews 

Appendix F Sealed Source and Device Casework Reviews 

Attachment June 25, 2008, Letter from Lawrence E. Nanney 

 Tennessee’s Response to Draft IMPEP Report 
APPENDIX A 

IMPEP REVIEW TEAM MEMBERS 

Name Area of Responsibility

Richard Blanton, FSME Team Leader 

Technical Quality of Incident and Allegation 

 Activities 

Joshua Palotay, FSME Technical Staffing and Training 

Compatibility Requirements 

Donna Janda, Region I Status of Materials Inspection Program 

Technical Quality of Inspections 

Inspector Accompaniments 

Bryan Parker, Region I Inspector Accompaniments 

Rachel Browder, Region III Technical Quality of Licensing Actions 

Karl Von Ahn, Ohio Sealed Source and Device Evaluation Program 
APPENDIX B 

TENNESSEE ORGANIZATION CHARTS 

ADAMS ACCESSION NO.: ML081500401 
APPENDIX C 

INSPECTION CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Licensee: World Testing, Inc. License No.: R-95009-K16 

Inspection Type: Routine/Special, Announced Priority: 2 

Inspection Date: 12/7/06 Inspectors: GK, TB 

File No.: 2 

Licensee: Regional Medical Center of Memphis License No.: R-79177-H05 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 8/28/07 Inspector: AG 

File No.: 3 

Licensee: Duratek Services, Inc. License No.: R-73006-F13 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Dates: 2/20-22/08 Inspectors: JT, JM, BW, NM 

Comment: 

Inspection report was dispatched to the licensee 45 days after the inspection. 

File No.: 4 

Licensee: Ivy Cooper Services, LLC License No.: R-33145-G11 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 11/17/05 Inspectors: SS, CB 

File No.: 5 

Licensee: Mobile Tech Service License No.: R-54007-H15 

Inspection Type: Routine, Announced Priority: 3 

Inspection Date: 6/29/07 Inspectors: WB, SS 

File No.: 6 

Licensee: Vanderbilt University License No.: R-19021-H09 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Dates: 12/13-14/06 Inspectors: GK, RH, et al 

Comments: 

a) Management review of the inspector’s observations and findings was not documented. 

b) Inspection report was dispatched to the licensee 37 days after the inspection. 
Tennessee Final Report Page C.2 

Inspection Casework Reviews

File No.: 7 

Licensee: Memorial Health Care System License No.: R-33120-L15 

Inspection Type: Initial, Unannounced Priority: 2 

Inspection Date: 2/2/07 Inspector: SS 

Comments: 

a) Inspection report did not document scope of high dose-rate remote afterloader (HDR) 

program, inspector observations, independent surveys, or interviews with workers for 

new HDR license. 

b) Management review of the inspector’s observations and findings was not documented. 

File No.: 8 

Licensee: Cardinal Health 414, Inc. License No.: R-33111-I14 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 12/8/04 Inspectors: SS, JP 

File No.: 9 

Licensee: American Industrial Testing License No.: R-79210-L15 

Inspection Type: Routine, Unannounced Priority: 1 

Inspection Date: 11/27/06 Inspectors: GS, SB 

Comment: 

Management review was conducted after the inspection report was dispatched to the 

licensee. 

File No.: 10 

Licensee: Radiosurgical Center of Memphis License No.: R-79245-G17 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 2/24/05 Inspectors: AG, BF 

Comment: 

Inspection report was dispatched to the licensee 49 days after the inspection. 

File No.: 11 

Licensee: University of Tennessee Memphis License No.: R-79019-J09 

Inspection Type: Routine, Announced Priority: 3 

Inspection Dates: 11/13-14/07 Inspector: LP 

Comment: 

Inspection report noted that the previous inspection was conducted on April 26, 2001; 

however, the review team found no documentation of this inspection. The last 

documented inspection was performed on January 30 and February 5-7, 1996. 
Tennessee Final Report Page C.3 

Inspection Casework Reviews

File No.: 12 

Licensee: Duratek Services, Inc. License No.: R-73006-F13 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Dates: 2/23-24, 3/1/06 Inspector: JT 

Comment: 

Inspection report was dispatched to the licensee 75 days after the inspection. 

File No.: 13 

Licensee: East Tennessee Ambulatory Services Center, LLC License No.: R-90047-A16 

Inspection Type: Initial, Announced Priority: 2 

Inspection Date: 12/1/06 Inspector: SH 

Comment: 

Inspection report was dispatched to the licensee 49 days after the inspection. 

File No.: 14 

Licensee: Ivy Cooper Services, LLC License No.: R-33145-G11 

Inspection Type: Initial/Special, Announced Priority: 1 

Inspection Date: 12/20/06 Inspector: SS 

File No.: 15 

Licensee: Baptist Hospital of East Tennessee License No.: R-47188-J14 

Inspection Type: Initial/Special, Announced Priority: 2 

Inspection Date: 11/2/06 Inspector: MA 

Comment: 

Inspection report was dispatched to the licensee 40 days after the inspection. 

INSPECTOR ACCOMPANIMENTS 

The following inspector accompaniments were performed prior to the on-site IMPEP review: 

Accompaniment No.: 1 

Licensee: World Testing, Inc. License No.: R-95009-K16 

Inspection Type: Routine/Special, Announced Priority: 1 

Inspection Date: 4/8/08 Inspectors: GK, TB 

Accompaniment No.: 2 

Licensee: Regional Medical Center at Memphis License No.: R-79177-J16 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 4/9/08 Inspector: SB 
Tennessee Final Report Page C.4 

Inspection Casework Reviews

Accompaniment No.: 3 

Licensee: St. Mary’s Jefferson Memorial Hospital License No.: R-45008-C16 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Date: 4/15/08 Inspector: MW 

Accompaniment No.: 4 

Licensee: Wellmont Health System 

 dba Bristol Regional Med. Ctr. License No.: R-82009-J15 

Inspection Type: Routine, Unannounced Priority: 3 

Inspection Dates: 4/16-17/08 Inspector: SH 
APPENDIX D 

LICENSE CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Licensee: Bristol Metals, LLC License No.: R-82057-B14 

Type of Action: New Amendment No.: N/A 

Date Issued: 2/20/04 License Reviewer: RP 

File No.: 2 

Licensee: Eagle Testing Co. License No.: R-33155-I14 

Type of Action: New Amendment No.: N/A 

Date Issued: 9/14/04 License Reviewer: RP 

File No.: 3 

Licensee: MedVet Memphis License No.: R-79291-J15 

Type of Action: New Amendment No: N/A 

Date Issued: 10/18/05 License Reviewer: Not recorded 

File No.: 4 

Licensee: PSC Metals, Inc. License No.: R-33163-J16 

Type of Action: New Amendment No: N/A 

Date Issued: 10/16/06 License Reviewer: RP 

File No.: 5 

Licensee: St. Francis Hospital License No.: R-79104-I15 

Type of Action: Amendment Amendment No.: 117 

Date Issued: 3/8/06 License Reviewer: GB 

Comment: 

The license amendment authorized HDR for two authorized users, as requested. Based 

on the way the license was written, three additional physicians were inadvertently 

authorized for HDR. The Division is going to amend the license to accurately reflect 

each physician’s authorizations. 

File No.: 6 

Licensee: St. Francis Hospital License No.: R-79104-I15 

Type of Action: Amendment Amendment No.: 120 

Date Issued: 6/26/07 License Reviewer: SK 

File No.: 7 

Licensee: Copper Bain Medical Center License No.: R-70002-L14 

Type of Action: Amendment Amendment No.: 3 

Date Issued: 2/4/08 License Reviewer: RP 
Tennessee Final Report Page D.2 

License Casework Reviews

File No.: 8 

Licensee: Vanderbilt University License No.: R-19021-I15 

Type of Action: Renewal Amendment No.: 116 

Date Issued: 9/6/05 License Reviewer: RP 

File No.: 9 

Licensee: Vanderbilt University License No.: R-19021-I15 

Type of Action: Amendment Amendment No.: 122 

Date Issued: 1/18/07 License Reviewer: CA 

File No.: 10 

Licensee: Precision Nuclear, LLC License No.: R-90046-K15 

Type of Action: Amendment Amendment No.: 3 

Date Issued: 10/11/06 License Reviewer: SK 

File No.: 11 

Licensee: Baptist Hospital of East Tennessee License No.: R-47188-J14 

Type of Action: New Amendment No.: N/A 

Date Issued: 10/11/04 License Reviewer: RP 

File No.: 12 

Licensee: JANX Integrity Group License No.: R-19219-H17 

Type of Action: Renewal Amendment No.: 9 

Date Issued: 8/3/07 License Reviewer: SK 

File No.: 13 

Licensee: Energy Solutions, LLC License No.: R-01105-L07 

Type of Action: Termination Amendment No: 1 

Date Issued: 12/20/07 License Reviewer: CA 

File No.: 14 

Licensee: Environmental Dimensions, Inc. License No.: R-01103-C17 

Type of Action: New Amendment No: N/A 

Date Issued: 3/7/07 License Reviewer: CA 

File No.: 15 

Licensee: RACE, LLC License No.: R-79273-H16 

Type of Action: Renewal Amendment No: 51 

Date Issued: 8/17/06 License Reviewer: CA 

File No.: 16 

Licensee: Duratek Services, Inc. License No.: R-73006-F13 

Type of Action: Amendment Amendment No: 112 

Date Issued: 3/10/08 License Reviewer: CA 
Tennessee Final Report Page D.3 

License Casework Reviews

File No.: 17 

Licensee: TOXCO, Inc. License No.: R-01037-E16 

Type of Action: Renewal Amendment No: 164 

Date Issued: 5/19/06 License Reviewer: JG 

File No.: 18 

Licensee: The LPA Group Incorporated License No.: R-15006-A18 

Type of Action: Amendment Amendment No: 1 

Date Issued: 3/17/08 License Reviewer: RP 

File No.: 19 

Licensee: Cardinal Health 414, Inc. License No.: R-19149-B15 

Type of Action: Amendment Amendment No: 101 

Date Issued: 1/18/08 License Reviewer: RP 

File No.: 20 

Licensee: Regional Hospital of Jackson License No.: R-57011-A09 

Type of Action: Amendment Amendment No: 55 

Date Issued: 5/17/04 License Reviewer: RP 

File No.: 21 

Licensee: Rusty’s Well Services, Inc. License No.: R-18009-C07 

Type of Action: Amendment Amendment No: 10 

Date Issued: 9/29/05 License Reviewer: GB 
APPENDIX E 

INCIDENT CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Licensee: Saint Francis Hospital License No.: GL-337 

Date of Incident: 3/25/04 NMED Log No.: 040213 

Investigation Date: 3/29/04 Type of Incident: Medical Event 

 Type of Investigation: Site 

File No.: 2 

Licensee: Professional Service Industry (PSI) License No.: R-19014 

Date of Incident: 4/03/04 NMED Log No.: 040636 

Investigation Date: 4/05/04 Type of Incident: Damaged Equipment 

 Type of Investigation: Site 

File No.: 3 

Licensee: American Tissue License No.: GL 

Date of Incident: 6/30/04 NMED Log No.: 050252 

Investigation Date: 6/30/04 Type of Incident: Lost/Stolen material 

 Type of Investigation: Site 

File No.: 4 

Licensee: Scientific Inspection Technology, Inc. License No.: R-33092 

Date of Incident: 8/9/04 NMED Log No.: None 

Investigation Date: 8/10/04 Type of Incident: Potential loss of control 

 Type of Investigation: Site 

File No.: 5 

Licensee: Cardinal Health License No.: R-47080 

Date of Incident: 12/2004 NMED Log No.: 050585 

Investigation Date: 2/15/05 Type of Incident: Overexposure 

 Type of Investigation: Site 

File No.: 6 

Licensee: University of Tennessee License No.: R-47005 

Date of Incident: 2/14/05 NMED Log No.: None 

Investigation Date: 3/12/05 Type of Incident: Lost/Stolen material 

 Type of Investigation: Telephone 

File No.: 7 

Licensee: FedEx (Non-licensee) License No.: None 

Date of Incident: 4/11/05 NMED Log No.: None 

Investigation Date: None Type of Incident: Lost/Stolen material 

 Type of Investigation: None 
Tennessee Final Report Page E.2 

Incident Casework Reviews

File No.: 8 

Licensee: S&ME. License No.: R-05018-H05 

Date of Incident: 6/24/05 NMED Log No.: 050653 

Investigation Date: 6/24/05 Type of Incident: Loss of control 

 Type of Investigation: Site 

File No.: 9 

Licensee: Nucor Steel. License No.: None 

Date of Incident: 2/8/08 NMED Log No.: None 

Investigation Date: 3/7/08 Type of Incident: Lose of control 

 Type of Investigation: Telephone 

File No.: 10 

Licensee: Duratek, Inc. License No.: R73008 

Date of Incident: 1/16/08 NMED Log No.: 080046 

Investigation Date: 1/17/08 Type of Incident: Release of material 

 Type of Investigation: Telephone 
APPENDIX F 

SS&D CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Registration No.: TN-1031-D-101-B SS&D Type: Gamma Gauge 

Applicant Name: Berthold Technologies, USA, LLC Type of Action: Amendment 

Date Issued: 2/25/05 SS&D Reviewers: CA, JG 

File No.: 2 

Registration No.: TN-1031-D-101-B SS&D Type: Gamma Gauge 

Applicant name: Berthold Technologies, USA, LLC Type of Action: Amendment 

Date Issued: 1/2/07 SS&D Reviewers: CA, JG 

Comment: 

 No checklist was used. 

File No.: 3 

Registration No.: TN-1031-D-101-B SS&D Type: Gamma Gauge 

Applicant name: Berthold Technologies, USA, LLC Type of Action: Amendment 

Date Issued: 8/15/07 SS&D Reviewers: GB, RP 

File No.: 4 

Registration No.: TN-1031-D-101-B SS&D Type: Gamma Gauge 

Applicant name: Berthold Technologies, USA, LLC Type of Action: Amendment 

Date Issued: 10/22/07 SS&D Reviewers: SK, CA 

Comments: 

a) For open shutter measurements – the dose rates were made of in-beam measurements 

instead of scatter measurements – applies to all prior registrations as well (see ANSI 

N43.8 and NUREG-1556, Volume 3). 

b) Registration certificate did not indicate a transition date (and/or serial numbers) for 

design changes to describe older devices in use. 

c) The environmental conditions not described in measurable terms. 
Tennessee Final Report Page F.2 

SS&D Casework Reviews

File No.: 5 

Registration No.: TN-1031-D-108-S SS&D Type: Gamma Gauge 

Applicant name: Berthold Technologies, USA, LLC Type of Action: Amendment 

Date Issued: 4/19/05 SS&D Reviewers: CA, JG 

Comments: 

a) Amendment added Cesium-137 radionuclide to device approved for Cobalt-60, but no 

dose profiles were obtained or added to device registration. 

b) The one dose profile summary provided in registration is for 8 mCi of Cobalt-60 in one 

model size, but maximum loading limit for device is 300 mCi. 

c) Registration certificate did not indicate a transition date (and/or serial numbers) for 

design changes to describe older devices in use. 

d) The temperature and vibration limitations for device based on detector environmental 

limits when the detector is not an integral part of the device. 

File No.: 6 

Registration No.: TN-1031-D-108-S SS&D Type: Gamma Gauge 

Applicant name: Berthold Technologies, USA, LLC Type of Action: Amendment 

Date Issued: 7/10/06 SS&D Reviewers: RP, CA 

Comments: 

a) Registration certificate was not updated for the conditions of use, or to add Cs-137 dose 

profile. 

b) No checklist was used. 

File No.: 7 

Registration No.: TN-237-S-103-S SS&D Type: Sealed Source 

Applicant name: Siemens Medical Solutions, USA Type of Action: Amendment 

Date Issued: 5/9/06 SS&D Reviewers: SK, RP 

Comments: 

a) Cover page principal use code was listed as “Instrument Calibration and Transmission 

Determinations,” the principal use code (from NUREG-1556, Volume 3, Appendix C) 

should have been “(X) Medical Reference Sources.” 

b) The radiation profile using non-standard isodose lines was for a 1.5 mCi Ge/Ga-68 

source, much less than the maximum activity of 10 mCi. 

c) The expected useful life of the source was not obtained or otherwise indicated on the 

 registration certificate. 
Tennessee Final Report Page F.3 

SS&D Casework Reviews

File No.: 8 

Registration No.: TN-237-S-104-S SS&D Type: Sealed Source 

Applicant name: Siemens Medical Solutions, USA Type of Action: Amendment 

Date Issued: 5/1/07 SS&D Reviewers: GB, RP 

Comments: 

a) Cover page principal use code was listed as “instrument calibration and transmission 

determinations;” the principal use code should have been “(X) Medical Reference 

Sources.” 

b) Radiation profiles in Attachment 3 & 4 of registration were for a 3.38 mCi Ge-68 source, 

but the maximum loading was 10 mCi. 

File No.: 9 

Registration No.: TN-1031-D-118-S SS&D Type: Gamma Gauge 

Applicant name: Berthold Technologies, USA, LLC Type of Action: New 

Date Issued: 8/7/06 SS&D Reviewers: CA, JG 

Comments: 

a) Vibration and shock limitations are defined by the scintillation detector system, not the 

device. The detector system is not an integral part of the device. 

b) The source is stated to be able to withstand the temperature limitations (up to 400 deg C) 

in the dip tube (dry well), but no temperature limits were defined for the device. The 

melting point of lead in the device is 327 deg C. 

c) Environmental conditions of use and limitations were not described in measureable 

terms. 

File No.: 10 

Registration No.: TN-1067-D-104-S SS&D Type: Transmission Assembly 

Applicant name: Siemens Medical Solutions, USA Type of Action: New 

Date Issued: 10/19/06 SS&D Reviewers: SK, RP 

Comments: 

a) Cover page principal use code listed as “(B) Medical Radiography” which was 

discontinued in 2004, principal use code should have been “(X) Medical Reference 

Source.” 

b) Labeling – when the sealed source is installed, the label must be transferred from the 

source pig to the device, a requirement of use not described in the registration certificate. 

c) The label may not be able to withstand the normal conditions of use. 

d) Under external radiation levels, the stated value for 100 cm in the closed position had the 

value for the maximum dose rate at the opening (transcription error). 
Tennessee Final Report Page F.4 

SS&D Casework Reviews

File No.: 11 

Registration No.: TN-1031-D-117-B SS&D Type: Moisture Gauge 

Applicant name: Berthold Technologies, USA, LLC Type of Action: New 

Date Issued: 4/28/05 SS&D Reviewers: CA, JG 

Comments: 

a) Cover page principal use code was “(D) Moisture Gauge” instead of “(H) General 

Neutron Source Application.” 

b) The maximum dose rate in the open shutter position, for both gamma and neutron, were 

for in-beam dose rates instead of scatter dose rates. 

File No.: 12 

Registration No.: TN-237-S-105-S SS&D Type: Line Source 

Applicant name: Siemens Medical Solutions, USA Type of Action: Amendment 

Date Issued: 5/10/06 SS&D Reviewers: SK, RP 

Comments: 

a) Cover page principal use code listed as “(B) Medical Radiography” which was 

discontinued in 2004; principal use code should have been “(X) Medical Reference 

Source.” 

b) Radiation profile dose rates were stated for 3.1 mCi and 4.02 mCi Ge-68 sources, but 

the maximum source activity is 30 mC. 

c) Registration certificate did not indicate a transition date (and/or serial numbers) for 

design changes to describe older devices in use. 

File No.: 13 

Registration No.: TN-1067-D-101-S SS&D Type: Scanner Holder 

Applicant name: Siemens Medical Solutions, USA Type of Action: Amendment 

Date Issued: 5/25/2006 SS&D Reviewers: SK, RP 

Comments: 

a) Cover page principal use code listed as “(B) Medical Radiography” which was 

discontinued in 2004; principal use code should have been “(X) Medical Reference 

Source.” 

b) Radiation dose rate profile was for a 15 mCi Ge-68 source loading, but the maximum 

device loading activity is 30 mCi. 

c) The FDA approval summary information was included in the file, but not identified in the 

device registration. 
Tennessee Final Report Page F.5 

SS&D Casework Reviews

File No.: 14 

Registration No.: TN-1031-D-104-B SS&D Type: Gamma Gauge 

Applicant name: Berthold Technologies, USA, LLC Type of Action: Amendment 

Date Issued: 2/21/08 SS&D Reviewers: RP, CA 

Comments: 

a) In the conditions of normal use and safety analysis sections, the environmental 

limitations were based on the detector limits, and not that of the device. The detector is 

not an integral part of the device. 

b) The prototype testing stated that the device was subjected to a vibration test of 50 Hz for 

90 minutes, but did not indicate the corresponding amplitude (displacement) of the 

vibration. 
ATTACHMENT 

June 25, 2008, Letter from Lawrence E. Nanney 

Tennessee’s Response to Draft IMPEP Report 

ADAMS Accession No.: ML081830728