UNITED STATES 

NUCLEAR REGULATORY COMMISSION 

WASHINGTON, D.C. 20555-0001 

June 16, 2016 

Robert J. Martineau, Jr. 

Commissioner 

Department of Environment and Conservation 

312 Rosa L. Parks Avenue 

2nd Floor 

Nashville, TN 37243 

Dear Mr. Martineau: 

On May 24, 2016, 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 the U.S. Nuclear Regulatory Commission’s program. 

Section 5.0, page 14, of the enclosed final report contains a summary of the IMPEP team’s 

findings. Because this review is the second consecutive review with all indicators satisfactory, 

you have received a 1-year extension, the next full review of the Tennessee Agreement State 

Program will take place in approximately 5 years, with a periodic meeting tentatively scheduled 

for September 2018. 

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/ 

 Scott W. Moore, Acting Director 

Office of Nuclear Material Safety 

 and Safeguards 

Enclosure: 

Tennessee Final IMPEP Report 

cc: See next page 
cc: Shari Meghreblian, Ph.D. 

Deputy Commissioner 

Debra Shults 

Director, Division of Radiological Health 

Sherrie Flaherty, MN 

Organization of Agreement States 

 Liaison to the MRB 
Robert J. Martineau, Jr. 

Commissioner 

Department of Environment and Conservation 

312 Rosa L. Parks Avenue 

2nd Floor 

Nashville, TN 37243 

Dear Mr. Martineau: 

On May 24, 2016, 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 the U.S. Nuclear Regulatory Commission’s program. 

Section 5.0, page 14, of the enclosed final report contains a summary of the IMPEP team’s 

findings. Because this review is the second consecutive review with all indicators satisfactory, 

you have received a 1-year extension, the next full review of the Tennessee Agreement State 

Program will take place in approximately 5 years, with a periodic meeting tentatively scheduled 

for September 2018. 

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/ 

 Scott W. Moore, Acting Director 

Office of Nuclear Material Safety 

 and Safeguards 

Enclosure: 

Tennessee Final IMPEP Report 

cc: See next page 

DISTRIBUTION: (SP05) 

See next page 

ML16153A003 

OFC MSTR/ASPB MSTR/ASPB RIV:TL NMSS/MSTR Tech Ed NMSS:D 

NAME LDimmick 

w/edits

PMichalak RErickson 

via e-mail 

w/edits

PHenderson WMoore SMoore 

DATE 06/02/16 06/07/16 06/01/16 06/08/16 06/10/16 06/16/16 

OFFICIAL RECORD COPY 
Letter to R. Martineau from S. Moore, Dated June 16, 2016 

SUBJECT: TENNESSEE FY2016 FINAL IMPEP REPORT 

DISTRIBUTION: (SP05) 

RidsEdoMailCenter 

MSampson, OEDO 

RidsSecyCorrespondenceMailCenter Chairman Burns 

RidsOgcMailCenter Commissioner Svonicki 

JOlmstead, OGC Commissioner Ostendorff 

RidsRgn1MailCenter Commissioner Baran 

JTrapp, RI SECY 

JNick, RI 

RidsNmssOD 

DCollins, NMSS 

DJanda, RI/RSAO 

KModes, NMSS 

RCraffey, RIII 

NStanley, NJ 

JPate, LA 

LRoldan-Otero, NMSS 

OAS Board 

JWeil, OCA 
Enclosure 

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM 

REVIEW OF THE TENNESSEE AGREEMENT STATE PROGRAM 

MARCH 7-11, 2016 

FINAL REPORT
EXECUTIVE SUMMARY 

This report presents the results of the Integrated Materials Performance Evaluation Program 

(IMPEP) review of the Tennessee Agreement State Program. The review was conducted 

during the period of March 7-11, 2016, by a review team composed of technical staff members 

from the U.S. Nuclear Regulatory Commission (NRC) and the States of New Jersey and 

Louisiana.

Based on the results of this review, Tennessee’s performance was found satisfactory for all 

indicators reviewed. The review team made one two-part recommendation concerning 

licensing. The review team recommends that the Tennessee Agreement State Program 

(1) review all waste processor licenses to ensure standard license conditions are appropriately 

applied and consistently used; and (2) continue to develop and finalize the licensing guidance 

for the unique activities associated with waste processors. 

Accordingly, the review team recommended, and the Management Review Board (MRB) 

agreed, that the Tennessee Agreement State Program is adequate to protect public health and 

safety and is compatible with the NRC's Program. Because this review is the second 

consecutive review with all indicators satisfactory, the review team recommended, and the MRB 

agreed, that the next IMPEP review take place in approximately 5 years and that a periodic 

meeting be held in approximately 2.5 years. 
Tennessee Final IMPEP 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 March 7-11, 2016, by a review 

team composed of technical staff members from the U.S. Nuclear Regulatory 

Commission (NRC) and the States of New Jersey and Louisiana. 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 NRC Management Directive 5.6 (MD 5.6), “Integrated Materials 

Performance Evaluation Program (IMPEP),” dated February 26, 2004. Preliminary 

results of the review, which covered the period of April 28, 2012 - March 11, 2016, were 

discussed with Tennessee managers on the last day of the review. 

In preparation for the review, a questionnaire addressing the common and applicable 

non-common performance indicators was sent to the State on October 30, 2015. The 

State provided its response to the questionnaire by electronic mail on February 24, 

2016. A copy of the questionnaire response can be found in the NRC’s Agencywide 

Documents Access and Management System (ADAMS) using the Accession Number 

ML16053A262. 

The Tennessee Agreement State Program (the Program) is administered by the Division 

of Radiological Health (the Division). The Division is located within the Bureau of 

Environment, which is in the Department of Environment and Conservation (the 

Department). The Division Director reports to the Deputy Commissioner for 

Environment and Conservation, who in turn reports to the Commissioner of the 

Department. Organization charts for the State can be found using the ADAMS 

Accession Number ML16053A256. 

A draft of this report was issued to Tennessee on April 11, 2016, for factual comment. 

Tennessee responded to the findings and conclusions of the review by letter dated 

May 5, 2016. A copy of Tennessee’s response can be found in ADAMS using the 

Accession Number ML16131A230. The Management Review Board (MRB) met on May 

24, 2016, to consider the proposed final report. The MRB found the Tennessee 

Agreement State Program adequate to protect public health and safety, and compatible 

with the NRC’s program. 

At the time of the review, the Tennessee Agreement State Program regulated 530 

specific licensees authorizing possession and use of radioactive materials. The review 

focused on the radioactive 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. 

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

each common and the applicable non-common performance indicators and made a 

preliminary assessment of the Tennessee Agreement State Program’s performance. 
Tennessee Final IMPEP Report Page 2 

2.0 PREVIOUS IMPEP REVIEW AND STATUS OF RECOMMENDATIONS 

The previous IMPEP review concluded on April 27, 2012. The final report is available in 

ADAMS using the Accession Number ML12194A239. The results of the 2012 review 

are as follows: 

Technical Staffing and Training: Satisfactory 

Recommendation: None 

Status of Materials Inspection Program: Satisfactory 

Recommendation: None 

Technical Quality of Inspections: Satisfactory 

Recommendation: None 

Technical Quality of Licensing Actions: Satisfactory 

Recommendation: None 

Technical Quality of Incident and Allegation Activities: Satisfactory 

Recommendation: None 

Compatibility Requirements: Satisfactory 

Recommendation: None 

Sealed Source and Device Evaluation Program: Satisfactory 

Recommendation: None 

Overall finding: Adequate to protect public health and safety and Compatible with the 

NRC’s program. 

3.0 COMMON PERFORMANCE INDICATORS 

Five common performance indicators are used to review the 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 

The ability to conduct effective licensing and inspection programs is largely dependent 

on having a sufficient number of experienced, knowledgeable, and well-trained technical 

personnel. Under certain conditions, staff turnover could have an adverse effect on the 

implementation of these programs, and thus could affect public health and safety. 

Apparent trends in staffing must be explored. Review of this indicator also requires a 

consideration and evaluation of the levels of training and qualification. The evaluation 

standard measures the overall quality of training available to, and taken by, materials 

program personnel.
Tennessee Final IMPEP Report Page 3 

a. Scope 

The review team used the guidance in State Agreements procedure SA-103, “Reviewing 

the Common Performance Indicator: Technical Staffing and Training,” and evaluated 

Tennessee’s performance with respect to the following performance indicator objectives: 

• A well-conceived and balanced staffing strategy has been implemented throughout 

the review period. 

• Agreement State training and qualification program is equivalent to NRC’s Inspection 

Manual Chapter (IMC) 1248, “Formal Qualifications Program for Federal and State 

Materials and Environmental Management Programs.” 

• Qualification criteria for new technical staff are established and are being followed or 

that qualification criteria will be established if new staff members are hired. 

• Any vacancies, especially senior-level positions, are filled in a timely manner. 

• There is a balance in staffing of the licensing and inspection programs. 

• Management is committed to training and staff qualification. 

• Individuals performing materials licensing and inspection activities are adequately 

qualified and trained to perform their duties. 

• License reviewers and inspectors are trained and qualified in a reasonable period of 

time. 

b. Discussion 

The Tennessee Agreement State Program is composed of 50 staff members totaling 

30 full-time equivalents for the radioactive materials program including vacancies. 

During the review period, 17 staff members left the program and 8 staff members were 

hired. Currently there are nine vacancies that have been vacant anywhere from 2 to 20 

months. In order to provide staff with better career progression, the Program is 

converting each vacant position from a health physicist job title to either an 

environmental consultant, environmental scientist, or environmental manager job title. 

This conversion requires approval from human resources before the position can be 

posted with the new job title. Once the Program receives approval from human 

resources to post the position, the Program must receive approval for funding the 

position. During the onsite review, the Program received approval from human 

resources to post six vacant positions. Since the onsite review, funding was approved, 

and the Program hired five of the six positions that were posted. The review team found 

that the Program has a training and qualification manual compatible with the NRC’s IMC 

1248. 

c. Evaluation 

Although the Program has some positions vacant up to 20 months, the review team did 

not identify any performance issues associated with these vacancies. During the review 

period, the Program did not have a backlog in licensing or inspection activities. The 

team determined that during the review period the Tennessee program met the 

performance indicator objectives listed in Section 3.1.a. 
Tennessee Final IMPEP Report Page 4 

d. Results 

Based on the IMPEP evaluation criteria in MD 5.6, the review team recommended, and 

the MRB agreed, that Tennessee’s performance with respect to the indicator, Technical 

Staffing and Training, be found satisfactory. 

3.2 Status of the Materials Inspection Program 

Periodic inspections of licensed operations are essential to ensure that activities are 

being conducted in compliance with regulatory requirements and consistent with good 

safety practices. The frequency of inspections is specified in NRC IMC 2800, “Materials 

Inspection Program,” and is dependent on the amount and kind of material, the type of 

operation licensed, and the results of previous inspections. There must be a capability 

for maintaining and retrieving statistical data on the status of the inspection program. 

a. Scope 

The review team used the guidance in State Agreements procedure SA-101, “Reviewing 

the Common Performance Indicator: Status of the Materials Inspection Program,” and 

evaluated Tennessee’s performance with respect to the following performance indicator 

objectives: 

• Initial inspections and inspections of Priority 1, 2, and 3 licensees are performed at 

the frequency prescribed in IMC 2800. 

• Candidate licensees working under reciprocity are inspected in accordance with the 

criteria prescribed in IMC 1220, “Processing of NRC Form 241, Report of Proposed 

Activities in Non-Agreement States, Areas of Exclusive Federal Jurisdiction, and 

Offshore Waters, and Inspection of Agreement State Licensees Operating under 

10 CFR 150.20.” 

• Deviations from inspection schedules are normally coordinated between technical 

staff and management. 

• There is a plan to perform any overdue inspections and reschedule any missed or 

deferred inspections; or a basis has been established for not performing any overdue 

inspections or rescheduling any missed or deferred inspections. 

• Inspection findings are communicated to licensees in a timely manner (30 calendar 

days, or 45 days for a team inspection, as specified in IMC 0610, “Nuclear Material 

Safety and Safeguards Inspection Reports”). 

b. Discussion 

Tennessee performed 516 Priority 1, 2, 3, and initial inspections during the review 

period, of which only one inspection was conducted overdue. The review team 

sampled 45 inspection reports and found that in each instance, inspection findings 

were communicated to the licensee within 30 days after the inspection exit. The 

Program completed more than 20 percent of candidate reciprocity inspections during 

each year of the review period.
Tennessee Final IMPEP Report Page 5 

c. Evaluation 

The team determined that during the review period Tennessee met the performance 

indicator objectives listed in Section 3.2.a. 

d. Results 

Based on the IMPEP evaluation criteria in MD 5.6, the review team recommended, and 

the MRB agreed, that Tennessee’s performance with respect to the indicator, Status of 

the Materials Inspection Program, be found satisfactory. 

3.3 Technical Quality of Inspections 

Inspections, both routine and reactive, provide assurance that licensee activities are 

carried out in a safe and secure manner. Accompaniments of inspectors performing 

inspections, and the critical evaluation of inspection records are used to assess the 

technical quality of a program’s inspection capability. 

a. Scope 

The review team used the guidance in State Agreements procedure SA-102, “Reviewing 

the Common Performance Indicator: Technical Quality of Inspections,” and evaluated 

Tennessee’s performance with respect to the following performance indicator objectives: 

• Inspections of licensed activities focus on health, safety, and security. 

• Inspection findings are well-founded and properly documented in reports. 

• Management promptly reviews inspection results. 

• Procedures are in place and used to help identify root causes and poor licensee 

performance. 

• Inspections address previously identified open items and violations. 

• Inspection findings lead to appropriate and prompt regulatory action. 

• Supervisors conduct annual accompaniments of each inspector to assess 

performance and assure consistent application of inspection policies. 

• For programs with separate licensing and inspection staffs, to verify that procedures 

are established and followed to provide feedback information to license reviewers. 

• For Agreement States, to determine if inspection guides are consistent with NRC 

guidance. 

• An adequate supply of calibrated survey instruments is available to support the 

inspection program. 

b. Discussion 

The review team evaluated the inspection reports and enforcement documentation for 

45 materials inspections conducted during the review period. The casework included 

inspections performed by 19 current and former inspectors and covered medical, 

industrial, commercial, academic, research, and service licenses. The inspection 

casework and inspector accompaniments were also assessed for implementation of 

security requirements for risk significant material, as applicable.
Tennessee Final IMPEP Report Page 6 

The IMPEP team members conducted accompaniments of 10 Program inspectors 

during the weeks of November 16, 2015, and February 22, 2016. The inspectors were 

accompanied during health, safety, and security inspections of industrial radiography, 

waste collector, radiopharmacy, medical diagnostic, high dose rate remote after loader, 

and waste processor licensees. During the accompaniments, the inspectors 

demonstrated appropriate inspection techniques, knowledge of the regulations, 

appropriate use of calibrated survey instruments, and conducted performance-based 

inspections. The inspectors were trained, well-prepared for the inspection, conducted 

interviews with appropriate personnel, observed licensed operations, conducted 

confirmatory measurements, and utilized good health physics practices. The inspections 

were adequate to assess radiological health and safety and Increased Controls at the 

licensed facilities. 

The review team noted the Program performed annual supervisory accompaniments for 

each of the inspectors throughout the review period. 

c. Evaluation 

The team determined that during the review period Tennessee met the performance 

indicator objectives listed in Section 3.3.a. 

d. Results 

Based on the IMPEP evaluation criteria in MD 5.6, the review team recommended, and 

the MRB agreed, that Tennessee’s performance with respect to the indicator, Technical 

Quality of Inspections, be found satisfactory. 

3.4 Technical Quality of Licensing Actions 

The quality, thoroughness, and timeliness of licensing actions can have a direct bearing 

on public health and safety, and security. An assessment of licensing procedures, 

actual implementation of these procedures, and documentation of communications and 

associated actions between the State licensing staff and regulated community will be a 

significant indicator of the overall quality of the Program. 

a. Scope 

The review team used the guidance in State Agreements procedure SA-104, “Reviewing 

the Common Performance Indicator: Technical Quality of Licensing Actions,” and 

evaluated Tennessee’s performance with respect to the following performance indicator 

objectives: 

• Licensing action reviews are thorough, complete, consistent, and of acceptable 

technical quality with health, safety, and security issues properly addressed. 

• Essential elements of license applications have been submitted and elements meet 

current regulatory guidance (e.g., financial assurance, increased controls, 

pre-licensing guidance). 

• License reviewers, if applicable, have the proper signature authority for the cases 

they review independently. 

• License conditions are stated clearly and are inspectable.
Tennessee Final IMPEP Report Page 7 

• Deficiency letters clearly state regulatory positions and are used at the proper time. 

• Reviews of renewal applications demonstrate a thorough analysis of a licensee’s 

inspection and enforcement history. 

• Applicable guidance documents are available to reviewers and are followed (e.g., 

NUREG-1556 series, pre-licensing guidance, regulatory guides, etc.). 

• Licensing practices for risk significant radioactive materials are appropriately 

implemented including increased controls and fingerprinting orders (Part 37 

equivalent). 

• Documents containing sensitive security information are properly marked, handled, 

controlled and secured. 

b. Discussion 

During the review period, the Program performed 2,175 radioactive materials licensing 

actions. The review team evaluated 30 radioactive materials licensing actions, including 

5 new applications, 12 amendments, 7 renewals, and 6 terminations. The casework 

sample represented work from all four current license reviewers. The review team also 

reviewed a sample of financial assurance and decommissioning actions. 

The review team evaluated casework which included the following license types and 

actions: waste processing, broad scope medical, broad scope academic, medical 

diagnostic and therapy, commercial manufacturing and distribution, industrial 

radiography, research and development, nuclear pharmacy, fixed and portable gauges, 

self-shielded irradiators, and service providers. 

With the exception of waste processor licensing, license reviewers and the licensing 

supervisor perform license reviews following the guidance in the NRC’s NUREG-1556 

series, “Consolidated Guidance about Materials Licenses” and consistently use the 

NRC’s Pre-Licensing Guidance. The State follows other processes for licensing the 

waste processors. The State has issued 14 waste processor licenses with 6 out of the 

14 owned by one company and with 7 out of the 14 authorized to perform bulk survey for 

release. One licensee is currently undergoing decommissioning. The 2008 IMPEP 

review team discussed developing guidance or a checklist for licensing unique activities 

associated with waste processors to ensure consistent and thorough licensing. The 

2012 IMPEP review team noted that the State had developed standard license 

conditions for use in waste processor licensing but had not yet developed written 

guidance. In reviewing the waste processor license files, the 2016 IMPEP review team 

identified, (1) standard license conditions are not used consistently, (2) written guidance 

has not been finalized, and (3) several licenses authorize storage for greater than 365 

days, two of which have an authorization for an indefinite period of time. 

c. Evaluation 

The team determined that during the review period Tennessee met the performance 

indicator objectives listed in Section 3.4.a., with exception. 

The license reviews for most license types are thorough, complete, consistent, and of 

acceptable technical quality with health and safety issues properly addressed. The 

license reviews for the waste processors showed inconsistencies which are attributed to 
Tennessee Final IMPEP Report Page 8 

the lack of final guidance, use of checklists, and standard license conditions. Based on 

this review, the review team recommended, and the MRB agreed, that the State (1) 

review all waste processor licenses to ensure standard license conditions are 

appropriately applied and consistently used, and (2) continue to develop and finalize the 

licensing guidance for the unique activities associated with waste processors. 

d. Results 

Based on the IMPEP evaluation criteria in MD 5.6, the review team recommended, and 

the MRB agreed, that Tennessee’s performance with respect to the indicator, Technical 

Quality of Licensing Actions, be found satisfactory with one recommendation. 

3.5 Technical Quality of Incident and Allegation Activities 

The quality, thoroughness, and timeliness of response to incidents and allegations of 

safety concerns can have a direct bearing on public health and safety. An assessment 

of incident response and allegation investigation procedures, actual implementation of 

these procedures, internal and external coordination, and investigative and follow-up 

procedures and actions will be a significant indicator of the overall quality of the 

program. 

a. Scope 

The review team used the guidance in State Agreements procedure SA-105, “Reviewing 

the Common Performance Indicator: Technical Quality of Incident and Allegation 

Activities,” and evaluated Tennessee’s performance with respect to the following 

performance indicator objectives: 

• Incident response, investigation, and allegation procedures are in place and 

followed. 

• Response actions are appropriate, well-coordinated, and timely. 

• On-site responses are performed when incidents have potential health, safety or 

security significance. 

• Appropriate follow-up actions are taken to ensure prompt compliance by licensees. 

• Follow-up inspections are scheduled and completed, as necessary. 

• Notifications are made to the NRC Headquarters Operations Center for incidents 

requiring a 24-hour or immediate notification to the Agreement State or the NRC. 

• Incidents are reported to the Nuclear Material Events Database (NMED). 

• Allegations are investigated in a prompt, appropriate manner. 

• Concerned individuals are notified of investigation conclusions. 

• Concerned individuals’ identities are protected, as allowed by law. 

b. Discussion 

During the review period, a total of 78 incidents were reported by Tennessee to the 

NMED database. The review team screened the incidents and selected 18 of the most 

significant events for review. The casework reviewed included lost/stolen radioactive 

materials events, damaged equipment incidents, internal and external contamination 

events, fire at a waste processor facility involving radioactive materials, and shipping 

incidents involving a Tennessee based common carrier. 
Tennessee Final IMPEP Report Page 9 

When an event occurs and is reported to the Program, management evaluates it to 

determine what the appropriate response should be. Responses can range anywhere 

from an immediate response to reviewing the event during the next inspection. For the 

more significant events, management directed inspectors to respond immediately. The 

review team also noted that Tennessee staff perform event reviews in accordance with 

their established procedures. 

During the review period, Tennessee also received 20 allegations of which 8 were 

related to radioactive materials. The review team evaluated all eight materials 

allegations and found that the Program took prompt and appropriate action in response 

to the concerns raised. Concerned individuals were notified of the findings in each case. 

Tennessee’s open records laws often make it difficult for the Program to protect alleger’s 

identities, so they have developed alternate methods where allegers can be notified of 

outcomes while still protecting their identities. No allegations were referred from NRC to 

Tennessee during the review period. 

c. Evaluation 

The team determined that during the review period Tennessee met the performance 

indicator objectives listed in Section 3.5.a. 

d. Results 

Based on the IMPEP evaluation criteria in MD 5.6, the review team recommended and 

the MRB agreed, that Tennessee’s performance with respect to the indicator, Technical 

Quality of Incident and Allegation Activities, be found satisfactory. 

4.0 NON-COMMON PERFORMANCE INDICATORS 

Four non-common performance indicators are used to review Agreement State 

programs: (1) Compatibility Requirements, (2) Sealed Source and Device Evaluation 

(SS&D) Program, (3) Low-Level Radioactive Waste Disposal (LLRW) Program, and 

(4) Uranium Recovery Program. The NRC’s Agreement with Tennessee does not 

relinquish regulatory authority for a uranium recovery program; therefore, only the first 3 

non-common performance indicators applied to this review. 

4.1 Compatibility Requirements 

State statutes should authorize the State to establish a program for the regulation of 

agreement material and provide authority for the assumption of regulatory responsibility 

under the agreement. The statutes must authorize the State to promulgate regulatory 

requirements necessary to provide reasonable assurance of protection of public health, 

safety, and security. The State must be authorized through its legal authority to license, 

inspect, and enforce legally binding requirements, such as regulations and licenses. 

NRC regulations that should be adopted by an Agreement State for purposes of 

compatibility or health and safety should be adopted in a time frame so that the effective 

date of the State requirement is not later than 3 years after the effective date of NRC's 

final rule. Other program elements, as defined in Appendix A of State Agreements 

procedure SA-200, “Compatibility Categories and Health and Safety Identification for 

NRC Regulations and Other Program Elements,” that have been designated as 
Tennessee Final IMPEP Report Page 10 

necessary for maintenance of an adequate and compatible program should be adopted 

and implemented by an Agreement State within 6 months following NRC designation. 

a. Scope 

The review team used the guidance in State Agreements procedure SA-107, “Reviewing 

the Non-Common Performance Indicator: Compatibility Requirements,” and evaluated 

Tennessee’s performance with respect to the following performance indicator objectives: 

• The Agreement State program does not create conflicts, duplications, gaps, or other 

conditions that jeopardize an orderly pattern in the regulation of radioactive materials 

under the Atomic Energy Act, as amended. 

• Regulations adopted by the Agreement State for purposes of compatibility or health 

and safety were adopted no later than 3 years after the effective date of the NRC 

regulation. 

• Other program elements, as defined in SA-200 that have been designated as 

necessary for maintenance of an adequate and compatible program have been 

adopted and implemented within 6 months of NRC designation. 

• The State statutes authorize the State to establish a program for the regulation of 

agreement material and provide authority for the assumption of regulatory 

responsibility under the agreement. 

• The State is authorized through its legal authority to license, inspect, and enforce 

legally binding requirements such as regulations and licenses. 

• Impact of sunset requirements, if any, on the State’s regulations. 

A complete list of regulation amendments can be found on the NRC Web site at the 

following address: https://scp.nrc.gov/rss_regamendents.html. 

b. Discussion 

Tennessee became an Agreement State on September 1, 1965. The Tennessee 

Agreement State Program‘s current effective statutory authority is contained in 

Tennessee Code Annotated Title 68, Chapter 202-101 through 202-7-9, of the 

Tennessee Statutes. The Department is designated as the State’s radiation control 

agency. No legislation affecting the radiation control program was passed during the 

review period. 

The State’s administrative rulemaking process takes approximately 12 months from 

drafting to finalizing a rule. The public, NRC, other agencies, and potentially impacted 

licensees and registrants are offered an opportunity to comment during the process. 

Comments are considered and incorporated, as appropriate, before the regulations are 

finalized and approved by the Secretary of State. 

During the review period, Tennessee submitted one final regulation amendment and six 

proposed regulation amendments to the NRC for a compatibility review. Three of these 

proposed amendments are now final regulations. During the onsite review, Tennessee 

submitted these three final regulation amendments to the NRC for review. The 

remaining three amendments will be published for final comment in September 2016. 

Once these regulations are final, Tennessee will submit them to the NRC for review. 
Tennessee Final IMPEP Report Page 11 

At the time of this review, the following two amendments were overdue: 

• “Decommissioning Planning” 10 CFR Parts 20, 30, 40, and 70 amendment (76 FR 

35512), that was due for Agreement State adoption by December 17, 2015. 

• “Requirements for Distribution of Byproduct Material” 10 CFR Parts 30, 31, 32, 40, 

and 70 amendment (77 FR 43666), that was due for Agreement State adoption by 

October 23, 2015. 

c. Evaluation 

The team determined that during the review period Tennessee met the performance 

indicator objectives listed in Section 4.1.a. 

d. Results 

Based on the IMPEP evaluation criteria in MD 5.6, the review team recommended, and 

the MRB agreed, that Tennessee’s performance with respect to the indicator, 

Compatibility Requirements, be found satisfactory. 

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

Adequate technical evaluations of SS&D designs are essential to ensure that SS&Ds will 

maintain their integrity and that the design is adequate to protect public health and 

safety. NUREG-1556, Volume 3, “Consolidated Guidance about Materials Licenses: 

Applications for Sealed Source and Device Evaluation and Registration,” provides 

information on conducting SS&D reviews and establishes useful guidance for review 

teams. Three sub elements; technical staffing and training, technical quality of the 

product evaluation program, and evaluation of defects and incidents regarding SS&D’s, 

will be evaluated to determine if the SS&D program is satisfactory. Agreement States 

with authority for SS&D evaluation programs that are not performing SS&D reviews are 

required to commit in writing to having an SS&D evaluation program in place before 

performing evaluations. 

a. Scope 

The review team used the guidance in State Agreements procedure SA-108, “Reviewing 

the Non-Common Performance Indicator: Sealed Source and Device Evaluation 

Program,” and evaluated Tennessee’s performance with respect to the following 

performance indicator objectives: 

Technical Staffing and Training 

• A well-conceived and balanced staffing strategy has been implemented throughout 

the review period. 

• Qualification criteria for new technical staff are established and are being followed or 

that qualification criteria will be established if new staff members are hired. 

• Any vacancies are filled in a timely manner. 

• Management is committed to training and staff qualification. 

• Individuals performing SS&D evaluation activities are adequately qualified and 

trained to perform their duties.
Tennessee Final IMPEP Report Page 12 

• SS&D reviewers are trained and qualified in a reasonable period of time. 

Technical Quality of the Product Evaluation Program 

• SS&D evaluations are adequate, accurate, complete, clear, specific, and consistent 

with NUREG 1556, Volume 3. 

Evaluation of Defects and Incidents 

• SS&D incidents are reviewed to detect possible manufacturing defects and the root 

causes of these incidents. 

• Incidents are evaluated to determine if other products may be affected by similar 

problems. Appropriate action and notifications to the NRC, Agreement States, and 

others, as appropriate, should occur in a timely manner. 

b. Discussion 

Technical Staffing and Training 

The SS&D program currently has four fully qualified SS&D reviewers. A fifth reviewer is 

in the qualification process and is currently qualified for device reviews but not for source 

reviews. A total of nine staff have attended NRC’s SS&D Workshop including those 

currently qualified, those in the qualification process, as well as four additional staff. At 

the present time, the SS&D program is fully staffed and the Program believes that 

current staffing levels are adequate. The SS&D training program is compatible with the 

training requirements identified in Appendix D to IMC 1248. 

Technical Quality of the Product Evaluation 

Over the review period, the SS&D program issued 20 actions of which 3 were new 

applications and 17 were amendments to existing device sheets. 

The review team evaluated 17 of these actions including 3 new applications and 14 

amendments. The review team determined that in each instance SS&D reviewers 

evaluated the cases against all applicable guidance and standards. The work performed 

by the SS&D reviewers was found to be comprehensive and of high quality. 

Evaluation of Defects and Incidents Regarding SS&Ds 

One event involving a leaking line source used for the calibration of PET/CT devices was 

reported to the Program during the review period. A total of three of these sources have 

been manufactured with this being the only leaking source to date. The Program is 

evaluating the incident for generic implications and the event is still under investigation. 

c. Evaluation 

The team determined that during the review period Tennessee met the performance 

indicator objectives listed in Section 4.2.a.
Tennessee Final IMPEP Report Page 13 

d. Results 

Based on the IMPEP evaluation criteria in MD 5.6, the review team recommended, and 

the MRB agreed, that Tennessee’s performance with respect to the indicator, Sealed 

Source and Device Evaluation Program, be found satisfactory. 

4.3 Low-level Radioactive Waste 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. 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. There are no plans for a LLRW disposal facility in Tennessee. 

Accordingly, the review team did not review this indicator. 

5.0 SUMMARY 

As noted in Sections 3.0 and 4.0 above, Tennessee’s performance was found 

satisfactory for all the performance indicators reviewed. The review team made one 

two-part recommendation regarding program performance by the State. The review 

team recommended, and the MRB agreed, that the State (1) review all waste processor 

licenses to ensure standard license conditions are appropriately applied and consistently 

used, and (2) continue to develop and finalize the licensing guidance for the unique 

activities associated with waste processors. 

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

Agreement State Program be found adequate to protect public health and safety and 

compatible with the 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 5 years. 
LIST OF APPENDICES 

Appendix A IMPEP Review Team Members 

Appendix B Inspection Accompaniments 
APPENDIX A 

IMPEP REVIEW TEAM MEMBERS 

Name Area of Responsibility

Randy Erickson, Region IV Team Leader 

 Technical Quality of Incident and 

 Allegation Activities 

 Inspector Accompaniments 

Donna Janda, Region I Technical Staffing and Training 

 Compatibility Requirements 

 Inspector Accompaniments 

Ryan Craffey, Region III Technical Quality of Inspections 

 Status of the Materials Inspection Program 

Kathy Modes, NMSS Technical Quality of Licensing Actions 

 Inspector Accompaniments 

Nancy Stanley Technical Quality of Licensing Actions 

State of New Jersey 

James Pate Sealed Source and Device Evaluation Program 

State of Louisiana 
 

APPENDIX B 

INSPECTION ACCOMPANIMENTS 

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

Accompaniment No.: 1 License No.: R-73014-H24

License Type: Waste Processor Priority: 2

Inspection Date: 11/17–18/2015 Inspectors: JM/MA

Accompaniment No.: 2 License No.: R-01092-A16

License Type: Industrial Radiography Priority: 1

Inspection Date: 11/19/2015 Inspector: MG

Accompaniment No.: 3 License No.: R-19190-I24

License Type: Radiopharmacy Priority: 2

Inspection Date: 02/22/2016 Inspector: GK

Accompaniment No.: 4 License No.: R-16028-A16

License Type: Medical Diagnostic Priority: 5

Inspection Date: 02/23/2016 Inspector: AP

Accompaniment No.: 5 License No.: R-79056-L16

License Type: HDR/Medical Therapy Priority: 2

Inspection Date: 02/24/2016 Inspector: AG

Accompaniment No.: 6 License No.: R-79313-D20

License Type: Industrial Radiography Priority: 1

Inspection Date: 02/25/2016 Inspector: GS

Accompaniment No.: 7 License No.: R-71029-C21

License Type: Radiopharmacy Priority: 2

Inspection Date: 02/24/16 Inspector: SB

Accompaniment No.: 8 License No.: R-73021-E25

License Type: Service Provider/Waste Collector Priority: 2

Inspection Date: 02/25/16 Inspectors: RM/NM