October 27, 2000

Mr. Jimmy D. Helton

Secretary

Cabinet for Health Services

275 East Main Street, 4th Floor West

Frankfort, Kentucky 40621

Dear Mr. Helton:

On October 24, 2000, the Management Review Board (MRB) met to consider the proposed final

Integrated Materials Performance Evaluation Program (IMPEP) report on the Kentucky

Agreement State Program. The MRB found the Kentucky program adequate to assure public

health and safety and compatible with NRC’s program. 

Section 5.0, pages 15 and 16, of the enclosed final report presents the IMPEP team’s

recommendations. We request your evaluation and response to the recommendations within 30

days from the receipt of this letter.

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

years.

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

support of the Radiation Control Program. I look forward to our agencies continuing to work

cooperatively in the future.

Sincerely,

 /RA/

Carl J. Paperiello

Deputy Executive Director for

 Materials, Research and 

 State and Tribal Programs

Enclosure:

As stated

cc: See next page
Jimmy D. Helton -2- October 27, 2000 

cc: Rice C. Leach, M.D.

Commissioner

Department for Public Health

David Klee, Division Director

Public Health Protection and Safety Division

John A. Volpe, Ph.D.

Manager

Radiation Health and Toxic Agents Branch

Steve Collins, IL

Agreement State Liaison to 

 Management Review Board
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM

REVIEW OF KENTUCKY AGREEMENT STATE PROGRAM

July 17-21, 2000

FINAL REPORT

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

1.0 INTRODUCTION

This report presents the results of the review of the Kentucky radiation control program. The

review was conducted during the period July 17-21, 2000, by a review team comprised of

technical staff members from the Nuclear Regulatory Commission (NRC) and the Agreement

State of South Carolina. 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 a Final General Statement of Policy," published in the

Federal Register on October 16, 1997, and the November 5, 1999, NRC Management Directive

5.6, "Integrated Materials Performance Evaluation Program (IMPEP)." Preliminary results of the

review, which covered the period April 20, 1996 to July 21, 2000 were discussed with Kentucky

management on July 21, 2000.

A draft of this report was issued to Kentucky for factual comment on August 21, 2000. The

Commonwealth responded in a letter dated September 8, 2000. The Management Review Board

(MRB) met on October 24, 2000 to consider the proposed final report. The MRB found the

Kentucky radiation control program was adequate to protect public health and safety and

compatible with NRC’s program.

The Commonwealth of Kentucky program is administered by the Radiation Health and Toxic

Agents Branch (the Branch) and is located within the Cabinet for Health Services (the Cabinet). 

An organization chart for the Branch is included as Appendix B. At the time of the review, the

Kentucky program regulated 396 specific licenses authorizing agreement materials. The review

focused on the materials program as it is carried out under the Section 274b. (of the Atomic

Energy Act of 1954, as amended) Agreement between the NRC and the Commonwealth of

Kentucky.

In preparation for the review, a questionnaire addressing the common and non-common

performance indicators was sent to the Branch on March 16, 2000. The Branch provided a

response to the questionnaire on June 19, 2000. During the review, discussions with the Branch

staff resulted in the responses being further developed. A copy of the questionnaire responses is

included as Appendix G to the proposed final report. 

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

the Branch’s response to the questionnaire; (2) review of applicable Kentucky statutes and

regulations; (3) analysis of quantitative information from the Branch’s licensing and inspection

data base; (4) technical review of selected licensing and inspection actions; (5) field

accompaniments of three Kentucky inspectors; and (6) interviews with staff and management to

answer questions or clarify issues. The team evaluated the information that it gathered against

the IMPEP performance criteria for each common and non-common performance indicator and

made a preliminary assessment of the Branch's performance.

Section 2 below discusses the Branch’s actions in response to recommendations made

following the previous IMPEP review. Results of the current review for the IMPEP common

performance indicators are presented in Section 3. Section 4 discusses results of the applicable

non-common performance indicators, and Section 5 summarizes the review team's findings and

recommendations. Recommendations made by the review team are comments that relate
Kentucky Final Report Page 2 

directly to program performance by the Branch. A response is requested from the Branch to all

recommendations in the final report. 

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS

During the previous IMPEP review, which concluded on April 19, 1996, three recommendations

were made and transmitted to Mr. John H. Morse, Secretary, Cabinet for Health Services, on

August 12, 1996. The team’s review of the current status of these recommendations is as

follows:

1. The review team recommends that the Branch maintain its policy of annual supervisory

accompaniments of all inspectors.

Current Status: Annual accompaniments are performed for all inspectors. In some

cases, these accompaniments are performed more frequently than annually. This

recommendation is closed.

2. The review team recommends that the Branch determine the specific isotope in all

incidents rather than assuming the source to be naturally occurring and accelerator

produced radioactive material (NARM).

Current Status: The Branch uses a portable germanium gamma spectroscopy system

and an Exploranium GR-130 portable multichannel analyzer to perform quantitative

analyses in the field. This recommendation is closed.

3. The review team recommends that the Branch continue with their plan to reassess all

previously issued sealed source and device (SS&D) sheets under their regulatory

jurisdiction to assure that the files contain all current background information and

drawings applicable to the device safety review and to verify and document that generally

licensed devices meet the current dose requirements. This is a recommendation from

the 1995 review visit.

Current Status: The Branch continued with their plan to reassess all previously issued

SS&D sheets by completing the review of one device and anticipates having another

device application forwarded for review in July 2000. However, because of staff turnovers

and the need to train new employees for routine and reactive type inspections, the Branch

elected to evaluate only the applications for device amendments that were needed to stay

current with the device workload and to schedule the re-evaluations as time and

resources permitted. This recommendation is closed.

During the 1996 review, one suggestion was made concerning the Cabinet obtaining necessary

statutory authority to apply civil penalties as an additional enforcement action. The team

determined that the Branch considered the suggestion and took appropriate action.
Kentucky Final Report Page 3 

3.0 COMMON PERFORMANCE INDICATORS

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

and Agreement State programs. These indicators are: (1) Status of Materials Inspection

Program; (2) Technical Quality of Inspections; (3) Technical Staffing and Training; 

(4) Technical Quality of Licensing Actions; and (5) Response to Incidents and Allegations.

3.1 Status of Materials Inspection Program

The team focused on four factors in reviewing this indicator: inspection frequency, overdue

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

licensees. The review team’s evaluation is based on the Kentucky questionnaire responses

relative to this indicator, data gathered independently from the Branch’s licensing and inspection

data tracking system, the examination of complete licensing and inspection casework, and

interviews with managers and staff.

A review of the Branch’s inspection priorities revealed that the inspection frequencies for the

various types of licenses are the same or more frequent than similar license types listed in NRC

Inspection Manual Chapter (IMC) 2800. The Branch may also extend the inspection frequency

based on the compliance history of the licensee. The Branch has a procedure whereby every

three months a listing of inspections due during the next three months is provided to each

inspector. The inspectors use these lists to determine their inspection schedules.

In their response to the questionnaire, the Branch indicated they had only one core inspection

overdue by more than 25% of the NRC frequency and this inspection was completed prior to the

team’s arrival to conduct the current IMPEP review. The team determined that 41 of 250 core

inspections completed since the last IMPEP review had been overdue by more than 25% of the

NRC frequency. The Branch Manager explained that staffing shortages during calendar years

1996 and 1997 had prevented the Branch from completing their inspection goals. The team

noted that only four overdue inspections had occurred since the first quarter of calendar year

1998. 

IMC 2800 states that if a license authorizes activities to be conducted from multiple permanent

field offices (satellite locations of use identified on the license), at least 50% of the field offices

should be inspected at the frequency specified in IMC 2800. The review team’s examination of

inspection casework and the Branch’s inspection manual revealed that the Branch has no written

procedure to inspect permanent field offices and therefore no permanent field offices had ever

been inspected by the Branch. The impact of this is minimal since the license review indicated

that less than five licensees maintain permanent field offices. The review team recommends that

the Branch revise their inspection manual to ensure that core licenses authorizing the conduct of

activities from multiple permanent field offices are inspected at the same frequency as specified

in IMC 2800. 

With respect to initial inspections of new licensees, the team evaluated a list of licensing actions

and determined that there were 44 new licenses issued during the review period. Although the

license review determined that 19 of the initial inspections were conducted more than six months

after issuance of the licenses, the team determined that only two of these instances had

occurred in the last two years. The hiring of additional staff and the Branch’s procedure noted
Kentucky Final Report Page 4 

above to identify the inspections due have been highly effective in improving this aspect of the

materials inspection program.

The timeliness of the issuance of inspection findings was evaluated during the inspection

casework review. Of the 20 cases reviewed by the team, 18 letters transmitting inspection

findings were transmitted to the licensees within 30 days following the inspection. The internal

audit conducted by the Branch determined that 250 core inspections had been completed since

the previous IMPEP review and identified only five cases in which inspection findings were issued

greater than 30 days following the inspection. The two cases reviewed by the team were also

identified in the Branch’s audit.

To evaluate the Branch’s reciprocity inspection program, the review team obtained a computer

printout of data for the years of 1996 through May 2000. With regard to core licensees, the

Branch received 16 requests for reciprocity in 1996; 11 requests for reciprocity in 1997; 14

requests for reciprocity in 1998; 14 requests for reciprocity in 1999; and 7 requests for reciprocity

in 2000 (through May). The Branch performed two core reciprocity inspections in 1996, one in

1997, one in 1998, and none in 1999 and 2000. To meet the goals established in IMC 1220, the

Branch was required to have completed at least 25 core reciprocity inspections. As noted above,

the Branch completed only 4 core reciprocity inspections, and none since 1998. The Branch

Manager explained that staffing shortages during calendar years 1996 and 1997 had prevented

the Branch from completing their inspection goals and that reciprocity inspections were of lower

priority relative to other inspections. He also indicated that an action plan (dated June 12, 2000)

for performing the required number of reciprocity inspections had been written. The review team

recommends that the Branch ensure that reciprocity licenses are inspected in accordance with

the frequency criteria specified in the Branch’s inspection manual.

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

performance with respect to the indicator, Status of the Materials Inspection Program, be found

satisfactory with recommendations for improvement.

3.2 Technical Quality of Inspections

The team evaluated the inspection reports, enforcement documentation, and inspection field

notes and interviewed inspectors for 20 radioactive materials inspections conducted during the

review period. The casework included five of the Branch’s materials license inspectors, and

covered inspections of various types including radiography, medical, academic, portable and

fixed gauges, well logging, mobile nuclear medicine, and nuclear pharmacy. Appendix C lists the

inspection casework files reviewed for completeness and adequacy with case-specific

comments.

The inspection procedures utilized by the Branch are consistent with the inspection guidance

outlined in IMC 2800. The Branch has specific inspection forms for the various types of licensees

and the inspection reports are in a checklist format that adequately cover all inspection areas. 

Narrative reports are completed for all broad scope licensee inspections. The Radioactive

Materials Section Supervisor (the Supervisor) reviews all inspection reports, and a letter

documenting the inspection findings is signed by the Supervisor and issued after each inspection.
Kentucky Final Report Page 5 

It was noted that Kentucky has an adequate number and types of survey meters to support the

current inspection program. Calibrated survey instruments such as GM meters, scintillation

detectors, ion chambers and micro-R meters were observed in the meter cabinet. Inspectors are

not assigned meters, but check out an appropriate meter for the inspection they are performing. 

The meters are calibrated by the manufacturer or a properly licensed facility. The task of ensuring

the survey meters are calibrated has been assigned to a senior member of the inspection staff. 

The Branch also oversees a Radiation/Environmental Monitoring Section which maintains a well

equipped and adequately staffed radiochemistry laboratory facility. 

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

licensee’s radiation programs. The review team found that inspection reports were thorough,

complete, consistent, and of high quality, with sufficient documentation to ensure that licensee’s

performance with respect to health and safety were acceptable. The documentation supported

violations, recommendations made to the licensee, unresolved safety issues, and discussions

held with the licensee during exit interviews. Team inspections were performed when appropriate

and for training purposes.

During the review period, inspector accompaniments were performed by the Supervisor on each

member of the inspection staff at least annually during calendar years 1996, 1998, 1999 and 2000. 

The Branch Manager stated that staff shortages did not permit accompaniments during calendar

year 1997. The inspectors employed by the Branch during 1997 were experienced and had all

been accompanied during 1996. The Branch Manager 

re-initiated accompaniment efforts in January 1998. The review team considered this approach

acceptable.

Three Radioactive Materials Section inspectors were accompanied during inspections by a review

team member during the period of April 24-27, 2000. The accompaniments included a nuclear

pharmacy, one institutional nuclear medicine, and one broad nuclear medicine licensee. These

accompaniments are also identified in Appendix C.

During the accompaniments, each inspector demonstrated appropriate inspection techniques and

knowledge of the regulations. The inspectors were trained, prepared, and thorough in their audits

of the licensees’ radiation safety programs. Overall, each inspector utilized good health physics

practices, their interviews with licensee personnel were performed in an effective manner, and

their inspections were adequate to assess radiological health and safety at the licensed facilities.

Based on the IMPEP evaluation criteria, the review team recommends that Kentucky’s

performance with respect to the indicator, Technical Quality of Inspections, be found satisfactory.

3.3 Technical Staffing and Training

Issues central to the evaluation of this indicator include the Branch’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 Branch’s questionnaire response relative to this

indicator, interviewed program management and staff, and considered any possible workload

backlogs. The team noted that Kentucky does not have a radiation oversight board.

The Branch Manager supervises the activities of the Radioactive Materials Section, the Radiation
Kentucky Final Report Page 6 

Producing Machines Section, and the Environmental Monitoring Section. Information provided by

the Branch indicates that 3 of the 4 staff in the Radioactive Materials Section departed during the

review period. The three positions were filled within 9, 13, and 2 months of becoming vacant. The

Branch Manager also informed the team that a new Branch position, approved in 1999, is not yet

filled because he is determining how to integrate the position into one or more of the Branch’s

sections. 

The review team found that the current staffing level is adequate to administer the basic regulatory

program, as evidenced by the significant reduction of backlogs in inspections and lack of backlogs

in licensing. However, according to the Branch Manager, providing support on issues concerning

the Paducah Gaseous Diffusion Plant currently requires approximately 50% of his time. 

Furthermore, complex licensing and compliance cases, complicated investigations, specialized

training needs, and frequent revisions to regulations continue to require the use of overtime and

delayed leave usage by the supervisors and staff. The Branch Manager indicated that he

anticipates the Supervisor becoming a part-time employee (4 days per week) in the near future

and retiring in the latter part of 2001. He also stated that a senior Materials Specialist retired from

the Branch on July 31, 2000 and that the vacancy was immediately filled by a junior Materials

Specialist from within the Branch. The resulting junior Materials Specialist vacancy is expected to

be filled by the end of 2000.

The licensing and inspection functions of the program are integrated such that all Materials

Specialists perform duties in licensing, inspection, and event response. Balance between the

licensing and inspection functions is achieved by basing staff assignments on program needs.

Technical staffing and training for the SS&D program is addressed in Section 4.2.2. Technical

staffing and training for the low-level radioactive waste disposal program is addressed in Section

4.3.3.

From Branch Manager interviews and review of the job descriptions, the team determined that

successful candidates for technical positions are required to have a Bachelor’s degree in science,

or an equivalent, for entry level positions and a Master’s degree and/or additional radiation-related

work experience for steps beyond the entry level. From review of the technical qualifications of the

current Radioactive Materials Section staff, the team concluded that the Branch has been able to

recruit qualified individuals. All of the Materials Specialists and the Supervisor have Bachelor’s

degrees in science; and the Branch Manager has a Ph.D.

The Branch has a written training program for license reviewers and inspectors which is based

upon the requirements specified in IMC 1246 and the Final Report of the NRC/OAS Training

Working Group Recommendations for Agreement State Training Programs (the NRC/OAS

Report). The Branch’s documentation of training does not include supervisory sign off for

completed areas of training as required in the NRC/OAS Report. The documentation also

indicates that, with one exception, all Section staff members have taken the required basic training

courses and continue to take specialized training courses as available. The exception noted was

that the training documentation for a junior Materials Specialist, who appeared to have the training

and experience equivalent to two of the basic courses, did not indicate that the Specialist had

completed the two basic courses or their equivalent. The team recommends that the Branch

revise their training program to include documentation of staff’s equivalent training and experience

in lieu of completing a required basic training course, including supervisory sign off for each

completed area of training.
Kentucky Final Report Page 7 

New staff are assigned independent inspections after demonstrating competence during

accompaniment evaluations and by use of written and oral examinations by the Supervisor. New

staff are assigned increasingly complex licensing duties under the direction of senior staff and

accompany experienced inspectors during increasingly complicated inspections. The 

Supervisor reviews the licensing work performed by the junior personnel and accompanies them

during inspections to assure regulatory consistency and quality of work performed. The team

determined that the program has a well balanced staff, confirmed the qualifications of the staff

hired since the l996 IMPEP review, and verified staff performance through licensing and

compliance casework and inspection accompaniments. The Branch Manager expressed a strong

commitment to training.

Based on the IMPEP evaluation criteria, the review team recommends that Kentucky’s

performance with respect to the indicator, Technical Staffing and Training, be found satisfactory.

3.4 Technical Quality of Licensing Actions

The review team examined completed licensing casework and interviewed staff for 18 specific

licenses. Licensing actions were evaluated for completeness, consistency, proper isotopes and

quantities used, qualifications of authorized users, adequate facilities and equipment, and

operating and emergency procedures sufficient to establish the basis for licensing actions. 

Licenses were evaluated for overall technical quality including accuracy, appropriateness of the

license, its conditions, and tie-down conditions. Casework was evaluated for timeliness;

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

of safety evaluation reports; product certifications or other supporting documents; consideration of

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

proper signature authority. 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 sampling included the following types: industrial

radiography, medical (institution and private practice), nuclear pharmacy, medical and academic

broad scope, portable and fixed gauge, teletherapy, well logging, mobile nuclear medicine, and a

self-shielded irradiator. Types of licensing actions selected for evaluation included four new

licenses, six amendments to existing licenses, six license renewals, and two license terminations. 

In discussions with the Supervisor, it was noted that there were no major decommissioning efforts

underway with regard to agreement material in Kentucky. A list of the licenses evaluated with

case-specific comments can be found in Appendix D.

The casework evaluation indicated that the staff follows appropriate licensing guides during the

review process to ensure that licensees submit information necessary to support their request. 

The review team found the licensing checklists used for each type of program to be

comprehensive with the exception that the requirement for alarming ratemeters was not in the

industrial radiography checklist. The Branch revised the checklist accordingly during the week of

the review. Deficiencies were addressed by letters and documented telephone conversations

containing appropriate regulatory language. License templates are currently under development

and were not yet available for use by the staff, however, notable consistency between reviewers

was observed. The Branch Manager signs each licensing action. The review team found that the

licensing actions were thorough, complete, consistent, of high quality and properly addressed
Kentucky Final Report Page 8 

health and safety issues. 

The questionnaire listed nine major licenses that had been amended (or are now in the process of

being amended) in their entirety during the review period, two of which were identified by the

Branch as requiring financial assurance for decommissioning. The review team identified a third

license, which had already been renewed, as needing financial assurance and there was no such

assurance in place. This was discussed with the Supervisor who indicated that there had been

verbal communication with the licensee on the financial assurance requirements and that

Kentucky is in the process of assessing the need for a decommissioning funding plan. 

Based on the IMPEP evaluation criteria, the review team recommends that Kentucky’s

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

satisfactory.

3.5 Response to Incidents and Allegations

In evaluating the effectiveness of the Branch’s actions in responding to incidents, the review team

examined the Branch’s response to the questionnaire relative to this indicator, evaluated selected

incidents reported for Kentucky in the Nuclear Material Events Database (NMED) against those

contained in the Kentucky files, and evaluated the casework and supporting documentation for ten

material incidents. A list of the incident casework examined with the case-specific comments is

included in Appendix E. The team also reviewed the Branch’s response to 17 allegations involving

radioactive materials including six allegations referred to the Commonwealth by NRC during the

review period.

The review team discussed the Branch’s incident and allegation procedure, file documentation,

the Commonwealth’s equivalent to the Freedom of Information Act, NMED, and notification of

incidents to the NRC Operations Center with the Branch Manager and selected staff.

Event calls or reports are handled by the individual receiving the notification, or are assigned to

another staff member by the Supervisor. The Supervisor is informed of the initial call and any

subsequent follow up or resolution of the case. A tracking form is utilized for tracking the status of

incidents and allegations and to record information on the initial report, any additional information

or action needed, closure date, and the Supervisor’s signature. 

The Branch had 18 significant radioactive materials incidents (those that are reportable

immediately or within 24 hours) during the review period and 10 were selected for review. The

incidents included: loss of radioactive material, damaged devices, misadministrations and

contamination events. The review team found that the Branch’s response to incidents was

complete and comprehensive. Initial responses were prompt and well-coordinated. The level of

effort was commensurate with the health and safety significance. Inspectors were dispatched for

on-site investigations when appropriate and the Branch took suitable enforcement action including

coordination with the license reviewers, other agencies, and follow up, as appropriate.

The Branch has been submitting event information to NRC via hard copy to the Office of State and

Tribal Programs as event information is developed. The Branch has the current software and a

computer system to submit event data directly to NMED; however, the person trained for the

NMED data entry left the Branch in 1999 and a replacement has not been trained. The team
Kentucky Final Report Page 9 

discussed the upgrade to the NMED system software scheduled for later this fiscal year and the

benefits of direct entry of incident data into the system with the Branch Manager and the

Supervisor. The team encouraged the Branch to install the NMED software and to train staff to

enter the event data.

During the review period, the Branch received 17 allegations/complaints, six of which were

referred to the Branch by NRC. The casework for all allegations was reviewed. The review of the

casework and the Branch’s files indicated that the Branch took prompt and appropriate action in

response to the concerns raised. All of the allegations reviewed were appropriately closed and the

team noted that allegations were treated and documented internally in the same manner as

incidents. There were no performance issues identified from the review of the casework

documentation. Although the Branch makes an effort to protect the identity of an alleger, the team

noted that Kentucky law requires that all public documents be made available for inspection and

copying unless specifically exempted from disclosure under Kentucky’s Open Records Act. The

Branch procedure, “Availability of Files to the Public,” Section 414, Title 400, of their Administrative

Manual provides guidance to the staff on public documents. 

Based on the IMPEP evaluation criteria, the review team recommends that Kentucky’s

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

satisfactory.

4.0 NON-COMMON PERFORMANCE INDICATORS

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

State programs: (1) Legislation and Program Elements Required for Compatibility; (2) Sealed

Source and Device Evaluation Program; (3) Low-Level Radioactive Waste Disposal Program; and

(4) Uranium Recovery Program. Kentucky's Agreement does not cover uranium recovery, so only

the first three non-common performance indicators were applicable to this review.

4.1 Legislation and Program Elements Required for Compatibility

4.1.1 Legislation

Along with their response to the questionnaire, the Branch provided the review team with the

opportunity to review copies of legislation that affects the radiation control program. Legislative

authority to create an agency and enter into an agreement with the NRC is granted in Kentucky

Revised Statutes (KRS) Title XVIII, Chapter 211, which names the Cabinet as the radiation control

agency of the Commonwealth of Kentucky. Chapter 211 also authorizes the Cabinet to regulate

the registration and licensing of the possession or use of any sources of ionizing or electronic

product radiation and the handling and disposal of radioactive waste and to fix fees and charges. 

The Branch is designated as the Commonwealth’s radiation control agency. The review team

noted that no legislation affecting the radiation control program was passed since being found

adequate during the previous review, and found that the Commonwealth’s legislation is adequate.

4.1.2 Program Elements Required for Compatibility

The Kentucky Regulations for Control of Radiation are located in 902 Kentucky Administrative
Kentucky Final Report Page 10 

Regulations (KAR) Chapter 100, Regulations for Radioactive Materials, and apply to all ionizing

radiation, whether emitted from radionuclides or devices. Kentucky requires a license for

possession, and use, of all radioactive material including naturally occurring materials, such as

radium, and accelerator-produced radionuclides. 

The review team examined the procedures used in the Branch’s regulatory process and found that

the public and other interested parties are offered an opportunity to comment on proposed rules

throughout the process. The NRC is provided with drafts for comment on the proposed rules early

in the promulgation process. The proposed rules are forwarded to the Legislative Research

Commission for review and approval. The regulations are then implemented by the Cabinet. 

Typically, rule promulgation requires 9 to 12 months, including drafting of revisions. The Cabinet’s

regulations are not the subject of “sunset” laws.

The team evaluated Kentucky’s responses to the questionnaire, reviewed the status of regulations

required to be adopted by the Commonwealth under the Commission’s Adequacy and

Compatibility Policy, and verified the adoption of regulations with data obtained from the Office of

State and Tribal Programs Regulation Assessment Tracking System.

The team identified the following regulation changes and adoptions that will be needed in the

future. 

! “Performance Requirements for Radiography Equipment,” 10 CFR Part 34 amendment

(60 FR 28323) that became effective June 30, 1995.

! “Clarification of Decommissioning Funding Requirements” - 10 CFR Parts 30, 40, and 70

amendments (60 FR 38235) that became effective November 24, 1995.

! “10 CFR Part 71: Compatibility with the International Atomic Energy Agency” - 

10 CFR Part 71 amendment (60 FR 50248 and 61 FR 28724) that became effective April

1,1996.

! “Recognition of Agreement State Licenses in Areas Under Exclusive Federal Jurisdiction

Within an Agreement State,” 10 CFR Part 150 amendment (62 FR 1662) that became

effective February 27, 1997.

! “Licenses for Industrial Radiography and Radiation Safety - Requirements for Industrial

Radiography Operations,” 10 CFR Parts 30, 34, 71, and 150 amendments 

(62 FR 28947) that became effective June 27, 1997.

! “Radiological Criteria for License Termination,” 10 CFR Parts 20, 30, 40, and 70

amendments (62 FR 39057) that became effective August 20, 1997.

! “Low-Level Waste Shipment Manifest Information and Reporting,” 10 CFR Parts 20 and

61amendments (60 FR 15649 and 25983) that became effective March 1, 1998.

! “Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon-14 Urea,”

10 CFR Part 30 amendment (62 FR 63634) that became effective January 2, 1998.
Kentucky Final Report Page 11 

! “Minor Corrections, Clarifying Changes, and a Minor Policy Change” - 10 CFR Parts 20,

35, and 36 amendments (63 FR 39347 and 63 FR 45393) that became effective October

26, 1998.

! “Transfer for Disposal and Manifests: Minor Technical Conforming Amendment” - 10 CFR

Part 20 amendment (63 FR 50127) that became effective November 20, 1998.

! “Deliberate Misconduct by Unlicensed Persons,” 10 CFR Parts 30, 40, 61, 70, and 150

amendments (63 FR 1890 and 13773) that became effective February 12, 1998.

! “License for Industrial Radiography and Radiation Safety Requirements for Industrial

Radiographic Operations; Clarifying Amendments and Corrections,” 10 CFR Part 34

amendment (63 FR 37059) that became effective July 9, 1998.

! “Termination of Transfer of Licensed Activities: Recordkeeping Requirements” - 10 CFR

Parts 20, 30, 40, 61, and 70 amendments (61 FR 24669) that became effective June 17,

1999.

! “Respiratory Protection and Controls to Restrict Internal Exposures,” 10 CFR Part 20

amendment (64 FR 54543 and 64 FR 55524) that became effective February 2, 2000.

! “Energy Compensation Sources for Well Logging and Other Regulatory Clarifications” - 10

CFR Part 39 amendment (65 FR20337) that became effective May 17, 2000.

The team reminded the Branch Manager that, in accordance with Management Directive 5.9,

Handbook, Part V, (1)(C)(III), and the Commission Policy Statement on Adequacy and

Compatibility, that the first seven regulations listed above should be adopted by the

Commonwealth as expeditiously as possible to comply with the September 3, 2000 deadline.

Three of the seven regulations have been submitted to NRC in a proposed form. The Supervisor

indicated that the other four regulations have been drafted, or are in the process of being drafted,

and anticipates their adoption no later than December 31, 2000. The Branch plans to adopt the

other eight regulations, which are due during the period of January 2001 through May 2003, in a

timely manner. The Branch Manager related to the team that the revisions to the regulations

would tax the staff and require significant overtime to complete.

Based on the IMPEP evaluation criteria, the review team recommends that Kentucky’s

performance with respect to the indicator, Legislation and Program Elements Required for

Compatibility, be found satisfactory.

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

In assessing the Branch's SS&D evaluation program, the review team examined information

provided by the Branch in response to the IMPEP questionnaire on this indicator. The team

observed the staff's use of guidance documents and procedures, interviewed the Supervisor and

Branch Manager involved in SS&D evaluations, and verified the use of regulations and license

conditions to enforce commitments made in the applications. 
Kentucky Final Report Page 12 

4.2.1 Technical Quality of the Product Evaluation Program

The Branch reviewed two new devices and issued SS&D sheets, as generally licensed devices. 

The team noted that the Branch currently has only one device manufacturer with 11 registrations,

and that the processing of the two new registrations and one amended registration from the same

manufacturer would provide a regulatory assessment of the manufacturer’s overall safety and

quality control program. The Branch will continue their re-evaluation of the seven other

registrations as their workload permits, and the Branch Manager estimated that two re-evaluations

could be accomplished per year. The team recommends that the Branch commit the necessary

resources to complete all the SS&D registry re-evaluations prior to the next IMPEP review period.

The review team selected the one amendment and the two new SS&D applications for review. 

The review included all amendments, supporting documentation, licenses, and inspections

associated with each of the registrations selected. The three certificates reviewed covered the

period since the last program review in April of 1996 and represented cases completed by the 

principal reviewer. 

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

recommended guidance from the NRC SS&D training workshops and the NUREG-1556, Volume

3, issued September 1997. The SS&D review checklist from the NRC SS&D workshop and

NUREG-1556 are used to assure all relevant information has been submitted and reviewed. The

checklists were contained in the registration files. All pertinent ANSI Standards, Regulatory

Guides, and references were confirmed to be available and are used when performing SS&D

reviews. The Branch’s SS&D reviewer related that non-AEA material reviews would be performed

in the same procedural manner using the same references as used for AEA sources and devices.

The registration files contained all correspondence, photographs, engineering drawings, radiation

profiles, and results of tests conducted by the applicant. The registrations clearly summarized the

product evaluation to provide license reviewers with adequate information to license possession

and use of the product. Deficiency letters clearly stated regulatory positions and all health and

safety issues were properly addressed. The team determined that the product evaluations were

thorough, complete, consistent, of acceptable technical quality, and adequately addressed the

integrity of the products during use and in the event of an accident.

4.2.2 Technical Staffing and Training

The Supervisor reviews and signs all registration sheets and a concurrence review is performed

by the Branch Manager. The Supervisor has a Bachelor of Science Degree, several years

experience in health physics and in performing SS& D reviews, and has attended the NRC/State

SS&D workshop. The Branch Manager has a Ph.D. in Chemistry, several years experience in the

regulatory program, serves as the Commonwealth’s consultant on radiation matters, and has also

attended the NRC/State SS&D workshop. The Branch Manager and the Supervisor are

committed to maintaining a high degree of quality in their SS&D reviews. The team determined

that the reviewers meet the technical training required for SS&D reviews as described under the

guidance. The Branch Manager indicated that a Branch staff member would be trained for SS&D

reviews, and that an additional SS&D workshop is needed.

4.2.3 Evaluation of Defects and Incidents Regarding SS&Ds
Kentucky Final Report Page 13 

There were two incidents related to the use of Ronan devices during the review period. These

events are listed under Appendix E. The team believes that these incidents were isolated and

there is no evidence that the events were generic in nature. An NMED system search of the

manufacturer was conducted by the team and no other incidents were identified that were related

to any malfunctioning devices or products during this review period. 

Based on the IMPEP evaluation criteria, the review team recommends that Kentucky’s

performance with respect to the indicator, Sealed Source and Device Evaluation Program, be

found satisfactory.

4.3 Low-Level Radioactive Waste (LLRW) Disposal Program

Background information on the Maxey Flats Disposal Site (the site) was detailed in the previous

1996 IMPEP review. The site was opened in January 1963 and operated through December of

1977. In 1978, the Commonwealth of Kentucky’s Natural Resources and Environmental

Protection Cabinet (NREPC) assumed responsibility for management and operations of the site. 

Regulatory responsibility for the site’s radiation safety program rests with the Cabinet. On

October 7, 1991, Kentucky was notified by the U.S. Environmental Protection Agency (EPA) that

the site had been approved for remedial action under the Comprehensive Environmental

Response, Compensation, and Liability Act (Superfund). 

4.3.1 Status of Low-Level Radioactive Waste Disposal Inspection

The Branch's frequency of inspection for the site is every two years, and the team noted that NRC

does not have an inspection frequency for closed LLRW sites. Following the April 1996 IMPEP

review, the Branch conducted formal inspections of the site in July of 1996 and again on February

24, 2000. No formal inspection was conducted in 1998 due to staffing issues, however, the

Branch Manager emphasized that other oversight activities such as on-site sample collection

were being performed on a monthly basis. The Branch Manager committed that the inspection

frequency would remain on two year frequency. Bi-monthly site visits for environmental sampling

and monitoring purposes are conducted by the Radiation/Environmental Monitoring Section

laboratory staff and the Branch Manager accompanies the laboratory staff at least once a quarter. 

In addition, NREPC conducts quarterly inspections at the site and provides detailed reports to the

EPA and the Branch. The Branch Manager related that he personally reviews the reports in detail. 

These monthly and quarterly reports were reviewed by the team for content and the full inspection

reports conducted by the Branch were reviewed in detail. 

4.3.2 Technical Quality of Inspections

Inspection and enforcement is handled in the same manner as the other Branch licensees. In

addition to the laboratory equipment discussed under Section 3.2, the Branch maintains a variety

of calibrated instrumentation, including micro R meters, and a portable multichannel analyzer,

which are used at the site. The laboratory has the capability of analyzing all required types of

environmental media. 

The inspection reports covered the scope, completeness, and technical accuracy necessary to

determine compliance with regulations, license conditions, and available guidance. The reports

provided details on the licensee organization, work performed under licensed procedures,
Kentucky Final Report Page 14 

personnel and training of on-site personnel, access control, personnel monitoring, contamination

control, protective equipment, environmental monitoring, trench cap inspections, and site

emergencies and incidents. The review team found that the inspection reports were thorough,

complete, consistent and of high quality, with sufficient documentation to ensure that the site’s

performance with respect to health and safety was acceptable.

Branch inspectors communicated inspection findings to the licensee in a timely fashion,

documented licensee responses to inspection findings, and closed outstanding inspection

issues. The Branch Manager participated in preparation, review and approval of the inspection

reports.

4.3.3 Technical Staffing and Training

The Branch Manager and the Supervisor, whose training and experience are discussed in Section

3.3, also serve as the LLRW site reviewers and inspectors. They have many years of experience

regulating this licensee. The review team believes they are both fully qualified for their

responsibilities.

 

The six laboratory technical staff involved with the site project consist of a Ph.D. biochemist, a

mechanical engineer, a hydrologist, and three chemists, all who have been trained in

radiochemistry, environmental sampling, and analysis and evaluation. Based on the previous

1996 IMPEP and the team’s discussion with the Branch manager, it was determined that the

qualifications of the technical staff are commensurate with expertise identified as necessary to

regulate a LLRW disposal facility. The Branch Manager has developed and conducted health and

safety training for the staff and other personnel involved in the daily operations at the site. 

4.3.4 Technical Quality of Licensing Actions

The license was revised on July 19, 2000 and will be due for amendment in its entirety by 

June 30, 2001. In examining the license and background information in the file, the review team

found that the license: (1) meets standard licensing practices (activity, location, RSO, regulations,

tie-downs, etc.); (2) ties the license to Kentucky regulations, including the equivalent Part 61; (3)

limits operations to maintenance, remedial, and monitoring activities; 

(4) precludes receipt or disposal of waste; (5) limits possession to existing material and

addresses possible form changes; and (6) requires qualified personnel to be designated in writing

before working on site.

The tie down conditions properly cite the renewal application, the radiological protection program,

specified radiological procedures, the Superfund consent decree Statement of Work, and other

documents as appropriate. The license file was complete with all background documents.

Applicable guidance documents such as the NUREG that support 10 CFR 61 are available and

used as needed. Overall, the team found that the DRWM licensing actions were very thorough,

complete, consistent, of high quality and properly addressed health and safety issues.

4.3.5 Response to Incidents and Allegations

There were no reportable incidents or allegations pertaining to the Branch’s LLRW program
Kentucky Final Report Page 15 

activities during the review period. The Branch Manager explained to the review team that

incidents and allegations relating to the site would be handled in the same manner as those

pertaining to any materials licensee.

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

performance with respect to the indicator, Low-Level Radioactive Waste Disposal Program, be

found satisfactory.

5.0 SUMMARY

As noted in Sections 3 and 4 above, the review team found Kentucky’s performance to be

satisfactory with recommendations for improvement in the Status of Materials Inspection Program

performance indicator and satisfactory for the remaining eight performance indicators. 

Accordingly, the review team recommended and the MRB concurred in finding the Kentucky

Agreement State program to be adequate to protect public health and compatible with NRC's

program. Based on the results of the current IMPEP review, the next full review will be in

approximately four years.

Below is a summary list of recommendations, as mentioned in earlier sections of the report, for

evaluation and implementation, as appropriate, by the Commonwealth. 

RECOMMENDATIONS:

1. The review team recommends that the Branch revise their inspection manual to ensure

that core licenses authorizing the conduct of activities from multiple permanent field offices

are inspected at the same frequency as specified in IMC 2800. (Section 3.1) 

2. The review team recommends that the Branch ensure that reciprocity licenses are

inspected in accordance with the frequency criteria specified in the Branch’s inspection

manual. (Section 3.1)

3. The team recommends that the Branch revise their training program to include

documentation of staff’s equivalent training and experience in lieu of completing a required

basic training course, including supervisory sign off for each completed area of training. 

(Section 3.3)

4. The team recommends that the Branch commit the necessary resources to complete all

the SS&D registry re-evaluations prior to the next IMPEP review period. (Section 4.2.1)
LIST OF APPENDICES AND ATTACHMENTS

Appendix A IMPEP Review Team Members

Appendix B Kentucky Organization Charts

Appendix C Inspection Casework Reviews

Appendix D License Casework Reviews

Appendix E Incident Casework Reviews

Appendix F Sealed Source & Device Casework Reviews

Attachment September 8, 2000 letter from Jimmy D. Helton

Kentucky Response to Draft IMPEP Report
APPENDIX A

IMPEP REVIEW TEAM MEMBERS

Name Area of Responsibility

Thomas O’Brien, STP Team Leader

Technical Staffing and Training

 Legislation and Program Elements Required 

for Compatibility 

Richard Woodruff, Region II Response to Incidents and Allegations 

Sealed Source and Device Evaluation Program

LLRW Disposal Program

Jeffrey Cruz, Region IV Technical Quality of Inspections

Status of Materials Inspection Program

James Peterson, SC Technical Quality of Licensing Actions
APPENDIX B

KENTUCKY DEPARTMENT FOR PUBLIC HEALTH

and

RADIATION HEALTH AND TOXIC AGENTS BRANCH

ORGANIZATION CHARTS

(ML003742489)


ATTACHMENT

ML003760456

SEPTEMBER 8, 2000 LETTER FROM JIMMY D. HELTON

KENTUCKY RESPONSE TO DRAFT IMPEP REPORT