November 30, 2004 

William G. Ross, Secretary 

North Carolina Department of Environment

 and Natural Resources 

1601 Mail Service Center 

Raleigh, NC 27699-1601 

Dear Mr. Ross:

On November 1, 2004, the Management Review Board (MRB) met to consider the proposed

final Integrated Materials Performance Evaluation Program (IMPEP) report on the North

Carolina Agreement State Program. The MRB found the North Carolina program adequate to

protect public health and safety and compatible with the U.S. Nuclear Regulatory Commission’s

program.

Section 5.0, page 15, of the enclosed final report presents the IMPEP team’s recommendation

for the State of North Carolina. We request your evaluation and response to the

recommendations within 30 days from receipt of this letter.

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

four years.

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

I also wish to acknowledge your continued support for the Radiation Control Program and the

excellence in program administration demonstrated by your staff, as reflected in the team’s

findings. I look forward to our agencies continuing to work cooperatively in the future.

Sincerely, 

/RA/

Martin J. Virgilio 

Deputy Executive Director

 for Materials, Research and State Programs 

Enclosure: 

As stated 

cc: Terry Pierce, Director 

Division of Environmental Health 

Beverly Hall, Chief 

Radiation Protection Section 

Michael Kelly, Deputy Director 

Division of Environmental Health 

Walter L. Cox, III, Manager 

Radioactive Materials Branch 

Pearce O’Kelley, SC 

OAS Liaison to the MRB 
William G. Ross 

bcc: Chairman Diaz

Commissioner McGaffigan

Commissioner Merrifield

Distribution: 

DIR RF DCD (SP01) PDR (YEST) 

KSchneider, STP 

JZabko, STP 

AMcCraw, STP 

ISchoenfeld, OEDO 

CMiller, NMSS/IMNS 

RStuckmeyer, NMSS/IMNS 

DWhite, RI 

OSiurano, STP 

SLodhi, RI 

Josh Daehler, MA 

STreby, OGC 

DOCUMENT NAME: E:\Filenet\ML043340258.wpd

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OFFICE STP STP:DD STP:D DEDMRS 

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(PHLohaus for) 

PHLohaus MJVirgilio 

DATE 11/23/04 11/26/04 11/26/04 11/30/04 

OFFICIAL RECORD COPY
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM

REVIEW OF NORTH CAROLINA AGREEMENT STATE PROGRAM

August 16 - 20, 2004

 FINAL REPORT 

U.S. Nuclear Regulatory Commission 
North Carolina Final Report Page 1 

1.0 INTRODUCTION 

This report presents the results of the review of the North Carolina Agreement State program. 

The review was conducted during the period of August 16-20, 2004, by a review team 

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

Agreement State of Massachusetts. 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 February 26, 2004, NRC Management Directive 

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

the review, which covered the period of September 18, 2000 to August 20, 2004 were 

discussed with North Carolina management on August 20, 2004. 

A draft of this report was issued to North Carolina for factual comment on September 21, 2004. 

The State responded by memorandum dated October 11, 2004. The Management Review 

Board (MRB) met on November 1, 2004 to consider the proposed final report. The MRB found 

the North Carolina radiation control program adequate to protect public health and safety and 

compatible with NRC's program. 

The North Carolina Agreement State program is administered by the Radiation Protection 

Section (the Section) within the Division of Environmental Health (the Division), which is part of 

the Department of Environment and Natural Resources (the Department). Within the Section, 

the Radioactive Materials Branch (the Branch) administers the radioactive materials program 

under the Agreement. In addition, the Section’s newly created Emergency Response and 

Environmental Branch, formerly the Environmental Radiation Branch, responds to all nonlicensed radioactive material incidents. 

Organization charts for the Department, the Division, Section, and the Branch are included in 

the report as Appendix B. The North Carolina Agreement program regulates approximately 751 

specific licenses authorizing radioactive materials. The review focused on the program as it is 

carried out under the Section 274b. (of the Atomic Energy Act of 1954, as amended) 

Agreement between the NRC and the State of North Carolina. 

In preparation for the review, a copy of the recently revised IMPEP questionnaire was sent to 

the Section on June 3, 2004. The Branch provided a response to the questionnaire on July 26, 

2004. A copy of the State’s questionnaire response can be found on NRC’s Agencywide 

Document Access and Management System using the Accession Number ML042160130. 

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

North Carolina's response to the questionnaire; (2) review of applicable North Carolina statutes 

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

inspection database; (4) technical evaluation of selected licensing and inspection actions; (5) 

field accompaniments of two North Carolina inspectors; and (6) interviews with staff and 

management to answer questions or clarify issues. The review team evaluated the information 

that it gathered against the IMPEP performance criteria for each common and applicable noncommon performance indicator and made a preliminary assessment of the radiation control 

program’s performance. 
North Carolina Final Report Page 2 

Section 2 discusses the State’s actions in response to previous IMPEP review 

recommendations and the review team’s conclusions regarding the closure of those 

recommendations. Results of the current review for the IMPEP common performance 

indicators are presented in Section 3. Section 4 discusses results of the applicable noncommon performance indicators, and Section 5 summarizes the review team's findings and 

recommendations. Recommendations made by the review team are comments that relate 

directly to program performance by the Section. A response is requested from the Department 

to all recommendations in the final report. 

2.0 STATUS OF ITEMS IDENTIFIED IN THE PREVIOUS REVIEW 

During the previous IMPEP review, which concluded on September 22, 2000, seven 

recommendations were made and the results transmitted to Robin Smith, Assistant Secretary, 

Department of Environment and Natural Resources, on December 20, 2000. The review 

team’s evaluation of the current status of the recommendations is as follows: 

1. The review team recommends that the Branch change the inspection frequency of 

nuclear pharmacies from a Priority 2 to a Priority 1 in accordance with NRC’s Inspection 

Manual Chapter (IMC) 2800 and conduct inspections at the appropriate frequency. 

(Section 3.1) 

Current Status: The Section revised the inspection frequency priority and it is consistent 

with the current NRC IMC 2800 criteria. This recommendation is closed. 

2. The review team recommends that the Branch meet the reciprocity inspection frequency 

goals specified in NRC IMC 1220. (Section 3.1) 

Current Status: The Section exceeded the reciprocity inspection frequency goals 

specified in NRC IMC 1220 for the review period. This recommendation is closed. 

3. The review team recommends that staff who conduct independent inspections and/or 

license reviews of teletherapy and brachytherapy licenses and irradiator licenses 

complete the teletherapy/brachytherapy course and irradiator course, or their equivalent. 

(Section 3.3) 

Current Status: The review team examined the Branch’s training records for the staff 

performing teletherapy/brachytherapy and irradiator inspections. In addition the review 

team accompanied two Branch inspectors during medical inspections that included 

brachytherapy. The review team noted that staff training records document on the job 

training. No performance issues were identified during the accompaniments. This 

recommendation is closed. 

4. The review team recommends that a formalized, written training program based upon 

the requirements specified in NRC IMC 1246 or “NRC/Organization of Agreement 

States Training Working Group Recommendations for Agreement State Training 

Programs,” be developed for license reviewers and inspectors. (Section 3.3) 
North Carolina Final Report Page 3 

Current Status: The review team noted that the current staff is trained in accordance 

with the requirements specified in NRC IMC 1246 or “NRC/Organization of Agreement 

States Training Working Group Recommendations for Agreement State Training 

Programs,” and formal documentation of staff training is in place. The Branch’s training 

policy and procedures are found in Policy and Procedure Statement T-001-R, Health 

Physicist Training Program. The Branch uses a mentoring program for training in 

several areas. This recommendation is closed. 

5. The review team recommends that the Nuclear Material Events Database (NMED) data 

be updated to reflect the status and close out of cases as appropriate, and that incident 

data be provided to the NRC in accordance with STP Procedure SA-300. (Section 3.5) 

Current Status: The review team noted that the Branch is providing incident data to 

NMED within 24 hours, when appropriate, and on a monthly basis for routine incidents. 

The events are closed in NMED as appropriate. This recommendation is closed. 

6. The review team recommends that all registration certificates reference the specific 

documents which were reviewed during the safety evaluation. (Section 4.2) 

Current Status: Each registration certificate issued during the review period references 

the specific documents reviewed during the safety evaluations. This recommendation is 

closed. 

7. The review team recommends that the Branch develop a tracking system to follow the 

status of Sealed Source and Device (SS&D) actions. (Section 4.2) 

Current Status: The team confirmed that the Branch has implemented a tracking 

system; however, the tracking system was only functional with test data. This 

recommendation is closed, but the review team’s concerns regarding the Branch’s 

databases are discussed further is Sections 3.2, Status of the Materials Inspection 

Program and Section 4.2.2, Technical Quality of the Product Evaluation Program. The 

review team made a new recommendation in Section 3.2. 

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) Technical Staffing and 

Training (2) Status of Materials Inspection Program; (3) Technical Quality of Inspections; (4) 

Technical Quality of Licensing Actions; and (5) Technical Quality of Incident and Allegation 

Activities. 

3.1 Technical Staffing and Training 

Issues central to the evaluation of this indicator include the Section’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 Section’s management and staff, reviewed job descriptions and training 

records, and considered any possible workload backlogs. 
North Carolina Final Report Page 4 

The Branch devotes approximately 8.5 full time equivalent (FTE) to the radioactive materials 

program of which 7 FTE are allotted to radioactive materials licensing, inspection, compliance 

and SS&D programs. The remaining 1.5 FTE includes program administration and emergency 

response. The Emergency Response and Environmental Branch staffing level supporting the 

Section’s initial emergency response to all radiological incidents is six FTE, including a 

supervisor. Additionally, the Section uses about 25 percent of the FTE of the Special Technical 

Projects staff member for the development of regulations. 

The Branch currently has no vacant positions. One individual transferred from the Branch to 

the Emergency Response and Environmental Branch and a new staff member was hired a year 

ago. Although the Section was re-designated and downsized from a Division since the last 

review, this change did not significantly affect the Branch’s overall responsibilities or workload. 

The review team concluded that staffing under the new arrangement is adequate for the 

radioactive materials program. The review team noted that the Branch had stable funding 

during the review period due to dedicated revenue from licensee fees and contributions from 

the general fund. 

The staff is well qualified from an education, training and experience standpoint. All staff have 

at least a Bachelor’s degree in the sciences, or equivalent training and experience. Seven 

experienced technical staff members have taken the NRC courses deemed appropriate for their 

tasks. Since August 2003, the newest staff member has completed five courses deemed 

appropriate for his responsibilities. The last IMPEP review recommended the Section have 

staff attend NRC’s brachytherapy and irradiator courses when they became available. 

However, the Section’s training funds for these courses, and others, were severely reduced 

over the previous four years. Management was unable to accomplish this recommendation. 

The team discussed the previous IMPEP team’s training recommendation with management, 

the Section’s funding difficulties over the last four years, and several other acceptable methods 

for qualifying staff in specific areas. The team pointed out that the results of the current IMPEP 

team’s accompaniment of a Branch inspector during a more complex medical inspection that 

included a brachytherapy program demonstrated that, although the inspector had not 

completed the NRC brachytherapy course, the inspector was knowledgeable, experienced, and 

qualified to perform independent brachytherapy inspections. The team suggested that the 

Branch consider holding a qualification “board” for this individual, based on training and on the 

job experience he had received since he was hired, to qualify the inspector in this area. 

During the review the team was informed that some money for training had just been received 

by the Section and the management team was working on plans to effectively use the funding 

to further develop and train the staff. 

The review team observed that management is committed to training and the review team 

found that the new staff were well trained, experienced and fully capable of inspecting these 

complex licenses. The review team found that the Branch’s training and qualification program, 

based on NRC IMC 1246 and the NRC/Organization of Agreement States Working Group 

guidance, is adequately documented. The Section has a written training policy and 

management signs off on completed tasks. The Branch also maintains computer records of 

individual training. During the review period, the Branch, despite training funding problems, 
North Carolina Final Report Page 5

 took the initiative to train new staff to acceptable standards. New employees, under the 

guidance of a mentor, became qualified to perform radioactive materials licensing and 

inspection tasks by starting with simple licenses and working towards the more complex types 

of licenses. When ready, the employee participates in a qualification board to test their 

knowledge and skills. If successful, the employee gains management sign-off on their ability to 

perform the task. Using this process, the team finds that the newest staff member is fully 

qualified. 

The North Carolina Radiation Protection Commission (the Commission) serves as an advisory 

group to the Division. The Commission is composed of eleven voting members, including the 

Chairman, and 10 “ex-officio” members. Several sub-committees report to the Commission on 

specific radiation issues. Members are appointed by the Governor. The Commission 

membership is composed of licensees, members of the public and government representatives 

to provide a broad overview of issues related to the regulation of radiation within the State. 

Prospective members must complete an ethics statement, a statement of economic interest 

before serving on the Commission, and recuse themselves from participation in issues where 

they may have a conflict of interest. In addition to its advisory role, the Commission has an 

administrative role in the development and promulgation of all radiation regulations within the 

State. The team found no evidence of any conflict of interest during this review. 

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

that North Carolina's performance with respect to the indicator, Technical Staffing and Training, 

be found satisfactory. 

3.2 Status of Materials Inspection Program 

The review team focused on five factors in reviewing the status of the materials inspection 

program: inspection frequency, overdue inspections, initial inspections of new licensees, timely 

dispatch of inspection findings to licensees, and the performance of reciprocity inspections. 

The review team’s evaluation is based on the Branch’s questionnaire response relative to this 

indicator, data gathered independently from the Branch’s licensing and inspection data tracking 

system, the examination of completed licensing and inspection casework, and interviews with 

managers and staff. 

In April 2003, the Branch revised its inspection frequencies for various types of material 

licenses to conform with the priorities listed in the latest revision to NRC IMC 2800 “Materials 

Inspection Program.” The team confirmed that the Branch’s new inspection priorities were at 

least the same or more frequent than those in NRC IMC 2800. Over the review period, 

inspection priorities previously used by the Branch also paralleled the frequencies used by 

NRC. 

Review of records indicated that at the time of the IMPEP review, there was one inspection 

currently overdue by more than 25 percent of the NRC’s inspection frequency. This inspection 

has been scheduled to be completed in the fourth quarter of 2004. The review team 

determined that of the 227 inspections of the Priority 1, 2 and 3 licenses performed by the 

Branch during the review period, 22 were performed overdue. The team noted that 17 of the 

overdue inspections, ranging from a few days to 12 months late, were for Priority 1 licenses. 
North Carolina Final Report Page 6 

With respect to initial inspections of new licenses, the Branch’s inspection frequency is 

consistent with the guidance in NRC IMC 2800. During the review period, the Branch issued 

128 new licenses and 11 of the inspections were not conducted within the one year time frame. 

The team found that the overdue inspections were performed seven days to one year late. 

Overall, the team found that 9.6 percent of the 355 core inspections, which includes new, 

Priority 1, 2 and 3 licenses, performed by the Branch were performed overdue. As noted 

below, the review team believes the increase of overdue inspections can be attributed to the 

unreliability of the inspection database. 

The review team determined that the Branch met and exceeded NRC’s current criteria of 

inspecting candidate licenses (Inspection Priority 1, 2 and 3) operating under reciprocity as 

specified in NRC IMC 1220 for the approximately 50 core reciprocity licenses granted 

reciprocity during the review period. The Branch conducted 19 inspections of candidate 

licenses during the review period. In addition, the Branch inspected 40 non-candidate 

reciprocity licenses during the review period. 

The review team examined the timeliness of inspection findings issued by the Branch during the 

review period. The Branch’s goal is to complete each inspection report and the letter to the 

licensee summarizing the inspection findings within 30 days of the inspection’s completion date. 

Of the 23 inspection files reviewed, only two inspection reports and findings were completed 

beyond the 30-day goal. The reports were 40 and 144 days late. The team attributes the 144 

day delay to the unreliability of the Branch’s inspection database that has been previously 

discussed. 

The review team found that the databases and the reports produced from the databases used 

by the Branch to track routine, initial and reciprocity inspections contained incorrect or missing 

information, did not include all licenses, and produced erroneous due dates. Consequently, the 

team had to verify the quality of the information in the inspection databases by comparison with 

written information in the files. The Branch Manager confirmed that the unreliable quality of the 

inspection databases is the result of ongoing technical problems resulting in an ineffective 

tracking and management tool that contributed to some inspections being performed overdue. 

The team also found that other databases used by the Branch (see discussion of SS&D 

database tracking system in Section 4.2.2, Technical Quality of the Product Evaluation 

Program), also had reliability and quality problems. The review team recommends that the 

Branch develop and implement a reliable and comprehensive licensing and inspection and 

SS&D product evaluation database that serves as an effective planning, tracking and 

management tool. 

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

that North Carolina’s performance with respect to the indicator, Status of the Materials 

Inspection Program, be found satisfactory. 

3.3 Technical Quality of Inspections 

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

field notes and interviewed inspectors for 15 inspections. The casework examined included 

inspections performed by all the Branch’s materials inspectors. The review examined 

inspections of various license types including industrial radiography, academic, industrial and 

medical broad scopes, service license (source exchange), medical institution, brachytherapy, 

nuclear pharmacy, panoramic irradiator, manufacturing and distribution, gamma 
North Carolina Final Report Page 7 

radiostereotactic surgery and research and development. Appendix C lists the inspection 

casework reviewed for completeness and adequacy with case-specific comments. 

Based on the casework file reviews, the review team found that routine inspections covered all 

aspects of each licensee’s radiation protection program. The inspection field notes and reports 

were thorough, complete, consistent, and of high quality, with sufficient documentation to 

ensure that each licensee’s performance with respect to health and safety was acceptable. The 

documentation adequately supported any cited violations. Exit interviews were held with 

appropriate licensee personnel. Team inspections were performed when appropriate and for 

training purposes. 

The review team found that all inspections include a written summary of the scope of the 

licensed activities and any violations identified by the inspector. The review team also noted 

that, in cases that involved significant or ongoing violations, the Branch had exercised 

escalated enforcement through the issuance of orders, imposition of civil penalties, or 

suspension of licensed activities. The review team found that the Branch has a good process 

for reviewing draft inspection documentation and enforcement actions, making any needed 

changes and providing the inspector with feedback regarding the quality of the draft document. 

The review team determined that no supervisory accompaniments were performed during 2001. 

This deficiency was self-identified by management and corrected. Subsequently in 2002 and 

2003, each material inspector was accompanied by the Branch Manager on an annual basis. 

Inspector accompaniments for 2004 have been scheduled for the fourth calendar quarter. The 

inspector accompaniments were documented. Based on a review of the Branch’s inspector 

accompaniment documentation for 2002-3, inspector accompaniments performed by the review 

team, and the experience of the inspectors, the team concluded that there were no 

performance issues from the lack of the supervisory accompaniments during the first part of the 

review period. 

The review team accompanied two material inspectors on August 10-11, 2004 during the 

inspections of medical institutions with brachytherapy programs. These accompaniments are 

identified in Appendix C. During the accompaniments, each of the inspectors demonstrated 

appropriate performance-based inspection techniques and knowledge of the regulations. The 

inspectors were well prepared and thorough in their reviews of the licensees’ radiation safety 

programs. The inspections were adequate to assess radiological health and safety at the 

licensed facilities. 

The Section has an adequate number and selection of survey meters to support both the 

Branch and the Emergency Response and Environmental Branch when responding to incidents 

and emergency conditions. The Branch has contractors who calibrate the Branch’s survey 

instruments on an annual basis. 

Appropriate documentation of calibrated survey instruments such as Geiger-Muller meters, 

scintillation detectors, ion chambers, and micro-R meters was provided. Air monitoring 

equipment as well as prepared emergency field kits are also available for emergency use. The 

Branch uses the services of the State’s Radiochemistry Unit in the Department of Health and 

Human Services. The review team visited the laboratory and its staff. Instrumentation includes 

intrinsic germanium and sodium iodide detectors with gamma spectroscopy capabilities, low 

background alpha-beta counters, liquid scintillation counters and radiochemistry capabilities. 

The laboratory is capable of analyzing a wide-range of environmental media. 
North Carolina Final Report Page 8 

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

that North Carolina’s performance with respect to the indicator, Technical Quality of 

Inspections, be found satisfactory. 

3.4 Technical Quality of Licensing Actions 

The review team interviewed license reviewers, evaluated the licensing process, and examined 

licensing casework for 13 specific licenses. Licensing actions were reviewed for completeness, 

consistency, proper radioisotopes and quantities, qualifications of authorized users, adequate 

facilities and equipment, adherence to good health physics practices, financial assurance, 

operating and emergency procedures, appropriateness of license conditions, and overall 

technical quality. The casework files were also reviewed for timeliness, use of appropriate 

deficiency letters and cover letters, reference to appropriate regulations, product certifications, 

supporting documentation, consideration of enforcement history, pre-licensing visits, 

supervisory review as indicated, and proper signatures. 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, 

which were completed during the review period. The sampling included the following types: 

panoramic irradiator, medical institution, medical private practice, portable gauge, fixed gauge, 

research and development, academic, research and development broad scope, and distribution 

of general license devices. Licensing actions reviewed included 12 renewals and one 

amendment. A listing of the licensing casework evaluated with case-specific comments can be 

found in Appendix D. 

Overall, the review team found that the licensing actions were thorough, complete, consistent, 

and of high quality with health and safety issues properly addressed. License tie-down 

conditions were older versions than are currently used by NRC. The team provided the Branch 

with the most current license conditions post review. While the older license conditions do not 

present any health and safety concerns, the license conditions are not as precisely written nor 

are they as clear as they could be if more current versions were used. Licensing actions were 

backed by information contained in the file, and were inspectible. The licensee’s compliance 

history was taken into account when reviewing renewal applications and amendments. The 

review team confirmed that there were no exemptions issued as indicated on the Branch’s 

questionnaire response. 

The licensing action is assigned to a reviewer on the same day it is received. There is an initial 

checklist that is used by the administrative staff and the reviewer to verify that the application 

includes the necessary administrative and technical information. Deficiencies, if any, are 

resolved either by letter(s) or for minor items by telephone discussions. There is a template for 

each type of license to ensure consistency between reviewers. The completed licensing action 

is checked for accuracy and completeness against a Quality Control checklist before it is signed 

by the Branch Manager on behalf of the Chief of the Radiation Protection Section. The Branch 

utilizes appropriate licensing guides, standard licensing conditions, and issues a complete 

license for each licensing action. 

The team noted that the Branch has developed a computerized database to track general 

licensed devices to account for all devices possessed by various entities in North Carolina. 

There is an effective follow-up of bankruptcy cases with special emphasis on security of 

licensed material. 
North Carolina Final Report Page 9 

The review team noted that the license reviewers do not routinely check the SS&D certificate 

before authorizing sealed sources on the license and authorize the possession limits that the 

applicants request. In addition, the team discussed the Branch’s procedure for reviewing the 

qualifications and experience of proposed authorized users before being listed on the license. 

Each license amendment is accompanied by a Quality Assurance sheet with a specific line-item 

for verification of a proposed authorized user’s training and experience. Based on discussion 

with the review team, management is considering revising applicant training and experience 

requirements for specific isotopes to ensure potential licensees have the training 

commensurate with the isotope and use requested on the license. 

The Branch uses templates when generating licenses. No health and safety issues were 

identified with the use of the templates. However, careless cutting and pasting, poor proof 

reading, repeated use of old versions of the license and a lack of adequate quality control may 

lead to gaps, conflicts, duplications, inconsistencies, and omissions that may eventually 

contribute to a future safety issue. For example, a licensee was authorized an isotope and had 

provided appropriate financial assurance for the requested possession limit. The license, 

however, included a condition that prohibited the licensee to possess the licensed material in 

amounts that required financial assurance. The review team recommends that the Branch 

assess their licensing quality control process and tools to improve the accuracy and consistency 

of licensing actions. 

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

that North Carolina's performance with respect to the indicator, Technical Quality of Licensing 

Actions, be found satisfactory. 

3.5 Technical Quality of Incident and Allegation Activities 

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

team examined the Branch’s response to the questionnaire relative to this indicator, reviewed 

the incident reports for North Carolina in the NMED against those contained in the Branch’s 

files, and evaluated reports and supporting documentation for 10 material incidents. A list of 

the incident casework examined with case-specific comments is included in Appendix E. The 

team also reviewed the Branch’s response to 12 allegations involving radioactive materials 

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

All calls involving events and allegations are initially routed to the Emergency Response and 

Environmental Branch. If the event, or allegation, involves licensed radioactive material it is 

immediately handed off to the Radioactive Materials Branch for investigation, evaluation and 

follow-up. 

The incidents selected for review included the following event categories: lost and abandoned 

radioactive material, equipment and procedural failures, transportation, contamination and 

leaking source. The review team found that the Branch’s response to incidents was complete 

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

was commensurate with the health and safety significance. The Branch dispatched inspectors 

for site investigations when appropriate, and took suitable enforcement and follow-up actions. 

The staff member who receives the initial notification has responsibility for initial response and 

follow-up to the incident. Each incident receives a unique tracking number. Written procedures 

require that two material inspectors evaluate each incoming incident report and present it to the 
North Carolina Final Report Page 10 

supervisor for direction. Complex incidents or those with potential for impacting public safety 

are evaluated by the Branch Manager in order to determine the appropriate response. 

Documentation related to an incident is placed in the Branch’s incident files and includes a 

cover sheet that summarizes the event. 

The review team identified 185 radioactive materials incidents during the review period 

including 42 incidents that required reporting under the NRC criteria. No additional reportable 

events were identified by the team during the review of the Branch’s incident files. A majority of 

the incidents involved naturally-occurring or accelerated-produced radioactive material (NARM), 

medical waste and radiation alarms at recycling facilities. The team found that reportable 

incidents were reported to the NRC Operations Center in a timely manner. However, the team 

noted considerable inconsistencies in providing follow-up NMED reports to the NMED 

contractor prior to 2003. The Branch Manager stated that the inconsistency was the result of 

software compatibility issues when entering NMED data. The follow-up information is now 

being provided to NMED as specified in the Office of State and Tribal Programs (STP) 

procedures. NMED information is provided and updated by a designated staff member. 

During the review period, the Branch received 17 allegations, six of which were referred to the 

Branch by the NRC. The casework for 12 allegations were reviewed, including all six 

allegations referred by the NRC. The review of the casework indicated that the Branch took 

prompt and appropriate action in response to the concerns raised. Each of the allegations 

reviewed were appropriately closed, and the allegers were informed of the results when 

possible. The team found that allegations are tracked and documented internally in the same 

manner as incidents. Allegation files are maintained in a separate, locked file cabinet for 

security and protection of the alleger’s identity. There were no performance issues identified 

from the review of the casework documentation. 

North Carolina law requires that all public documents be made available for inspection and 

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

review team confirmed that the Branch adequately protects an alleger’s identity. 

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

that North Carolina’s performance with respect to the indicator, Technical Quality of Incident 

and Allegation Activities, be found satisfactory. 

4.0 NON-COMMON PERFORMANCE INDICATORS 

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

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

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

Program. North Carolina's Agreement does not cover a uranium recovery program, so only the 

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

4.1 Compatibility Requirements 

4.1.1 Legislation 

In addition to their response to the questionnaire, the Section provided the review team with the 

opportunity to review copies of legislation that affects the radiation control program. The 
North Carolina Final Report Page 11 

authority under which the Section administers the Agreement is granted in the General Statutes 

of North Carolina, Chapter 104E, North Carolina Radiation Protection Act. The Department is 

designated as the State’s radiation control agency. 

The review team noted that legislation affecting the radiation control section was amended 

during the review period. This change did not result in a change to the Department’s overall 

operational authority but did create organizational changes within the Department. On July 1, 

2002 the Radiation Protection Division within the Department was re-organized and became a 

Section under the existing Division of Environmental Health. The review team found the 

revision to the enabling legislation caused no significant impact on the Section. 

4.1.2 Program Elements Required for Compatibility 

The North Carolina Regulations for Control of Radiation, found in the North Carolina 

Administrative Code, Title 15A, Chapter 11, Radiation Protection, apply to all ionizing radiation, 

whether emitted from radionuclides or machines. North Carolina requires a license for 

possession, and use, of all radioactive material including NARM. 

The review team examined the regulation promulgation procedures used by the Section. The 

Section identifies the need for regulation changes, requests, and obtains Commission approval 

to develop new rules and regulations. The Section’s staff drafts proposed regulations for the 

Commission’s Radioactive Materials Control Committee for discussion with the regulated 

community and concerned citizens. The Commission reviews the draft proposed regulations 

and authorizes an official notice of proposed rule. Once the official notice is approved, the 

proposed regulations are published for a minimum 60-day comment period. The comment 

period may be longer depending on the types or number of proposed regulations. The NRC is 

provided with drafts of the proposed regulations for review and comment around the time they 

are published for public comment. Approximately two weeks after the rule is published, a public 

hearing is held to allow the public and other interested parties to comment on the proposed 

regulations. Based on the comments received, the rule is revised as needed and is then sent to 

the State Rules Review Commission. The State Rules Review Commission meets monthly to 

review and approve regulations promulgated by all State agencies. Once the State Rules 

Review Commission approves the final regulations, they become effective the first day of the 

month following approval. However, if ten or more written objections to a specific regulation 

are received, the proposed regulation is submitted to the State legislature for review and 

approval on the first day of the next legislative session following the State Rules Review 

Commission’s final review. If the State legislature declines to review the proposed regulation, 

the rule becomes effective one month after the first day the legislative session starts. 

Typically, regulation promulgation requires 4-14 months. The Section has the authority to issue 

legally binding requirements, such as orders or license conditions. This option has not been 

necessary in the past. The review team discussed with the Special Technical Projects staff, the 

process described in STP Procedure SA-200, for submitting legally binding requirements to 

meet NRC compatibility requirements. In addition, the Section has alternative rulemaking 

procedures to put regulations in place outside of the normal process. Under the Emergency 

Rulemaking procedure, a regulation is put in place between 6-12 days and expires on the date 

specified in a regulation or the temporary regulation that must be submitted for promulgation 

simultaneously with the Emergency Rulemaking. For Temporary Rulemaking a regulation is 

put in place usually within 60 days and expires either in 270 days or once a regulation is 

reviewed and approved under the normal Rulemaking Process, whichever happens sooner. 
North Carolina Final Report Page 12 

The Special Technical Projects staff noted that, there has not been a need to use the 

alternative rulemaking procedures. Additionally, the Department’s rules and regulations are not 

subject to “sunset” laws. 

The team evaluated the Branch’s response to the questionnaire, reviewed the status of 

regulations required to be adopted by the State under the NRC’s Adequacy and Compatibility 

Policy, and verified the adoption of regulations with data obtained from the STP State 

Regulation Status Tracking Sheet. 

Since the previous IMPEP review, the State has adopted four amendments in one rule package 

that became effective in August 2002. 

The team noted that at the time of the review, the Branch had not submitted the following two 

final regulations for NRC’s review: 

• “Licenses for Industrial Radiography and Radiation Safety Requirements for Industrial 

Radiographic Operations,” (63 FR 37059) that became effective July 9, 1998. 

• “Transfer for Disposal and Manifests: Minor Technical Conforming Amendment,” 

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

Prior to the MRB meeting the Branch provided, and the NRC reviewed with no comment, final 

rules covering NRC amendment “Transfer for Disposal and Manifests: Minor Technical 

Conforming Amendment,” (63 FR 50127). Section management agreed to submit NRC 

amendment, “Licenses for Industrial Radiography and Radiation Safety Requirements for 

Industrial Radiographic Operations,” (63 FR 37059) for NRC review in accordance with STP 

Procedure SA-201. 

Current NRC policy requires that Agreement States adopt certain equivalent regulation or 

legally binding requirements no later than three years after they become effective. The review 

team found that the Branch is overdue for the following NRC amendments: 

• “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 FR 20337) that became effective May 17, 2000. 

• “New Dosimetry Technology,” 10 CFR Parts 34, 36 and 39 amendments (65 FR 63750) 

that became effective January 8, 2001. 

• “Requirements for Certain Generally Licensed Industrial Devices Containing Byproduct 

Material,” 10 CFR Parts 30, 31 and 32 amendment (65 FR 79162) that became effective 

February 16, 2001. 

On February 10, 2004, the Branch provided the draft regulations to the NRC for review and 

comment. The NRC commented by letter dated March 16, 2004. The comment review period 

on these regulations was scheduled to be completed on August 30, 2004 and the regulations 

are expected to be adopted by December 2004. The Branch will be submitting the final 

regulations to the NRC for review once the rulemaking process is completed. 
North Carolina Final Report Page 13 

The Branch will need to address the following four regulations in upcoming rulemaking or by 

adopting legally binding requirements: 

• “Revision of the Skin Dose Limit,” 10 CFR Part 20 amendment (67 FR 16298) that 

became effective April 5, 2002. 

• “Medical Use of Byproduct Material,” 10 CFR Part 20, 32 and 35 amendments (67 FR 

20249) that became effective April 24, 2002. 

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

(68 FR 57327) that became effective December 3, 2003. 

• “Compatibility With IAEA Transportation Safety Standards and Other Transportation 

Safety,” 10 CFR Part 71 amendment (69 FR 3697) that will become effective October 1, 

2004 

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

that North Carolina’s performance with respect to the indicator, Compatibility Requirements, be 

found satisfactory. 

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

In conducting this review, three sub-indicators were used to evaluate the Branch’s performance 

regarding the SS&D Evaluation Program. These sub-indicators include: (1) Technical Staffing 

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

Incidents Regarding SS&D. 

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

provided in response to the IMPEP questionnaire for this indicator. The team evaluated all four 

SS&D registrations issued during the review period, and the supporting document files. The 

team evaluated the use of guidance documents and procedures, interviewed staff currently 

conducting SS&D evaluations, and verified the use of regulations and license conditions to 

enforce commitments made in the applications. 

4.2.1 Technical Staffing and Training 

Since the last review, two new staff members have been qualified by the Branch to perform 

SS&D evaluations. One of the new staff members is limited to performing concurrence reviews 

until he gains further casework experience and obtains management sign off. The Branch has 

two additional qualified SS&D reviewers. 

The Branch has documented the training received by the SS&D reviewers, and the review team 

evaluated the qualifications of the two new staff members authorized by the Branch. One of the 

new members performed SS&D evaluations during the review period. Each new reviewer has 

worked with the Branch for over five years, has either a bachelor’s degree in physical sciences 

or a master’s degree in health physics, and has attended the NRC’s SS&D workshop. 

The Branch also has contractual access to a professor at North Carolina State University’s 

Department of Material Sciences and Engineering for consultation purposes related to SS&D 

evaluations. The consultant has a doctoral degree in engineering and is a licensed 
North Carolina Final Report Page 14 

Professional Engineer. The Branch’s SS&D review procedure documents the process for use 

of the consultant. 

4.2.2 Technical Quality of the Product Evaluation Program 

The review team evaluated all four SS&D product evaluations that the Branch completed during 

the review period. Each case was for an SS&D registration amendment. No new, inactivated 

nor reactivated registrations were issued during the review period. A list of the SS&D casework 

examined along with specific comments are found in Appendix F. 

The Branch’s SS&D reviewers stated that they used the guidance in NRC’s NUREG-1556, 

Volume 3. The team’s review of the casework, written procedures and interviews with the staff, 

confirmed that the Branch followed the NRC SS&D guidance with a few exceptions as noted in 

Appendix F. Appropriate standards, Regulatory Guides, and NRC’s SS&D workshop 

references were available and used when performing SS&D reviews. The Branch handles 

proprietary information by placing it in separate files. 

The depth and scope of the SS&D evaluations performed during the review period were good. 

The evaluation documentation found in registration files was also good. The review team did 

not identify any missed safety issues in the casework reviewed. 

The review team noted that a vendor had requested an amendment to an SS&D registration in 

a letter dated November 21, 2001, and that the Branch has neither requested further 

information from the vendor nor has it issued an amended SS&D registration as of the date of 

this review. The team also notes that there is no documentation in the file that would indicate 

that the vendor had again contacted the Branch concerning the status of their request nor is 

there evidence that the vendor has cancelled the requested amendment. Also, the team 

determined that the Branch was not aware of the pending request. The team believes that this 

administrative problem is due to a poorly functioning of the SS&D tracking system. 

Consequently, the Branch puts more reliance in a manual method of tracking that consists of 

reviewing the SS&D Registry, paper documents, and staff notes to follow the status of SS&D 

actions. 

The Branch reported that a database had been developed to follow the status of SS&D actions 

and that the tracking system was corrupted when it was placed onto their local area network 

computer system. The tracking system was rebuilt just before this review and there was a 

demonstration on the designer’s computer during the review. However, the tracking system 

was not useful because it contained only test data. A recommendation, as stated in Section 3.2 

of this report, related to developing a quality database system is reiterated here. The system 

should include a process for tracking SS&D product evaluations. 

4.2.3 Evaluation of Defects and Incidents Regarding SS&D 

There were no new defects or incidents involving SS&D’s registered with the Branch that were 

discovered or reported during the review period. 

In November of 2000, the Branch closed a consent order agreement made between the Branch 

and a distributor of SS&D’s. The order required that the distributor notify customers of a 

potential problem and also required that the distributor perform inspections and testing of 

certain device components. The distributor supplied the Branch with all of the information 
North Carolina Final Report Page 15 

required in the order. The review team examined the SS&D registration related to the device 

and noted that a beneficial design change related to the device component was approved by 

and registered with the Branch. 

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

that North Carolina's performance with respect to the indicator, Sealed Source and Device 

Evaluation Program, be found satisfactory. 

4.3 Low-Level Radioactive Waste (LLRW) Disposal Program 

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

Discontinuance of NRC Authority and Assumption Thereof by States Through Agreement" to 

allow a State to seek an amendment for the regulation of LLRW as a separate category. Those 

States with existing Agreements prior to 1981 were determined to have continued LLRW 

disposal authority without the need of an amendment. Although North Carolina has such 

disposal authority, NRC has not required States to have a program for licensing a 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 North Carolina. Accordingly, the review team did not evaluate this 

indicator. 

5.0 SUMMARY 

As noted in Sections 3 and 4 above, the review team and the MRB found North Carolina's 

performance to be satisfactory for all seven performance indicators. Accordingly, the review 

team recommended and the MRB concurred in finding the North Carolina Agreement State 

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

program. Based on the results of the current IMPEP review, the review team recommended and 

the MRB agreed that the next full review should 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 State. 

RECOMMENDATIONS 

1. The review team recommends that the Branch develop and implement a reliable and 

comprehensive licensing and inspection, and SS&D product evaluation database that 

serves as an effective planning, tracking and management tool. (Section 3.2, 4.2) 

2. The review team recommends that the Branch assess their licensing quality control 

process and tools to improve the accuracy and consistency of licensing actions. 

(Section 3.4) 
LIST OF APPENDICES AND ATTACHMENT

Appendix A IMPEP Review Team Members 

Appendix B North Carolina Organization Charts 

Appendix C Inspection Casework Reviews 

Appendix D License Casework Reviews 

Appendix E Incident Casework Reviews 

Appendix F Sealed Source and Device Casework Reviews 

Attachment October 11, 2004 Memorandum from W. Lee Cox 

North Carolina’s Response to Draft IMPEP Report 
APPENDIX A

IMPEP REVIEW TEAM MEMBERS

Name Area of Responsibility 

James Myers, STP Team Leader 

Technical Staffing and Training 

Duncan White, Region I Status of Materials Inspection Program 

Technical Quality of Inspections 

Technical Quality of Incident and Allegation Activities 

Inspector Accompaniments 

Sattar Lodhi, Region I Technical Quality of Licensing Actions 

Osiris Siurano-Perez, STP Technical Quality of Incident and Allegation Activities 

Compatibility Requirements 

Joshua Daehler, Massachusetts Sealed Source and Device Evaluation Program 
APPENDIX B

NORTH CAROLINA ORGANIZATION CHARTS

ADAMS: ML042160130

pages 17-20
ATTACHMENT 

Email/Memorandum from W. Lee Cox dated October 11, 2004 

North Carolina’s Response to Draft IMPEP Report

ADAMS: ML042990135, ML042990154, ML042990161