DATED: MARCH 26, 1996 SIGNED BY: RICHARD L. BANGART FOR

 HUGH L. THOMPSON, JR.T

Mr. Jonathan B. Howes, Secretary

Department of Environment, Health, 

 and Natural Resources

3825 Barrett Drive

Post Office Box 27687

Raleigh, NC 27611-7687

Dear Mr. Howes:

On March 20, 1996, 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 considered and

concurred with the review team's recommendation that the North Carolina

program be found adequate to protect public health and safety and compatible

with NRC's regulatory program. Based on State performance, the next IMPEP

review will be scheduled in four years, unless program concerns develop that

require an earlier evaluation.

NRC recognizes the efforts of North Carolina and the other Agreement States to

maintain an adequate and compatible program. During the MRB meeting, the

impact of high staff turnover on the North Carolina's Agreement Program was

discussed. North Carolina's efforts to improve the program while at the same

time devoting significant effort in hiring and training new staff by

experienced staff is commendable. Your consideration of methods to minimize

staff turnover could result in further strengthening of the program. For

example, other Agreement States have examined salary structures in their

assessment of staff turnover.

Section 5 (page 22) of the enclosed final report presents the IMPEP team's

recommendations. We request your evaluation and response to those

recommendations within 30 days from receipt of this letter.

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

the review.

Sincerely,/RA BY RICHARD L. BANGART FOR/

Hugh L. Thompson, Jr. 

Deputy Executive Director for

 Nuclear Materials Safety, Safeguards,

 and Operations Support

Enclosure: 

As stated

cc: Linda Bray Rimer, Department of 

 Environment, Health, and 

 Natural Resources (DEHNR)

Dayne Brown, DEHNR

Billy Cameron, State Liaison Officer
Mr. Jonathan B. Howes, Secretary

Department of Environment, Health, 

 and Natural Resources

3825 Barrett Drive

Post Office Box 27687

Raleigh, NC 27611-7687

Dear Mr. Howes:

On March 20, 1996, 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 considered and

concurred with the review team's recommendation that the North Carolina

program be found adequate to protect public health and safety and compatible

with NRC's regulatory program. Based on State performance, the next IMPEP

review will be scheduled in four years, unless program concerns develop that

require an earlier evaluation.

NRC recognizes the efforts of North Carolina and the other Agreement States to

maintain an adequate and compatible program. During the MRB meeting, the

impact of high staff turnover on the North Carolina's Agreement Program was

discussed. North Carolina's efforts to improve the program while at the same

time devoting significant effort in hiring and training new staff by

experienced staff is commendable. Your consideration of methods to minimize

staff turnover could result in further strengthening of the program. For

example, other Agreement States have examined salary structures in their

assessment of staff turnover.

Section 5 (page 22) of the enclosed final report presents the IMPEP team's

recommendations. We request your evaluation and response to those

recommendations within 30 days from receipt of this letter.

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

the review.

Sincerely,

Hugh L. Thompson, Jr. 

Deputy Executive Director for

 Nuclear Materials Safety, Safeguards,

 and Operations Support

Enclosure: 

As stated

cc: Linda Bray Rimer, Department of 

 Environment, Health, and 

 Natural Resources (DEHNR)

Dayne Brown, DEHNR

Billy Cameron, State Liaison Officer

BCC: See next page Distribution: See next page

*See previous concurrence 

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To receive a copy of this document, indicate in the box: "C" = Copy without attachment/enclosure "E" = Copy with attachment/enclosure "N" = No copy

OFFICE RIV/WCFO* E OSP* E OSP:DD* OSP:D* DEDS

NAME JHornor:kk KSchneider PLohaus RLBangart HLThompson

DATE 03/25/96 03/25/96 03/25/96 03/25/96 03/ /96

 OSP FILE CODE: SP-AG-21
bcc: Chairman Jackson

Commissioner Rogers

Commissioner Dicus

 

Distribution: 

DIR RF

EDO RF

HLThompson, DEDS

DCD (SP01)

RLBangart

PLohaus

SDroggitis

KSchneider

CPaperiello, NMSS

ELJordan, AEOD

KCyr, OGC

JHornor, RIV/WC

RWoodruff, RII

RWescott, NMSS

SBaggett, NMSS

SGiddings, Utah

DCool, NMSS

GPangburn, NMSS

FCameron, OGC

HNewsome, OGC

TCombs, OCA
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM

REVIEW OF NORTH CAROLINA AGREEMENT STATE PROGRAM

December 11-15, 1995

FINAL REPORT

Office of State Programs

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 radiation

control program. The review was conducted during the period December 11-15,

1995, by a review team comprised of technical staff members from the Nuclear

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

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

"Interim Implementation of the Integrated Materials Performance Evaluation

Program Pending Final Commission Approval of the Statement of Principles and

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

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

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

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

Preliminary results of the review, which covered the period December 13, 1993

to December 15, 1995, were discussed with North Carolina management on

December 15, 1995. 

A draft of this report was issued to North Carolina for factual comment on

January 30, 1996. The State of North Carolina responded in a letter dated

February 21, 1996 (Attachment 1) and the comments were incorporated into the

proposed final report. The Management Review Board (MRB) met on March 20,

1996, to consider the proposed final report. The MRB concurred in the team's

overall recommendation and found that the North Carolina's program was

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

regulatory program.

The Department of Environment, Health, and Natural Resources (DEHNR) is a

cabinet-level agency within North Carolina State government. The Secretary,

DEHNR, is appointed by and reports directly to the Governor. Within DEHNR,

the North Carolina radiation control program is administered by the Division

of Radiation Protection (DRP). The DRP organization chart is included as

Appendix B. The North Carolina program regulated 538 specific licensees and

was in the process of licensing a low-level radioactive waste disposal site at

the time of the review. In addition to its radioactive materials and lowlevel radioactive waste disposal programs, DRP is responsible for regulating

electronic products and conducts other functions related to nuclear facility

safety, environmental monitoring, and emergency planning. The review focused

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

Atomic Energy Act of 1954, as amended) agreement between the NRC and the State

of North Carolina.

In preparation for the review, a questionnaire addressing the common and noncommon indicators was sent to the State on October 17, 1995. North Carolina

provided its response to the questionnaire on November 20, 1995. A copy of

that response is included as Appendix C to this report. 

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

(1) examination of North Carolina's response to the questionnaire; (2) review

of applicable North Carolina statutes and regulations; (3) analysis of

quantitative information from the DRP licensing and inspection data base;

(4) technical review of selected files; (5) field accompaniments of three

North Carolina 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 noncommon indicator and made a preliminary assessment of DRP's performance. As

noted above, that preliminary assessment was discussed with program management

before the team's departure.
North Carolina Draft IMPEP Report Page 2

Section 2 below discusses the State's actions in response to recommendations

made following the previous review. Results of the current review for the

IMPEP common performance indicators are presented in Section 3. Section 4

discusses results of the applicable non-common indicators, and Section 5

summarizes the review team's findings and recommendations.

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS

The previous routine review concluded on December 10, 1993, and the results

were transmitted to Jonathan Howes, Secretary, Department of Environment,

Health, and Natural Resources, on April 6, 1994. A special review of the

State's sealed source and device product evaluations was held during the

period April 18-22, 1994, with the results transmitted to Mr. Howes on

December 28, 1994. 

2.1 Status of Items Identified During December 1993 Routine Review

The December 1993 review resulted in two recommendations for action by the

State. (1) It was recommended that the State expedite the adoption of

regulations equivalent to the NRC 10 CFR Part 34 amendment, "Safety

Requirements for Industrial Radiographic Equipment," as well as other

regulations needed to maintain compatibility. (2) Because of the complexity

of the major licenses issued by the State, it was recommended the staffing

level be increased to 1.5 person-years per 100 specific licenses.

(1) On July 7, 1995, North Carolina provided the Office of State Programs

(OSP) with copies of their compatible final equivalent regulations. The State

regulations were determined to be compatible in correspondence dated

October 27, 1995, from Richard L. Bangart, Director, Office of State Programs,

to Dayne Brown, Director, Division of Radiation Protection. (2) The State's

satisfactory rating in all performance indicators during this review confirms

that the staffing level was adequate during the review period. The review

team considers both items closed.

2.2 Status of Items Identified in April 1994 Special Review of Sealed Source

and Device Product Evaluations

Deficiencies found during the April 1994 special review of the State's sealed

source and device (SS&D) product evaluations resulted in the NRC's decision to

withhold a finding of adequacy to protect the public health and safety. In

their July 1995 response to the NRC recommendations, the State submitted an

action plan for improving their SS&D evaluation procedures and for

reevaluating and updating previously issued SS&D registry sheets. After

reviewing all new and revised SS&D evaluations completed since the special

review, the review team found that the deficiencies found in the special

review have now been corrected and the State's performance in this indicator

is satisfactory. The review team considers this item to be closed.

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 include:

(1) Status of Materials Inspection Program; (2) Technical Staffing and

Training; (3) Technical Quality of Licensing Actions; (4) Technical Quality of

Inspections; and (5) Response to Incidents and Allegations. 
North Carolina Draft IMPEP Report Page 3

3.1 Status of Materials Inspection Program

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

frequency, overdue inspections, initial inspection of new licenses, and timely

dispatch of inspection findings to licensees. This evaluation is based on the

North Carolina questionnaire responses relative to this indicator, data

gathered independently from the State's licensing and inspection data tracking

system, the examination of licensing and inspection casework files, and

interviews with managers and staff.

Review of the State's inspection priorities showed that the State's inspection

frequencies for various types or groups of licenses are at least as frequent

as similar license types or groups listed in the frequency schedule in the NRC

Inspection Manual Chapter 2800 (IMC 2800). Inspection frequencies under the

State's system range from 1-year to 4-year intervals. The State requires more

frequent inspections in some license categories as follows: institutional and

private medical facilities are inspected on a 2-year frequency compared with

an NRC 3-year or 5-year frequency; broad academic licenses have a 1-year

frequency compared with an NRC 3-year frequency; and portable gauges have a 3-

year frequency compared with the NRC 5-year frequency. The inspection

frequencies of licenses selected for license and inspection file reviews were

compared with the frequencies listed in the State's data system and verified

to be consistent with the State's system and as frequent as similar license

types under the IMC 2800 system.

In their response to the questionnaire, North Carolina indicated that as of

November 1, 1995, only three licenses identified as core inspections in

IMC 2800 were overdue by more than 25 percent of the NRC frequency. This

number is well within the 10 percent criterion for overdue inspections of

Management Directive 5.6. Two of the licenses are scheduled for inspection by

the end of January 1996, and the other, an academic broad license, will be

inspected by the end of April, 1996. The inspection interval for this broad

license was extended to permit the licensee's new Radiation Safety Officer to

become familiar with the licensee's safety program. The State explained that

the compliance history of this licensee supports the extension of the

inspection period.

With respect to initial inspections of new licensees, the team reviewed the

inspection tracking data system and verified that the initial inspections had

been entered into the tracking system. Discussions with staff members were

conducted to determine how initial inspections are assigned and how data are

entered into the system. The administrative staff enters data on a monthly

basis, and then a quality check is performed by supervision based upon a

computer printout used for inspection planning. It was also noted that two of

the inspection files selected for casework reviews were initial inspections.

The timeliness of the issuance of inspection findings was also evaluated

during the inspection file review. Out of 16 files examined, all of the

inspection correspondence had been sent to the licensee within 30 days after

completion of the inspection except for one escalated enforcement case which

is awaiting action by the North Carolina Office of Attorney General.

The State reported in their response to the questionnaire that 131 requests

for reciprocity were received during the review period, of which 30 were from

industrial radiographers and 77 from portable gauge users. The State reported

performing three field inspections of reciprocity licensees. They also

reported conducting 17 field inspections on other industrial radiography

licensees. The State utilizes a license condition that requires all licensees

using temporary locations to notify DRP of work being performed in the State
North Carolina Draft IMPEP Report Page 4

and provide information on when and where the work will take place. This

information is posted on a bulletin board along with requests for reciprocity. 

This allows the staff to select field inspections as needed and perform the

inspections in an efficient manner. 

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

Carolina's performance with respect to the indicator, Status of Materials

Inspection Program, be found satisfactory.

3.2 Technical Staffing and Training

Issues central to the evaluation of this indicator include the radioactive

materials program staffing level, technical qualifications of the staff,

training, and staff turnover. To evaluate these issues, the review team

examined the State's questionnaire responses relative to this indicator,

interviewed DRP management and staff, and considered any possible backlogs in

licensing or compliance actions. Technical staffing and training for the lowlevel radioactive waste disposal program are addressed in Section 4.3.3 below.

The DRP organization chart shows that the radioactive materials program was

funded for one program supervisor and eight health physicists at the time of

the review. However, one of the health physicist positions was vacant and one

was staffed on a part-time basis. The licensing and inspection functions of

the program are integrated, and therefore, all health physicists perform

duties in licensing, inspection, and event response. Because of the need for

continuity and specialized training, however, sealed source and device

evaluations are assigned to two specific individuals. Balance between the

licensing and inspection functions is achieved by basing staff assignments on

program needs. 

Program managers explained that successful candidates for technical positions

are required to have bachelor's degrees or at least three years experience and

equivalent training in radiation protection. The review team reviewed the

qualifications of the technical staff and concluded that the State has been

able to recruit well-qualified individuals. All health physicists have at

least a bachelor's degree in science and several have advanced degrees. The

DRP deputy director is a certified health physicist. 

According to information provided in the questionnaire, the State's training

program requires all newly hired health physicists to attend the NRC core

training courses in licensing, inspection procedures, industrial radiography,

and medical, as well as the 2-week or 5-week health physics course, depending

on the level of the individual's education. The State also explained the inhouse training process in their response. Briefly, new staff are assigned

increasingly complex licensing duties under the direction of senior staff and

accompany experienced inspectors during increasingly complicated inspections. 

New staff are assigned independent inspections after demonstrating competence

during accompaniments by the radioactive materials section supervisor. DRP

program managers demonstrated a strong commitment to staff training during the

review. 

Staff turnover was high during this review period as four experienced health

physicists left the program. According to program management, the State has

been able to recruit well-educated staff from local universities. However,

State representatives indicated low salaries offered by the State in

comparison to other employers in the area have made it difficult to retain

experienced staff. In their response to the questionnaire, the State reported

that the four health physicists hired since August 1994 had little work

experience other than the experience gained during their educational pursuits. 
North Carolina Draft IMPEP Report Page 5

At the time of the review, three of the new health physicists had not taken

the licensing course, and one had not taken the inspection procedures course;

however, the State advised the review team that the training classes are

scheduled. The review team interviewed each health physicist and was

satisfied that duties assigned to new staff are commensurate with their

training and experience.

In the questionnaire and during discussions with the review team, DRP managers

emphasized that it has taken a considerable effort on the part of all existing

staff members to complete all the health and safety related work of the

program throughout the review period. As a means to increase program

efficiency, the State explained that they are in the process of establishing a

local area network (LAN) and are planning to add the position of LAN manager. 

The review team agrees that the installation of a LAN would improve staff

efficiency by providing the means to collectively store, retrieve, and

transmit information. 

During the review, program management announced that the supervisor of the

radioactive materials section had accepted a promotion to an engineering

position in the low-level radioactive waste disposal section, leaving her key

position vacant. This vacancy, along with an already vacant health physicist

position, could potentially affect the ability of the program to adequately

protect public health and safety. During the MRB meeting, the State indicated

that the supervisor position had been filled. The review team recommends that

the State fill the existing vacancy as soon as possible.

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

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

Training, be found satisfactory.

3.3 Technical Quality of Licensing Actions

The review team examined casework and interviewed the reviewers for nineteen

specific licenses. Licensing actions were reviewed 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. Casework

was reviewed for timeliness, adherence to good health physics practices,

reference to appropriate regulations, documentation of safety evaluation

reports, product certifications or other supporting documents, consideration

of enforcement history on renewals, pre-licensing visits, peer or supervisory

review as indicated, and proper signature authorities. Licenses were reviewed

for accuracy, appropriateness of the license and of its conditions and tiedown conditions, and overall technical quality. The files were checked for

retention of necessary documents and supporting data.

The cases were selected to provide a representative sample of licensing

actions which had been completed in the review period and to include work by

all reviewers. The cross-section sampling included thirteen of the State's

major licenses and included the following types: large irradiator, medical

broad scope (with a HDR afterloader), academic broad scope, nuclear pharmacy,

research and development, mobile nuclear medicine, manufacturing and

distribution, and industrial fixed radiography. Licensing actions included

two new licenses, four renewals, ten amendments, and three terminations. A

list of these licenses with case-specific comments can be found in Appendix D.

The review team found that the licensing actions were generally thorough,

complete, consistent, and of acceptable quality with health and safety issues

properly addressed. Special license tie-down conditions were almost always
North Carolina Draft IMPEP Report Page 6

stated clearly, backed by information contained in the file, and inspectable. 

The licensee's compliance history was taken into account when reviewing

renewal applications. The State's licensing guides and license policy

procedures were revised and updated during the review period, and reviewers

were observed to have good research skills in using these and other licensing

documents. With few exceptions, reviewers appropriately used the new

licensing guides and accompanying check sheets. The licensing supervisor

reviews and signs all new or renewed licenses and amendments. No potentially

significant health and safety issues were identified. 

The review team found that, because of the high staff turnover, some new

reviewers had not attended the NRC licensing course. As discussed in Section

3.2, the State reported that those reviewers are scheduled for upcoming

courses. Licensing weaknesses identified by the review team appeared to

relate to the inexperienced license reviewers, the minimal staffing of the

program during the review period, and the need for improved peer and

supervisory review. Reviewers did not always use correct guidance, and as a

result, issued some inappropriate deficiency letters. For example, new

reviewers inappropriately asked a gas chromatograph applicant to perform a

survey to determine compliance with public dose limits and, in other cases,

missed asking how volatile gas releases would be measured. One license

amendment and several background and tie-down documents were missing from the

files. The review team recommends that consideration be given to peer and

supervisory review of licensing products to include review of all background

information and correspondence. 

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

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

Licensing Actions, be found satisfactory.

3.4 Technical Quality of Inspections

The team reviewed the inspection reports, enforcement documentation, and the

data base information for 16 materials inspections conducted during the review

period. The casework included all of the State's materials inspectors and

covered a sampling of the higher priority categories of license types as

follows: four institutional and one private medical, one mobile nuclear

medicine, two nuclear pharmacies, one broad medical, one broad academic, two

large irradiators, one fixed location industrial radiography, two temporary

location industrial radiography including a field site inspection, and one

portable gauge. Appendix E provides a list of the inspection cases reviewed

in depth with case-specific comments.

In addition, several spot checks were performed on the files to verify that

enforcement correspondence was being maintained in a consistent manner and to

verify the implementation of the proper inspection frequency. In all cases,

license files selected from the data base for the spot checks were determined

to have the proper inspection frequency and current inspection findings and

correspondence. Some of the inspection files were also reviewed during the

license file review, thus providing further insight on how the State considers

inspection findings when completing a licensing action. 

 

The inspection procedures and techniques utilized by the State were reviewed

and determined to be consistent with the inspection guidance provided in

IMC 2800. The inspection report forms were found to be consistent with the

types of information and data collected under IMC 2800. The report forms

provided documentation of inspection findings in a consistent manner and in

accordance with State policies and internal procedures. The State uses

separate supplements to the inspection report form for various classes of
North Carolina Draft IMPEP Report Page 7

license types, such as medical, portable gauges, fixed gauges, industrial

radiography, accelerators, irradiators, gas chromatographs, broad licenses,

and service type licenses. In general, the inspection form supplements

provide documentation of licensee and radiation safety organization, scope of

licensee's program, material uses, procedures, leak tests, surveys,

instrumentation, dosimetry, incidents, interviews with staff, confirmatory

surveys, items of non-compliance, and exit interviews. 

For the most part, the review team found that the inspection reports contained

only minor discrepancies, when compared to State internal guidance or standard

practice. Four of the reports contained references to who was present during

the exit meetings but did not summarize the discussion. In one case, the

inspection was at a temporary job site and the exit meeting was held with the

radiographer in the field, rather than the manager at the licensee's office. 

The review team recommends that (a) all inspection reports include a summary

of the exit meeting discussion, as addressed by internal guidance, including

the licensee's comments regarding items of non-compliance; and (b) inspectors

make every effort to hold exit meetings at the highest possible management

level.

Three inspector accompaniments were performed by a review team member during

the period of November 14-15, 1995. Two inspectors were accompanied during

the early morning inspection of a nuclear pharmacy facility, and another

inspector was accompanied to a fixed radiographic facility. These

accompaniments are also identified in Appendix E. All of the other inspectors

have been accompanied during previous reviews. On the accompaniments, the

North Carolina inspectors demonstrated appropriate inspection techniques and

knowledge of the regulations. The inspectors were well prepared and thorough

in their reviews of the licensees' radiation safety programs. Overall, the

technical performance of the inspectors was satisfactory, and their

inspections were adequate to assess radiological health and safety at the

licensed facilities.

In response to the questionnaire, the State reported that three inspectors

were accompanied by the radioactive materials section chief during the review

period and provided copies of the fieldwork evaluation forms for each

accompaniment. The State further reported that supervisory accompaniments are

required for junior staff before they are allowed to perform independent

inspections but that accompaniments of senior inspectors are not required. 

The review team considered the unusually high demands placed on supervisory

staff during this review period because of the high staff turnover rate, the

effort necessary to update regulations, and the need to reevaluate previously

issued SS&D registrations. However, supervisory accompaniments provide

management with important insight into the quality of the inspection program. 

The review team recommends that the State consider for adoption a policy of

annual supervisory accompaniments of all inspectors.

It was noted that the State has a variety of portable instruments for routine

confirmatory surveys and use during incidents and emergency conditions. The

instruments were a good mix of low range GM tubes and pancake probes, micro R

meters, high range instruments, instrumentation with calibration standards for

alpha detection, a neutron rem ball, a portable multichannel analyzer, and the

Environmental Laboratory maintains a mobile laboratory van for use in

emergencies and emergency exercises. Air monitoring equipment is also

available. The portable instruments used during the inspector accompaniments

were observed to be operational and calibrated. The portable instruments

maintained in the office were also observed to be calibrated. Program staff

explained that instruments are calibrated at least on an annual basis, and
North Carolina Draft IMPEP Report Page 8

staggered so as to always have instruments calibrated within the calendar

quarter for use during industrial radiography inspections. 

It was found that the State is generally performing unannounced inspections of

materials licensees, except for initial inspections and geographically-distant

locations. Inspections of broad licenses are also announced. 

Inspectors sign all routine enforcement correspondence. All of the inspection

results and routine enforcement letters were verified as having been reviewed

and signed off by the supervisor before issuing the results to licensees. The

review team concluded that this supervisory review enhanced the quality of the

inspection and enforcement documents. The inspectors are also cross trained

as license reviewers which also strengthens the continuity of the regulatory

program. The review team agreed with program management that the State's

proposed LAN system would allow additional standardization and implementation

of inspection modules, enforcement language, and tracking systems. 

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

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

Inspections, be found satisfactory.

3.5 Response to Incidents and Allegations

In evaluating the effectiveness of the State's actions in responding to

incidents and allegations, the review team examined the State's response to

the questionnaire relative to this indicator and reviewed the casework of

eight incidents and six allegations. In addition, the review team interviewed

the DRP director, deputy director, the radioactive materials supervisor, and

the health physicists assigned to incident response.

It was found that within the DRP, responsibility for initial response and

follow up actions to materials incidents and allegations rests solely with the

radioactive materials section. Written procedures require two qualified

health physicists to evaluate each incoming incident report or allegation and

present it to the supervisor for direction. All complex events or those with

potential for impacting public safety are evaluated by the radioactive

materials supervisor, the director, and the deputy director in order to

determine the appropriate response. Review of the files indicated that this

approach provided effective response actions and did not delay the response

time.

The review team examined the State's response to eight events that were

identified as significant in the incident log provided by the State and the

NMED file provided by the NRC Office for Analysis and Evaluation of

Operational Data. Events reviewed involved a repeated switch failure at a

large pool irradiator, a broken rack cable at a second large pool irradiator,

radioactive contamination at a hospital, missing radioactive material, a

leaking source, and three cases in which radiation monitors were tripped

because of improper disposal of sources. Six allegation files involving a

variety of technical and administrative issues were selected from a list

provided by the State. A list of the incident casework with comments is

included in Appendix F.

In the cases reviewed in depth, the review team found that the State's

response was well within the performance criteria. Incident response was

prompt and well-coordinated, and the level of effort was commensurate with

health and safety significance. As a general rule, health physicists were

dispatched to the site when appropriate. The State took suitable corrective

and enforcement actions, notified the NRC as appropriate, and followed the
North Carolina Draft IMPEP Report Page 9

progress of the investigation through until close out. Allegations were

responded to promptly with appropriate investigations and follow up actions. 

Proper procedures were used for the control of information, and the results of

the investigation were promptly related to the alleger.

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

Carolina's performance with respect to the indicator, Response to Incidents

and Allegations, be found satisfactory.

4.0 NON-COMMON PERFORMANCE INDICATORS

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

reviewing Agreement State programs: (1) Legislation and Regulations, 

(2) Sealed Source and Device Evaluation Program, (3) Low-Level Radioactive

Waste Disposal Program, and (4) Uranium Recovery Operations. Because North

Carolina has no agreement to regulate uranium recovery operations, only the

first three performance indicators were applicable to this review.

4.1 Legislation and Regulations

4.1.1 Legislative and Legal Authority

Along with their response to the questionnaire, the State provided the review

team with copies of legislation that affects the radiation control program. 

DEHNR is designated as the State radiation protection agency in the General

Statues of North Carolina, Chapter 104E, North Carolina Radiation Protection

Act. The Act creates the North Carolina Radiation Protection Commission, and

grants the Commission the authority to promulgate rules and regulations to be

followed in the administration of a radiation protection program, including a

low-level radioactive waste disposal facility. 

4.1.2 Status and Compatibility of Regulations

North Carolina's final equivalent amendments to the following rules became

effective in May 1995, after being approved on a temporary basis in August

1994: "Safety Requirements for Industrial Radiographic Equipment," 10 CFR

Part 34; "Notification of Incidents," 10 CFR Parts 20, 30, 31, 34, 39, 40, and

70; and "Quality Management Program and Misadministrations" 10 CFR Part 35. 

In correspondence dated October 27, 1995, OSP indicated the State regulations

were compatible, based on NRC staff review of the amended regulations. 

According to information provided in the questionnaire, the State has drafted

regulations equivalent to the following NRC rules:

• "Licensing and Radiation Safety Requirements for Irradiators," 10 CFR

Part 36 amendments (58 FR 7715) that became effective July 1, 1993. The

State reported that all irradiator licenses issued since July 1993

implement the rule through license conditions. 

• "Decommissioning Recordkeeping and License Termination: Documentation

Additions," 10 CFR Parts 30, 40, 70, and 72 amendments (58 FR 39628)

that became effective on October 25, 1993.

• "Self-Guarantee as an Additional Financial Mechanism," 10 CFR Parts 30,

40, and 70 amendments (58 FR 68726 and 59 FR 1618) that became effective

on January 28, 1994.
North Carolina Draft IMPEP Report Page 10

• "Timeliness in Decommissioning of Materials Facilities," 10 CFR Parts

30, 40, and 70 amendments (59 FR 36026) that became effective on 

August 15, 1994.

• "Performance Requirements for Radiography Equipment," 10 CFR Part 34

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

The following rules are under review, but have not been drafted:

• "Definition of Land Disposal and Waste Site QA Program," 10 CFR Part 61

amendments (58 FR 33886) that became effective on July 22, 1993.

• "Preparation, Transfer for Commercial Distribution and Use of Byproduct

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

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

• "Frequency of Medical Examinations for Use of Respiratory Protection

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

on March 13, 1995. Note, this rule is designated as a Division 2 matter

of compatibility. Division 2 compatibility allows the Agreement States

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

continue to require annual medical examinations). 

• "Low-Level Waste Shipment Manifest Information and Reporting," 10 CFR

Parts 20 and 61 amendments (60 FR 15649, 60 FR 25983) that will become

effective March 1, 1998. North Carolina and other Agreement States are

expected to have that equivalent rule effective on the same date.

The State has not started review of the following compatibility rules:

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

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

August 14, 1995.

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

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

November 24, 1995.

• "Compatibility with the International Atomic Energy Agency," 10 CFR Part

71 amendment (60 FR 50248) that will become effective April 1, 1996.

The review team examined the procedures used in the State's regulation

promulgation process and found that the public is offered the opportunity to

comment on proposed regulations in public hearings. According to program

management, the NRC is provided with drafts for comment on the proposed

regulations early in the promulgation process and again prior to final

adoption. 

Although the State's regulations were compatible with those of the NRC at the

time of the review, not all compatibility regulations had been adopted within

the three-year time frame prescribed in the performance criteria. During

discussions with the review team, program management explained that they are

aware of the importance of maintaining compatible regulations and the State

plans to make every effort to maintain compatibility. However, they pointed

out that recent legislative changes have placed additional constraints on

adopting new regulations. It is less likely that the State can continue to

adopt effective regulations within 3 years for new regulations. The review

team recommends that the State evaluate the process for promulgating
North Carolina Draft IMPEP Report Page 11

compatibility regulations to better ensure that the State meets the three-year

time frame. 

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

Carolina's performance with respect to the indicator, Legislation and

Regulations, be found satisfactory.

4.2 Sealed Source and Device Evaluation Program

In evaluating the State's SS&D evaluation program, the review team studied the

information provided by the State relative to this indicator in their response

to the questionnaire, reviewed the casework and background information of all

certificates of registration issued since the April 1994 review, reviewed new

procedures and guidance, and interviewed the DRP staff and managers

responsible for SS&D evaluations.

In response to the NRC's recommendations following the April 1994 special SS&D

review, on July 17, 1995, the State submitted an action plan for improving

their SS&D evaluation procedures and for reevaluating and updating previously

issued SS&D registry sheets. The review team found that DRP had made

excellent progress in meeting the goals set forth in the plan. The

reevaluation effort is being conducted with a lot of planning in the

priorities of reviews, with the single thought that those with health and

safety concern are to be given higher priority. Under the action plan, each

SS&D manufacturer was required to submit complete sets of updated product

information to enable DRP to perform the reevaluations and updates. The State

explained that progress on the reevaluation plan is not moving as fast as they

would like because they have encountered difficulty getting the level of

detail from the vendors needed to initiate a product safety evaluation. The

review team noted that some of the devices were approved many years ago before

a formalized registration process was in place. These products have

historically been in use in the United States with few reported design

problems. The staff has been diligent in their efforts to collect old

information and update the original safety approvals, and have strong

management support in this area. Details of the status of the reevaluation

program are provided by the State in Appendix C.

4.2.1 Technical Quality of the Product Evaluation Program

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

sheets issued since the April 1994 review, including the State's approval of a

newly designed source rod used in several different Troxler extendable source

machines. The SS&D registry sheets issued by the State and evaluated by the

review team are listed with case-specific comments in Appendix G. Overall,

the quality of the evaluations was good, with only minor technical comments,

and showed a vast improvement since the April 1994 review. The review team,

however, found that the State has no procedures for handling proprietary

information used in evaluating SS&D products. Documents containing

proprietary information were sometimes attached to registry sheets distributed

publicly. The review team recommends that the State consider developing

written guidance for preserving the integrity of proprietary information

furnished by the manufacturer when issuing SS&D registry sheets. The review

team identified two other items that need action by the State. (1) The

Troxler drawings show an ANSI classification requirement of C54444 for sources

they use. However, they are using an IPL source with a rating of C66535. It

could not be determined if this was an oversight or if the performance

specification is not being met by Troxler. (2) The American Duesenberg Bosson

registry sheet for a gamma gauge did not have the necessary attachments. The

review team recommends that (1) the State clarify the Troxler source ratings
North Carolina Draft IMPEP Report Page 12

and evaluate Troxler's QA plan to ensure that it includes health physics

evaluation; and (2) that the necessary attachments to the American Duesenberg

certificate be distributed.

It was noted that the State has a very well defined regulatory basis for its

SS&D registry program. This basis is found in §.0117 of the North Carolina

Regulations for Protection Against Radiation, which incorporates by reference

10 CFR part 32 including 32.210. This, in conjunction with §.0327 (f) gives

the State a firm basis to conduct and inspect against source or device

evaluation. The incorporation also clearly defines the approval criteria and

the type of information to be submitted by the applicant.

4.2.2 Technical Staffing and Training

The State reported that a two-person team with combined staff efforts

equalling approximately one FTE is dedicated to performing safety evaluations. 

Both staff members have master's degrees, one in physics, the other in

environmental health. The senior of the two reviewers attended the SS&D

workshop training and is spending about 75 percent of his time in this area. 

He demonstrated to the review team an ability to understand and interpret the

information submitted by applicants as described in the performance criteria. 

The junior reviewer also attended the workshop but has not performed

independent SS&D evaluations. He expressed a need to become familiar with the

process first. An offer was extended to the State for this reviewer to work

with the Sealed Source Safety Section at NRC Headquarters, and his management

is considering that option. The review team is aware that promotion of the

radioactive materials supervisor and the recent high turnover rate of the

State program presents potential for weaknesses to develop. However, these

potential weaknesses appear to be offset by the staff's dedication to a

quality product, the use of a team approach to performing the evaluations,

management support, and the ability to seek outside engineering consultants

for assistance as needed.

4.2.3 Evaluation of Defects and Incidents Regarding SS&Ds

The State is following up on two SS&D-related incidents, one involving a

source rod break on Troxler equipment and the other involving a broken cable

attached to a source rack hoist for a category IV irradiator. The State's

responses to these incidents were evaluated by the review team and are

included in the incidents reviewed in section 3.5 of this report.

Based on the IMPEP evaluation criteria, the review team recommends 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 the process of evaluating this performance indicator, the review team

studied the State's responses to the questionnaire, compared North Carolina

LLRW statutes and regulations with those of the NRC, evaluated the

qualifications of the technical staff and contractors, reviewed the State's

written procedures and plans, examined parts of the site characterization

report and associated documents, reviewed parts of the safety analysis report

(SAR), surveillance reports, audits, and contractor reports, and interviewed

all staff and managers assigned to the LLRW program.
North Carolina Draft IMPEP Report Page 13

4.3.1 Introduction

In 1987 the North Carolina Legislature formed the Low Level Radioactive Waste

Management Authority (LLRWMA) for the purpose of developing a low-level

radioactive waste disposal facility within the State of North Carolina. DEHNR

is granted authority to regulate LLRW activities under the General Statues of

North Carolina, Chapter 104E, North Carolina Radiation Protection Act. Within

DEHNR, the North Carolina LLRW program is administered by the DRP.

In 1989 Chem Nuclear Systems, Inc. (CNSI) was selected to site, construct,

operate and close such a facility. A site characterization plan for two sites

was submitted to DRP in June 1990. DRP commented on the plan through a series

of memoranda and open meetings between July 1990 and August 1991, and the plan

was approved August 16, 1991.

According to DRP officials, during the characterization effort, DRP met with

CNSI at 3-month intervals to review the CNSI approach. The State raised a

number of major objections to the conduct of site characterization. CNSI made

a number of adjustments but key issues remained unresolved and, in April 1993,

LLRWMA requested a statement of detailed concerns from DRP. Detailed concerns

were provided by DRP on May 13, 1993. The site characterization report was

submitted in October 1993 and the SAR was submitted on December 13, 1993. The

SAR was found to be incomplete and CNSI was directed to furnish additional

information. At the end of January 1994, CNSI had provided sufficient

information for DRP to begin detailed review.

In March 1994, DRP sent 38 interrogatories to CNSI detailing major problems in

the hydrologic characterization, requiring more field work and also requesting

a field work plan. By August 1994, 556 additional interrogatories had been

transmitted to CNSI, including requests for construction details for some of

the engineered barriers. In November 1994, LLRWMA hired the firm of HardingLawson to evaluate the DRP review. The Harding-Lawson evaluation, released in

April 1995, expressed agreement with the DRP concerns.

In November 1995, CNSI stated that resolving the DRP concerns would add

approximately $20,000,000 to the cost of the facility and the site would

likely not be licensed until mid-1998. CNSI is expected to submit an issue

resolution plan to the LLRWMA in January 1996. The LLRWMA will decide whether

or not to continue pursuing a license for the proposed site.

On December 13, 1995, the LLWRMA Executive Director spoke before the North

Carolina Joint Legislative Commission on Governmental Operations in regard to

the status of activities, revenues, and expenditures of the project. A review

team member attended that session where the Legislative Commission was advised

that LLWRMA has spent approximately $87 million thus far on the project and

that DRP has spent approximately $6 million on licensing activities.

4.3.2 Status of Low-Level Radioactive Waste Disposal Inspection

The applicant is presently in the pre-license stage and the DRP inspection

program consists of surveillances of site characterization work at the site

and Quality Assurance (QA) audits. The review team found that the State has

been diligent in conducting surveillances and audits. Fifteen surveillance

reports are on file for 1994, and 23 are on file for 1995. In addition a QA

informational audit was performed on the applicant in September-October 1995. 

DRP's QA manual requires audits to be performed at least on an annual basis. 

A database is being established which will have the capability of maintaining

and retrieving statistical data on the status of the LLRW inspection program.
North Carolina Draft IMPEP Report Page 14

The DRP License Application Review Management Plan provides for periodic

inspections including tests on waste, facilities, and environment and an

operational inspection program to be defined in advance of issuing a license

for operations. By regulation, the licensee is required to provide an office

and storage space for a resident State inspector at the facility.

4.3.3 Technical Staffing and Training

DRP's LLRW section has six full-time employees and three employees devoting

approximately 50 percent of their time to LLW. Two of the 50 percent

employees may devote up to 100 percent of their time as needed. Current

demand is about 50 percent. In addition, the North Carolina Geological Survey

has three full-time employees assigned to the LLRW project; the North Carolina

Groundwater Section has three full-time employees assigned; and the North

Carolina Air Quality Section has one full-time employee assigned. Other State

agencies provide part-time help on an as-needed basis for areas including

waste quality, forest resources, epidemiology, and cultural resources. 

Contractual assistance has been obtained for performance assessment (PA) and

engineering from Rogers and Associates Engineering Corporation in Salt Lake

City, Utah; in hydrology, PA, and QA from ERM Program Management Company in

McLean, Virginia; and in program management from Environmental Issues

Management, Inc., in Seattle, Washington.

The review team reviewed the training records and interviewed the eight

technical staff members assigned to the LLRW section, and found that all

technical staff hold bachelor's or advanced degrees in appropriate scientific

fields. In Appendix C, the State identifies the staff members assigned to the

LLRW program and lists their training and experience. Review of the training

procedures show that all individuals are required to be familiar with DRP LLRW

review procedures and applicable NRC NUREGS such as 1199, 1200, and 1300. In

addition, senior level personnel are required to be familiar with NRC QArelated NUREGS 1293 and 1383. From the interviews, it was determined that all

personnel appeared to be qualified for their positions of responsibility

either through education and/or experience. Also from the interviews, it was

determined that all have participated in additional technical training either

through college courses, government sponsored courses, or workshops. The

review team encourages DRP management to take an active role in supporting

professional licensing of the technical staff. This should be especially

encouraged for staff without graduate degrees or degrees specific to their

title and position of responsibility. 

The qualifications of the three contractors were also reviewed. Each of the

contractors appeared qualified for the responsibilities assigned.

The overlap in skills provided for in the program through contractors and

participating State agencies is expected to help to lessen possible adverse

effects from staff turnovers.

The review team found that the qualifications of the technical staff are

commensurate with expertise identified as necessary to regulate a low-level

radioactive waste disposal facility. Management has developed and implemented

a training program for staff. Staff trends that could have an adverse impact

on the quality of the program are tracked, analyzed and addressed. The review

team recommends that the State consider keeping records of LLRW staff members'

technical training and participation in workshops, conferences, etc., in the

individual's training files and also maintain a collective staff training

record to help formalize such training as an ongoing requirement for the
North Carolina Draft IMPEP Report Page 15

position and to better allow management to assess the training level of the

staff.

4.3.4 Technical Quality of Licensing Actions

The technical quality of LLRW licensing actions was evaluated with regard to

aspects considered essential to performance assessment. These aspects

included comparison of pertinent sections of the North Carolina regulations

with 10 CFR 61, programmatic aspects of the review process, and issues under

resolution of sufficient complexity to evaluate the technical adequacy of the

review process. 

The North Carolina low-level waste regulations, Title 15A. Chapter 11 §.1200

Land Disposal of Radioactive Waste, were compared with the parts of 10 CFR 61

which govern performance assessment. Specifically the North Carolina

regulations were compared to Subpart C of 10 CFR 61, "Performance Objectives,"

and parts 61.50 through 61.53 of Subpart D, "Technical Requirements for Land

Disposal Facilities." The North Carolina regulations were found to be

completely compatible with Subpart C of 10 CFR 61. The North Carolina

regulations were found to be equivalent to Subpart D 61.50 to 61.53 with the

following exceptions:

• In 10 CFR 61.50(a)(7), the Commission will consider an exception to the

requirement that the disposal site will provide sufficient depth to the

water table that groundwater intrusion will not occur. North Carolina

regulations do not provide for this exception and require that the

disposal facility be at least seven feet above the seasonal high water

table.

• North Carolina regulations also require that areas shall be avoided that

are recharge areas for sole source aquifers or drinking water supply

watersheds unless it can be demonstrated with reasonable assurance that

the disposal site can be designed, constructed, operated, and closed

without an unreasonable risk to an aquifer or drinking water supplies. 

10 CFR 61 does not have this requirement.

• North Carolina regulations state that waste disposal shall not take

place within 1000 ft. of drinking water wells, except for on-site wells

controlled by the licensee and used to supply water solely to the

facility. 10 CFR 61 does not have this requirement.

• North Carolina regulations require the incorporation of engineered

barriers that will complement and where appropriate, improve the land

facilities ability to isolate the radioactive waste through the

institutional control period. 10 CFR 61 does not have this requirement.

• Mixed waste is prohibited. The Radiation Protection Commission may

waive this prohibition if specified conditions are met. 10 CFR 61 does

not have this prohibition.

• North Carolina regulations require a description of an action plan which

would be implemented in the event of unforeseen differences between

expected and actual behavior of the disposal system. North Carolina's

requirements in this area are significantly more detailed than the 10

CFR 61 requirements.

These differences, however, do not make the North Carolina regulations

incompatible with 10 CFR 61 for the purposes of performance assessment. The

team notes that the prohibition on the disposal of mixed waste can be a
North Carolina Draft IMPEP Report Page 16

compatibility issue. However, since some other Agreement States that regulate

the disposal of low-level radioactive waste have similar prohibitions, the

review team recommends that the issue of Agreement State prohibition of mixed

waste disposal be resolved generically by NRC.

In regard to programmatic aspects of the review program, the License

Application Review Management Plan (LARMP) and its implementation was

evaluated. The LARMP requires the formation of a review team with an

identified LLRW Section staff lead reviewer for each section of the SAR. The

LARMP also requires the establishment of an integration team to assure that

the review is integrated across all applicable disciplines. DRP has a

contractual arrangement with ERM to provide senior-level technical expertise

to the integration team. ERM is the primary PA contractor. DRP is extremely

interested in developing and maintaining a process which will assure

efficiency and quality in its evaluation and has used one of its contractors

to assess its program in this regard. The November 2, 1995, Environmental

Issues contractors report was reviewed. Recommendations from this report are

being considered for implementation. Discussions with the LLRW section chief,

indicate a management understanding of PA basic steps and how PA can help make

a finding with reasonable assurance.

In evaluating the State's review and resolution of technical issues, the

review team selected four issues in the areas of source term, engineered

barrier performance, hydrologic transport and dose assessment.

• Interrogatory Number 06-A-17 (6/17/94) requested the applicant to

justify the IMPACTS methodology. The interrogatory asked specific

questions about coefficients used in the methodology and provided

technical discussions as to why such coefficients may or may not be

applicable to the site. The interrogatory referenced the NRC Draft

Branch Technical Position (BTP) on LLRW PA as not endorsing generic

codes and cautioning against the use of certain parameters. DRP

provided minutes of conference calls and meetings with the applicant. 

On October 2, 1995, CNSI transmitted an interim report to DRP providing

for alternative means of calculating the groundwater source term. The

issue appears to be moving toward adequate resolution.

• Interrogatories 03-A-006 (3/16/94) and 03-A-052 (8/18/94) requested

detailed drawings and technical discussions regarding the design of the

infiltration cap. The DRP review of the conceptual design of the

infiltration cap as presented in the SAR determined that the cap as

conceptualized may not be constructable using conventional engineering

and construction techniques and, therefore, may not perform as intended. 

DRP requested construction details before proceeding further with an

evaluation of the cap. In December 1994, CNSI transmitted a draft of

their revised cover design and construction details to DRP. DRP

expressed further concerns in a letter dated March 14, 1995. In October

1995, CNSI made a presentation of their overall systems model to DRP

which included a revised cover design. DRP engineers expect resolution

in the near future.

• Interrogatories 02-A-119 (8/18/94), 02-A-120 (8/18/94), and 02-A-126

(8/18/94) were directed at saturated zone modeling, characterization,

and scale effects. Interrogatory 02-A-119 resulted from the recognition

by DRP that fractured rock could probably not be successfully modeled as

an equivalent porous media (EPM). Interrogatory 02-A-120 requested

three dimensional geologic data at aquifer test sites so that pumping

tests could be effectively planned and interpreted. Interrogatory

02-A-126 requested geostatistical analysis around various well cluster
North Carolina Draft IMPEP Report Page 17

packered intervals as a means to understand scale effects on the value

of hydraulic conductivity at the site. Letters to CNSI on

October 12, 1992, and later on February 15, 1993, before completion of

the SAR, expressed concern about the EPM assumption and the need for

more complete geologic understanding. The Harding-Lawson Associates

report issued in April 1995, also expressed concern about the validity

of the EPM model and expressed the need for detailed 3-D hydrogeology. 

On November 2, 1995, a presentation to DRP by CNSI and other LLRWMA

contractors presented a revised modeling approach which will incorporate

hydrologically significant geologic features, test alternate conceptual

models including continuum and discrete fracture approaches, simulate

multiple scales of features and allow for model confirmation at large

and detailed scales. The issue appears to be moving toward adequate

resolution.

• Interrogatory 06-A-018 (6/17/94) was directed at dose calculations

incorporating decay products of Th-232 and U-238. It requested CNSI to

provide a performance assessment including maximum dose even if it

occurred after 1,500 years. This issue was discussed further at a

source term/PA topical meeting at DRP on July 20, 1994. CNSI replied to

the interrogatory claiming that DRP requirements on period of

performance were stricter than those of NRC. CNSI reiterated this

concern in a letter dated September 13, 1994, to DRP and cited NRC

PG-8-08 as limiting the period of consideration of decay products of

thorium and uranium to 1000 years for decommissioning of nuclear

facilities. The 10,000 year period of the Draft BTP on PA was

acknowledged, however. On September 22, 1994, a public meeting was held

to discuss performance assessment. At the meeting a DRP consultant

noted that the cited period of performance (1000 years) was for

decommissioning of nuclear power plants. In this meeting CNSI requested

a written statement from DRP addressing the required time period for

performance. On November 2, 1995, DRP issued a letter stating that for

the first few thousand years, CNSI should assess performance in detail

and assess whole body dose rate equivalents by nuclide, pathway, and

scenario. After the first few thousand years, CNSI may use simplifying

and conservative assumptions to bound peak dose. CNSI must also

demonstrate an understanding of nuclides important to dose, factors

affecting mobility and transport of radionuclides, decay and ingrowth,

and the general time frame within which associated doses will result. 

DRP expects resolution based on the November 2, 1995, letter.

The review team found that pre-licensing interactions with the applicant are

occurring on a regular basis. Applicable guidance documents are available to

reviewers in most cases, and are generally followed. Public meetings in

accordance to the State administrative laws have occurred. Review of certain

technical aspects of the low-level waste license files indicates that aspect

of the license review is generally thorough, complete, consistent, and of

acceptable technical quality. Health and safety issues are properly

addressed. An evaluation of the license review process indicates that the

process is thorough and consistent. No potentially significant health and

safety issues can be linked to licensing practices. 

4.3.5 Technical Quality of Inspections

Review of this area focused on the scope, completeness, and technical accuracy

of inspections and related documentation and consisted of a review of the

surveillances and QA audits performed by DRP.
North Carolina Draft IMPEP Report Page 18

DRP uses surveillance reports to document all visits by DRP personnel or

contractors to the site and includes documentation of meetings with the

applicant, site tours, and surveillance of data collection. A review of the

surveillances found them to be generally in accordance with the requirements

of QAP-10, "Surveillances." However, a master list of surveillances conducted

was not readily available. In addition, the numbering of early surveillances

(1994) appeared to be in error. The numbering system also indicated that some

surveillance reports may be missing from the file. At present, surveillance

reports are prepared by technical staff and are not logged by the QA manager

prior to filing. The review team recommends that consideration be given to

changing the LLRW section filing procedures to ensure that surveillance

reports become part of the licensing database subject to internal QA

inspections.

The team reviewed DRP's plans for the new licensing database, which does

include surveillance reports, and concluded that the computerized data base

should help to eliminate these problems. The review team feels that errors of

the type found during the review team's review of the document tracking system

may cause significantly greater problems for the operation of a computer

database. The review team recommends consideration of an internal audit on

the SAR review database during input to the new database to assure that all

LLRW section review leaders are entering data properly. 

The review team reviewed the LLRW Disposal Facility Project Quality Assurance

Plan (QAP) to determine its compatibility with NRC NUREG-1293 "Quality

Assurance Guidance for Low-level Radioactive Waste Disposal Facility." The

QAP was issued on October 15, 1993, and contains descriptions of the plan's

organization, the QA program and other areas as addressed in NUREG 1293. The

QAP also contains an implementation matrix showing the implementation

procedures for pertinent sections of the QAP and the applicable sections of

NUREG 1293. From this matrix QP-10, "Surveillance Inspection," and QP-18,

"Quality Assurance Audits," were selected for comparison to NUREG-1293. Both

were found to conform with the general guidance as presented in NUREG-1293.

The results of two audits performed by LLRW staff were reviewed. The first

audit was an internal audit of DRP LLRW performed in August 1995. This audit

was performed at the request of the section chief and was performed for the

purpose of checking the quality of internal documentation in the areas of

document review records, internal review records, interrogatories, letters of

transmittal to CNSI, and training records for contractor personnel. Computer

databases containing information are to be audited later. The overall

objective was to ensure that review documentation is traceable and

retrievable. Problems were identified, corrective actions outlined, and

preventive measures were suggested in the internal audit report. As of

December 1995, over 95 percent of the required corrective actions have been

completed.

The second audit reviewed was Information Audit 95-001, performed on CNSI and

Law Engineering at CNSI on intermittent days between September 11, 1995, and

October 27, 1995, by LLRW personnel and technical auditors from North Carolina

Geological Survey. The purpose of the audit was to review the evaluation and

documentation of rock core data by the applicant and its contractor. Records

showed the audit to be conducted in accordance with QAP-18 and consisted of a

pre-audit meeting, the preparation of QA and technical check lists, the audit,

and a post audit meeting. However, a number of discrepancies were noted

during the audit and an audit report is in preparation. The quality of the

information audit (95-001) appeared to be excellent but very narrowly focused

and resource intensive. During discussions with the LLRW managers, the review

team pointed out that shorter audits on a wider variety of performance
North Carolina Draft IMPEP Report Page 19

assessment significant areas may be a more efficient use of resources and that

involvement of the PA contractor in the selection of audit subjects and in the

conduct of appropriate audits should be considered.

4.3.6 Response to Incidents and Allegations

There were no reported allegations in the area of LLRW. The State explained

to the review team that allegations directed to the low-level radioactive

waste program will be handled in the same manner as those of the radioactive

materials program, which was discussed earlier in Section 3.5 of this report.

The recommendations made in the LLRW performance indicator are administrative

in nature, and do not directly affect public health and safety.

Based on the IMPEP evaluation criteria for the above five performance areas,

the review team recommends that North Carolina'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 the State's

performance with respect to each of the performance indicators to be

satisfactory. Accordingly, the team recommends the MRB find the North

Carolina program to be adequate to protect public health and safety and

compatible with NRC's program. The MRB found the North Carolina program to be

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

program. 

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

of the report, for action by the State. 

1. The review team recommends that the State fill existing vacancy as soon

as possible. (Section 3.2)

2. The review team recommends that the State consider peer and supervisory

review of licensing products to include review of all background

information and correspondence. (Section 3.3)

3. The review team recommends: (a) that all inspection reports include a

summary of the exit meeting discussion, as addressed by internal

guidance, including the licensee's comments regarding items of noncompliance; and (b) that inspectors make every effort to hold exit

meetings at the highest possible management level. (Section 3.4)

4. The review team recommends that the State consider adopting a policy of

annual supervisory accompaniments of all materials inspectors. (Section

3.4)

5. The review team recommends that the State evaluate the process for

promulgating compatibility regulations to better ensure that the State

meets the three-year time frame. (Section 4.1)

6. The review team recommends that the State consider developing written

guidance for preserving the integrity of proprietary information

furnished by the manufacturer when issuing SS&D registry sheets.

(Section 4.2)
North Carolina Draft IMPEP Report Page 20

7. With respect to the sealed source and device evaluation program, the

review team recommends that (a) the State clarify the Troxler source

ratings and evaluate Troxler's QA plan to ensure that it includes health

physics evaluation; and (b) that the necessary attachments to the

American Duesenberg certificate be distributed. (Section 4.2)

8. The review team recommends that the State consider keeping records of

LLRW staff members' technical training and participation in workshops,

conferences, etc., in the individual's training files and also maintain

a collective staff training record to help formalize such training as an

ongoing requirement for the position and to better allow management to

assess the training level of the staff. (Section 4.3.3)

9. The review team recommends that consideration be given to changing the

LLRW section filing procedures to ensure that surveillance reports

become part of the licensing database subject to internal QA

inspections. (Section 4.3.5)

10. The review team recommends consideration of an internal audit on the SAR

review database during input to the new database to assure that all LLRW

section review leaders are entering data properly. (Section 4.3.5)

For NRC, the review team recommends that the issue of the compatibility of

Agreement State programs that prohibit the disposal of mixed waste be resolved

as a generic issue.
LIST OF APPENDICES AND ATTACHMENTS

Appendix A IMPEP Review Team Members

Appendix B North Carolina DRP Organization Chart

Appendix C North Carolina's Questionnaire Response

Appendix D License File Reviews

Appendix E Inspection File Reviews

Appendix F Incident File Reviews

Appendix G Sealed Source and Device Evaluation Reviews

Attachment 1 North Carolina's Response to Review Findings
APPENDIX A

IMPEP REVIEW TEAM MEMBERS 

Name Area of Responsibility

Jack Hornor, RIV, WCFO Team Leader

Technical Staffing and Training

Incidents and Allegations

Legislation and Regulations

Richard Woodruff, RII Status of Materials Inspection Program

Technical Quality of Inspections

Susan Giddings, Utah Technical Quality of Licensing

Steve Baggett, NMSS/IMNS Sealed Source and Device Evaluation Program 

Rex Wescott, NMSS/DWM Low Level Radioactive Waste Program 
APPENDIX B

NORTH CAROLINA DIVISION OF RADIATION PROTECTION

ORGANIZATION CHARTS