August 22, 2001

J. Nick Baird, M.D.

Director

Ohio Department of Health

246 North High Street

Columbus, OH 43266

Dear Dr. Baird:

On August 9, 2001, the Management Review Board (MRB) met to consider the proposed final

Integrated Materials Performance Evaluation Program (IMPEP) report on the Ohio Agreement

State Program. The MRB found the Ohio program adequate to protect public health and safety

and compatible with the Nuclear Regulatory Commissionís program. 

Section 5.0, page 12, of the enclosed final report presents the IMPEP teamís single

recommendation for the State of Ohio. We received your June 29, 2001 letter which described

your staffís actions taken in response to the recommendation in the draft report. We request no

additional information.

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

four years.

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

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

work cooperatively in the future.

Sincerely,

/RA/

Carl J. Paperiello

Deputy Executive Director 

 for Materials, Research

 and State Programs

Enclosures: 

As stated

cc: Roger Suppes, Chief 

Bureau of Radiation Protection

Ohio Department of Health

Carol OíClaire, State Liaison Officer

Supervisor, Radiological Branch

Ohio Emergency Management Agency 

Richard M. Fry, North Carolina

OAS Liaison to the MRB
J. Nick Baird, M.D. August 22, 2001 

Director

Ohio Department of Health

246 North High Street

Columbus, OH 43266

Dear Dr. Baird:

On August 9, 2001, the Management Review Board (MRB) met to consider the proposed final

Integrated Materials Performance Evaluation Program (IMPEP) report on the Ohio Agreement

State Program. The MRB found the Ohio program adequate to protect public health and safety

and compatible with the Nuclear Regulatory Commissionís program. 

Section 5.0, page 12, of the enclosed final report presents the IMPEP teamís single

recommendation for the State of Ohio. We received your June 29, 2001 letter which described

your staffís actions taken in response to the recommendation in the draft report. We request no

additional information.

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

four years.

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

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

work cooperatively in the future.

Sincerely,

/RA/

Carl J. Paperiello

Deputy Executive Director 

 for Materials, Research

 and State Programs

Enclosures: 

As stated

cc: Roger Suppes, Chief bcc: Chairman Meserve

Bureau of Radiation Protection Commissioner Dicus

Ohio Department of Health Cimmissioner McGaffigan

Commissioner Merrifield

Carol OíClaire, State Liaison Officer

Supervisor, Radiological Branch

Ohio Emergency Management Agency 

Richard M. Fry, North Carolina DCD (SP01)

OAS Liaison to the MRB PDR (YES)

Distribution:

DIR RF CSanders, GA DCool, NMSS

SDroggitis JCook, NRC/RIV GDeegan, NMSS

KSchneider, STP DWiedeman, NRC/RIII SCollins, IL

LRakovan, STP SLee, NMSS/MSIB STreby, OGC

Ohio State File

DOCUMENT NAME: C:\Program Files\Adobe\Acrobat 4.0\PDF Output\2001 OH Final Report and Le~.wpd

ML012320443

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 STP STP:DD STP:D DEDMRS

NAME DMSollenberger:gd FCombs PHLohaus CPaperiello

DATE 8/20/01 8/20/01 8/20/01 8/22/01

 STP-AG-31
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM

REVIEW OF OHIO AGREEMENT STATE PROGRAM

May 14 -18, 2001

FINAL REPORT

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

1.0 INTRODUCTION

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

was conducted during the period May 14-18, 2001, by a review team comprised of technical

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

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

accordance with the "Implementation of the Integrated Materials Performance Evaluation

Program and Rescission of a Final General Statement of Policy," published in the Federal

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

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

of the review, which covered the period August 31, 1999 to May 18, 2001 were discussed with

Ohio management on May 18, 2001.

A draft of this report was issued to Ohio for factual comment on June 13, 2001. The State

responded in a letter dated June 29, 2001. The Management Review Board (MRB) met on

August 9, 2001 to consider the proposed final report. The MRB found the Ohio radiation control

program was adequate to protect public health and safety and compatible with NRCís program.

The Ohio Agreement State program is administered by the Bureau of Radiation Protection

(the Bureau), Division of Prevention, Department of Health (the Department). Organization

charts for the Department and the Bureau are included as Appendix B. At the time of the

review, the Ohio program regulated 702 specific licenses authorizing Agreement materials. The

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

Atomic Energy Act of 1954, as amended) Agreement between the NRC and the State of Ohio.

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

indicators was sent to the Bureau on March 8, 2001. The Bureau provided a response to

the questionnaire on April 19, 2001. A copy of the questionnaire response is included as

Appendix G of the proposed final report and can be found on the NRCís Agencywide

Documents Access and Management System (ADAMS) using the accession number

ML011620625.

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

of Ohio's response to the questionnaire; (2) review of applicable Ohio statutes and regulations;

(3) analysis of quantitative information from the Bureau licensing and inspection data base;

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

five Ohio inspectors; and (6) interviews with staff and management to answer questions or

clarify issues. The team evaluated the information that it gathered against the IMPEP

performance criteria for each common and non-common indicator and made a preliminary

assessment of the radiation control program's performance.

Section 2 below, Status of Items Identified in Previous Reviews, is not applicable to the State as

this was the initial program review. Results of the current review for the IMPEP common

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

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

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

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

State to all recommendations in the final report. 
Ohio Final Report Page 2

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS

The State of Ohio became an Agreement State on August 31, 1999. The Agreement includes

byproduct material as defined in Section 11e.(1) and 11e.(2), source and limited quantities of

special nuclear materials, low-level radioactive waste disposal (LLRW), and sealed source and

device (SS&D) evaluations. 

This was the initial program review. A management orientation meeting was held with the

Bureau on June 7, 2000. The purpose of the meeting was to discuss the status of the program

and the initial program activities following the transfer of authority. No attempt to evaluate the

performance of the program was made at that meeting. 

3.0 COMMON PERFORMANCE INDICATORS

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

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

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

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

3.1 Status of Materials Inspection Program

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

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

licensees. The review teamís evaluation is based on the Bureauís questionnaire responses

relative to this indicator, data gathered independently from the Bureauís licensing and

inspection data tracking system, the examination of completed licensing and inspection

casework, and interviews with managers and staff.

The review teamís evaluation of the Bureauís inspection priorities revealed that inspection for

each type of license were the same or more frequent than similar license types listed in the

NRC Inspection Manual Chapter (IMC) 2800. Core licensees were inspected at intervals in

accordance with frequencies consistent with IMC 2800 procedures. At the time of the review,

there were no overdue inspections for core licensees. The Bureau is in the process of

changing over from an ACCESS data base to a new Oracle data tracking system. The present

ACCESS data tracking system is not able to capture or archive the inspection history of each

licensee. The review team discussed the flexibility of the new Oracle data base to capture and

maintain a history of the inspection dates for each licensee. This feature would enhance the

Bureauís management of the inspection program by facilitating access and review of the 

inspection history of its licensees. Bureau management indicated that they believe the new

data base system has these features and they will ensure that this capability is available to the

Bureau.

The Bureau conducted 391 inspections since the effective date of the Agreement, and

approximately 70 new licenses were issued during this time. Forty-two reciprocity inspections

were conducted and more than 50% of the industrial radiography reciprocities were inspected

during the review period. Initial inspections were generally conducted within 6 months of the

new license approval/issuance date. The review team discussed with the staff the importance
Ohio Final Report Page 3

of properly documenting in the inspection files justification whenever the initial inspection for a

new licensee has been extended, such as the licensee does not yet possess any radioactive

material. Inspectors were not consistently documenting this information in the file.

Of the 14 inspection files reviewed by the team, the response letter to the licensee regarding

inspection results was sent within 30 days of the inspection date. Inspection finding letters to

licensees were dated within 2 to 19 calendar days after the inspection date.

Based on the IMPEP evaluation criteria, the review team recommends that Ohioís performance

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

3.2 Technical Quality of Inspections

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

inspectors for 14 radioactive materials inspections conducted during the review period. The

casework included 11 of the Bureauís materials license inspectors, and covered inspections of

various types including: medical (broad scope, private practice and institutional), mobile high

dose remote afterloader (HDR), mobile nuclear medicine, teletherapy, nuclear pharmacy,

industrial radiography, pool irradiator, portable and fixed gauges, and reciprocity (including

source loading services) inspections. Appendix C lists the inspection casework reviewed for

completeness and adequacy with case-specific comments, as well as the results of the

inspection accompaniments. 

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

the licenseesí radiation programs. The review team found that inspection reports were

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

licenseeís performance with respect to health and safety was acceptable. The documentation

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

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

when appropriate and for training purposes.

Inspection reports were signed by the appropriate supervisor and the Administrator Supervisory

accompaniments were adequately documented in the inspection reports. Inspectors are

qualified to perform a certain type of inspection once they have been accompanied by a Senior

Health Physicist/Supervisor at least three times on that particular type of inspection. The

inspectorsís Supervisor must sign off for each area and for the overall final approval and

qualification. 

The inspection findings were appropriate and prompt regulatory actions were taken as

necessary. The Bureau normally issues Compliance letters, Observations, or Notice of

Violations, as it deems appropriate. Violations of minor safety or environmental concerns which

are below the level of significance of Severity Level IV are documented in the inspection report

and issued to the licensee as a letter of Observations. The licensee is required to respond to

the noted Observations within 30 days. An administrative penalty is assessed with a Notice of

Violations. A ìGeneral Statement of Policy - Enforcement Actionsî procedure has been

established and implemented which explains the enforcement program.

The review included a check of survey instruments and equipment monitoring, including

calibration frequency and repairs. Each inspector is assigned a Ludlum 3 survey meter. A staff
Ohio Final Report Page 4

member in the Technical Services Unit is responsible for sending survey instruments out to the

Ohio Emergency Management Agency for calibration and repairs, however, the multichannel

analyzers are sent to the manufacturer for servicing. The Departmentís Laboratory performs

sampling analysis for the Bureau, as needed.

Five Bureau inspectors were accompanied during inspections by a review team member during

the week of April 30, 2001 through May 4, 2001. Inspection accompaniments included: medical

institution/HDR, nuclear pharmacy, fixed industrial radiography, and pool irradiator. These

accompaniments are identified in Appendix C.

During the accompaniments, each inspector demonstrated appropriate inspection techniques,

knowledge of the regulations, and conducted performance based inspections. The inspectors

were trained, prepared, and thorough in their audits of the licenseesí radiation safety programs. 

Overall, each inspector utilized good health physics practices, their interviews with licensee

personnel were performed in an effective manner, and their inspections were adequate to

assess radiological health and safety at the licensed facilities.

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

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

3.3 Technical Staffing and Training

Issues central to the evaluation of this indicator include the Bureauís 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 Bureau's questionnaire responses relative to this

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

backlogs. 

The Bureau desires that all technical staff have the equivalent of a bachelorís degree in the

sciences. The personnel regulations did not allow the Bureau to require a bachelors degree.

The new class plan currently being processed in the personnel office would require a bachelors

degree. The technical staff positions are classified as Health Physicist I, II, or III. 

The Bureau, headed by the Bureau Chief, has approximately 702 licenses with a total of 23.5

full time equivalent (FTE) assigned to implement the materials licensing and inspection

program. The Bureau is divided into four sections: Nuclear Material Safety Section;

Environmental Radiation Safety Section; Technical Services Section; and X-ray Section. Each

Section is managed by an Administrator. The Nuclear Materials Safety Section has the medical

and the non-medical programs managed by program supervisors. This included the routine

licensing and inspection of most of the materials facilities. The Environmental Radiation

Section has the radiological assistance program and the decommissioning program is managed

by program supervisors. The decommissioning program conducts license terminations and

partial site releases including the contaminated sites transferred from NRC. The Technical

Services Section conducts the SS&D evaluations with assistance from staff in the other

sections. The Agreement State program is implemented by the Nuclear Material Safety

Section, a portion of the decommissioning program in the Environmental Radiation Safety

Section, and the Technical Services Section. Technical staff perform both inspection and

licensing functions. 
Ohio Final Report Page 5

The Bureau has had limited staff turnover. Since entering into the Agreement, three staff

members have left the program and three staff members have been hired. There are currently

two vacant positions in the materials program with an additional position that became vacant on

June 15, 2001. Vacant positions are quickly posted. The Office of Personnel is evaluating the

candidates for the first two vacancies. A request for posting has been sent to the Office of

Personnel for the other position. In addition, the Bureau has submitted a reclassification plan

for the Bureau staff to the Office of Personnel. This plan would provide an increase in the

overall salary scale as well as additional career opportunities within current grade structure. 

The Bureau request also included two additional positions (one for regulation and guidance

development, one for training and quality assurance activities). As part of this plan, the Bureau

began a revision of the training and qualification requirements. The Bureau is fully supported

by fees and has had ample funding for training and travel needs. 

The Bureau has a documented training and qualifications program for technical staff that is

modeled after NRCís IMC 1246, ìFormal Qualification Programs in the Nuclear Materials Safety

and Safeguards Area.î The technical staff is well qualified from an educational and experience

standpoint. Staff has attended the basic courses as part of the transition to an Agreement

State. The Bureau staff has a wide variety of work experience in licensed facilities which has

helped the Bureau. The review of staff training documentation was difficult because the

different Bureau sections kept different records to demonstrate staff qualification. Also, in the

Nuclear Materials Safety Section there were many pages of qualifications with no clear

supervisor approval that the individual had met the minimum qualification. The review team

discussed and the Bureau management agreed to consider the desirability of establishing

consistent summary documentation for staff qualifications as part of the revision to the training

requirements discussed above.

 

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

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

3.4 Technical Quality of Licensing Actions

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

specific licenses. Licensing actions were evaluated for thoroughness, completeness,

consistency, proper isotopes and quantities used, qualifications of authorized users, adequate

facilities and equipment, and operating and emergency procedures sufficient to establish the

basis for licensing actions. Licenses were reviewed for accuracy, appropriateness of the

license and of its conditions and tie-down conditions, and overall technical quality. 

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

to appropriate regulations, or other supporting documents, consideration of enforcement history

on renewals, peer or supervisory review as indicated, and proper signature authority. The files

were checked for retention of necessary documents and supporting data. Pre-licensing visits

are conducted for broad scope licensees and radiography licensees adding new vaults to their

facility. For medical licensees, the pre-licensing visit is dependent upon the scope of the

licensing request.

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: 

HDR (including mobile); medical (broad scope, private practice and institutional); broad scope
Ohio Final Report Page 6

research and development; mobile nuclear medicine; broad scope manufacturing and

distribution; fixed gauges; industrial radiography; and portable gauges. Types of licensing

actions included three new licenses, five renewals (including one denial and one exemption), six

amendments, and four terminations (including one bankruptcy and one partial site

decommissioning of a facility). A list of the licenses evaluated with case-specific comments can

be found in Appendix D. 

The licenses transferred from NRC to the Bureau are being reissued as Department licenses

when the licensee requests the combination of their existing NARM (Naturally-Occurring and

Accelerator-Produced Radioactive Material) license and the transferred NRC byproduct material

license, or when the transferred NRC byproduct material license is renewed in its entirety. 

It was noted that in nearly all of the licensing actions reviewed, a pre-existing NRC license was

available for use as the basis for the Department license. For those actions which did not

involve a transferred NRC license, appropriate Bureau review procedures were followed and

checklists were used, as appropriate.

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

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

conditions were almost always clearly stated, backed by information contained in the file, and

inspectable. The licenseeís compliance history was taken into account when reviewing renewal

applications and amendments. Program staff followed appropriate licensing guides to ensure

that licensees submitted information necessary to support their license requests. No potential

health and safety issues were identified. 

The team noted the desirability of retaining records of telephoned deficiencies or secondary

deficiency letters in the license files. Also, in several casework reviews, the Bureau license

reviewer was not documented or the supervisory sign off not documented. The review team

discussed these two issues with the Bureau staff and they indicated that they would consider

them. 

In discussions with the Decommissioning Program Supervisor, it was noted that the

decommissioning program is responsible for all license terminations, decommissioning

including partial decommissioning, contaminated sites (such as the Site Decommissioning

Management Plan (SDMP) sites that were transferred from NRC to the Bureau), and future

licensing of decontamination service providers and waste processors. The Bureau issued each

of the transferred SDMP sites a decommissioning license, except for the Horizons, Inc. site,

which did not have an NRC license, and is being managed in a similar manner by the Bureau. 

The Chevron/Harshaw site was transferred to the Formerly Utilized Sites Remedial Action

Program (FUSRAP) for remediation by the Army Corps of Engineers.

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

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

3.5 Response to Incidents and Allegations

In evaluating the effectiveness of the Bureauís actions in responding to incidents and

allegations, the review team examined the Bureauís response to the questionnaire relative to

this indicator and reviewed the incidents reported for Ohio in the "Nuclear Material Events
Ohio Final Report Page 7

Database (NMED)" against those contained in the Bureauís casework and license files, and

supporting documentation, as appropriate for eight incidents. A list of the incident casework 

with comments is included in Appendix E. The team reviewed the Bureauís response to the 18

allegations received during the review period involving radioactive materials including eight

allegations referred to the Bureau by NRC. 

The review team discussed the Bureauís incident and allegation procedures, file

documentation, the Bureauís equivalent to the Freedom of Information Act, NMED, and

notification of incidents to the NRC Operations Center with the Bureau managers and selected

staff.

Responsibility for initial response and follow-up actions to material incidents and allegations 

rests with the Bureau staff. When the Bureau is notified of an incident during working hours,

the assigned ìOfficer of the Weekî takes the incoming notification and briefs the responsible

Supervisor, Administrator, and/or the Bureau Chief to determine the approach to be taken

regarding the incident. The Department provides a 24-hour emergency number for anyone to

use to report emergencies involving hazardous materials. When a radiological incident is

reported after work hours, Bureau staff are contacted at home.

The review team found good correlation of the Bureauís response to the questionnaire and the

incident information in the casework. The review team also queried the incident information

reported on the NMED system for Ohio which identified ten reported incidents during this review

period. The review team identified, through discussions with Bureau staff, an additional incident

that was listed as an allegation which needed to be included in the NMED system. 

The eight incidents selected for evaluation included one medical event with five

misadministrations at a facility, three events involving lost/stolen gauges, one reported

damaged portable gauge, one reported loss of control of radioactive material, one event

involving contaminated scrap at a non-licensee facility, and one event involving exposure to a

member of the public during a radiography incident. 

The review of incident casework, licensing casework, and interviews with staff revealed that

incidents are promptly evaluated for the need for on-site investigations. For those incidents not

requiring on-site investigations, copies of letters to licensees were in the incident and licensing

files indicating that the incident would be investigated during the next scheduled inspection. In

response to incidents, the Bureau took prompt, appropriate action in all but one case. The

evaluation of casework indicated that incident reports were thorough and well-documented. 

The incident reports were reviewed and signed by the appropriate level of management. The

review team noted that one incident had been originally classified as an allegation and several

deficiencies were identified by the review team with respect to this incident. These were

discussed with the Bureau staff as is noted in Appendix E. The review team concluded that the

root cause of these deficiencies was a lack of written procedures and guidance on handling of

incidents at this facility. In their Program Description for the Agreement Application, the Bureau

previously identified the need for such a procedure and had committed to develop it. The

review team discussed the need for the Bureau to place a high priority on developing and

implementing a written procedure on handling of incidents. 

The evaluation of the 18 allegation cases indicated that the Bureau took prompt and

appropriate action in response to the allegersí concerns. Further review of the casework and a
Ohio Final Report Page 8

staff interview determined that the Bureau did provide feedback to allegers either verbally or in

writing. The Bureau drafted an allegation procedure that was going through management

examination at the time of the review. There were no performance issues identified from the

review of allegation files and documentation. 

Based on the IMPEP evaluation criteria, the review team recommends that Ohioís performance

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

4.0 NON-COMMON PERFORMANCE INDICATORS

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

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

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

and (4) Uranium Recovery Program. Ohio's Agreement covers the SS&D evaluation, LLRW

disposal, and uranium recovery programs. However, Ohio does not have any licenses or

activity in the LLRW disposal or uranium recovery programs so only the first two non-common

performance indicators were applicable to this review.

4.1 Legislation and Program Elements Required for Compatibility

4.1.1 Legislation 

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

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

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

Revised Code, Section 3748.03. The Department is designated as the State's radiation control

agency. The Director has designated the Bureau Chief to administer the Agreement State

program for the Department. The review team noted that no legislation affecting the radiation

control program was passed since being found adequate during the review to become an

Agreement State. The Public Health Council approved modifications to rule 3701-38-02.1. 

This rule establishes fees for the radioactive materials program. As required by Ohio Law, the

Joint Committee on Agency Rule Review (JCARR) reviewed the rules.

4.1.2 Program Elements Required for Compatibility 

The Ohio Regulations for Control of Radiation, found in Section 3701-38 and 3701-39 of the

Ohio Administrative Code apply to all ionizing radiation, whether emitted from radionuclides or 

devices. Ohio requires a license for possession, and use, of all radioactive material including

Atomic Energy Act materials and NARM. Ohio also requires registration of all devices that emit

radiation. 

The review team examined the procedures used in the Department's regulatory process and

found that regulations are developed by the staff with a committee of the Radiation Advisory

Council and the regulated community. The regulations are posted on the Department web site

with a 60-day comment period. The comments received are evaluated and the regulations

revised and submitted to the Radiation Advisory Council for a recommendation to adopt. 

Following this recommendation, the formal rule adoption process begins with submittal to the

Public Health Council (PHC) which will place it on their calendar, hold a hearing, and then
Ohio Final Report Page 9

submit them to the JCARR. After JCARR completes its review of a proposed rule and takes no

action against the rule, the PHC is able to take final action to enact the rule. The rule becomes

final after it is filed with several State rule codification agencies. The minimum amount of time

for a rule to become final is ten days after such filing.

The team evaluated the Bureauís responses to the questionnaire, reviewed the status of

regulations required to be adopted by the State under the Commissionís adequacy and

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

of State and Tribal Programs (STP) Regulation Assessment Tracking System. Since the

Department incorporated NRC regulations by reference as of October 8, 1998, there were no

regulations overdue at the time of the review. The Department is in the process of adopting

specific Ohio regulations to replace the NRC regulations adopted by reference. 

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

future, and Bureau management related that the regulations would be addressed in upcoming

rulemaking, incorporation by reference, or by adopting alternate legally binding requirements: 

! ìTransfer for Disposal and Manifest; Minor Technical Conforming Amendments,î

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

! ìRadiological Criteria for License Termination of Uranium Recovery Facilities,î 10 CFR

Part 40, Appendix A amendment (64 FR 17506) that became effective June 11, 1999. 

! ìRespiratory Protection and Controls to Restrict Internal Exposures,î 10 CFR Part 20

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

! ìEnergy Compensation Sources for Well Logging and Other Regulation Clarification,î

10 CFR Part 39 amendment (65 FR 20337) that became effective May 17, 2000. 

Ohio has begun the process of adopting Ohio specific regulations to replace the referenced

NRC regulations. They have submitted two regulation packages to NRC for review. The NRC

comment letter for the first package was sent to the Bureau the week of the on-site review. The

second letter was issued on June 11, 2001. The Bureau Chief anticipates that these 

regulations will be finalized by the end of July 2001. The Bureau plans to update the effective

date of the incorporation by reference during the July 2001 rulemaking process; therefore, the

rules listed above will be included in the Ohio Administrative Code by reference. 

Based on the IMPEP evaluation criteria, the review team recommends that Ohioís performance

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

found satisfactory. 

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

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

provided by the Bureau in response to the IMPEP questionnaire on this indicator. A review of

selected new, amended, and inactivated SS&D evaluations and supporting documents covering

the review period was conducted. The team observed the staff's use of guidance documents

and procedures, interviewed the staff involved in SS&D evaluations and the Technical Services

Section Administrator who has supervisory responsibility for the SS&D program, and verified
Ohio Final Report Page 10

the use of regulations and license conditions to enforce commitments made in the applications.

4.2.1 Technical Quality of the Product Evaluation Program

The review team reviewed all registration certificates issued for the review period. The six

SS&D registration certificates issued by the Bureau and evaluated by the review team are listed

with case-specific comments in Appendix F. 

Analysis of the casework and interviews with staff confirmed that the Bureau follows the

recommended guidance from the NRC SS&D training workshops and NUREG-1556, Volume 3,

issued in September 1997. All pertinent American National Standards Institute standards,

Regulatory Guides, and applicable references were confirmed to be available and were used

when performing SS&D reviews. 

The registration certificate background files contained all correspondence, engineering

drawings, radiation profiles, and results of tests conducted by the applicant. The files were well

organized in a consistent manner. Deficiency letters clearly stated regulatory positions and

health and safety issues were properly addressed. The team determined that product

evaluations were thorough, complete, consistent, of acceptable technical quality, and

adequately addressed the integrity of the products during use and in the event of likely

accidents. Registration certificates summarize the product evaluation and provide license

reviewers with adequate information to license the possession and use of the product.

Overall, the quality of the evaluations was good, but the review team identified and discussed

with the staff several deficiencies in the files. For example, the section entitled ìSafety Analysis

Summaryî in the Ohio registration certificates contained text that applied to both specifically and

generally licensed devices regardless of the type of device. Certificates should contain only

those requirements that are unique to the regulatory requirements for the type of device. The

review team traced this deficiency to NUREG-1556, Vol. 3 which provides examples of safety

analysis summary statements for registration certificates, but does not clearly distinguish

between the statements for generally licensed devices versus specifically licensed devices. 

Ohio followed the guidance in NUREG-1556, Vol. 3 as they understood it and included the

summary statements for both types of devices in each sheet. The review team believes that

this guidance is potentially misleading. This issue was discussed during the MRB meeting on

August 9, 2001. The MRB recommends that NRC staff revise NRC guidance so that the

differences between safety analysis summary documentation for certificates for specifically

licensed versus generally licensed devices is clarified.

The review team identified weaknesses in documentation in all six cases reviewed. The review

team discussed the benefits of, and need for, the SS&D sheets being in a consistent format

and that the Bureau may want to issue corrected sheets to address the weaknesses identified

in Appendix F. During the exit meeting with the staff and management, the review team noted

that the deficiencies were discussed with the Bureau's technical staff. 

4.2.2 Technical Staffing and Training

Presently, there are five staff members involved in the SS&D evaluation program. The

Technical Services Section Administrator has the program responsibility for the SS&D program. 

The technical reviewers are either in the Technical Services Section or the Non-medical
Ohio Final Report Page 11

program in the Nuclear Materials Safety Section. Two staff members are fully qualified and

have performed either the first reviews, or the concurrence reviews for the six SS&D actions

completed by the Bureau. Two newly hired staff members are health physicists and one has a

masters of science degree in nuclear engineering. They have recently attended the NRCís

SS&D training workshop and a two-day, on-the-job training session at the State of Illinois to

supplement their academic education. 

The review team could not identify the qualification requirements for the new SS&D staff other

than the general statements of meeting the reviewer requirements in MD 5.6. The minimum

number and the types of case work should be formally established before a person is qualified

to sign the registration certificates. Given the small number of SS&D reviews conducted by the

Bureau, the review team discussed potential training in the form of actual reviews that could be

obtained through working with other SS&D reviewers at the NRC or other Agreement States. 

The review team recommends that the Bureau develop formal training and qualification

requirements for SS&D reviewers. 

4.2.3 Evaluation of Defects and Incidents Regarding SS&Ds

Two incidents or defects related to SS&D issues were reported to the Bureau during the review

period concerning the devices registered by the Bureau and are noted in Appendix E. There

were no generic design or performance issues identified from the review of SS&D incident files

and documentation. 

Based on the IMPEP evaluation criteria, the review team recommends that Ohioís performance

with respect to the indicator, SS&D Device Evaluation Program, be found satisfactory. 

4.3 Low-Level Radioactive Waste (LLRW) Disposal Program

Although Ohio has LLRW disposal authority, NRC has not required States to have a program

for licensing a LLRW disposal facility until such time as the State has been designated as a

host State for a LLRW disposal facility. When an Agreement State has been notified or

becomes aware of the need to regulate a LLRW disposal facility, they are expected to put in

place a regulatory program which will meet the criteria for an adequate and compatible LLRW

disposal program. There are no plans for a LLRW disposal facility in Ohio. Accordingly, the

review team did not review this indicator.

4.4 Uranium Recovery Program

Although Ohio has Uranium Recovery authority, NRC has not required States to have a

program for licensing a uranium recovery facility until such time as the State has such a facility.

When an Agreement State has been notified or becomes aware of the need to regulate a

Uranium Recovery facility, they are expected to put in place a regulatory program which will

meet the criteria for an adequate and compatible Uranium Recovery program. There are no

plans for a Uranium Recovery facility in Ohio. Accordingly, the review team did not review this

indicator.
Ohio Final Report Page 12

5.0 SUMMARY

As noted in Sections 3 and 4 above, the review team found that Ohioís performance to be

satisfactory for all performance indicators reviewed. Accordingly, the review team

recommended and the MRB concurred in finding the Ohio Agreement State program to be

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

review, the next full review will be in approximately four years.

Below is the single recommendation, as mentioned earlier in the report, for evaluation and

implementation, as appropriate, by the State. An additional recommendation was made for the

NRC during the August 9, 2001 MRB meeting. 

RECOMMENDATION FOR THE STATE:

1. The review team recommends that the Bureau develop formal training and qualification

requirements for SS&D reviewers. (Section 4.2.2)

RECOMMENDATION FOR THE NRC:

1. The MRB recommends that NRC staff revise NRC guidance so that the differences

between safety analysis summary documentation for certificates for specifically licensed

verses generally licensed devices is clarified. (Section 4.2.1)
LIST OF APPENDICES AND ATTACHMENTS

Appendix A IMPEP Review Team Members

Appendix B Ohio Organization Charts

Appendix C Inspection Casework Reviews

Appendix D License Casework Reviews

Appendix E Incident Casework Reviews

Appendix F Sealed Source & Device Casework Reviews

Attachment June 29, 2001 Letter from Dr. J. Nick Baird

Ohioís Response to Draft IMPEP Report
APPENDIX A

IMPEP REVIEW TEAM MEMBERS

Name Area of Responsibility

Dennis Sollenberger, STP, NRC Team Leader

Technical Staffing and Training

Legislation and Program Elements Required 

for Compatibility

Cynthia Sanders, Georgia Status of Materials Inspection Program

Technical Quality of Inspections

Inspector Accompaniments

Jacqueline Cook, Region IV, NRC Technical Quality of Licensing Actions 

Darrel Wiedeman, Region III, NRC Response to Incidents and Allegations 

Seung Lee, MSIB, NMSS, NRC Sealed Source and Device Evaluation Program
APPENDIX B

OHIO

DEPARTMENT OF HEALTH

and 

BUREAU OF RADIOLOGICAL PROTECTION

ORGANIZATION CHARTS

ML011630376


Attachment

June 29, 2001 Letter from Dr. J. Nick Baird

Ohioís Response to Draft IMPEP Report

ML011910388