Ms. Elinor Hall, Administrator

Oregon Health Division

Department of Human Resources

800 NE Oregon Street, Suite 925

Portland, OR 97232

Dear Ms. Hall:

On October 13, 1998, the Management Review Board (MRB) met to consider the proposed final

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

State Program. The MRB found the Oregon program adequate to assure public health and

safety and compatible with NRC’s program. 

Section 5.0, page 13, of the enclosed final report presents the IMPEP team’s recommendations 

and suggestions. We received Mr. Ray Paris’ September 30, 1998 letter which described the

actions taken in response to the team’s recommendations. We request no additional

information.

Based on the results of the current IMPEP review, the next full review will be in approximately 4

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,

Hugh L. Thompson, Jr.

Deputy Executive Director

 for Regulatory Programs

Enclosure:

As stated

cc: Ray D. Paris, Manager

Oregon Health Division

David Stewart-Smith DCD (SP01)

Oregon State Liaison Officer PDR (YES / NO )

Distribution:

DIR RF EDO R/F bcc:

SDroggitis TCombs, OCA (2) Chairman Jackson

RWoodruff, RII CHackney, RIV HThompson, EDO Commissioner Dicus

SMerchant, NMSS LMcLean, RIV RBangart, OSP Commissioner Diaz

DBunn, OAS,CA DCool, NMSS CPaperiello, NMSS Commissioner McGaffigan

FCameron, OGC KSchneider KCyr, OGC Commissioner Merrifield

HNewsome, OGC LRakovan SRubin, AEOD

Oregon File GDeegan, NMSS *SEE PREVIOUS CONCURRENCE.

DOCUMENT NAME: G:\IMPEP\98FINLTR.OR / G:\IMPEP\OR98FIN.WPD

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 OSP OSP:DD OSP:D DEDR

NAME TO’Brien:nb PHLohaus RLBangart HLThompson

DATE 10/22/98 * 10/22/98 * 10/26/98 * 10/ /98

OSP FILE CODE: SP-AG-23
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM

REVIEW OF OREGON AGREEMENT STATE PROGRAM

August 10-13, 1998

FINAL REPORT

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

1.0 INTRODUCTION

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

review was conducted during the period August 10-13, 1998 by a review team comprised of

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

State of California. Review 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 25, 1997, revised NRC Management

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

results of the review, which covered the period July 11, 1996 to August 13, 1998, were discussed

with Oregon management on August 13, 1998.

A draft of this report was issued to Oregon for factual comment on September 16, 1998. The

State responded in a letter dated September 30, 1998 (Attachment 1). The Oregon’s factual

comments were considered by the team and accommodated in the report. The Management

Review Board (MRB) met on October 13, 1998 to consider the proposed final report. The MRB

found the Oregon radiation control program was adequate to protect public health and safety and

compatible with NRC’s program.

The Oregon Agreement State program is administered by the Radiation Protection Service (RPS)

in the State Health Division of the Department of Human Resources. Organization charts for the

Department of Human Resources are included as Appendix B. 

At the time of the review, the Oregon RPS regulated 352 specific licenses, including limited and

broad scope medical institutions, academic institutions, industrial radiography, fixed and portable

gauge units, and nuclear pharmacy licensees. 

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 Oregon.

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

performance indicators was sent to the State on June 4, 1998. The State provided a response to

the questionnaire on June 26, 1998. During the review, discussions with State staff resulted in

the responses being further developed. A copy of their final response is included in Appendix F

to the draft report.

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

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

regulations; (3) analysis of quantitative information from the RPS licensing and inspection data

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

of two RPS inspectors; and (6) interviews with staff and management to answer questions or

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

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

preliminary assessment of the RPS performance. 

Section 2 below identifies that there were no recommendations resulting from the follow-up

review conducted in 1996. The previous full program review conducted in 1995 found the

Oregon program compatible, but withheld a finding of adequacy. The 1996 follow-up review

closed all of the recommendations from the 1995 review, noted a delay in adoption of
Oregon Final Report Page 2

regulations, and found the Oregon program adequate. 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 indicator, and Section 5 summarizes the review

team's findings, recommendations, and suggestions. The review team identified two good

practices in the RPS. 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. Suggestions are comments that the review team believes

could enhance the State’s RPS. The State is requested to consider suggestions, but no

response is requested. 

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS

During the previous follow-up review, which concluded on July 11, 1996, no recommendations

were made although one open item, concerning delays in rulemaking activities, was noted in the

report. This open item is discussed further in section 4.1.

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 review team focused on four factors in reviewing this indicator: (1) inspection frequency, (2)

overdue inspections of licenses, (3) initial inspections of new licenses, and (4) timely dispatch of

inspection findings to the licensee and corrective action. The review team’s evaluation is based

on Oregon’s questionnaire responses relative to this indicator, data gathered independently from

the State's licensing and inspection data tracking system, the examination of completed

inspection casework, and interviews with the RPS manager, the Radioactive Material Program

(RMP) manager, and inspection and licensing staff. 

The State’s inspection frequencies are compatible with NRC program codes and inspection

priorities. They are the same as NRC’s, with the exception that portable gauge licenses are

inspected more frequently than NRC, 4 years versus 5 years by NRC.

In their response to the questionnaire, Oregon indicated that as of June 26, 1998 no licensees,

which were identified as requiring core inspections in IMC 2800, were overdue. Throughout the

review period, less than 10 percent of the number of core licensees were inspected at

frequencies exceeding the intervals in IMC 2800 by more than 25 percent. 

The RPS policy, which adopts the guidance in IMC 2800, Section 04.03a, states that new

licenses are inspected within six months of issuance of the license. The RPS does not normally

extend the 6 month period in cases where the licensee does not receive material or initiate

licensed activities. There were 43 initial inspections of in-state licensees due during the review

period. Of those due, 24 (55%) were not inspected within the 6 month requirement. The team

noted that 41 of the initial inspections were completed within 7 months and the remaining 2

inspections were completed within 8 months. The team recommends that Oregon continue to

implement its policy for inspecting new licenses.
Oregon Final Report Page 3

The RMP manager indicated that the RPS accelerated the inspection workload and eliminated

the entire backlog by the end of July 1998. The accelerated workload resulted in 19 inspections

being completed in June 1998 and 15 completed in July 1998. The team verified from the

records that as of August 13, 1998 there were 352 active licenses and all inspections were

current.

An internally generated monthly report to management tracks inspections that are completed 

and overdue. All licenses are entered into the RPS database and printouts allow an easy

determination of the status of inspections at a given time period. 

Reciprocity licensees are handled in the following manner:

1. Out-of-state licensees that frequently perform work in Oregon are provided the

option of requesting an Oregon State license. When the license is issued they are

listed in the database under their home state address. The company is not

required to have an address in Oregon and the license application process simply

consists of a review of their home State or NRC license. Each license includes a

special condition that requires notification to the RPS before the licensee enters

the State to do work using licensed material. Six months after the out-of-state

license is issued, the licensee is mailed an “inspection by mail” form which is

mailed back to the RPS and is considered an initial inspection. When the licensee

notifies RPS that they are entering the State to do work, the RPS inspects them in

the field if possible. The license is renewed annually by payment of a fee.

2. Out-of-state licensees that infrequently perform work in Oregon may choose not to

apply for an Oregon State license. In these cases, the licensees are identified in

the RPS database using license numbers that are coded to indicate that

reciprocity is granted on each occasion work is to be performed in Oregon. When

the licensee notifies RPS that they are entering the State to do work, the RPS

inspects them in the field if possible. Seven of these licenses were listed on the

August 1998 printout.

Two of the ten inspection reports of out-of-state licensees that were reviewed were inspected by

mail. All others had an onsite inspection completed following their notification that they were

entering the State to do work using sources. The State met the inspection percentage goals for

conducting inspections of reciprocity licensees as outlined in Appendix III of NRC Inspection

Manual Chapter 1220 (IMC 1220). 

The review team did not consider the “inspection by mail” a valid inspection because the form

only asks the make and model of devices used by the licensee and the names of their operators. 

The review team suggests that the RPS consider using another term such as “status report”

rather than call the “inspection by mail” process for out-of-state licenses an inspection.

In 1984, the RPS instituted a program that tracks registered general license (GL) devices (i.e.,

gamma gauges and in-vitro test kits). Although other States track such devices, Oregon’s

implementation practices of the program are unique. In addition to requiring accountability of the

devices, the State will also perform onsite inspections and request additional information (e.g.,

leak test results) from the general licensee. The program for registering these GL devices has

been recognized by NRC which is considering adoption of a similar program nationwide. The
Oregon Final Report Page 4

review team recommends that the Management Review Board recognize Oregon’s GL device

tracking program as a good practice. 

The RPS uses Safety Inspection Form 591 for inspections to report the findings to the licensee at

the conclusion of the inspection. The inspector indicates any violations found on the form and

the licensee signs it acknowledging receipt and understanding of the nature of any violations. 

The form requires posting by the licensee. If an inspector is not certain of a finding, he will return

to the RPS and discuss the matter with the RMP manager. In these cases, the licensee will be

sent a letter outlining the violations and requiring a written response. The letter requires posting

by the licensee. The issuance of inspection findings is timely with letters to the licensee being

sent within two weeks of the inspection.

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

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

satisfactory.

The team notes that one finding from the 1995 full program evaluation was the development of a

significant number of overdue inspections. However, at the time of the 1996 follow-up review

visit, all overdue inspections had been eliminated.

3.2 Technical Quality of Inspections

The team reviewed inspection reports, enforcement documentation, inspection field notes, and

interviewed inspectors for 16 materials inspections conducted during the review period. The

casework included all of the State's materials inspectors, including the RMP manager, and

covered: medical (5), medical (HDR) (1), mobile medical (1), industrial broad scope (1), portable

gauge (4), radiography (2), academic broad scope A (1), and pharmacy (1) inspections. A review

team member performed accompaniments of two State inspectors on three separate inspections

of licensed facilities. Appendix C lists the completed inspections reviewed with case-specific

comments as well as the results of the accompaniments.

Inspection findings appear to lead to appropriate regulatory action. Although the RPS does not

have administrative penalties, they can pursue penalties through the Attorney General’s office. 

The RPS also uses Office Hearings to achieve escalated enforcement. One escalated

enforcement case that used an Office Hearing was reviewed. The licensee had several serious

violations on their initial inspection and eventually requested termination of their license due to

increased enforcement activities of the RPS. The review team noted that the participation of the

RPS manager in the Office Hearing was not documented. The review team suggests that all

attendees, including senior managers, be documented in future enforcement activities involving

meetings or hearings with licensees.
Oregon Final Report Page 5

All enforcement letters reviewed were written in the appropriate regulatory language and directed

the licensee to post the enforcement letter as the State does not use a Notice of Violation form. 

Follow up to enforcement letters was evident and complete. All enforcement cases were

resolved promptly.

There were 229 inspections performed during the review period. Through 1998 to date, 89

inspections have been completed. The RPS uses NRC inspection guides and checklists. The

team reviewed the inspection field notes and, with the exceptions noted below and in Appendix

C, found them to be comparable with the types of information and data collected under NRC

Inspection Procedure (IP) 87100 and thorough with all items checked and written comments

where necessary. The inspection field notes provided documentation of the licensee's program

including: posting; storage and use of radioactive material; receipt, transfer, and disposal of

radioactive material; inventory; leak tests; radiation protection program; personnel monitoring;

training; independent measurements; and inspection findings. The review team also noted the

inspectors observed licensed operations or had operations demonstrated whenever possible. 

The review team noted that the inspector used NRC’s checklist for Nuclear Medicine operations

to perform a high dose rate (HDR) inspection. It was also noted that the inspection reports did

not use the most recent version of NRC checklists and, therefore, there was no section to

document the scope of the operation. The review team suggests that the RPS obtain and use

the HDR inspection checklist and the latest version of inspection checklists found in IMC 87100. 

The RPS management policy is to conduct unannounced inspections whenever possible. 

Announced inspections usually involve initial inspections or inspections at licensees in

geographically-distant locations from Portland. Inspection reports were signed by management. 

The RMP manager was aware of inspection findings through de-briefing by the inspector. In

response to the questionnaire and through discussions with the RMP manager, the State

reported the number and type of supervisory accompaniments performed during the review

period. All inspectors were accompanied annually. The RPS manager accompanied the RMP

manager during various licensee management meetings throughout the review period. 

The RPS uses a rating system to score the licensee after an inspection. A low score can lead to

the shortening of the inspection frequency down to 75% of the actual due date or, if the score is

extremely low, then the licensee is subject to escalated enforcement or a follow up review within

6 months.

The RPS employs a unique method for educating the licensee of Oregon’s regulations as they

pertain to the licensees’ operation. At the conclusion of each inspection, the inspector provides a

checklist to the licensee that specifies Oregon’s administrative rule requirements applicable to

the licensee. The licensee can use this checklist to facilitate the annual review of their radiation

safety program. Additionally, the inspectors routinely utilize a form to document their “vertical

slice” approach to their inspections where several types of radioactive sources are tracked from

their receipt on through to disposal. The review team recommends that use of the checklist and

the form and the resulting discussions with licensees during the inspection, be recognized as a

good practice by the Management Review Board.

The RPS has an adequate supply of survey instruments to support the inspection program. Each

inspector and the supervisor have a kit with Ludlum meters and probes to monitor all isotopes. 

All survey equipment is calibrated annually by Oregon State University under a calibration license

issued by Oregon. In addition, the RPS operates a small laboratory to count wipes and analyze

samples obtained during inspections, follow-up actions, or licensing terminations. The laboratory

participates in the routine Environmental Protection Agency (EPA) - Environmental Monitoring
Oregon Final Report Page 6

and Safety Laboratory (EMSL) cross-check program and is used routinely by inspectors taking

wipe samples. Gamma spectroscopy quality assurance (QA)/quality control (QC) appears

adequate with routine use of a National Institute for Standards and Technology (NIST)-traceable

mixed gamma standard. The RPS has a liquid scintillation counter and germanium detector

system for gamma spectroscopy and a portable multichannel analyzer. Samples are also sent

out to contract labs for analysis as necessary. 

Two inspectors were accompanied by a review team member during the period of June 23-24,

1998. One inspector was accompanied during an unannounced inspection of an institutional

nuclear medicine facility with brachytherapy on June 23, 1998. The other inspector was

accompanied on June 24, 1998 during unannounced inspections of a research and development

facility using americium-241, and another facility that manufactures iodine-125 test kits. These

accompaniments are listed in Appendix C. 

During the accompaniments, the State inspectors demonstrated appropriate inspection

techniques and knowledge of the regulations. The inspectors were equipped with, and used,

appropriate and calibrated survey and safety equipment. The inspectors were well prepared and

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

performance of the inspectors was excellent, 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 Oregon'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 radioactive materials program 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 State's questionnaire responses relative

to this indicator, and interviewed RPS management and staff, and considered any possible

workload backlogs. 

At the time of the review, Oregon’s radioactive materials program was staffed by the RPS

manager, RMP manager, three full time technical staff, and one full time administrative staff

member. All staff have been with the RPS for the entire review period. One staff member each

from the Electronics Products Program and the Emergency Response Program also provide

partial support in rulemaking and event response activities, respectively. In general, the team

found that the current staffing level is adequate, except the team noted that there was minimal

staff time devoted to rulemaking efforts due to licensing and inspection needs. The State also

identified this area as a weakness in the IMPEP questionnaire. Given the status of rulemaking

actions as discussed in Section 4.1.2, the review team recommends that the RPS management

assess whether additional staffing is warranted to complete overdue rulemaking actions and to

ensure timely completion of upcoming rulemaking actions. 
Oregon Final Report Page 7

Based on the response to the IMPEP questionnaire and discussions with the RPS and RMP

managers, the review team noted that during the review period one technical staff member

retired from the radioactive materials program in March 1998. This vacancy was recently filled by

an individual who is expected to receive a Master’s Degree in Health Physics in December 1998. 

The review team also noted that the individual exceeds the minimum requirements for the

position. 

There are currently no vacancies in the radioactive materials program, however, the team was

advised that the RMP manager will retire in December 1998. The RPS manager stated that he

intends to fill the upcoming vacancy by making a nationwide announcement. Discussions with

staff indicate that a significant loss of program history and knowledge of current procedural

practices will be experienced. The review team suggests timely filling of the impending RMP

manager vacancy with a well qualified individual and that revisions to written procedures to

reflect current operations continue to be developed.

A written and RPS management approved training policy implements the guidelines in the

October 1997 NRC/OAS Training Working Group Recommendations for Agreement State

Training Programs. The RPS manager requires each staff member to successfully complete the

basic courses identified for materials inspectors and license reviewers. Waivers from specific

courses may be granted, at the manager’s discretion, for individuals with extensive work

experience and education in a specific topic area. The RPS manager indicated that funding for

basic training is available. A review of Oregon’s training records and interviews with the staff

identified two staff members, a member of the technical staff and an administrative assistant who

performs licensing assistant duties, that should attend the Licensing Practices and Procedures

course or its equivalent to fully address their training needs. The technical staff member is

currently registered for the September 1998 presentation of the course. The review team

suggests that the administrative assistant attend the Licensing Practices and Procedures course

or its equivalent to enhance effectiveness in performance of licensing assistant duties.

The review team also noted that the documentation of staff training is not up to date and does

not have management sign-off when a course is completed or waived for an individual. The

review team suggests that the RPS training form be updated to reflect the completion of the

Teletherapy and Brachytherapy course by an inspection staff member and that the training form

be modified to allow for management sign-off of completed and waived courses.

In discussions with the RPS, the team found that there are no radiation oversight boards and,

therefore, the team determined that there is no potential for conflict of interest issues.

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

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

3.4 Technical Quality of Licensing Actions

The review team interviewed the RMP manager, evaluated the licensing process, and examined

licensing casework for 32 specific licenses. Licensing actions were reviewed for completeness,

consistency, proper radioisotopes and quantities authorized, 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 its conditions, and overall technical quality. The casework was reviewed for

timeliness, adherence to good health physics practices, reference to appropriate regulations,
Oregon Final Report Page 8

documentation of safety evaluation reports, product certifications or other supporting documents,

consideration of enforcement history on renewals, pre-licensing visits, supervisory review as

indicated, and proper signature authorities. The files were checked for retention of necessary

documents and supporting data including terminated licenses.

The licensing casework was selected to provide a representative sample of licensing actions

which had been completed during the review period and included all amendments to the selected

casework since the previous review. The cross-section sampling focused on the State’s core

licenses in priorities 1, 2, and 3; new licenses issued; renewals; and licenses terminated during

the review period. The sample included the following licensing types: broadscope academic;

broadscope medical; research and development; source material; industrial radiography; portable

gauges, institutional nuclear medicine; private clinics, mobile nuclear medicine; therapy; and

nuclear pharmacy. Licensing actions reviewed included 3 new, 7 renewals, 38 amendments,

and 4 terminations. A listing of the casework licenses with case specific comments can be found

in Appendix D.

Licenses are renewed on a 5 year frequency. Licenses that are under timely renewal are

amended as necessary to assure that public health and safety issues are addressed during the

period that the license is undergoing the renewal process. Each licensing action receives an

initial review by one individual, then a second technical review by a senior health physicist. All

licenses are signed by the RPS manager or his designee. 

The review team found that the licensing actions were generally very thorough, complete, of high

quality, and with health and safety issues properly addressed. The licensee's compliance history

is taken into account when reviewing renewal applications and amendments as determined from

documentation in the license files and discussions with the license reviewers and inspectors. 

Some comments were made on files as identified in Appendix D. Following the team’s

discussion of these comments, the RMP manager initiated actions to resolve the comments. 

The review team suggests that the comments in Appendix D be reviewed for actions as

appropriate.

The casework review also confirmed that, with one exception, the materials staff follows the

State’s licensing guides which have been patterned after the NRC guides. The State has one

license for a HDR brachytherapy device (Appendix D, casework number 11), in which two license

conditions do not contain the same information as similar conditions utilized as standard practice

by NRC and other Agreement States. A copy of a model NRC license with standard practice

license conditions for an HDR unit was provided to the State during the review. The review team

recommends that the State adopt the NRC standard practice license conditions for HDR units for

the casework #11 license and future HDR licenses.

All licensing actions were signed by management. Deficiencies are addressed by letters and

documented telephone inquiries which use appropriate regulatory language.

The State provided a listing of 58 licenses that have been terminated since the last review. A

review of termination actions over the period showed that most of the terminations were for

licensees possessing only sealed sources and/or for uses of radiopharmaceuticals with short half

lives. Four termination files were selected for review based upon the potential for residual

contamination, and to confirm the State’s termination procedures. The review team found that

terminated licensing actions were well documented, showing appropriate transfer records or

appropriate disposal methods and records, confirmatory surveys, and survey records.
Oregon Final Report Page 9

Based on the IMPEP evaluation criteria, the review team recommends that Oregon'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 State’s actions in responding to incidents, the review team

examined the State’s response to the questionnaire regarding this indicator, reviewed selected

incidents reported for Oregon in the “Nuclear Material Events Database” (NMED) against those

contained in the Oregon files, and reviewed the casework and supporting documentation for 11

material incidents and 10 allegations. There were no medical related events during the review

period that met the definition of a misadministration. A list of selected incident files examined

along with case specific comments is contained in Appendix E.

The review team interviewed the RPS Manager, the RMP manager, and the individual

responsible for Emergency Response tracking. The subject areas discussed with staff included

the State's incident and allegation process, tracking system, file documentation, Freedom of

Information Act, NMED, and notification of incidents to the NRC Emergency Operations Center. 

The staff was familiar with NRC’s ”Handbook on Nuclear Event Reporting in the Agreement

States” and Procedure Number: SA-300, “Reporting Material Events,” dated February 1998.

Reports have been submitted appropriately for NMED entry. The review team noted to

management the Commission’s position that, under the Policy Statement on Adequacy and

Compatibility of Agreement State Programs, it is mandatory for Agreement States to report

events to the NRC. 

The State has consistently reported incidents, that require immediate or 24-hour reporting by the

State licensee, to the NRC Operations Center. However, there were multiple written policies and

procedures for incident response dated from 1984 to the present within the State’s policy and

procedure manual. The review team suggests that the policies and procedures for responding to

incidents be consolidated into one policy or procedure.

When notification of an incident or an allegation is received, the individual receiving the report

sends an electronic message to the staff providing information of the incident or allegation. The

RMP manager usually directs the initial response and evaluates the need for an on-site

investigation. An Incident Report Checklist and Summary form is used to document and track

the staff’s response to an incident or allegation. 

The review team found that the State’s actions were appropriate. Initial responses were prompt

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

significance. Inspectors were dispatched for onsite investigations in 7 of the 11 incidents

reviewed. Of those 7 onsite investigations, 6 were conducted on the same day of the

notification, and 1 was conducted within 2 days of the notification. When appropriate, the State

took suitable enforcement action that required corrective measures by the licensee.

During the review period, there were 2 allegations referred to the State by NRC and there were 

11 allegations that the State handled directly. The State promptly contacts the alleger, conducts

an inspection when appropriate, and informs the alleger of the outcome of the investigation. 

Although the State’s responses to allegations were satisfactory, the review team found that the

State had no written policy or procedures for responding to allegations. The RPS advises

allegers that they can provide reasonable assurance that any information they provide
Oregon Final Report Page 10

will be kept confidential but are not able to guarantee confidentiality unless all of the five criteria

specified in State statute 192.502(4) are met. The review team recommends that the State

develop a written policy with procedures for responding to allegations.

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

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

satisfactory.

4.0 NON-COMMON PERFORMANCE INDICATORS

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

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

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

and (4) Uranium Recovery Program. Oregon recently turned back the sealed source and device

evaluation program portion of their Agreement and Oregon’s Agreement does not include

uranium recovery program authority. 

4.1 Legislation and Program Elements Required for Compatibility

4.1.1 Legislation 

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

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

currently effective statutory authority for the RPS is contained in Oregon Statute 453.625. The

Radiation Protection Service is designated as the State's radiation control agency. The review

team noted that no legislation affecting the radiation control program was passed during the

review period.

4.1.2 Program Elements Required for Compatibility 

The Oregon Regulations for Control of Radiation, found in Oregon Administrative Rules 453.605-

453.755, apply to all ionizing radiation, whether emitted from radionuclides or devices. Oregon

requires a license for possession and use of all radioactive material including naturally occurring

materials, such as radium, and accelerator-produced radionuclides. Oregon also requires

registration of all equipment designed to produce x-rays or other ionizing radiation.

The review team examined the State’s administrative rulemaking process and found that the

process takes up to six months after filing the draft administrative rule with the Secretary of

State. Prior to filing with the Secretary of State, the draft administrative rule is reviewed by

management and legal counsel (for fiscal impact issues) within the Department of Human

Resources Office of the Administrator. When an acceptable draft proposed revision to a rule has

been prepared, it is sent to the Secretary of State, all potentially impacted licensees and

registrants, and the NRC for comment. The Secretary of State announces a public

comment/hearing period for the proposed revision to the rule. After responding to comments, the

RPS forwards the proposed revision to the rule with the addressed comments to the Office of the

Administrator for final approval. Comments are considered and incorporated as appropriate

before the regulations are finalized. The State has the authority to issue legally binding

requirements (e.g., license conditions) in lieu of regulations until compatible regulations become

effective.
Oregon Final Report Page 11

The team evaluated Oregon’s responses to the questionnaire and reviewed the status of 

regulations required to be adopted by the State during the review period. No regulations were

adopted by the State during the review period. The review team noted that Oregon prepared

initial drafts of the NRC regulation amendments required to be adopted, however, they have not

been finalized and, therefore, they have not been adopted. As stated in Section 3.3, the State

identified this area as a weakness. Discussions with management indicate that they believe the

requirements in the revised NRC regulations are covered by license conditions and/or through

incorporation by reference in their current administrative rules. No legal position has been made

to this effect. The review team recommends that management obtain a State legal view on their

interpretation that existing administrative rules require the implementation of all new

requirements in the revised NRC regulations where required for compatibility purposes.

The State has not adopted the following regulations; however, they anticipated adoption by late

1999.

! “Licensing and Radiation Safety Requirements for Irradiators,” 10 CFR Part 36 amendment

(58 FR 7715) that became effective July 1, 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 and 65243) that became

effective January 1, 1995. 

! “Frequency of Medical Examinations for Use of Respiratory Protection Equipment,” 10 CFR

Part 20 amendment (60 FR 7900) that became effective March 13, 1995. 

! “Low-Level Waste Shipment Manifest Information and Reporting,” 10 CFR Parts 20 and 61

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

Agreement States are to promulgate their regulations no later than March 1,1998 so that

NRC and the State would require this national system to be effective at the same time. 

! "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 became effective April 1, 1996. 

! “Medical Administration of Radiation and Radioactive Materials,” 10 CFR Parts 20 and 35

amendments (60 FR 48623) that became effective October 20, 1995.

! “Termination or Transfer of Licensed Activities: Record Keeping Requirements,” 10 CFR

Parts 20, 30, 40, 61, 70 amendments (61 FR 24669) that became effective June 17, 1996.

! “Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials; Clean Air Act,”

10 CFR Part 20 amendment (61 FR 65119) that became effective January 9, 1997.
Oregon Final Report Page 12

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

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

effective February 27, 1997.

! “Criteria for the Release of Individuals Administered Radioactive Material,” 10 CFR Parts 20

and 35 amendments (62 FR 4120) that became effective May 29, 1997.

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

Radiography Operations,” 10 CFR Parts 30, 34, 71, 150 amendments (62 FR 28947) that

became effective June 27, 1997.

! “Radiological Criteria for License Termination,” 10 CFR Parts 20, 30, 40, 70 amendments (62

FR 39057) that became effective August 20, 1997.

The State indicated they anticipate adoption of the overdue regulations and the regulations which

require adoption through 2000, by late 1999. A recommendation that Oregon examine the rule

procedures and adopt compatible regulations within the 3 year time frame was made during the

July 29, 1995 full review. A delay in regulation adoption was also noted during the July 11, 1996

follow-up review. The review team recommends that RPS management evaluaterulemaking

activities to ensure that NRC rule changes are adopted within the specified 3 year time period. 

It is noted that Management Directive 5.9, Handbook, Part V, paragraph (1)(c)(iii), provides that

the above regulations should be adopted by the State as expeditiously as possible, but not later

than three years after the effective date of the new Commission Policy Statement on Adequacy

and Compatibility, i.e., September 3, 2000.

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

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

Compatibility, be found satisfactory.

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

In April of 1998, the Commission approved the turnback of the SS&D Program to NRC. There

were two sealed source device actions completed by the State during the review period. One

action involved the administrative reactivation of a terminated registry that formerly was

registered by NRC, and the other action was a custom evaluation that is authorized for use only

in the State of Oregon. The State has discussed these actions with NMSS and committed to

forwarding these files to NRC at the conclusion of the review. The associated licensing actions

were reviewed under the Technical Quality of Licensing Actions (Common Indicator 3.4). 

Therefore, this indicator was not reviewed.
Oregon Final Report Page 13

4.3 Low-Level Radioactive Waste (LLW) Disposal Program

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

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

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

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

disposal authority without the need of an amendment. Although Oregon 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 Oregon. Accordingly, the review team did not review this indicator.

5.0 SUMMARY

As noted in Sections 3 and 4 above, the review team found Oregon’s performance for the

common and non-common performance indicators to be satisfactory. Accordingly, the review

team recommended and the MRB concurred in finding the Oregon Agreement State Program to

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

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

of the report, for implementation and evaluation, as appropriate, by the State. 

RECOMMENDATIONS:

1. The team recommends that Oregon continue to implement its policy for inspecting new

licences (Section 3.1).

2. The review team recommends that the RPS management assess whether additional staffing

is warranted to complete overdue rulemaking actions and to ensure timely completion of

upcoming rulemaking actions (Section 3.3). 

3. The review team recommends that the State adopt the NRC standard practice license

conditions for HDR units for the casework #11 license and future HDR licenses (Section 3.4).

4. The review team recommends that the State develop a written policy with procedures for

responding to allegations (Section 3.5).

5. The review team recommends that management obtain a State legal view on their

interpretation that existing administrative rules require the implementation of all new

requirements in the revised NRC regulations where required for compatibility purposes

(Section 4.1.2).

6. The review team recommends that RPS management initiate rulemaking activities to ensure

that NRC rule changes are adopted within the specified 3 year time period (Section 4.1.2). 
Oregon Final Report Page 14

SUGGESTIONS:

1. The review team suggests that the RPS consider using another term such as “status report”

rather than call the “inspection by mail” process for out-of-state licenses an inspection 

(Section 3.1).

2. The review team suggests that all attendees, including senior managers, be documented in

future enforcement activities involving meetings or hearings with licensees (Section 3.2). 

3. The review team suggests that the RPS obtain and use the HDR inspection checklist and the

latest version of inspection checklists found in IMC 87100 (Section 3.2). 

4. The review team suggests timely filling of the impending RMP manager vacancy with a well

qualified individual and that revisions to written procedures to reflect current operations

continue to be developed (Section 3.3). 

5. The review team suggests that the administrative assistant attend the Licensing Practices

and Procedures course or its equivalent to enhance effectiveness in performance of licensing

assistant duties.

6. The review team suggests the RPS training form be updated to reflect the completion of the

Teletherapy and Brachytherapy course by an inspection staff member and that the training

form be modified to allow for management sign-off of completed and waived courses

(Section 3.3).

7. The review team suggests that the comments on Appendix D be reviewed for actions as

appropriate (Section 3.4).

8. The review team suggests that policies and procedures for responding to incidents be

consolidated into one policy or procedure (Section 3.5).

GOOD PRACTICES:

1. In 1984, the RPS instituted a program that tracks registered general license (GL) devices

(i.e., gamma gauges and in-vitro test kits). Although other States track such devices,

Oregon’s implementation practices of the program are unique. In addition to requiring

accountability of the devices, the State will also perform onsite inspections and request

additional information (e.g., leak test results) from the general licensee. The program for

registering these GL devices has been recognized by NRC which is considering adoption of a

similar system nationwide. The review team recommends that the Management Review

Board recognize Oregon’s GL device tracking program as a good practice (Section 3.1).

2. The RPS employs a unique method for educating the licensee of Oregon’s regulations as

they pertain to the licensees’ operation. At the conclusion of the inspection, the inspector

provides a checklist to the licensee that specifies the Oregon’s administrative rule

requirements applicable to the licensee. The licensee can use this checklist to facilitate the

annual review of their radiation safety program. Additionally, the inspectors routinely utilize a

form to document their “vertical slice” approach to their inspections where several types of

radioactive sources are tracked from their receipt on through to disposal. The review team

recommends that use of the checklist and the form, and the resulting discussions with
Oregon Final Report Page 15

licensees during the inspection be recognized as a good practice by the Management Review

Board (Section 3.2).
LIST OF APPENDICES AND ATTACHMENTS

Appendix A IMPEP Review Team Members

Appendix B Oregon Organization Charts

Appendix C Inspection Casework Reviews

Appendix D License Casework Reviews

Appendix E Incident Casework Reviews

Attachment 1 State’s Response to Proposed Final Report Dated September 30, 1998
APPENDIX A

IMPEP REVIEW TEAM MEMBERS

Name Area of Responsibility

Tom O’Brien, OSP Team Leader

Technical Staffing and Training

Legislation and Program Elements Required for

 Compatibility

Donald Bunn, California Status of Materials Inspection Program

Technical Quality of Inspections

Sally Merchant, NMSS Response to Incidents and Allegations

Richard Woodruff, Region II Technical Quality of Licensing Actions
APPENDIX B

State of Oregon

DEPARTMENT OF HUMAN RESOURCES

OREGON HEALTH DIVISION

RADIATION PROTECTION SERVICES

ORGANIZATION CHARTS