February 28, 2003

Patricia A. Nolan, M.D.

Director

Department of Health

3 Capitol Hill

Providence, RI 02908-5097

Dear Dr. Nolan:

On February 3, 2003, the Management Review Board (MRB) met to consider the proposed

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

Island Agreement State program. The IMPEP review was conducted November 18-22, 2002. 

The MRB received for consideration the comments in your letter dated January 15, 2003. The

MRB found the Rhode Island program adequate but needs improvement, and compatible with

the Nuclear Regulatory Commission’s program. Because of the significance of the concerns,

the MRB recommends heightened oversight of the Rhode Island program. I request that

bimonthly conference calls take place with the appropriate Rhode Island and NRC staffs to

discuss the status of the program. Mr. Duncan White, Regional State Agreements Officer,

Region I, will coordinate the bimonthly conference calls. I request that, two weeks prior to the

calls, you submit a brief status report on the activities conducted since the last report and the

necessary statistical data.

I also request that you prepare and submit a program improvement plan that addresses the

recommendations in Section 5 of the enclosed final report. I request that this report be

submitted within 30 days of receipt of this letter. Upon review of the program improvement

plan, the staff will schedule the first conference call and a more detailed outline for the status

reports. I request the initial conference call be scheduled and conducted no later than April 4,

2003.

Based on the results of the current IMPEP review, a follow-up review will be scheduled during

the period November 2003 - January 2004. The follow-up review will cover the State’s actions

on the recommendations from the November 2002 review.
Patricia A. Nolan 2 February 28, 2003

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

your continuing support of the Office of Occupational and Radiological Health. 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

Enclosure: 

As stated

cc: Walter S. Combs, Jr., Ph.D.

Executive Director

Environmental Health

Marie Stoeckel, Chief

Occupational and Radiological Health

Roland Fletcher, MD

OAS Liaison to the MRB
Patricia A. Nolan 2 February 28, 2003

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

your continuing support of the Office of Occupational and Radiological Health. 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

Enclosure: 

As stated

cc: Walter S. Combs, Jr., Ph.D. bcc: Chairman Meserve

Executive Director Commissioner Dicus

Environmental Health Commissioner Diaz

Commissioner McGaffigan

Marie Stoeckel, Chief Commissioner Merrifield

Occupational and Radiological Health

Roland Fletcher, MD

OAS Liaison to the MRB

Distribution:

DIR RF SP01 PDR (YES) *Peter Todd - State Liaison

EDO RF KCyr, OGC Officer was mailed a copy.

KSchneider, STP FCameron, OGC

LRakovan, STP STreby, OGC

AMauer, STP JLieberman, OGC

DSollenberger, STP/ASPO MVirgilio, NMSS

OSiurano, STP DCool, NMSS/IMNS

DWhite, RI/RSAO RStruckmeyer, NMSS/IMNS

CSanders, Georgia TCombs, OCA (2 copies)

RColes, GAO ISchoenfeld, EDO

PRuedel, GAO Rhode Island File

DOCUMENT NAME: I:\Reviews\RI03\2003 RI Final Report and Ltr.wpd

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

OFFICE RSAO:RIII STP:DD STP:D DEDMRS

NAME JLynch:kk

(KNSchneider for)

JMPiccone PHLohaus

(JMPiccone for)

CJPaperiello

DATE 2/12/03 2/14/03 2/14/03 02/28/03

 ML030500535 Pkg. OFFICIAL RECORD COPY
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM

REVIEW OF RHODE ISLAND AGREEMENT STATE PROGRAM

November 18-22, 2002

FINAL REPORT

U. S. Nuclear Regulatory Commission
Rhode Island Final Report Page 1

1.0 INTRODUCTION

This report presents the results of the review of the Rhode Island radiation control program. 

The review was conducted during the period November 18-22, 2002, 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 team was

accompanied by a representative from the General Accounting Office. The review was

conducted in accordance with the "Implementation of the Integrated Materials Performance

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

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

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

results of the review, which covered the period of July 31, 1998 to November 22, 2002, were

discussed with Rhode Island management on November 22, 2002.

A draft of this report was issued to Rhode Island for factual comment on December 18, 2002.

The State responded in a letter dated January 15, 2002. At the time of the review, the review

team found Rhode Island’s performance to be satisfactory for six performance indicators and

unsatisfactory for the indicator, “Status of Materials Inspection Program.” Because of the

significance of the concerns, the team recommended that a program of heightened oversight

be implemented to assess the progress of the State in implementing corrective actions. 

The MRB met on February 3, 2002, to consider the proposed final report. The MRB concurred

in the individual findings by the review team for each indicator and concurred in the review

team’s recommendation for a program of heightened oversight to assess the progress of the

State in implementing corrective actions. The MRB found the Rhode Island radiation control

program was adequate, but needs improvement, and compatible with NRC’s program.

The MRB directed that: (1) a program improvement plan be submitted in addition to the

responses to the recommendations found in Section 5; (2) that a follow-up review be

conducted during the period November 2003 - January 2004; and (3) that bimonthly

conference calls take place with Rhode Island staff, and that written progress reports be

submitted two weeks prior to each call.

The Rhode Island Agreement State program is administered by the Office of Occupational and

Radiological Health (the Office). The Office Chief reports directly to the Executive Director of

Environmental Health located in the Department of Health. Organization charts for the Office

and the Rhode Island Radiation Control Hierarchy are included as Appendix B. At the time of

the review, the Rhode Island program regulated 58 specific licenses authorizing Agreement

materials.

The review focused on the material 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 Rhode Island.

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

performance indicators was sent to the State on July 11, 2002. The State provided an

electronic response to the questionnaire on October 17, 2002. A copy of the questionnaire
Rhode Island Final Report Page 2

response may be found on NRC’s Agencywide Document Access and Management Systems

using the Accession Number ML023370670.

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

Rhode Island’s response to the questionnaire; (2) review of applicable Rhode Island statutes

and regulations; (3) analysis of quantitative information from the radiation control program

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

actions; (5) field accompaniments of one State inspector; and (6) interviews with staff and

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

that it gathered against the IMPEP performance criteria for each common and applicable

non-common performance indicator and made a preliminary assessment of the Rhode Island

Agreement State program’s performance.

A Periodic Meeting was held with Rhode Island in July 2001. During that meeting, the NRC

learned that staffing problems had resulted in the radiation control program falling behind in

licensing and inspections, and in fact, the program had not performed routine inspections in

over 18 months. In October 2001, the State was placed under increased monitoring. Monthly

teleconferences began between the State and NRC to discuss the status of the Agreement

State program and closely track the State’s progress in addressing staffing and training issues

and the inspection backlog. The teleconferences continued until this IMPEP review.

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

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

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

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

Recommendations made by the review team are comments that relate directly to performance

by the State. A response is requested from the State to all recommendations in the final

report.

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS

During the previous routine review, which concluded on July 30, 1998, two recommendations

were made and the results were transmitted to Dr. Patricia Nolan, Director, Rhode Island

Department of Health, on October 29, 1998. The review team’s evaluation of the current

status of these recommendations is as follows:

1. The review team recommends that the State upgrade their inspection tracking system

to assure that all licensees are inspected in accordance with the frequency established

by the program. (Section 3.1)

Current Status: The State upgraded their inspection tracking system and now has an

accurate tool to plan inspection workload. This recommendation is closed. As noted in

Section 3.2, inspections were not performed timely, and a recommendation is made to

resolve that issue.

2. The review team recommends that the State document a training and qualifications

program equivalent to that contained in the “NRC/OAS Training Working Group

Recommendations for Agreement State Training Programs.” (Section 3.3)
Rhode Island Final Report Page 3

Current Status: The State developed a table outlining the qualifications and needed

training for the technical staff. The requirements are based on NRC Inspection Manual

Chapter 1246 and are equivalent to the Working Group recommendations. This

recommendation is closed.

During the 1998 review, six suggestions were also made for the State to consider. The team

determined that the State considered the suggestions.

3.0 COMMON PERFORMANCE INDICATORS

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

Regional and Agreement State programs. These indicators are: (1) Technical Staffing and

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

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

3.1 Technical Staffing and Training

Issues central to the evaluation of this indicator include the program’s staffing level and staff

turnover, as well as the technical qualifications and training histories of the staff. To evaluate

these issues, the review team examined the State's questionnaire responses relative to this

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

backlogs.

Since the last IMPEP review, the Rhode Island radiation control program experienced

significant turnover due to retirements and promotions. In 1999 and 2000, the senior license

reviewer, the principal inspector and the radioactive materials program supervisor left the

program. The loss of the three key staff members severely impacted the radioactive materials

program.

Also during this period, the Department of Health implemented a new Department-wide system

(License 2000) to standardize and integrate licensing and inspection. In order to support this

effort, the radiation control program invested a significant amount of time reviewing existing

licenses to ensure that they were accurate. A new accounting system was also integrated with

License 2000. The radiation control program was directed by Department of Health

management to revise its fee structure and integrate it into the new licensing system. The

implementation of this system involved a significant amount of time and effort from Office

management and staff. Direct effects were felt in the inspection program as discussed in

Section 3.2.

In March 2001, the former principal inspector returned to the program to fill the Supervising

Radiological Health Specialist (the Supervisor) position. The principal inspector position was

filled in February 2001. An industrial hygienist was hired in October 2000, primarily for the xray program but with limited (5% of her time) in the radioactive materials area. Another

industrial hygienist hired in September 2002 provides emergency response and

instrumentation assistance to the program.
Rhode Island Final Report Page 4

The addition of new staff from the private sector was done during a time when there was a

Department-wide hiring freeze in place. The supervisory position was filled in an expedient

manner in part by posting the position prior to it being vacated.

A Department toxicologist, currently working in another Office but formerly with the radiation

control program, continues to provide support (approximately 0.25 FTE) to the Agreement

State program in the area of regulations and therapeutic radiation modalities (inspection and

licensing).

Current staffing in the radioactive materials program is approximately 2.1 FTE, including the

contribution from the Department toxicologist. With a total of 58 radioactive materials licenses,

the level of staffing appears adequate.

The Office continues to use the NRC/OAS Training Working Group Recommendations as a

template to train their new Radiological Health Specialist and Industrial Hygienist for licensing

and inspection of radioactive materials licensees.

The Radiological Health Specialist completed a number of training courses including: Applied

Health Physics (5 weeks), Inspection Procedures, Licensing and Industrial Radiography. The

Industrial Hygienist completed the Introductory Health Physics and Inspection Procedures

courses and received basic radiation protection training at the University of Rhode Island

Nuclear Science Center. A detailed training schedule has been prepared for each of the staff

members who lack full qualification.

During the last periodic meeting with the State, the concept of interim qualification for

inspections of various categories of licenses was discussed to allow the newer employees to

assist the program with its backlogged inspections, prior to their full qualification as inspectors. 

Reference was made to the format used in the NRC/OAS Training Working Group

Recommendations Report including documentation of interim qualification levels. The review

team recommends that the Office use a fully documented interim qualification program for

inspectors.

The Radiation Advisory Commission, as constituted under Rhode Island General Law Title 23 -

Chapter 1.3.-13 through 15, consists of 11 members appointed by the Director of Health. The

Commission acts in a purely advisory role for the Program, primarily for the review of draft

regulations. No potential conflicts of interest were identified.

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

that Rhode Island's performance with respect to the indicator, Technical Staffing and Training,

is satisfactory.

3.2 Status of Materials Inspection Program

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

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

licensees, and the performance of reciprocity inspections. The review team’s evaluation is

based on the Office’s questionnaire responses relative to this indicator, data gathered
Rhode Island Final Report Page 5

independently from the Office’s inspection data tracking system, the examination of complete

licensing and inspection casework, and interviews with managers and staff.

The review team's review of the Office’s inspection priorities verified that inspection

frequencies for various types of material licenses were at least as frequent as those listed in

NRC Inspection Manual Chapter (IMC) 2800. The Office extends inspection intervals for good

performance. During the review, the team noted that two licenses were categorized as Priority

3, but based on their authorized material and use, could be categorized as Priority 5. This was

bought to the attention of Office staff who indicated that they will make the appropriate

changes to their database.

For a period of approximately 22 months starting in early 2000, the Office did not conduct any

routine inspections. This was the result of a number of personnel changes, the necessity of

hiring new staff and the implementation of the Department of Health’s License 2000 system

(see Section 3.1 for details). This problem was discussed during Periodic Meetings in July

2001 and April 2002.

In their response to the questionnaire, the Office indicated that there are currently 13

inspections of core licensees overdue by more than 25 percent of the State frequency. This

information was verified during the inspection casework reviews and the review of the Office’s

inspection priority list which was provided to the team.

The Office has 11 Priority 1 licenses, three Priority 2 licenses and 12 Priority 3 licenses for a

total of 26 core licenses. With regard to the Priority 1 licenses, nine were overdue at the time

of the review and the other two licenses were inspected overdue during the review period. All

three Priority 2 licenses and one Priority 3 license were overdue at the time of the review. 

Three additional Priority 3 licensees were inspected overdue during the review period.

The review team also evaluated the Office’s initial inspections. The team noted that the Office

issued nine new licenses during the review period. At the time of the review, two of the

licenses were not yet due for inspection, one was conducted at four months, four were

conducted between six and eight months, and the remaining three were conducted at 17 - 37

months post-license issuance.

The Office provided an action plan with their questionnaire response to conduct overdue

inspections and train the two newest staff members to conduct inspections independently. 

The team reviewed the action plan and discussed some needed plan enhancements with

Office management. The enhancements should include specific milestones and assignment of

responsibilities. The review team recommends that the Office implement the action plan and

perform inspections of core licenses at their appropriate frequencies.

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

file review. The Office has an effective and efficient process which ensures that inspection

findings are communicated to licensees in a timely manner. The Office tries to complete each

inspection report and deliver the notice of violation to the licensee within 30 days. The

licensee is then instructed to respond within 30 days. Of the eight license files reviewed, the

Office generally met the 30-day goal with the longest duration to issue inspection findings

being 38 days post inspection.
Rhode Island Final Report Page 6

During the review period, the Office granted 37 core reciprocity licenses. The Office exceeded

the 20 percent criteria prescribed in IMC 1220 for 1998 when three of the seven core licensees

were inspected. For the remainder of the review period, the Office performed two inspections

of the 30 core licensees who filed for reciprocity. The review team recommends that the Office

inspect core licensees granted reciprocity in accordance with the criteria in IMC 1220.

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

that Rhode Island’s performance with respect to the indicator, Status of Materials Inspection

Program, is unsatisfactory.

3.3 Technical Quality of Inspections

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

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

casework included all of the Office’s materials inspectors, and covered inspections of various

types including: gamma knife, medical private practice, high dose-rate remote afterloader

(HDR), teletherapy, industrial radiography, and manufacturing/distribution. Appendix C lists

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

comments.

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

of the licensees’ radiation programs. The review team found that inspection reports were

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

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

documentation supported violations and 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. All inspection reports and

correspondence are reviewed by the Supervisor prior to issuance.

For the casework reviewed, inspection findings were appropriate and prompt regulatory actions

were taken as necessary. The Office issues timely compliance letters to licensees explaining

inspection findings and violations. The Supervisor stated that escalated enforcement action

was limited to the issuance of orders, as monetary penalties are not authorized.

One inspector was accompanied during inspections by a review team member on October 22,

2002. The inspector, formerly with the Office, works for another program in the Department of

Health and is assisting the program in its recovery from loss of technical staff. The

accompaniment was at a medical private practice facility with teletherapy and high dose-rate

afterloader licenses. The accompaniment is identified in Appendix C.

During the accompaniment, the inspector demonstrated appropriate inspection techniques,

and knowledge of the regulations. The inspector was trained, prepared, and thorough in his

audit of the licensee’s radiation safety program. He utilized good health physics practices,

interviewed licensee personnel in an effective manner, and his inspections were adequate to

assess radiological health and safety at the licensed facilities.
Rhode Island Final Report Page 7

The Office has a policy requiring supervisory accompaniments of inspectors on an annual

basis. The Supervisor accompanied each of the inspectors several times as part of the

training process.

The review team confirmed that the Rhode Island program has an adequate number of

portable radiation detection instruments for use during routine inspections and response to

incidents. Instrument calibrations are performed annually by the University of Rhode Island

Nuclear Science Center using NIST-traceable sources. The review team evaluated a sampling

of portable instruments and determined that all were calibrated and operational. The State

also utilizes the Nuclear Science Center for analysis of wipes and environmental samples

taken during inspections. A revised Memorandum of Understanding was executed with the

University in January 2002.

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

that Rhode Island's performance with respect to the indicator, Technical Quality of Inspections,

is satisfactory.

3.4 Technical Quality of Licensing Actions

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

licensing casework for nine specific licenses. Licensing actions were reviewed for

completeness, consistency, proper radioisotopes and quantities, qualifications of authorized

users, adequate facilities and equipment, adherence to good health physics practices,

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

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

deficiency letters, reference to appropriate regulations, supporting documentation,

consideration of enforcement history, pre-licensing visits, supervisory review as indicated, and

proper signatures. The files were checked for retention of necessary documents and

supporting data.

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

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

academic type A broad scope, medical institution broad scope (with HDR and gamma knife),

industrial radiography, portable gauges, medical private practice, teletherapy, veterinary

medicine, and nuclear pharmacy. Licensing actions reviewed included two new licenses, four

renewals, and three amendments to existing licenses. A listing of the casework licenses

evaluated with case-specific comments may be found in Appendix D.

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

and of very good quality, with health and safety issues properly addressed. License tie-down

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

discussed in Section 3.1, the casework evaluation identified two medical private practice

licensees categorized as Priority 3 which could have been Priority 5.

Licenses are currently being reviewed by three staff members, including the Supervisor. The

Supervisor performs a technical and supervisory review on all licensing actions prior to the

issuance and signs each license. The State issues licenses for a five-year period. The Office
Rhode Island Final Report Page 8

utilizes NRC licensing guides and policies as appropriate, uses standard licensing conditions,

and uses internal check lists as appropriate for each licensing action.

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

that Rhode Island’s performance with respect to the indicator, Technical Quality of Licensing

Actions, is satisfactory.

3.5 Response to Incidents and Allegations

In evaluating the effectiveness of the State’s actions in responding to incidents and

allegations, the review team examined the Office response to the questionnaire relative to this

indicator, evaluated selected incidents reported for Rhode Island in the "Nuclear Material

Events Database (NMED)" against those contained in Office files, and evaluated the casework

and supporting documentation for three material incidents. The team also reviewed the State's

response to one allegation. No allegations were referred to the State by NRC during the

review period. A listing of the incident casework evaluated with case-specific comments may

be found in Appendix E.

The incidents selected for review involved misadministrations and an intentional overexposure. 

Two of the incident files evaluated were incomplete with very little information available for

review. However, one incident file was well documented. The team found that the Office’s

response to incidents was generally complete and comprehensive. Initial responses to each

incident were prompt and the level of effort was commensurate with the health and safety

significance. The Office took suitable enforcement and follow-up actions, as appropriate.

Initial response and follow-up actions to materials incidents were assigned to and handled by

the Supervisor. Upon receipt, the Supervisor reviews the report, decides on the appropriate

response, assigns the report a specific identification number, and then logs it into the incident

tracking system. Written documentation related to each incident is placed in an incident file. 

Management and staff informed the team that missing documentation for the two incomplete

incident files was likely misplaced during the transition period between the prior and current

supervisors.

The team identified three incidents in NMED for Rhode Island during the review period. The

Office adheres to procedures providing that reports of incidents that require immediate

notification to the State be provided to the NRC within 24 hours of notification, and that reports

of incidents that require notification to the State within 30 days be provided to the NRC

monthly. The review team noted that all significant events (requiring 24-hour notification) and

routine and/or event updates (requiring 30-day notification) were reported to the NMED in a

timely manner. Also, the team noted that the Office was responsive in providing the requested

information to the NMED contractor by way of e-mail with attachments. The Office is aware of

the NMED web site address for reporting incidents.

In evaluating the effectiveness of Rhode Island’s actions responding to allegations, the review

team examined the Office’s questionnaire response relative to this indicator. No allegations

were reported in the questionnaire response, and none were referred by the NRC for review. 

However, the team discovered that one allegation was reported directly to the State. The

Office evaluated the allegation, determined the proper level of response, and took prompt and
Rhode Island Final Report Page 9

appropriate action in response to the alleged complaint. The allegation was appropriately

closed. The documentation for the one allegation was discovered in the inspection section of

the license file. Separate files are not created for allegation reports, and allegations are not

tracked in the database system for incidents and allegations. The team discussed this issue

with Office management.

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

that Rhode Island’s performance with respect to the indicator, Response to Incidents and

Allegations, is 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. Rhode Island's Agreement does not authorize regulation

of uranium recovery activities, so only the first three non-common performance indicators were

applicable to this review.

4.1 Legislation and Program Elements Required for Compatibility

4.1.1 Legislation

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

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

currently effective statutory authority for the Program is contained in the Rhode Island General

Law Title 23 - Chapter 1.3. The Office is designated as the State's radiation control agency. 

The review team noted that no legislation affecting the Office was passed during the review

period.

4.1.2 Program Elements Required for Compatibility

The Rhode Island Rules and Regulations for the Control of Radiation (R23-1.3-RAD) applies to

all sources of ionizing radiation. Rhode Island requires a license for possession and use of all

radioactive material including naturally occurring materials, such as radium, and acceleratorproduced radionuclides. Rhode Island also requires registration of all equipment designed to

produce x-rays or other ionizing and non-ionizing radiation, as well as non-ionizing radiation

from tanning equipment.

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

process takes approximately four to six months after the proposed regulation is prepared by

the Program and sent to the State’s Radiation Advisory Commission. Often, the Commission

will form a subcommittee to review the proposed regulation and make recommendations to the

full Commission. When the Commission completes its review and recommends its adoption,

the Department’s legal counsel reviews the proposed regulations. Once the legal counsel has

given its preliminary approval, a public hearing is scheduled to take place in approximately four

to six weeks. The proposed regulation is sent to the public, the NRC, other agencies, and all

potentially impacted licensees and registrants, for comment. After the public hearing and the
Rhode Island Final Report Page 10

collection of written and oral testimony, the Office reviews the comments and prepares an

analysis of the comments. The finalized regulations are returned to the Department of

Health’s legal counsel for approval. The Director of Health gives final approval and signs the

final regulations. The regulations are then filed with the Secretary of State and become

effective 21 days later. The State can adopt other agency regulations by reference and has

the authority to issue legally binding requirements (e.g., license conditions) in lieu of

regulations until compatible regulations become effective.

The review team evaluated the Office’s responses to the questionnaire, reviewed the status of

regulations required to be adopted by the State under the NRC’s adequacy and compatibility

policy and verified the adoption of regulations with data obtained from the NRC Office of State

and Tribal Program’s “State Regulation Status Data Sheet.” Since the previous IMPEP review,

the Program adopted 17 amendments in a rule package that became effective in July 1999.

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

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

discussed during the Periodic Meetings, the review team found that the following amendments

are currently overdue.

! “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.

! “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 January 27, 1997.

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

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

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

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

Due to staffing changes and the need to address higher priority items during parts of the

review period, the Office made the decision to prepare one rulemaking package that included

the amendment that completely revised NRC’s regulations on the Medical Uses of Byproduct

Material. All of the above amendments have been drafted and are currently under review by

the State’s Radiation Advisory Commission. The anticipated adoption date for these

amendments is during the first half of 2003. The review team recommends that the State

adopt overdue regulations required for compatibility.

The Office will need to address the following six regulations in upcoming rulemakings or by

adopting alternate legally binding requirements:

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

amendment (64 FR 54543; 64 FR 55524) that became effective February 2, 2000.
Rhode Island Final Report Page 11

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

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

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

63749) that became effective January 8, 2001.

! “Requirements for Certain Generally Licensed Industrial Devices Containing Byproduct

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

effective February 16, 2001. The Program addressed the reporting requirements for

generally licensed device distributors which was due by August 16, 2001 by amending

the license of the State’s sole manufacturer/distributor of generally licensed devices.

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

became effective April 5, 2002.

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

20249) that became effective October 24, 2002.

All of the above amendments, including the overdue amendments, have been drafted and are

currently under review by the State’s Radiation Advisory Commission. The anticipated

adoption date for these amendments is during the first half of 2003.

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

that Rhode Island’s performance with respect to the indicator, Legislation and Program

Elements Required for Compatibility, is satisfactory.

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

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

regarding their SS&D Evaluation Program. These sub-indicators are: (1) Technical Quality of

the Product Evaluation Program; (2) Technical Staffing and Training; and (3) Evaluation of

Defects and Incidents Regarding SS&Ds.

In assessing the Office’s SS&D Evaluation Program, the review team examined information

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

the SS&D evaluations and supporting documents covering the review period was conducted. 

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

the staff and the Supervisor involved in SS&D evaluations.

4.2.1 Technical Quality of the Product Evaluation Program

The State has one licensee that manufactures x-ray fluorescence (XRF) devices and

distributes them under a general license. The Office processed one new SS&D application

since the last review and performed three amendments to existing SS&D registry sheets. The

casework review indicated that Office staff follows NRC guidance during the review process to

ensure that licensees submit the information necessary to support the product. The tie-down

conditions are stated clearly and are inspectible and enforceable. Deficiency letters clearly

stated regulatory positions and were used at the proper time. A concurrent review was
Rhode Island Final Report Page 12

accomplished by a second qualified SS&D reviewer for the new application and amendment

completed in 1998 and 2000. Since 2001, the Office has had only one qualified SS&D

reviewer. The concurrence review for the amendments completed in 2001 was performed by

the Supervisor. This matter is discussed in more detail in Section 4.2.2. A listing of the SS&D

casework evaluated with case-specific comments may be found in Appendix F.

The review team interviewed the staff and supervisor responsible for SS&D evaluations,

and examined the staff's use of guidance documents and procedures. The Office used

NUREG-1556, Volume 3, and pertinent ANSI standards and regulatory guides for their

reviews. The team found no health and safety issues relative to the SS&D evaluations which

were reviewed.

4.2.2 Technical Staffing and Training

During the first half of the review period, the former Supervisor and the license reviewer

conducted SS&D reviews. Both individuals had more than 10 years of experience and were

qualified to conduct and sign safety evaluations of SS&D applications in accordance with the

NRC/OAS Training Working Group Recommendations. These individuals are no longer with

the Office and since 2001, the Office has had only one qualified reviewer whose recent

experience with SS&D reviews is limited. The review team interviewed this individual and

determined that he was familiar with the SS&D evaluation process, applicable guidance and

reference documents. The team also determined that this reviewer meets the technical

training required for SS&D reviewers as described in the NRC/OAS Training Working Group

Recommendations.

With only one qualified reviewer, the current Supervisor conducted the concurrence review for

the two amended SS&D registry sheets issued by the Program in 2001. The Supervisor does

not meet the technical training required for SS&D reviewers as described in the NRC/OAS

Training Working Group Recommendations. Without a second qualified SS&D reviewer, the

Office currently does not have sufficient trained staff to perform SS&D reviews. In the opinion

of the team, the two uncomplicated concurrence reviews performed by the Supervisor during

this review period were satisfactory. The review team recommends that the Office train and

qualify a sufficient number of reviewers to conduct and sign safety evaluations of SS&D

applications in accordance with NRC/OAS Training Working Group Recommendations.

The review team discussed with Office management the difficulty of maintaining an SS&D

evaluation program considering the technical staffing and training requirements and a limited

number of device reviews. Office management indicated that, if necessary, they would draw

upon resources outside their office including State engineers, a local University engineering

department, the NRC, or another Agreement State to maintain the SS&D evaluation program if

a complex source or device evaluation is required which surpasses the Office’s expertise. The

review team also discussed the potential for return of the SS&D portion of the Agreement to

the NRC, if so desired by the State.

4.2.3 Evaluation of Defects and Incidents Regarding SS&Ds

Two incidents were reported to the Office by other Agreement States caused by the improper

assembly or modification of devices during the review period. The team found that the Office
Rhode Island Final Report Page 13

addressed these issues in a comprehensive manner and took appropriate actions. This

included conducting an inspection, issuing inspection findings that addressed the root cause,

following up on corrective actions taken by the manufacturer, and interacting with other

Agreement States. A listing of the SS&D incident casework evaluated with case-specific

comments may be found in Appendix E.

The review team conducted a search of the NMED system to determine whether other

incidents or defects might have taken place that were not identified by the Office. No

additional incidents or defects were identified that could have been related to malfunctioning

devices or products considered during the review.

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

that Rhode Island’s performance with respect to the indicator, Sealed Source and Device

Evaluation Program, is satisfactory.

4.3 Low-Level Radioactive Waste Disposal Program

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

Discontinuance of NRC Regulatory Authority and Assumption Thereof by States Through

Agreement" to allow a State to seek an amendment for the regulation of low-level radioactive

waste (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 the Rhode Island Agreement State program 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 Rhode Island. Accordingly, the review team did not

review this indicator.

5.0 SUMMARY

As noted in Sections 3 and 4 above, the review team and the MRB found Rhode Island’s

performance to be satisfactory for six performance indicators, and unsatisfactory for the

indicator “Status of Materials Inspection Program.” Accordingly, the review team

recommended and the MRB concurred in finding the Rhode Island Agreement State program

to be adequate, but needs improvement, and compatible with NRC's program. Based on the

results of the current IMPEP review, the review team recommended and the MRB concurred

that a period of heightened oversight (including bimonthly teleconferences and progress

reports) and a follow-up review be performed in approximately one year.

Below are the recommendations, as mentioned earlier in the report, for evaluation and

implementation, as appropriate, by the State.
Rhode Island Final Report Page 14

RECOMMENDATIONS:

1. The review team recommends that the Office use a fully documented interim

qualification program for inspectors. (Section 3.1)

2. The review team recommends that the Office implement the action plan and perform

inspections of core licenses at their appropriate frequencies. (Section 3.2)

3. The review team recommends that the Office inspect core licensees granted

reciprocity in accordance with the criteria in IMC 1220. (Section 3.2)

4. The review team recommends that the State adopt overdue regulations required for

compatibility. (Section 4.1.2)

5. The review team recommends that the Office train and qualify a sufficient number of

reviewers to conduct and sign safety evaluations of SS&D applications in accordance

with NRC/OAS Training Working Group Recommendations. (Section 4.2.2)
LIST OF APPENDICES AND ATTACHMENTS

Appendix A IMPEP Review Team Members

Appendix B Rhode Island Organization Charts

Appendix C Inspection Casework Reviews

Appendix D License Casework Reviews

Appendix E Incident Casework Reviews

Appendix F Sealed Source and Device Casework Reviews

Attachment January 15, 2003 Letter from Dr. Patricia A. Nolan

Rhode Island’s Response to Draft IMPEP Report
APPENDIX A

IMPEP REVIEW TEAM MEMBERS

Name Area of Responsibility

James Lynch, Region III Team Leader

Technical Quality of Inspections

Technical Staffing and Training

Inspector Accompaniments

Duncan White, Region I Status of Materials Inspection Program

Sealed Source and Device Evaluation Program 

Legislation and Program Elements Required for

 Compatibility

Cynthia Sanders, Georgia Technical Quality of Licensing Actions

Response to Incidents and Allegations
APPENDIX B

Rhode Island

Radiation Control Hierarchy

and

Office of Occupational and Radiological Health

ORGANIZATION CHARTS

ML023370673


ATTACHMENT

January 15, 2003 Letter from Dr. Patricia A. Nolan

Rhode Island’s Response to Draft IMPEP Report

ML030240390