January 19, 2007

W. Clough Toppan, MS, PE 

Division of Environmental Health

11 State House Station

286 Water Street, 3rd Floor

Augusta, ME 04333

Dear Mr. Toppan:

On December 18, 2006, the Management Review Board (MRB) met to consider the proposed

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

Agreement State Program. The MRB found the Maine Agreement State Program adequate to

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

program.

Section 5.0, page 10, of the enclosed final report contains a summary of the IMPEP review

team’s findings and recommendation. We request your evaluation and response to the

recommendations within 30 days from receipt of this letter.

Based on the results of the current IMPEP review, the next full review of the Maine Agreement

State Program will take place in approximately 4 years, with a periodic meeting tentatively

scheduled for October 2008.

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

I also wish to acknowledge your continued support for the Agreement State Program and the

excellence in program administration demonstrated by your staff, as reflected in the review

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

Sincerely,

/RA/

Martin J. Virgilio

Deputy Executive Director for Materials, Waste,

 Research, State, Tribal, and Compliance Programs

Office of the Executive Director for Operations

Enclosure: Maine Final IMPEP Report

cc: Jay Hyland, Manager

Maine Radiation Control Program

Jared Thompson, Arkansas

Organization of Agreement States

 Liaison to the MRB
January 19, 2007

W. Clough Toppan, MS, PE 

Division of Environmental Health

11 State House Station

286 Water Street, 3rd Floor

Augusta, ME 04333

Dear Mr. Toppan:

On December 18, 2006, the Management Review Board (MRB) met to consider the proposed

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

Agreement State Program. The MRB found the Maine Agreement State Program adequate to

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

program.

Section 5.0, page 10, of the enclosed final report contains a summary of the IMPEP review

team’s findings and recommendation. We request your evaluation and response to the

recommendations within 30 days from receipt of this letter.

Based on the results of the current IMPEP review, the next full review of the Maine Agreement

State Program will take place in approximately 4 years, with a periodic meeting tentatively

scheduled for October 2008.

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

I also wish to acknowledge your continued support for the Agreement State Program and the

excellence in program administration demonstrated by your staff, as reflected in the review

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

Sincerely,

/RA/

Martin J. Virgilio

Deputy Executive Director for Materials, Waste,

 Research, State, Tribal, and Compliance Programs

Office of the Executive Director for Operations

Enclosure: Maine Final IMPEP Report

cc: Jay Hyland, Manager

Maine Radiation Control Program

Jared Thompson, Arkansas

Organization of Agreement States

 Liaison to the MRB

DISTRIBUTION: See next page.

ML070080459

OFFICE FSME/DMSSA/SAIS FSME/DMSSA/SAIS:BC FSME/DMSSA:DD

NAME ATMcCraw PARathbun SWMoore

DATE 01/04/07 01/04/07 01/08/07

OFFICE FSME/DMSSA:D FSME:DD DEDMRT

NAME JRSchlueter GCPangburn MJVirgilio

DATE 01/08/07 01/16/07 01/19/07

OFFICIAL RECORD COPY
Letter to Clough Toppan from Martin J. Virgilio dated January 19, 2007.

DISTRIBUTION:

DMSSA RF

EDO RF Chairman Klein

DWhite, RI Commissioner McGaffigan

WRautzen, FSME/DMSSA Commissioner Merrifield

PBishop, OK Commissioner Jaczko

KKarcagi, FSME/DMSSA Commissioner Lyons

TPGwynn, RIV

KCyr, OGC

FCameron, OGC

AKock, OEDO SUNSI Review Complete

CMiller, FSME : Publicly Available G Non-Publicly Available

TCombs, OCA (2 copies) : Non-Sensitive G Sensitive
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM

REVIEW OF MAINE AGREEMENT STATE PROGRAM

October 10 - 13, 2006

FINAL REPORT

U.S. Nuclear Regulatory Commission

 ENCLOSURE
Maine Final Report Page 1

1.0 INTRODUCTION

This report presents the results of the review of the Maine Agreement State Program. The

review was conducted during the period of October 10-13, 2006, by a review team comprised of

technical staff members from the U.S. Nuclear Regulatory Commission (NRC) and the State of

Oklahoma. 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 Final General Statement of Policy,” published in the Federal

Register on October 16, 1997, and the February 26, 2004, NRC Management Directive 5.6,

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

review, which covered the period of November 2, 2002, to October 13, 2006, were discussed

with Maine management on the last day of the review.

A draft of this report was issued to Maine for factual comment on November 3, 2006. The State

responded by e-mail on December 6, 2006, from Jay Hyland, Program Manager, Radiation

Control Program (the Program). The Management Review Board (MRB) met on December 18,

2006, to consider the proposed final report. The MRB found the Maine Agreement State

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

The Maine Agreement State Program is administered by the Program, which is located within

the Division of Environmental Health (the Division). The Division is part of the Center for

Disease Control and Prevention (the Center). The Director of the Center reports to the

Commissioner for the Department of Health and Human Services (the Department). 

Organization charts of the Department, Center, and Program are included in Appendix B. At the

time of the review, the Maine Agreement State Program regulated 128 specific licenses

authorizing Agreement materials. The review focused on the materials program as it is carried

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

between the NRC and the State of Maine.

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

performance indicators was sent to the Program on August 8, 2006. The Program provided its

response to the questionnaire on September 27, 2006. A copy of the questionnaire response

may be found in the NRC’s Agencywide Documents Access and Management System

(ADAMS) using the Accession Number ML062990008.

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

the Program’s response to the questionnaire; (2) review of applicable Maine statutes and

regulations; (3) analysis of quantitative information from the Program’s databases; (4) technical

review of selected files; (5) two field accompaniments of a Maine inspector; and (6) interviews

with staff and management to answer questions or clarify issues. The review team evaluated

the information gathered against the established criteria for each common and applicable noncommon performance indicator and made a preliminary assessment of the Agreement State

program’s performance.

Section 2.0 of this report discusses the Program’s actions in response to recommendations

made during the previous review. Results of the current review for the IMPEP common

performance indicators are presented in Section 3.0. Section 4.0 discusses results of the

applicable non-common performance indicators, and Section 5.0 summarizes the review team's
Maine Final Report Page 2

findings and recommendations. The 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.

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS

During the previous IMPEP review, which concluded on November 1, 2002, no

recommendations were made by the review team.

3.0 COMMON PERFORMANCE INDICATORS

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

and Agreement State programs. These indicators include: (1) Technical Staffing and Training,

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

(4) Technical Quality of Licensing Actions, and (5) Technical Quality of Incident and Allegation

Activities.

3.1 Technical Staffing and Training

Issues central to the evaluation of this indicator include the 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 Program’s questionnaire response relative to this

indicator; interviewed Program management and staff; and reviewed job descriptions, training

plans, and training records. The review team also considered any possible workload backlogs

in evaluating this indicator.

Program staffing was unchanged over the review period and consequently, the Program

benefitted from the experienced personnel. The Program has two technical staff who report to

the Program Manager. Both staff members are fully qualified inspectors and license reviewers. 

There is also one individual (currently serving in the military) who is also being cross trained in

the Program. This individual is currently the Low-Level Waste Coordinator and recently

assigned to decommissioning activities at Maine Yankee. In addition, the Program has a

Nuclear Safety Inspector assigned to the Maine Yankee activities, two X-ray staff members, and

two individuals assigned to the radon program. The Program currently has no vacant positions.

The Program Manager is supportive of staff training opportunities, as well as staff participation

in various Federal and State working groups. Both staff in the radioactive materials program

attended the NRC Security Systems and Principles course, one in September 2005 and one in

October 2005. The Program Manager will attend the NRC Security Systems and Principles

Course in the near future.

The review team noted that the Program had stable funding during the review period due to

dedicated revenue from licensee fees; however, the Program has not had an increase in fees

for over 10 years. The Program Manager noted that the three previous requests for fee

increases were denied. A fourth request, to be made in the coming months, may be more

successful due to the monetary shortfall in the Program.

The Program has a documented training plan that is consistent with the guidance in the

NRC/Organization of Agreement States Training Working Group Report and NRC’s Inspection
Maine Final Report Page 3

Manual Chapter (IMC) 1246. They also have on-the-job training to supplement the course work,

so that individuals may broaden their work areas. The staff are well-trained and well-qualified

from an education and experience standpoint. All have Bachelor’s degrees in the sciences, and

the Program Manager is a Professional Engineer. Inspector requirements include NRC training

courses, when available, or equivalents.

The Advisory Committee on Radiation of the State of Maine, as constituted under the law, acts

only in an advisory role to the Program. Meetings of the committee are on an as needed basis.

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

that Maine’s performance with respect to the indicator, Technical Staffing and Training, was

satisfactory.

3.2 Status of Materials Inspection Program

The review team focused on five factors while reviewing this indicator: inspection frequency,

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

licensees, and performance of reciprocity inspections. The review team’s evaluation was based

on the Program’s questionnaire response relative to this indicator, data gathered from the

Program’s databases, examination of completed inspection casework, and interviews with

management and staff.

The review team verified that the Program’s inspection priorities for various types of licenses

are generally the same as those listed in IMC 2800. There are some categories of licenses that

were assigned inspection priority codes that prescribe a more frequent inspection schedule than

those currently prescribed in IMC 2800.

The review team determined that, during the review period, the Program conducted 8 of 38

Priority 1, 2, and 3 inspections overdue by more than 25 percent of the inspection frequency

listed in IMC 2800. Thirteen initial inspections were performed during the review period, one of

which was conducted overdue. There were two overdue Priority 3 inspections which had not

been inspected at the time of the review. Overall, 16 percent of the inspections conducted by

the Program during the review period were overdue (9 late inspections out of 51).

There were a number of factors identified by the review team that contributed to the number of

overdue inspections. These included problems with maintaining and updating the databases

used for tracking inspections and licensing actions; the redeployment of one or both of the

radioactive materials staff to higher priority activities during the review period that included 

Maine Yankee decommissioning activities and responding to a large number of waste alarms;

and the extended absence of one staff member due to illness. The information gaps created by

not maintaining the database or not entering data for periods of time proved to reduce the

effectiveness of the database as a tool to manage the status of inspections. The small size of

the Program also created difficulties in completing routine Agreement State activities when

individuals were either assigned to other work or absent. The review team recommends that

the State evaluate current and future staffing needs and business processes to develop and

implement a strategy that improves the effectiveness and efficiency of the Program and ensures

its continued adequacy and compatibility.
Maine Final Report Page 4

The review team evaluated the Program’s timeliness in providing inspection findings to

licensees. The review team determined that, during the review period, the large majority of

inspection findings were communicated to the licenses in less than 30 days.

During the review period, the Program granted 39 reciprocity permits, 17 of which were

candidate licensees based upon the criteria in IMC 1220. The review team determined that the

Program met and/or exceeded NRC’s criteria of inspecting 20 percent of candidate licensees

operating under reciprocity in each of the 4 years covered by the review period.

The review team determined that with respect to Commission Staff Requirements Memorandum

(SRM) for COMSECY-05-0028, on Increased Controls, the Program has planned for the initial

set of inspections of these licensees in accordance with the Increased Controls requirements. 

The review team evaluated the Program’s prioritization methodology and found it acceptable. 

Two of six Increased Controls inspections had been completed at the time of the review. The

Program plans to have the remaining four inspections completed by April 2007.

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

that Maine’s performance with respect to the indicator, Status of Materials Inspection Program,

was satisfactory, but needs improvement.

3.3 Technical Quality of Inspections

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

notes and interviewed inspectors for 15 radioactive materials inspections conducted during the

review period. The casework reviewed included inspections conducted by both Program

inspectors, and covered inspections of various license types, including: medical broad scope,

medical institutions requiring written directives, medical private practice, fixed and portable

gauges, industrial radiography, academic broad scope, nuclear pharmacy, and research and

development. Appendix C lists the inspection casework files reviewed, with case-specific

comments, as well as the results of the inspector accompaniments.

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

aspects of licensed radiation programs. The review team found that inspection reports were

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

ensure that licensees’ performance with respect to health and safety was acceptable. The

documentation supported violations, recommendations made to licensees, unresolved safety

issues, and discussions held with licensees during exit interviews.

The inspection procedures utilized by the Program are generally consistent with the inspection

guidance outlined in IMC 2800. An inspection report is completed by the inspector which is

then reviewed and signed by the Program Manager. Supervisory accompaniments are

generally being conducted annually for all inspectors.

The review team determined that the inspection findings were appropriate and prompt

regulatory actions were taken, as necessary. All inspection findings are clearly stated and

documented in the report, and sent to the licensee with the appropriate form or letter detailing

the results of the inspection. The Program issues the licensee either a form equivalent to NRC

Form 591 or a Notice of Violation (NOV) in letter format detailing the results of the inspection. 

The Program identifies their equivalent NRC Form 591M as Maine Form HHE-891. When the
Maine Final Report Page 5

Program issues a NOV in letter format, the licensee is required by the Program to provide,

within 30 days, a written plan of correction for the violations cited. All findings are reviewed by

the Program Manager.

The review team noted that the Program has an adequate supply of survey instruments to

support the current inspection program. Appropriate, calibrated survey instrumentation such as

Geiger-Mueller (GM) meters, scintillation detectors, ion chambers, a neutron detector and

micro-R meters were observed to be available. The instruments are calibrated at least annually

by a commercial calibration service. The Program has a portable multi-channel analyzer and

has access to the Health and Environmental Testing Laboratory which is part of the Center.

Accompaniments of an inspector were conducted by an IMPEP team member on June 10,

2004, and September 8, 2006. The inspector was accompanied during a health and safety

inspection of a medical broad scope and an Increased Controls inspection of a self-shielded

irradiator. The accompaniments are identified in Appendix C. During the accompaniments, the

inspector demonstrated appropriate inspection techniques, knowledge of the regulations, and

conducted performance-based inspections. The inspector was trained, well-prepared for the

inspection, and thorough in the audits of the licensees’ radiation safety and Increased Controls

programs. The inspector conducted interviews with appropriate licensee personnel, observed

licensed operations, conducted confirmatory measurements, and utilized good health physics

practices. The inspections were adequate to assess radiological health and safety and

Increased Controls at the licensed facilities.

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

that Maine’s performance with respect to the indicator, Technical Quality of Inspections, was

satisfactory.

3.4 Technical Quality of Licensing Actions

The review team examined completed licensing casework and interviewed license reviewers for

19 specific licenses. Licensing actions were reviewed for completeness, consistency, proper

radioisotopes and quantities, qualifications of authorized users, adequate facilities and

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

emergency procedures, appropriateness of the license conditions, Increased Controls and

overall technical quality. The casework was also reviewed for timeliness, use of appropriate

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

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

supervisory review as indicated, and proper signatures. The casework was checked for

retention of necessary documents and supporting data.

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

completed during the review period. Licensing actions selected for evaluation included four new

licenses, five renewals, eight amendments, and two terminations. The sampling included the

following types of licenses: medical (institution - written directive required, private practice - no

written directive, and high dose rate remote afterloader), industrial radiography, manufacturing,

portable and fixed gauges, academic broad scope, research and development broad scope,

self-shielded irradiator, service and a nuclear pharmacy. A listing of the licensing casework

evaluated, with case-specific comments, may be found in Appendix D.
Maine Final Report Page 6

The review team found that the licensing actions were thorough, complete, consistent, and of

high quality with health, safety, and security issues properly addressed. Licenses are issued for

a 5-year period under a timely renewal system. License tie-down conditions were stated

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

correspondence are generated using standardized conditions and formats. The Program

utilizes NRC licensing guides (NUREG-1556 series), as appropriate. The licensee’s compliance

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

Terminated licensing actions are well documented, showing appropriate transfer and survey

records.

Licensing actions are assigned to one of two qualified license reviewers along with a priority

based on the type of action. Once the reviewer completes the action, the other reviewer

performs a secondary review of the action. An internally developed checklist specific to the type

of license is completed by the initial reviewer and signed by the secondary reviewer for the

licensing actions. The status of all licensing actions are tracked on a database, but the review

team found that the database was not updated on a routine basis, sometimes for periods of

several months. The lack of current information limits the effectiveness of the database as a

management tool for the Program. This matter is discussed in more detail in Section 3.2. 

Written licensing procedures have been updated as needed. Licenses are signed by one of the

two qualified reviewers, or if necessary, the Program Manager.

The Program does not have a backlog of licensing actions. Most amendments are completed

within one month of receipt and renewals are typically completed within two months. There is

one license renewal that has been pending for more than one year. The fixed gauge licensee

has not been responsive to the Program’s requests for additional information; consequently, an

inspection had been scheduled for later in the year. The review team did not find any safetysignificant impact on the licensee’s program due to the length of the pending renewal.

Since July 2000, the Program has been certifying radiographers in accordance with Part E of

the State’s regulations. The Program administers the radiographer certification examination

developed by the Texas Department of State Health Services and administered through the

Conference of Radiation Control Program Directors, Inc. Certification is valid for 5 years. 

Through the review of select individual files, the review team determined that the Program only

issued identification cards when the individual passed the examination and provided appropriate

documentation of 40 hours of formal training and two months of on-the-job training.

The review team reviewed the State’s general licensing registration program with Program staff. 

The Program requires annual registration and submission of an inventory (manufacturer, model

number, serial number, isotope and activity) of all generally licensed devices in the State. 

Changes in inventory or failure to respond to the annual registration request results in a follow

up by the Program. Fees are charged to those registrants that possess portable and fixed

gauging devices, in-vitro testing and depleted uranium shielding. No fees are charged for static

eliminators, electron capture devices, gas chromatographs, or exit signs. The Program

maintains databases of generally licensed devices, which is periodically updated.

The review team examined the list of licensees that the Section had determined met the criteria

for the Increased Controls per COMSECY-05-0028. The review team determined that the

Section had correctly identified the licensees that require Increased Controls based on this

criteria, and will continue to issue Increased Controls to any additional licensees, as
Maine Final Report Page 7

appropriate. Each licensee was issued a license amendment requiring Increased Controls in

accordance with the time lines established by the Commission in the SRM for COMSECY-05-

0028.

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

that Maine’s performance with respect to the indicator, Technical Quality of Licensing Actions,

was satisfactory.

3.5 Technical Quality of Incident and Allegation Activities

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

allegations, the review team examined the Program’s response to the questionnaire relative to

this indicator, evaluated selected incidents reported for Maine in the Nuclear Material Events

Database (NMED) against those contained in the Program’s files, and evaluated the casework

for seven radioactive materials incidents. A listing of the incident casework examined, with

case-specific comments, is included in Appendix E. The review team also evaluated the

Program’s response to allegations involving radioactive materials, including an allegation

referred to the State by the NRC.

When notified of an incident, one of the two radioactive materials staff in the Program will be

assigned to investigate and document the incident and determine if the event requires a call to

the NRC Headquarters Operations Center. The senior inspector is responsible for recording the

event in the NMED local incident database and transferring updates to the NRC’s contractor

responsible for maintaining NMED. The incident file is either maintained in the docket file for a

specific licensee or a separate file for a general or non-licensee. The Program responded to a

total of 139 incidents involving radioactive materials during the review period. Nearly all of the

events (132) involved trash alarms. A total of ten incidents were entered into NMED. Three of

the incidents required reporting to the NRC. Monthly reports and followup information are

submitted electronically by transmitting the appropriate contents of the local Maine NMED

database to the NRC’s contractor responsible for maintaining NMED. The review team

evaluated seven of the incidents, which were required to be reported to the State, including all

three incidents that required reporting to the the NRC. The incidents included personnel

overexposures, a fire involving radioactive material, a lost and recovered gauge, a medical

event, and an equipment failure.

The review team noted that close coordination with the NRC was maintained, and the

Program’s response to incidents was commensurate with the health and safety significance of

the event. Inspectors were dispatched for investigations when appropriate and enforcement

actions were taken when necessary. Incident reports were thorough, well-documented and

were generally timely. All incident reports were reviewed and signed by the Program Manager.

During the review period, the Program received one allegation involving Agreement material

which was referred to the State by the NRC. The review team evaluated the casework for this

allegation. The evaluation indicated that prompt and appropriate action was taken in response

to the concern raised. The allegation was promptly reviewed and appropriately closed with the

alleger. The alleger was informed of the results. There were no performance issues identified

from the review of the allegation casework.
Maine Final Report Page 8

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

that Maine’s performance with respect to the indicator, Technical Quality of Incident and

Allegation Activities, was satisfactory.

4.0 NON-COMMON PERFORMANCE INDICATORS

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

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

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

Program. The first two non-common performance indicators were applicable to this review.

4.1 Compatibility Requirements

4.1.1 Legislation 

Maine became an Agreement State on April 1, 1992. The current effective statutory authority

for the Program is contained in the Maine Radiation Protection Statutes in 22 MRSA § 661-690. 

The Radiation Control Program is designated as the State's radiation control agency. The

review team noted that no legislation affecting the Program was passed during the review

period.

4.1.2 Program Elements Required for Compatibility 

The Maine Regulations for Control of Radiation, found in Maine Administrative Rules 10-144A

CMR 220, apply to all ionizing radiation. Maine requires a license for possession and use of all

radioactive material, including naturally occurring materials, and accelerator-produced

radionuclides. Maine 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 approximately four months after filing the draft rule with the Secretary of State. 

Prior to filing with the Secretary of State, the draft rule is reviewed by Department management,

the Attorney General’s Office, and the Governor’s Office. When an acceptable draft proposed

revision to a rule has been prepared, it is sent to the Secretary of State, the public, the NRC,

other agencies, and all potentially impacted licensees and registrants for comment. The

Secretary of State announces a public meeting/hearing period for the proposed revision to the

rule. Comments are considered and incorporated, as appropriate, before the regulations are

finalized. After responding to comments, the Program forwards the proposed revision to the

rule with the addressed comments to the Commissioner, the Department, and Attorney

General’s Office for final approval. The Commissioner and the Attorney General sign the final

regulations. The State can adopt other agency’s 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 Program’s response to the questionnaire relative to this

indicator, reviewed the status of regulations required to be adopted by the State under the

Commission’s adequacy and compatibility policy, and verified the adoption of regulations with

data obtained from the Office of Federal and State Materials and Environmental Management

Programs’ (FSME) State Regulation Status Sheet.
Maine Final Report Page 9

At the time of the review, there were no overdue NRC amendments; however, since that time,

one NRC amendment has become overdue for adoption. The State indicated that the following

overdue amendment would be addressed in an upcoming rulemaking:

• "Financial Assurance for Materials Licensees," 10 CFR Part 30, 40, and 70 amendments

(68 FR 57327) that became effective on December 3, 2003, and was due for Agreement

State adoption by December 3, 2006.

The review team identified the following four NRC amendments that will be needed in the future,

and the State indicated that the regulations would be addressed in upcoming rulemakings or by

issuance of alternate legally binding requirements:

• "Compatibility with IAEA Transportation Safety Standards and Other Transportation

Safety Amendments," 10 CFR Part 71 amendment (69 FR 3697) that became effective

on October 1, 2004, and is due for Agreement State adoption by October 1, 2007.

• "Security Requirements for Portable Gauges Containing Byproduct Material," 10 CFR

Part 30 amendment (70 CFR 2001) that became effective on July 11, 2005, and is due

for Agreement State adoption by July 11, 2008.

• "Medical Use of Byproduct Materials - Recognition of Specialty Boards," 10 CFR Part 35

amendment (70 FR 16336, 71 FR 1926) that became effective on April 29, 2005, and is

due for Agreement State adoption by April 29, 2008.

• “Minor Amendments,” 10 CFR Part 20, 30, 32, 35, 40 and 70 amendments (71 FR

15005) that became effective March 27, 2006, and is due for Agreement State adoption

by March 27, 2009.

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

that Maine’s performance with respect to the indicator, Compatibility Requirements, was

satisfactory.

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

During the review period, no SS&D certificates were issued by the Program and there are

currently no manufacturers of SS&Ds in the State. The State, however, does not wish to

relinquish the authority to regulate SS&D manufacturers in the future. The State has committed

to have a program in place prior to performing evaluations and as a member of the New

England Radiological Health Committee, the State will also use the technical expertise that the

Commonwealth of Massachusetts has in this area. Accordingly, the review team did not review

this indicator.
Maine Final Report Page 10

5.0 SUMMARY

As noted in Sections 3.0 and 4.0, Maine’s performance was found to be satisfactory, but needs

improvement, for the indicator, Status of Materials Inspection Program and satisfactory for all

remaining performance indicators reviewed. The review team made one recommendation

regarding the performance of the Maine Agreement State Program. Accordingly, the review

team recommended and the MRB agreed that the Maine Agreement State Program is adequate

to protect public health and safety and compatible with NRC's program. Based on the results of

the current IMPEP review, the review team recommended and the MRB agreed that the next full

IMPEP review take place in approximately 4 years.

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

implementation, as appropriate, by the State.

The review team recommends that the State evaluate current and future staffing needs

and business processes to develop and implement a strategy that improves the

effectiveness and efficiency of the Program and ensures its continued adequacy and

compatibility. (Section 3.2)
LIST OF APPENDIXES AND ATTACHMENT

Appendix A IMPEP Review Team Members

Appendix B Maine Organization Charts

Appendix C Inspection Casework Reviews

Appendix D License Casework Reviews

Appendix E Incident Casework Reviews

Attachment December 6, 2006, E-mail from Jay Hyland

Maine’s Response to Draft IMPEP Report
APPENDIX A

IMPEP REVIEW TEAM MEMBERS 

Name Area of Responsibility

Duncan White, Region I Team Leader

Technical Quality of Licensing

Technical Quality of Incident and Allegation

 Activities

Inspector Accompaniments

William Rautzen, FSME Technical Staffing and Training

Compatibility Requirements

Pamela Bishop, Oklahoma Status of Materials Inspection Program

Technical Quality of Inspections
APPENDIX B

MAINE ORGANIZATION CHARTS

ADAMS: ML062990008

Attachment A
APPENDIX C

INSPECTION CASEWORK REVIEWS

NOTE: CASEWORK LISTED WITHOUT COMMENT ARE INCLUDED FOR COMPLETENESS

ONLY.

File No.: 1

Licensee: Bruce A. Manzer, Inc. License No.: 25205

Inspection Type: Initial, Announced Priority: 5

Inspection Date: 3/18/04 Inspector: SS

File No.: 2

Licensee: MidCoast Hospital License No.: 23611

Inspection Type: Routine, Unannounced Priority: 3

Inspection Date: 2/13/03 Inspector: SS

Comment:

One cited Severity Level IV violation was issued on Maine Form HHE-891 (equivalent of

NRC’s Form 591), but the corrective action was not documented.

File No.: 3

Licensee: Pharm-Corp of Maine License No.: 11713-01MD

Inspection Type: Routine, Unannounced Priority: 2

Inspection Date: 8/10/06 Inspector: SS

File No.: 4

Licensee: Maine Medical Center License No.: 05611

Inspection Type: Routine, Unannounced Priority: 2

Inspection Date: 7/27/06 Inspector: SS

File No.: 5

Licensee: Mount Desert Island Biological License No.: 09623

Inspection Type: Routine, Unannounced Priority: 3

Inspection Date: 4/19/05 Inspector: SS

File No.: 6

Licensee: Bath Iron Works License No.: 23209

Inspection Type: Routine, Unannounced Priority: 1

Inspection Date: 2/8/05 Inspector: SS

Comment:

Radiography report form does not provide for documentation of exit meeting attendees

and their titles.
Maine Final Report Page C.2

Inspection Casework Reviews

File No.: 7

Licensee: Quality Assurance Labs License No.: 05139

Inspection Type: Routine, Unannounced Priority: 1

Inspection Date: 7/28/04 Inspector: SS

Comment:

Radiography report form does not provide for documentation of exit meeting attendees

and their titles.

File No.: 8

Licensee: Mayo Regional Hospital License No.: 21601

Inspection Type: Routine, Unannounced Priority: 3

Inspection Date: 12/16/02 Inspector: SS

File No.: 9

Licensee: Redington Fairview Hospital License No.: 25707

Inspection Type: Routine, Unannounced Priority: 3

Inspection Date: 6/22/04 Inspectors: WM

File No.: 10

Licensee: St. Mary’s Regional Medical Center License No.: 01709

Inspection Type: Routine, Unannounced Priority: 3

Inspection Date: 11/18/04 Inspector: SS

File No.: 11

Licensee: Maine Molecular Imaging License No.: 05623

Inspection Type: Routine, Unannounced Priority: 3

Inspection Date: 6/3/02 Inspector: SS

File No.: 12

Licensee: Waldo County General Hospital License No.: 27901

Inspection Type: Routine, Unannounced Priority: 3

Inspection Date: 8/3/05 Inspector: SS

File No.: 13

Licensee: TEI Analytical Services License No.: 37-2804 

Inspection Type: Reciprocity Priority: 1

Inspection Date: 6/20/06 Inspector: SS

File No.: 14

Licensee: CoPhysics Corportation License No.: NY 269-3949

Inspection Type: Reciprocity Priority: 5

Inspection Date: 6/27/06 Inspector: SS

File No.: 15

Licensee: J. L. Shepherd & Associates License No.: CA 1777-19 

Inspection Type: Reciprocity Priority: 2

Inspection Date: 4/19/05 Inspector: SS
Maine Final Report Page C.3

Inspection Casework Reviews

INSPECTOR ACCOMPANIMENTS

The following inspector accompaniments were performed prior to the on-site IMPEP review:

Accompaniment No.: 1

Licensee: Maine Medical Center License No.: 05611

Inspection Type: Routine, Unannounced Priority: 2

Inspection Date: 6/10/04 Inspector: SS

Accompaniment No.: 2

Licensee: Nordx License No.: 05607

Inspection Type: Increased Controls Priority: N/A

Inspection Date: 9/8/06 Inspector: SS
APPENDIX D

LICENSE CASEWORK REVIEWS

NOTE: CASEWORK LISTED WITHOUT COMMENT ARE INCLUDED FOR COMPLETENESS

ONLY.

File No.: 1

Licensee: Pharm-Corp of Maine License No.: 11713-01MD

Type of Action: Renewal Amendment No.: 13

Date Issued: 8/16/06 License Reviewer: SS

File No.: 2

Licensee: Solidphase, Inc. License No.: 05711

Type of Action: Renewal Amendment No.: 1

Date Issued: 12/12/03 License Reviewer: SS

File No.: 3

Licensee: GE Security, Inc. License No.: 25305

Type of Action: Renewal Amendment No.: 9

Date Issued: 12/12/03 License Reviewer: SS

File No.: 4

Licensee: Elite Inspection Services, Inc. License No.: 05703

Type of Action: Termination Amendment No.: 3

Date Issued: 8/3/06 License Reviewer: SS

File No.: 5

Licensee: Mid Coast Cardiology License No.: 05621

Type of Action: Renewal Amendment No.: 3

Date Issued: 10/4/06 License Reviewer: WM

File No.: 6

Licensee: University of Southern Maine License No.: 05807

Type of Action: New Amendment No.: N/A

Date Issued: 7/18/03 License Reviewer: SS

File No.: 7

Licensee: Idaho Nuclear Specialties License No.: 15401

Type of Action: New Amendment No.: N/A

Date Issued: 6/27/05 License Reviewer: WM

File No.: 8

Licensee: Eastern Maine Medical Center License No.: 19301

Type of Action: Amendment Amendment No.: 22

Date Issued: 3/27/06 License Reviewer: WM
Maine Final Report Page D.2

License Casework Reviews

File No.: 9

Licensee: Bigelow Laboratory for Ocean Sciences License No.: 15201

Type of Action: Renewal Amendment No.: 6

Date Issued: 6/16/06 License Reviewer: SS

Comment:

Current financial assurance instrument (surety bond) issued in 2003 incorrectly lists the

NRC as holder, not the State of Maine.

File No.: 10

Licensee: Mount Desert Island Biological Laboratory License No.: 09623

Type of Action: Amendment Amendment No.: 3

Date Issued: 5/13/04 License Reviewer: SS

File No.: 11

Licensee: University of Maine License No.: 19827

Type of Action: Amendment Amendment No.: 6

Date Issued: 3/7/03 License Reviewer: WM

Comment:

Possession limits authorized on license requires financial assurance. Licensee has not

submitted Letter of Intent as required by Part C.8.F.(4) of the State’s regulations.

File No.: 12

Licensee: National Semiconductor Corporation License No.: 05637

Type of Action: Amendment Amendment No.: 5

Date Issued: 11/21/05 License Reviewer: SS

File No.: 13

Licensee: Longview Inspection Inc. License No.: 17501

Type of Action: Termination Amendment No.: 8

Date Issued: 7/21/05 License Reviewer: SS

File No.: 14

Licensee: Nordx License No.: 05607

Type of Action: Amendment Amendment No.: 6

Date Issued: 11/21/05 License Reviewer: SS

File No.: 15

Licensee: Mount Desert Island Hospital License No.: 09609

Type of Action: New Amendment No.: 19

Date Issued: 3/4/05 License Reviewer: WM

File No.: 16

Licensee: John Turner Consulting, Inc. License No.: 05503

Type of Action: New Amendment No.: N/A

Date Issued: 7/7/03 License Reviewer: WM
Maine Final Report Page D.3

License Casework Reviews

File No.: 17

Licensee: Katahdin Paper Company LLC License No.: 19401

Type of Action: Amendment Amendment No.: 9

Date Issued: 4/29/03 License Reviewer: WM

Comments:

a) Letter dated 4/28/03 referenced in the tie-down condition not in docket file.

b) Reviewer did not request information needed for transfer of control application as

required in NUREG-1556, Volume 4, Appendix C.

File No.: 18

Licensee: Maine Department of Transportation License No.: 16903

Type of Action: Amendment Amendment No.: 5

Date Issued: 6/9/03 License Reviewer: SS

File No.: 19

Licensee: The Aroostook Medical Center License No.: 03803-02

Type of Action: Amendment Amendment No.: 6

Date Issued: 10/29/03 License Reviewer: SS
APPENDIX E

INCIDENT CASEWORK REVIEWS

NOTE: CASEWORK LISTED WITHOUT COMMENT ARE INCLUDED FOR COMPLETENESS

ONLY.

File No.: 1

Licensee: Longview Inspection Inc. License No.: 17501

Date of Incident: 10/01/03 Incident Log No.: ME020046 (NMED 040147)

Investigation Date: 11/25/03 Type of Incident: Overexposure

Type of Investigation: Inspection

File No.: 2

Licensee: Elite Inspection License No.: 05703

Date of Incident: 12/29/04 Incident Log No.: ME050019

Investigation Date: 12/30/04 Type of Incident: Fire

Type of Investigation: Inspection

File No.: 3

Licensee: Simplex Grinnell License No.: General License

Date of Incident: 5/27/03 Incident Log No.: ME030026 (NMED 040140)

Investigation Date: 5/27/03 Type of Incident: Lost and Recovered RAM

Type of Investigation: Inspection

File No.: 4

Licensee: Huhtamaki License No.: General License

Date of Incident: 3/31/03 Incident Log No.: ME040041 (NMED 040680)

Investigation Date: 8/30/04 Type of Incident: Lost RAM

Type of Investigation: Telephone

Comment:

Program left this event open in NMED until October 2006 since the device was not

recovered.

File No.: 5

Licensee: Bath Iron Works License No.: 23209

Date of Incident: 11/22/02 Incident Log No.: ME020046 (NMED 021146)

Investigation Date: 11/23/02 Type of Incident: Equipment Failure

Type of Investigation: Telephone, Inspection Follow Up

File No.: 6

Licensee: Maine Medical Center License No.: 05611

Date of Incident: 5/8/03 Incident Log No.: ME030018 (NMED 030812)

Investigation Date: 5/9/03 Type of Incident: Medical Event

Type of Investigation: Telephone, Inspection Follow Up
Maine Final Report Page E.2

Incident Casework Review

File No.: 7

Licensee: Maine Medical Center License No.: 05611

Date of Incident: 10/29/03 Incident Log No.: ME030031 (NMED 040145)

Investigation Date: 10/29/03 Type of Incident: Overexposure

Type of Investigation: Telephone, Inspection Follow Up
ATTACHMENT

December 6, 2006, E-mail from Jay Hyland

Maine’s Response to Draft IMPEP Report

ADAMS: ML063410046