August 18, 2011 

Shiela Pinette, D.O., Director 

Maine Center for Disease Control 

 and Prevention 

286 Water Street 

11 State House Station 

Augusta, ME 04333-0011 

Dear Dr. Pinette: 

On July 21, 2011, 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 (NRC) 

program. 

Section 5.0, page 11, of the enclosed final report contains a summary of the IMPEP review 

team’s findings and recommendations. 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. During the periodic meeting and at the 

next IMPEP review, NRC will evaluate the effectiveness of the Maine’s response to the review 

team’s recommendations and the overall implementation of your Agreement State Program. 

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. I look 

forward to our agencies continuing to work cooperatively in the future. 

Sincerely, 

 /RA Brian Sheron for/ 

Michael F. Weber 

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 

 Radiation Control Program 

 
August 18, 2011 

Dr. Shiela Pinette, D.O., Director 

Maine Center for Disease Control 

 and Prevention 

286 Water Street 

11 State House Station 

Augusta, ME 04333-0011 

Dear Dr. Pinette: 

On July 21, 2011, 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 (NRC) 

program. 

Section 5.0, page 11, of the enclosed final report contains a summary of the IMPEP review 

team’s findings and recommendations. 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. During the periodic meeting and at the 

next IMPEP review, NRC will evaluate the effectiveness of the Maine’s response to the review 

team’s recommendations and the overall implementation of your Agreement State Program. 

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. I look 

forward to our agencies continuing to work cooperatively in the future. 

Sincerely, 

 /RA Brian Sheron for/

Michael F. Weber 

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 

 Radiation Control Program 

DISTRIBUTION: EDATS: FSME-2011-0088 

See next page 

ADAMS Accession Number: ML112140280 

OFFICE FSME/MSSA FSME/MSSA FSME/MSSA FSME/MSSA 

NAME LDimmick DWhite MDelligatti TReis 

DATE 08/02/11 08/3/11 08/3/11 08/4/11 

OFFICE Tech Editor FSME DEDMRT 

NAME CPoland (PTressler 

for) 

CCarpenter (RLewis 

for) 

MWeber (BSheron 

for) 

DATE 08/5/11 08/5/11 08/18/11 

OFFICIAL RECORD COPY 
Letter to Dr. Sheila Pinette, D.O. from Michael F. Weber dated: August 18, 2011 

SUBJECT: MAINE FINAL IMPEP REPORT 

DISTRIBUTION: EDATS: FSME-2011-0088 

MSSA_Technical_Asst_Resource DCD (SP01) 

RidsEdoMailCenter 

RidsFsmeOd 

RidsOgcMailCenter 

RidsSecyCorrespondenceMailCenter Chairman Jaczko 

JDeCicco, FSME Commissioner Svinicki 

DJanda, RI/RSAO Commissioner Apostolakis 

DShearer, PA Commissioner Magwood 

BJones, OGC Commissioner Ostendorff 

CPederson, RIII SECY 

RGallagher, MA 

AImboden, OEDO 

TRothschild, OGC 

JBiggins, OGC 

RLewis, FSME 

MOrendi, RI/RSAO 

RLorson, RI 

DLew, RI 

JWeil, OCA (2 copies)
Enclosure 

 INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM 

 REVIEW OF THE MAINE AGREEMENT STATE PROGRAM 

 May 2 – 6, 2011 

FINAL REPORT
EXECUTIVE SUMMARY

This report presents the results of the Integrated Materials Performance Evaluation Program 

(IMPEP) review of the Maine Agreement State Program. The review was conducted during the 

period of May 2-6, 2011, by a review team composed of technical staff members from the U.S. 

Nuclear Regulatory Commission (NRC) and the Commonwealth of Pennsylvania. 

The Management Review Board (MRB) met on July 21, 2011, to consider the proposed final 

report. Based on the results of this review, the review team had recommended that Maine’s 

performance be found satisfactory for all common and non-common performance indicators 

reviewed. However, the Management Review Board (MRB) determined that Maine’s 

performance regarding the indicator Technical Quality of Staffing and Training be found 

satisfactory, but needs improvement. The review team made three recommendations regarding 

the performance of the Maine Agreement State Program. These recommendations included 

addressing staffing vacancies, performing annual inspector accompaniments, and expediting 

actions needed to complete the promulgation of their overdue regulations. 

The review team recommended, and the MRB agreed, that the Maine Agreement State 

Program be found 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 IMPEP review take place in approximately four years. 

 
Maine Final IMPEP Report Page 2 

1.0 INTRODUCTION 

Under Section 274 of the Atomic Energy Act (AEA) of 1954, as amended, the U.S. Nuclear 

Regulatory Commission (NRC) has programmatic responsibility to periodically review the 

actions of the Agreement States to comply with the requirements of the AEA to continue to 

maintain adequate and compatible programs. The current review process under the Integrated 

Materials Performance Evaluation Program (IMPEP) is conducted with State staff participation 

under the National Materials Program. 

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

review was conducted during the period of May 2 - 6, 2011, by a review team composed of 

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

Commonwealth of Pennsylvania. Team members are identified in Appendix A. The review was 

conducted in accordance with the AImplementation 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 October 14, 2006, to May 6, 2011, 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 June 2, 2011. The State 

responded by letter dated June 28, 2011 from Sheila Pinette, D.O., Director, Department of 

Health and Human Services, Maine Center for Disease Control and Prevention. Copies of the 

State’s responses are included as an Attachment to this report. The Management Review 

Board (MRB) met on July 21, 2011, 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 Radiation Control Program (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). The organization chart of the Department, Center, and Program are included in 

Appendix B. 

At the time of the review, the Maine Agreement State Program regulated 125 specific licenses 

authorizing byproduct, source, and certain special nuclear 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 March 1, 2011. The Program provided its 

response to the questionnaire on April 22, 2011. A copy of the questionnaire response may be 

found in the NRC=s Agencywide Documents Access and Management System (ADAMS) using 

the Accession Number ML111430833. 

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

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 
Maine Final IMPEP Report Page 3 

review of selected files; (5) one field accompaniment 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 a recommendation 

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 details results of the 

applicable non-common performance indicators, and Section 5.0 summarizes the review team's 

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 October 13, 2006, one recommendation 

was made by the review team regarding the Maine Agreement State Program’s performance. 

The team’s review of the current status of the recommendation is as follows: 

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) 

Current Status: The review team found that during the time period covered by this 

review, the staffing issue had been resolved, however another vacancy occurred late in 

the review period which the Program is currently addressing. The team found that the 

second part of the recommendation regarding business process development had been 

addressed as evidenced by the improvement in the status of inspections. The program 

has created and utilized a database of license activities. From this database, the 

program can track inspection frequencies, which allowed the program to improve their 

inspection efficiency. The review team made a new recommendation regarding the 

current staffing vacancy (Section 3.1) but found that the issues creating this 

recommendation have been addressed, and therefore closed this recommendation. 

For the indicator, Status of Materials Inspection Program, Maine’s 2007 IMPEP Final Report 

indicated a satisfactory, but needs improvement rating. The contributing factors leading to this 

rating included problems with maintaining and updating databases used for tracking inspection 

and licensing actions, a redeployment of staff to higher priority activities, and an extended 

absence of a staff member. Since the 2007 IMPEP, these factors have been addressed. The 

program created and utilized a new database for tracking license and inspection activities, and 

has been keeping the database up-to-date. Addressing the staffing issues, along with the new 

database tracking activities, has eliminated the backlog of inspections that previously existed. 

 
Maine Final IMPEP Report Page 4 

3.0 COMMON PERFORMANCE INDICATORS 

Five common performance indicators are used to review 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 the Program Manager and technical staff member, reviewed job 

descriptions and training records, and considered workload backlogs. 

The materials program is allocated two technical staff who report to the Program Manager. 

Currently the Program has one full-time qualified inspector/license reviewer. The second 

inspector/license reviewer left State employment in July 2010. The Program Manager posted 

the vacant position shortly after the individual left the Program. In January 2011, a State-wide 

hiring freeze went into effect before the position could be filled. The Program Manager is now 

considering cross training an individual who is currently the Low-Level Waste Coordinator who 

has completed some qualification courses in the past. 

In order to avoid backlogs in licensing and inspection activities while the hiring freeze is in 

effect, the Program Manager changed the inspection frequencies for several program codes 

that the State was inspecting at a higher frequency than that which is required by Inspection 

Manual Chapter 2800. There is currently no backlog in licensing or inspection activities. The 

ability to conduct effective licensing and inspecting programs, maintain training qualifications of 

staff, provide for normally-encountered non-availability of staff personnel, and avoid adverse 

impacts on other performance indicators, is mostly dependent on the Program having a 

sufficient number of technical staff. Based on the existing staff vacancy for one of the two 

positions in the radioactive materials program and the hiring freeze in effect, the review team is 

concerned that any additional losses in staff could severely impact the State’s performance, and 

therefore recommends that the State develop and implement a strategy to address current and 

future staffing vacancies in order to maintain the effectiveness and efficiency of the Program. 

In addition to the two positions in the radioactive materials program, the Program has a Nuclear 

Safety Inspector assigned to Maine Yankee decommissioning activities, two X-ray staff 

members, and two individuals assigned to the radon program.

The Program has a documented training plan for technical staff that is consistent with the 

requirements in the NRC/Organization of Agreement States Training Working Group Report and 

NRC’s Inspection Manual Chapter (IMC) 1246, “Formal Qualification Programs in the Nuclear 

Material Safety and Safeguards Program Area.” The Program also has on-the-job training to 

supplement course work so that individuals may broaden their work experience. All technical 

staff have at minimum Bachelor’s degrees in the sciences and the Program Manager is a 

Professional Engineer. Staff members are assigned increasingly complex duties as they 

progress through the qualification process. The review team concluded that the Program’s 

training program is adequate to carry out its regulatory duties and noted that Program 

management is supportive of staff training opportunities. 
Maine Final IMPEP Report Page 5 

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

dedicated revenue from licensee fees. The Program instituted a two-step fee increase which 

became effective in May 2010. By the end of 2012, the Program anticipates that licensee fees 

will be at 50% of NRC‘s 2009 fiscal year fees. 

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

only in an advisory role to the Program. The committee meets on an as-needed basis. 

Based on the IMPEP evaluation criteria, the review team recommended that Maine’s Program 

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

However, due to concerns about the Program’s backup plan in case additional technical staff 

left or could no longer perform their duties, the MRB determined that the performance with 

respect to this indicator, Technical Staffing and Training, be found satisfactory, but needs 

improvement.

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 database, examination of completed inspection casework, and interviews with the 

manager and staff members. 

The review team verified that the Program’s inspection frequencies for all types of radioactive 

materials licenses are at least as frequent as those listed in NRC’s IMC 2800, “Materials 

Inspection Program.” The Program did conduct inspections of some license types, such as 

medical – written directive not required, portable gauge users, and medical broad scopes, more 

frequently than prescribed by IMC 2800 up until January 1, 2011, at which point the Program 

adjusted all inspection frequencies back to those of IMC 2800. The Program indicated that this 

adjustment was based on a vacancy in a Program inspector position and a current hiring freeze. 

The review team noted that security inspections were being performed concurrently with routine 

safety inspections for applicable licensees. The review team also verified that the Program 

conducts inspections of multiple locations of use for multi-site licenses. In all instances reviewed 

by the team, the Program met or exceeded the minimum criterion of 20 percent of sites for 

licenses with five or more locations of use listed on the license. 

The Program conducted a total of 46 Priority 1, 2, and 3 (higher priority) inspections during the 

review period. The review team verified that 4 of the 46 higher priority inspections were late by 

more than 25 percent of the inspection frequency prescribed by IMC 2800. The review team 

verified that no high priority inspections were overdue at the time of the review. The review 

team also evaluated the Program’s timeliness for conducting initial inspections, and noted that 

the Program issued 16 new licenses during the review period. The Program conducted 14 initial 

inspections, of which none were conducted greater than 12 months after license issuance as 

prescribed by IMC 2800. The two remaining new licensees are scheduled for inspection in the 

remaining calendar year. Overall, the review team calculated that the Program performed 5 

percent of its Priority 1, 2, and 3 and initial inspections overdue during the review period. 

 
Maine Final IMPEP Report Page 6 

The review team evaluated the timeliness of issuance of inspection reports. Of the 15 inspection 

files reviewed, the review team identified that a majority (14 of 15 files reviewed) of the 

inspection findings were issued within the 30-day goal. 

Reciprocity activities under IMC 1220 require inspection of 20 percent of candidate licensees 

operating under reciprocity annually. The Program indicated that each reciprocity licensee is 

considered a priority 1. During the review period, the Program received requests for reciprocity 

from 37 licensees and 8 inspections were conducted. The review team determined that the 

Program met and/or exceeded NRC’s criteria. 

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

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

Program, be found satisfactory. 

3.3 Technical Quality of Inspections

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

notes, and interviewed the responsible inspector for 15 radioactive materials inspections 

conducted during the review period. Appendix C lists the inspection casework files reviewed as 

well as the results of the inspector accompaniment performed by the review team. 

The casework examined included a cross-section of inspections conducted by Program 

inspectors and covered a wide variety of inspection types: 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. The casework included initial, routine, follow-up, reciprocity, and Increased 

Controls inspections. Appendix C lists the inspection casework files reviewed. Based on the 

evaluation of casework, the review team determined that inspections covered all aspects of the 

licensees’ radiation safety and security programs. The review team noted that the inspections 

covered the Increased Controls, fingerprinting, and the National Source Tracking System when 

appropriate. 

Inspection report documentation supported violations, recommendations made to licensees, and 

unresolved safety issues. In addition to paper copies that are maintained in Augusta, pertinent 

information about each inspection is entered into the Program's electronic filing system, which is 

accessible to all staff members. The review team evaluated the Program’s handling and storing 

of sensitive documents, and determined that documents containing sensitive information were 

appropriately protected, segregated from other files (electronic and paper), and maintained in a 

manner to limit access. The review team found that outgoing correspondence was marked, as 

appropriate. 

The review team verified that supervisor accompaniments were not being performed on an 

annual basis during the review period as specified in IMC 2800. Over the review period, the 

team determined that there were 5 out of 6 missed accompaniments. The Radiation Control 

Program Manager indicated that the Program contains no written policy or procedure to have a 

supervisor accompany staff performing radioactive materials inspections on an annual basis

and that the Radiation Control Program Manager should be responsible for this duty. The 

Program’s human resources section requires an employee performance review, and that this 

requirement might be a trigger to perform the annual accompaniments. The review team 
Maine Final IMPEP Report Page 7 

recommends that annual supervisor accompaniments be performed for each radioactive 

materials staff member to ensure quality and consistency within the program. 

The review team accompanied the Program's only fully qualified inspector on April 14, 2011. 

The inspector conducted an inspection of a broad scope medical licensee, which covered a 

wide range of licensed activities including research and development, diagnostic and 

therapeutic procedures, including activities involving radioiodine therapy, permanent implant 

brachytherapy, and high dose-rate remote afterloader brachytherapy. The inspector 

accompaniment is listed in Appendix C. The inspector demonstrated performance-based 

inspection techniques and knowledge of the regulations. The inspector was well trained, 

prepared for the inspection, and thorough in his assessment of the licensee’s radiation safety 

and security program. The inspector conducted interviews with appropriate personnel, 

observed licensed operations and appropriately pursued issues noted, conducted confirmatory 

measurements, and utilized good health physics practices. The review team determined that 

the inspection was adequate to assess radiological health, safety, and security at the licensed 

facility. 

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

that Maine’s Program performance with respect to the indicator, Technical Quality of Inspection, 

be found satisfactory. 

3.4 Technical Quality of Licensing Actions

The review team interviewed a license reviewer and examined completed licensing casework 

for 16 specific licensing actions. Licensing actions were reviewed for completeness, 

consistency, proper radioisotopes and quantities, qualifications of authorized users, adequacy of 

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

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

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

letters and cover letters, reference to appropriate regulations, supporting documentation, 

consideration of enforcement history, pre-licensing visits, peer/supervisory review, and proper 

signatures. 

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

completed during the review period. Licensing actions selected for evaluation included, 4 new 

licenses, 4 renewals, 2 decommissioning or termination actions, and 6 amendments. Files 

reviewed included a cross-section of license types, including: industrial radiography, broad 

scope medical institution, fixed gauge, limited medical institution, academic broad scope, 

radiopharmacy, veterinary, high dose rate remote afterloader, research and development broad 

scope, and self-shielded irradiators. The casework sample represented work from two license 

reviewers. A listing of the licensing casework reviewed is provided in Appendix D. 

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

and of high quality with health, safety, and security issues properly addressed. License tiedown conditions were stated clearly and were supported by information contained in the file. 

Deficiency letters clearly stated regulatory positions, were used at the proper time, and identified 

substantive deficiencies in the licensees’ documents. Terminated licensing actions were well 

documented, showing appropriate transfer and survey records. License reviewers use the 

Program’s licensing guides, policies, checklists, and standard license conditions specific to the 

type of licensing actions to ensure consistency in licenses. The licensee’s compliance history 
Maine Final IMPEP Report Page 8 

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

Licenses are issued for a five-year period under a timely renewal system. Licenses are signed 

by qualified license reviewers, which could include the Program Manager. The status of all 

licensing actions is tracked on a database which is updated on a routine basis. 

The Program’s pre-licensing review methods incorporate the essential elements of NRC’s 

revised pre-licensing guidance to verify that the applicant will use requested radioactive 

materials as intended. The Program hand delivers all new licenses as part of their pre-licensing 

review. These site visits include an evaluation of the applicant’s radiation safety and security 

programs prior to receipt of the initial license. 

The review team examined the Program’s licensing practices regarding the Increased Controls 

and Fingerprinting Orders. The review team noted that the State uses legally binding license 

conditions that meet the criteria for implementing the Increased Controls Orders, including 

fingerprinting, as appropriate. The review team analyzed the Program’s methodology for 

identifying those licenses and found the rationale was thorough and accurate. The review team 

confirmed that license reviewers evaluated new license applications and license amendments 

using the same criteria. The Program requires full implementation of the Increased Controls 

prior to issuance of a new license or license amendment that meets the established criteria. 

The review team determined that documents containing sensitive security-related information 

were appropriately controlled and maintained in a manner to limit access.

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

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

Actions, be found 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 ten radioactive materials incidents. A listing of the incident casework examined is included in 

Appendix E. The review team also evaluated the Program=s response to allegations involving 

radioactive materials. 

When notified of an incident, the radioactive material 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 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 Program responded to a total of 71 incidents involving radioactive 

materials during the review period. Fifty-seven of the events involved trash alarms. A total of 

ten incidents were entered into NMED. Nine of the incidents required reporting to the NRC. 

Monthly reports and follow-up 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 ten incidents reviewed included a leaking gauge source, a medical 

event, a fire near a nuclear gauge, lost or missing tritium exit signs, and a transportation 

incident. 
Maine Final IMPEP Report Page 9 

The review team noted that the Program=s response to incidents was commensurate with the 

health and safety significance of the event. Inspectors were dispatched to the site of the 

incident or for investigations when appropriate. Incident reports were thorough, welldocumented and timely. 

During the review period, the Program received two allegations. Only one allegation involved 

potential byproduct and source material. An evaluation indicated that thorough and appropriate 

action was taken in response to the concern raised. The allegation was well documented, 

promptly reviewed, and appropriately closed with the alleger. The Program also addressed 

another allegation that was received by another Maine State department; the allegation did not 

fall under NRC jurisdiction, but the Program took actions similar to the allegation that was 

reviewed. There were no performance issues identified from the review of the allegation 

casework. 

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

that Maine=s Program performance with respect to the indicator, Technical Quality of Incident 

and Allegation Activities, be found satisfactory. 

4.0 NON-COMMON PERFORMANCE INDICATORS 

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

State Programs: (1) 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 as it applies to the 

Program, and found that the process takes approximately four months after filing a 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 of a 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 
Maine Final IMPEP Report Page 10 

and registrants for comment. The Secretary of State announces a public meeting/hearing 

period for the proposed revision to a rule. Comments are considered and incorporated, as 

appropriate, before a rule is finalized. After responding to comments, the Program forwards the 

proposed revision to a 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 rule. The State can adopt other agency=s rules and regulations by reference, but 

NRC regulations are not incorporated in this manner. The Program 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 

NRC’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. 

During the review period, 13 NRC amendments were addressed and adopted in two rule 

packages that were issued in November 2009 and May 2010. At the time of the review, there 

were no overdue NRC amendments. However, it was noted that the final published rules 

submitted for NRC review in March 2010 generated 22 NRC comments. These NRC comments 

list minor issues and editorial corrections from nine amendments that need to be addressed to 

have the Maine State regulations completely meet the established compatibility and health and 

safety categories. There is also one outstanding comment that resulted from the State’s 

implementation of the NRC amendment for addressing certain generally licensed industrial 

devices (RATS ID: 2001-1). The review team recommends that the State expedite action to 

address the comments identified in NRC letters dated August 31, 2006, and June 18, 2010, to 

promulgate and complete changes to the State regulations. 

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

legally binding requirements no later than 3 years after the effective date of NRC’s regulations. 

At the time of the review, Maine had no overdue regulations and had completed all outstanding 

regulation changes through the last NRC final rulemaking which was issued in 2009. 

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

that Maine=s Program performance with respect to the indicator, Compatibility Requirements, be 

found satisfactory. 

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

During the 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. Accordingly, the team did not review this 

indicator. 

 
Maine Final IMPEP Report Page 11 

5.0 SUMMARY 

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

improvement, for the indicator, Technical Staffing and Training, and satisfactory for the 

remaining performance indicators reviewed. The review team made three recommendations 

regarding the Maine Agreement State program. Overall, the review team recommended, and 

the MRB agreed, that the Maine Agreement State Program be found 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 are the recommendations, as mentioned in the report, for evaluation and implementation, 

as appropriate, by the State: 

1. The review team recommends that the State develop and implement a strategy to 

address current and future staffing vacancies in order to maintain the effectiveness and 

efficiency of the Program. (Section 3.1) 

2. The review team recommends that annual supervisor accompaniments be performed for 

each radioactive materials staff member to ensure quality and consistency within the 

program. (Section 3.3) 

3. The review team recommends that the State expedite action to address the comments 

identified in NRC letters dated August 31, 2006, and June 18, 2010, to promulgate and 

complete changes to the State regulations. 

(Section 4.1)
LIST OF APPENDIXES AND ATTACHMENT 

Appendix A IMPEP Review Team Members 

Appendix B Maine Organization Chart 

Appendix C Inspection Casework Reviews 

Appendix D License Casework Reviews 

Appendix E Incident Casework Reviews 
APPENDIX A 

IMPEP REVIEW TEAM MEMBERS 

Name Area of Responsibility

Joseph DeCicco, FSME Team Leader 

 Technical Quality of Incidents and Allegations 

 Activities 

 Compatibility Requirements 

Donna Janda, RI Technical Staffing and Training 

 Technical Quality of Licensing Actions 

 Inspector Accompaniment 

Dwight Shearer, Pennsylvania Status of Materials Inspection Program 

 Technical Quality of Inspections 
APPENDIX B 

MAINE ORGANIZATION CHART 

ADAMS Accession No:. ML111470677 
APPENDIX C 

INSPECTION CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT ARE INCLUDED FOR COMPLETENESS 

ONLY 

File No.: 1 License No.: 05611 

Licensee: Maine Medical Center Priority: 2 

Inspection Type: Routine Unannounced Inspector: WM 

Inspection Date: 4/14/11 

 

File No.: 2 License No.: 05139 

Licensee: Quality Assurance Labs Priority: 1 

Inspection Type: Routine, Unannounced Inspector: WM 

Inspection Date: 4/12/10 

Comment: The licensee was not notified of the inspection findings, on either a Maine form 

HHE-891 or form letter. 

File No.: 3 License No.: 11921 

Licensee: Inland Hospital Priority: 3 

Inspection Type: Routine, Unannounced Inspector: SS 

Inspection Date: 9/24/08 

Comment: Corrective action from the licensee could not be located. 

File No.: 4 License No.: 13701 

Licensee: Penobscot Bay Medical Priority: 3 

Inspection Type: Routine, Unannounced Inspectors: WM 

Inspection Date: 4/22/10 

File No.: 5 License No.: 25707 

Licensee: Redington Fairview Hospital Priority: 3 

Inspection Type: Routine, Unannounced Inspectors: SS 

Inspection Date: 6/30/08 

File No.: 6 License No.: 13207 

Licensee: Camden Hospital for Animals Priority: 5 

Inspection Type: Initial, Announced Inspector: SS 

Inspection Date: 10/29/07 

File No.: 7 License No.: 19233 

Licensee: Cardinal Health Priority: 3 

Inspection Type: Initial, Announced Inspector: SS 

Inspection Date: 12/8/09 
Maine Final IMPEP Report Page C.2 

File No.: 8 License No.: 42-32219 

Licensee: TEAM Industrial Services Priority: 1 

Inspection Type: Reciprocity, Unannounced Inspector: SS 

Inspection Date: 4/19/07 

File No.: 9 License No.: 133-2008-01 

Licensee: ACCUREN Inspection Priority: 1 

Inspection Type: Reciprocity, Unannounced Inspector: SS 

Inspection Date: 6/2/10 

File No.: 10 License No.: 23209 

Licensee: Bath Iron Works Priority: 1 

Inspection Type: Routine, Unannounced Inspector: SS 

Inspection Date: 6/4/10 

File No.: 11 License No.: 05739 

Licensee: Portland Cardiology Priority: 5 

Inspection Type: Routine, Unannounced Inspector: WM 

Inspection Date: 4/9/10 

File No.: 12 License No.: 19501 

Licensee: Lane Construction Priority: 5 

Inspection Type: Routine, Unannounced Inspector: SS 

Inspection Date: 3/1/07 

Comment: The licensee was notified of the inspection findings outside of 30 days. 

File No.: 13 License No.: 01709 

Licensee: St. Mary’s Regional Medical Center Priority: 3 

Inspection Type: Routine, Unannounced Inspector: WM 

Inspection Date: 3/10/11 

File No.: 14 License No.: 19301 

Licensee: Eastern Maine Medical Priority: 2 

Inspection Type: Routine, Unannounced Inspector: WM 

Inspection Date: 8/12/10 

File No.: 15 License No.: 09623 

Licensee: Mt Desert Island Biological Lab Priority: 5 

Inspection Type: Routine, Unannounced Inspector: WM 

Inspection Date: 2/16/11 

INSPECTOR ACCOMPANIMENT 

The following inspector accompaniment was performed prior to the on-site IMPEP review: 

Licensee: Maine Medical Center License No.: 05611 

Inspection Type: Routine, Unannounced Priority: 2 

Inspection Date: 4/14/11 Inspector: WM
APPENDIX D 

LICENSE CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS 

ONLY. 

File No.: 1 

Licensee: Camden Hospital for Animals License No.: 13207 

Type of Action: New Amendment No.: 0 

Date Issued: 3/7/07 License Reviewer: SS 

File No.: 2 

Licensee: SAPPI dba S.D. Warren Co. License No: 05751 

Type of Action: Renewal Amendment No.: 8 

Date Issued: 3/11/09 License Reviewer: SS 

File No.: 3 

Licensee: Maine Medical Center License No.: 05611 

Type of Action: Amendment Amendment No.: 19 

Date Issued: 3/4/11 License Reviewer: WM 

File No.: 4 

Licensee: Libertytown USA2, Inc. 

 dba Quality Assurance Laboratories License No.: 05139 

Type of Action: Amendment Amendment No.: 14 

Date Issued: 12/6/10 License Reviewer: WM 

Comment: The file did not contain documentation of licensee’s request for amendment to 

license for the change in ownership. 

File No.: 5 

Licensee: Rumford Hospital License No.: 17705 

Type of Action: Termination Amendment No.: 10 

Date Issued: 4/8/08 License Reviewer: SS 

File No.: 6 

Licensee: Central Maine Medical Center License No.: 01207 

Type of Action: Amendment Amendment No.: 13 

Date Issued: 1/11/11 License Reviewer: WM 

File No.: 7 

Licensee: Bath Iron Works License No.: 23209 

Type of Action: Renewal Amendment No.: 8 

Date Issued: 2/25/09 License Reviewers: SS, WM 
Maine Final IMPEP Report Page D.2 

File No.: 8 

Licensee: Cardinal Health, Nuclear Pharmacy Services License No.: 19233-01MD 

Type of Action: New Amendment No.: 0 

Date Issued: 4/9/09 License Reviewer: WM 

File No.: 9 

Licensee: Redington Fairview General Hospital License No.: 25707 

Type of Action: Renewal Amendment No.: 11 

Date Issued: 3/12/09 License Reviewer: SS 

File No.: 10 

Licensee: Maine Medical Partners Endocrinology & Diabetes Center License No.: 05643 

Type of Action: Termination Amendment No.: 6 

Date Issued: 4/1/11 License Reviewer: WM 

File No.: 11 

Licensee: SAPPI Fine Paper Technology Center License No.: 05747 

Types of Action: New Amendment No.: 0 

Date Issued: 7/29/09 License Reviewer: SS 

Comments: 

a) Standard license condition regarding testing of on/off mechanism was not included on 

the license. 

b) Tie down license condition does not include licensee’s letter dated 6/24/2009 regarding 

procedures used to prevent unauthorized access. 

File No.: 12 

Licensee: Maine General Medical Center License No.: 11623 

Types of Action: Amendment Amendment No.: 21 

Date Issued: 2/27/07 License Reviewer: SS 

File No.: 13 

Licensee: mb-Microtec (USA) Inc. License No.: 05331 

Type of Action: New Amendment No.: 0 

Date Issued: 8/26/10 License Reviewer: WM 

File No.: 14 

Licensee: Maine Cardiology Associates License No.: 05627 

Type of Action: Amendment Amendment No.: 18 

Date Issued: 6/5/08 License Reviewer: SS 

File No.: 15 

Licensee: The Jackson Laboratory License No.: 09507-01 

Type of Action: Amendment Amendment No.: 10 

Date Issued: 8/17/10 License Reviewer: WM 

 
Maine Final IMPEP Report Page D.2 

File No.: 16 

Licensee: University of Maine Safety & Environmental 

 Management License No.: 19827-01 

Type of Action: Renewal Amendment No.: 9 

Date Issued: 6/17/10 License Reviewer: WM
APPENDIX E 

INCIDENT CASEWORK REVIEWS 

NOTE: CASEWORK LISTED WITHOUT COMMENT ARE INCLUDED FOR COMPLETENESS 

ONLY 

File No.: 1 License No.: General 

Licensee: City of Presque Isle Incident Log No: ME070001 (NMED 070016) 

Date of Incident: 8/1/06 Type of Incident: Lost material (H-3 exit sign) 

Investigation Date: N/A Type of Investigation: None 

File No.: 2 License No.: ME25709 

Licensee: Sappi SD Warren Incident Log No: ME07002 (NMED 070095) 

Date of Incident: 1/30/07 Type of Incident: Leaking source 

Investigation Date: 1/31/07 Type of Investigation: Phone 

File No.: 3 License No.: ME03803-02 

Licensee: Aroostook Medical Center Incident Log No: ME07016 (NMED 070276) 

Date of Incident: 1/16/07 Type of Incident: Medical event 

Investigation Date: 5/24/07 Type of Investigation: On site 

File No.: 4 License No.: ME19401 

Licensee: Katahdin Paper Company Incident Log No: ME07028 (NMED 070693) 

Date of Incident: 8/3/07 Type of Incident: Equipment external fire 

Investigation Date: N/A Type of Investigation: None 

File No.: 5 License No.: General 

Licensee: Regal Cinema Incident Log No: ME080012 (NMED 080179) 

Date of Incident: 12/15/07 Type of Incident: Lost material (H-3 exit sign) 

Investigation Date: 3/11/08 Type of Investigation: On site 

File No.: 6 License No.: ME05139 

Licensee: Quality Assurance Laboratories Incident Log No: ME080006 (NMED 08216) 

Date of Incident: 2/14/08 Type of Incident: Transportation 

Investigation Date: 2/14/08 Type of Investigation: On site 

File No.: 7 License No.: General 

Licensee: Wal-Mart Incident Log No: ME090004 (NMED 090063) 

Date of Incident: 1/9/09 Type of Incident: Lost material (H-3 exit sign) 

Investigation Date: N/A Type of Investigation: None 

File No.: 8 License No.: General 

Licensee: Wal-Mart Incident Log No: ME090001 (NMED 090064) 

Date of Incident: 5/1/07 Type of Incident: Lost material (H-3 exit sign) 

Investigation Date: N/A Type of Investigation: None 
Maine Final IMPEP Report Page E.2 

File No.: 9 License No.: General 

Licensee: Wal-Mart Incident Log No: ME090002 (NMED 090065) 

Date of Incident: 5/1/08 Type of Incident: Lost material (H-3 exit sign) 

Investigation Date: N/A Type of Investigation: None 

File No.: 10 License No.: General 

Licensee: Wal-Mart Incident Log No: ME090003 (NMED 090066) 

Date of Incident: 8/7/08 Type of Incident: Lost material (H-3 exit sign) 

Investigation Date: N/A Type of Investigation: None 
ATTACHMENT 

June 28, 2011 Letter from Dr. Sheila Pinette 

Maine’s Response to the Draft Report 

ADAMS Accession No.: ML111810910