August 31, 2006

Ms. Suzanne K. Condon

Associate Commissioner

Center for Environmental Health

Department of Public Health

250 Washington Street, 7th Floor

Boston, MA 02108

Dear Ms. Condon:

On August 14, 2006, the Management Review Board (MRB) met to consider the proposed final

Integrated Materials Performance Evaluation Program (IMPEP) report on the Massachusetts

Agreement State Program. The MRB found the Massachusetts program adequate to protect

public health and safety and compatible with the U.S. Nuclear Regulatory Commission’s (NRC)

program.

Although the MRB found the Massachusetts program adequate to protect public health and

safety and compatible with NRC’s program, the review team recommended and the MRB

agreed that Massachusetts’ performance did not meet the full performance level for two of the

performance indicators reviewed. The Massachusetts program was found “satisfactory, but

needs improvement” for the indicators, Technical Quality of Incident and Allegation Activities

and Compatibility Requirements.

The MRB’s decision to find the Massachusetts program “satisfactory, but needs improvement”

for the indicator, Technical Quality of Incident and Allegation Activities, was driven by the

program’s performance in reporting events to the NRC and the Nuclear Material Events

Database in a timely manner. The reporting of events to the NRC in a timely manner is crucial

to the nationwide protection of public health and safety and is a matter of compatibility with the

NRC’s program for the Agreement States. The NRC analyzes all reported events for potential

generic issues and trends. If the NRC determines that a generic issue exists, the NRC will

distribute notices to the Agreement States and affected NRC licenses to prevent similar

occurrences at other facilities. The NRC depends on Agreement States to report events in a

timely manner to ensure dispatch of generic issue notifications in an effective manner.

The finding of “satisfactory, but needs improvement” for the indicator, Compatibility

Requirements, was primarily based on the Commonwealth’s performance in adopting

compatible regulations for the use of radioactive material in a timely manner. In accordance

with the Commission’s Policy Statement on the Adequacy and Compatibility of Agreement State

Programs, Agreement States are required to adopt regulations compatible with those of the 
S. K. Condon -2-

NRC within three years from the effective dates of the NRC’s regulations. The IMPEP team

found that the Commonwealth adopted several regulations, and that some of those overdue

had been identified during a 2002 IMPEP review. Although the Commonwealth recently

adopted a rulemaking package that addresses all overdue NRC amendments, the

Commonwealth did not adopt these amendments within the three-year timeframe. Based on

the Commonwealth’s performance, the MRB decided the finding of “satisfactory, but needs

improvement” was warranted. 

During the IMPEP review, the review team determined that there was a reduction of

approximately 30 percent in Radiation Control Program staff assigned to Agreement State

program functions since the 2002 IMPEP review and that staff shortages contributed to a

backlog of licensing actions. Although no safety significant impacts were noted due to staffing

shortages, during the last 10 years, the NRC has noted during IMPEP reviews that such

reductions in program resources, both funding and staffing, can contribute to declines in

program performance in Agreement States. The MRB believes that adequate funding and

support is essential to the maintenance of a healthy program, which can ensure that staffing

levels are appropriate to guarantee proper protection of public health and safety. With the

increased focus on the safety and security of radioactive material, adequate program resources

have become much more critical. Any further reduction in staff may be detrimental to the

Commonwealth’s Radiation Control Program.

At this time, the NRC is not questioning the Commonwealth’s ability to adequately protect public

health and safety. As noted earlier, the MRB found the Massachusetts Agreement State

Program to be adequate to protect public health and safety and compatible with NRC’s

program. However, if the existing issues mentioned above continue to go unresolved or the

status of the program declines, additional action on the part of the NRC may be necessary to

ensure continued protection of public health and safety. Additional actions can include placing

the Commonwealth on Heightened Oversight, placing the Commonwealth on Probation, or

temporarily suspending the Agreement until the NRC believes that the Commonwealth can

adequately protect public health and safety.

Section 5.0, page 18, of the enclosed final report contains a summary of the IMPEP team’s

findings and recommendations for the Commonwealth. 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 Massachusetts Agreement State

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

scheduled for May 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. I look

forward to our agencies continuing to work cooperatively in the future.
S. K. Condon -3-

If you have any questions regarding this correspondence, please contact Janet R. Schlueter,

Director, Office of State and Tribal Programs, at (301) 415-3340.

Sincerely,

/RA/

Martin J. Virgilio

Deputy Executive Director for Materials, Research, 

 State and Compliance Programs

Office of the Executive Director for Operations

Enclosure:

As stated

cc w/ encl: Robert Walker, Director

Radiation Control Program

Massachusetts Department 

 of Public Health

Christine McCombs, Director

Massachusetts Emergency

 Management Agency

State Liaison Officer

Steve Collins, Illinois

Organization of Agreement 

 States Liaison to the MRB
S. K. Condon - 3 -

If you have any questions regarding this correspondence, please contact Janet R. Schlueter,

Director, Office of State and Tribal Programs, at (301) 415-3340.

Sincerely,

/RA/

Martin J. Virgilio

Deputy Executive Director for Materials, Research, 

 State and Compliance Programs

Office of the Executive Director for Operations

Enclosure:

As stated

cc w/ encl: Robert Walker, Director

Radiation Control Program

Massachusetts Department 

 of Public Health

Christine McCombs, Director

Massachusetts Emergency

 Management Agency

State Liaison Officer

Steve Collins, Illinois

Organization of Agreement 

 States Liaison to the MRB

Distribution DCD (SP01)

DIR RF

KHsueh, STP SUNSI Review Complete

SSmith, STP : Publicly Available G Non-Publicly Available

JJankovich, NMSS : Non-Sensitive G Sensitive

SMinnick, RI

SSeeley, ME

AJones, STP, ASPO KCyr, OGC Chairman Klein

RStruckmeyer, NMSS/IMNS STreby, OGC Commissioner McGaffigan

CMiller, NMSS/IMNS FCameron, OGC Commissioner Merrifield

JStrosnider, NMSS TCombs, OCA (2 copies) Commissioner Jaczko

AKock, OEDO Commissioner Lyons

DOCUMENT NAME: E:\Filenet\ML062360274.wpd

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

copy

OFFICE STP STP:DD STP:D DEDMRS

NAME ATMcCraw:kk DKRathbun

(DMSollenberger for)

JRSchlueter

(KNSchneider for)

MJVirgilio

DATE 8/23/06 8/24/06 8/24/06 8/ 31 /06

ML062360259 Pkg. OFFICIAL RECORD COPY
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM

REVIEW OF MASSACHUSETTS AGREEMENT STATE PROGRAM

May 15-19, 2006

FINAL REPORT

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

1.0 INTRODUCTION

This report presents the results of the review of the Massachusetts Agreement State Program. 

The review was conducted during the period of May 15-19, 2006, by a review team comprised

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

State of Maine. Team members are identified in Appendix A. The review was conducted in

accordance with the "Implementation of the Integrated Materials Performance Evaluation

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

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

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

review, which covered the period of June 29, 2002 to May 19, 2006, were discussed with

Massachusetts management on the last day of the review.

A draft of this report was issued to Massachusetts for factual comment on June 20, 2006. The

Commonwealth responded by letter on July 21, 2006, from Robert Walker, Director, Radiation

Control Program (the Program). The Management Review Board (MRB) met on August 14,

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

State Program adequate to protect public health and safety, and compatible with NRC's

program.

The Massachusetts Agreement State Program is administered by the Program, which is located

within the Center for Environmental Health (the Center). The Center is located within the

Department of Public Health (the Department). Organization charts for the Department, the

Center and the Program are included in Appendix B. At the time of the review, the

Massachusetts Agreement State Program regulated approximately 516 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 Commonwealth of Massachusetts.

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

performance indicators was sent to the Program on January 26, 2006. The Program provided a

response to the questionnaire on April 28, 2006. A copy of the questionnaire response can be

found in NRC’s Agencywide Document Access and Management System (ADAMS) using the

Accession Number ML061230678.

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

Massachusetts’ response to the questionnaire; (2) review of applicable Massachusetts’ statutes

and regulations; (3) analysis of quantitative information from the Program’s licensing and

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

accompaniments of three Program inspectors; and, (6) interviews with staff and management to

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

against the IMPEP performance criteria for each common and applicable non-common

performance indicator and made a preliminary assessment of the Massachusetts Agreement

State Program’s performance.

Section 2 below discusses Massachusetts’ actions in response to recommendations made

following the previous routine and follow-up IMPEP reviews. Results of the current review for

the IMPEP common performance indicators are presented in Section 3. Section 4 discusses

results of the applicable non-common performance indicators, and Section 5 summarizes the
Massachusetts Final Report Page 2

review team's findings and recommendations. Recommendations made by the review team are

comments that relate directly to performance by the Commonwealth. A response is requested

from the Commonwealth to all recommendations in the final report. 

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS

During the previous IMPEP review, which concluded on June 28, 2002, four recommendations

were made and transmitted to Dr. Howard K. Koh, Commissioner of the Department on

September 19, 2002. The review team’s evaluation of the current status of the

recommendations is as follows:

1. The review team recommends that the Commonwealth take necessary steps to ensure

that all reportable events are submitted and updated to NRC in accordance with STP

Procedure SA-300. (Section 3.5 of the 2002 IMPEP report)

Current Status: Although the review team found that there has been some progress

made in reporting recent events to the NRC in accordance with STP Procedure SA-300,

there were a large number of older events which had not been properly reported as

required. Further details are discussed in Section 3.5. This recommendation remains

open.

2. The review team recommends that the Commonwealth adopt regulations necessary for

compatibility within the required three year time frame and submit alternate forms of

legally binding requirements for NRC review following the guidance in SA-201. (Section

4.1.2 of the 2002 IMPEP report)

Current Status: The review team found that the Commonwealth has 16 overdue

regulations that have not been adopted during the on-site review. The Commonwealth

used license conditions as alternate legally-binding requirements to address three of the

overdue regulations and one NRC Order. The Program submitted the license condition

addressing the NRC Order to the NRC for a compatibility review. The other three

license conditions will be replaced by regulations in an upcoming rulemaking package. 

Further details are discussed in Section 4.1.2. The recommendation remains open.

3. The team recommends that in the interest of national consistency, and where practical,

the Program closely follow the format for documenting product evaluations in SS&D

registry certificates as detailed in NUREG 1556, Vol. 3. (Section 4.2.1 of the 2002

IMPEP report)

Current Status: The review team found that the registration certificates issued by the

program during the review period follow the format of the guidance document. This

recommendation is closed.

4. The review team recommends that the Program make corrections to registration

certificates MA-1142-D-102-G and MA-0116-102-B. (Section 4.2.1 of the 2002 IMPEP

report)

Current Status: The review team found that the corrections have been made to

registration certificate MA-1142-D-102-G. Therefore, this part of the previous
Massachusetts Final Report Page 3

recommendation is closed. However, regarding registration certificate MA-0116-D-102-

B, the Program has identified additional issues for the vendor, Eurotherm, presently

called EGS Gauging Systems, that also needed corrections. The Program sent

deficiency letters dated January 9, 2003, and June 26, 2003, to the licensee. At the

time of the current review, the Program has not received a response to the deficiency

letters and, consequently, was not able to make the corrections to the registration

certificate. Therefore, the second part of this recommendation remains open.

3.0 COMMON PERFORMANCE INDICATORS

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

Regional and Agreement State programs. These indicators 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, reviewed job descriptions and training

records, and considered any possible workload backlogs.

The Program, headed by the Program Director, has a total of 18.4 full time equivalents (FTE)

assigned to implement the Agreement State program. The Program consists of six units: the

Radioactive Materials Unit, the Environmental Unit, the Mammography and Healing Arts Unit,

the Low Level Radioactive Waste (LLRW) Unit, the Administration Unit and the

Planning/Monitoring Unit. The technical staff in the Radioactive Materials Unit are classified as

Environmental Engineers and perform both inspection and licensing functions of radioactive

materials. A subset of the technical staff also conduct SS&D evaluations, which is further

discussed in Section 4.2.1 of this report. As a result of the Legislature abolishing the LLRW

Facility Siting Board (the Board) in February 2002, the Program gained the Board’s

responsibilities, particularly for conducting an annual survey of LLRW generated by

Commonwealth licensees. An additional FTE was gained by the Program to fulfill its new

LLRW responsibilities.

The Radioactive Materials Unit (the Unit) is managed by the Radioactive Materials Supervisor

and is divided into the basic functions of inspection and licensing. The Unit also has an

Inspection Supervisor and a Licensing Supervisor to assist the Radioactive Materials Supervisor

in managing the Unit. The review team noted that the Program’s policy of requiring staff to be

qualified to perform both licensing and inspection functions provides the ability to shift

resources to meet program demands.

The review team noted that the Program’s funding was obtained through the retained revenue

program. The Program’s licensees are assessed annual fees based on the licensed activity

category and amendment fees. The Program retains revenue up to the total estimated

expenses of operating the Program. Excess revenue is deposited in the Commonwealth’s

general fund.
Massachusetts Final Report Page 4

Six staff members left the Program and two staff members were hired during the review period.

At the time of the review, the Program had three vacancies. One vacated each in 2001, 2002

and 2005. The positions vacated in 2001 and 2002 were not filled due to lack of funding for the

positions since the Program had been flat funded for about five years since 2000. Beginning

July 1, 2005, the Program budget cap was increased and two vacant position could be filled. 

However, one of the positions had to be rescinded due to unforseen financial obligations to pay

for cost of living increases for the rest of the Program staff.

The Program has been in the process of filling the one vacant position since July 2005. The

position was offered to several individuals after interviews with potential candidates but they all

declined mainly due to the fact that the pay was not competitive to attract qualified individuals

who may have other employment opportunities working in the nearby nuclear industry and the

high cost of living in the Boston area. The Program management indicated that if the Program

budget continues to be capped at the current level in the future, they may not have the funding

to support the vacancy position due to potential financial obligations to pay for cost of living

increases for the rest of the Program staff.

The review team determined that there was a reduction of approximately 30 percent in FTE for

staff members assigned to conduct inspections, license reviews and SS&D reviews since the

last IMPEP review (11.75 in 2002 versus 7.4 at the time of the on-site review). This represents

a significant reduction of staff members working in those areas.

To overcome the staff shortage, the Program adopted most of the NRC’s inspection priorities

found in Inspection Manual Chapter (MC) 2800, which allowed the Program to reduce a

significant number of inspections yet still maintain an adequate inspection program. The

Inspection Supervisor indicated that the Program has benefitted by adopting the inspection

priorities MC 2800 and is willing to share their success experience with other Agreement States. 

The review team noted that the staffing shortages have contributed to the cause of licensing

backlog discussed in Section 3.4.

The review team concluded that the Program will continue to face the challenge of staffing

shortages due to the fact that in addition to routine licensing, inspection and response to

incidents and allegations activities, there are greater demands for Program staff resources to

deal with the increased concerns for safety and security of radioactive material. Without

increasing funding to support the demands for Program staff resources, the Program is

vulnerable to further losses of Program staff positions or may not have sufficient staff resources

to meet increasing workload demand which could adversely affect performance. Program

management acknowledged the need to promptly fill the current vacancies, as well as address

future staffing needs. The review team recommends that the Commonwealth pursue adequate

funding to support and implement the staffing plan which is needed to meet current program

demands as well as the projected increase in workload.

The Program has a documented training and qualification program that is consistent with the

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

the NRC’s MC 1246. Each staff member must document formal training, including basic,

specialized, and advanced training, on a Training Qualification record. The Program also has

on-the-job training to supplement the course work so that individuals may broaden their work

areas. As a part of the Program’s in-house and on-the-job training processes, new staff

members are assigned increasingly complex licensing duties under the direction of the
Massachusetts Final Report Page 5

Licensing Supervisor and accompany experienced inspectors during increasingly complicated

inspections under the direction of the Inspection Supervisor. The review team found that the

Program staff is well qualified from an education and experience stand point. All technical staff

members have at least Bachelor’s degrees in the sciences, or equivalent training and

experience.

The staff training records demonstrated that the Program is committed to a high degree of

training for the staff. Program management indicated that upper-level management has been

very supportive of staff training opportunities.

The Commonwealth does not have an oversight board or committee to provide direction to the

Agreement State program.

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

that Massachusetts’ 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 in reviewing this indicator: inspection frequency,

overdue inspections of Priority 1, 2, and 3 licensees, initial inspection of new licenses, timely

dispatch of inspection findings to licensees, and the performance of reciprocity inspections. 

The review team’s evaluation is based on the Program’s questionnaire response relative to this

indicator, data gathered from the Program’s licensing and inspection database, the examination

of completed inspection casework, and interviews with managers and staff.

The review team's evaluation of the Program's inspection priorities verified that the inspection

frequencies for all types of licenses, with the exception of two license types, are equal to those

listed in MC 2800. Very large, multi-site Medical Institution Broad Scope licenses are inspected

annually whereas MC 2800 allows a two year periodicity. Those licensees listed as Priority T

(telephone inspections) in MC 2800 are listed as Priority 5 on the Program’s schedule.

At the time of the review, there were no overdue core inspections, including initial inspections. 

The review team examined the Program’s tracking information for a total of 277 inspections,

which included 97 initial inspections. Four core inspections, in addition to four initial

inspections, were conducted overdue during the review period. The overdue inspections

ranged from a few days to 12 months overdue at the time of inspection.

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

inspection casework. The Program has an effective and efficient process which ensures that

inspection findings are communicated to licensees in a timely manner. The Program’s goal is

to complete each inspection report and deliver the notice of violation, as appropriate, to the

licensee within 30 days of the inspection’s completion date. For 10 routine inspection files

examined, all inspection findings were sent to the licensees within 30 days, with the exception

of two, which were awaiting final supervisory signature.

During the review period, the Program granted 166 reciprocity certificates, of which, 40

certificates were candidate licensees based upon MC 1220. The review team determined that

the Program met and exceeded NRC’s criteria of inspecting 20 percent of candidate licensees
Massachusetts Final Report Page 6

operating under reciprocity for the review period. The Program attempts to conduct

unannounced reciprocity inspections. However, the Program has found that often the

reciprocity licensees have already completed the job when the inspector arrives at the job site.

The review team determined that with respect to Commission Staff Requirements

Memorandum (SRM) for COMSECY-05-0028, on increased controls, the Program has started

to plan for the initial set of inspections of these licensees in accordance with the increased

controls requirements.

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

that Massachusetts' performance with respect to the indicator, Status of Materials Inspection

Program, was satisfactory.

3.3 Technical Quality of Inspections

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

field notes and interviewed inspectors for 11 radioactive materials inspections conducted during

the review period. The casework included all of the Program’s fully trained materials

inspectors, and covered a variety of license types as follows: manufacturing and distribution

broad scope, manufacturing and distribution other, medical institution written directive required,

research and development, industrial radiography, medical broad scope, academic broad

scope, nuclear pharmacy, medical product distribution, brachytherapy, and limited medical. 

Appendix C lists the inspection casework reviewed, with case-specific comments, as well as the

results of the inspector accompaniments.

The review team noted that the Program currently has seven experienced materials inspectors

and one Inspection Supervisor. Based on the casework file reviews, the review team found that

routine inspections covered all aspects of the licensee’s radiation protection program. The

inspection reports were thorough, complete, consistent, and of high quality, with sufficient

documentation to ensure that licensee’s performance with respect to health and safety was

acceptable. The documentation adequately supported violations, recommendations made to

the licensee, unresolved safety issues, and discussions held with the licensee during exit

interviews. Team inspections were performed when appropriate and for training purposes.

Inspection reports include a written summary of the scope of the licensed activities and

categorize violations into severity levels which can be used for escalated enforcement, if

necessary. Field notes or inspection reports used to document the inspection reflected a

performance-based, risk-informed approach. The Inspection Supervisor conducts and

documents supervisory accompaniments of each material inspector once a year.

The Program has adequate numbers and appropriate types of survey meters to support the

current inspection program, as well as for responding to incidents and emergency conditions. 

Each inspector is assigned an instrument kit to be used for inspections and response to

incidents. The Program has an outside contractor to calibrate their survey instruments

annually. Appropriate, calibrated survey instruments such as Geiger-Mueller (GM) meters,

scintillation detectors, ion chambers and micro-R meters were observed by the review team. 

Contamination wipes and other environmental samples are evaluated at the Program’s

laboratory located in Jamaica Plains. Instrumentation available at the laboratory includes gas
Massachusetts Final Report Page 7

flow proportional counter, liquid scintillation counter, thermoluminescence dosimeter reader,

and high purity germanium detectors with supporting electronics and software.

Three inspectors were accompanied by a review team member during the week of April 3,

2006. The accompaniments included inspections of facilities that were licensed for research

and development, medical institution with brachytherapy, and a nuclear cardiology clinic. The

facilities inspected are identified in Appendix C. During the accompaniments, each inspector

demonstrated appropriate performance-based, and risk informed inspection techniques,

adhered to good health physics practices and exhibited knowledge of the regulations. The

inspectors were well prepared for the inspection, and thorough in their audits of the licensees’

radiation safety programs. Their inspections were adequate to assess radiological health and

safety at the licensed facilities.

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

that Massachusetts’ 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 the staff for 15

specific licenses. Seventeen separate 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, 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 files were checked for retention of necessary documents

and supporting data.

Licensing casework was selected to provide a representative sample of licensing actions that

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

licenses: research and development, manufacturing and distribution, medical (mobile and

broad scope), fixed gauge, portable gauge, irradiator, nuclear pharmacy, and industrial

radiography. Types of licensing actions selected for evaluation included new licenses,

amendments to existing licenses, renewals, and terminations. A listing of the licensing

casework reviewed can be found in Appendix D.

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

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

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

The licensee's compliance history was taken into account when reviewing renewal applications

and amendments. Except as noted below, the licensing reviewers appropriately used the

Program’s licensing guides and standard license conditions.

The Program renews licenses every five years. The review team noted that most licensing

actions were promptly acted upon, usually within 30 days of receipt. However, the review team

noted that the Program has eight renewals that have been pending for more than one year, with

a couple dating back to 2002 and 2003. The Licensing Supervisor indicated that it is a staffing
Massachusetts Final Report Page 8

resource issue. The review team did not find any safety-significant impacts on the licensee's

programs due to the length of pending renewals.

The review team found that the Program staff routinely use detailed licensing checklists when

reviewing licensing actions. All licensing actions are reviewed by a primary license reviewer,

who closely monitors the timeliness of licensing actions. All completed licensing actions are

then reviewed by a secondary license reviewer and the Licensing Supervisor. The Program

Director signs all licensing documents.

The Program issued a revision to their Licensing Procedures in October 24, 2005. This

procedure includes guidance for new applications, renewals and amendments. The most

significant change was to the section on issuance of reciprocity certificates. The Program also

refers to NRC NUREG-1556 series for detailed procedures when needed.

The review team evaluated financial assurance and decommissioning activities conducted in

the Program. The review team found that termination actions were well documented from the

initiating action to final surveys, materials disposition and termination of the license. No

potentially significant health and safety issues were identified.

In 1977, the NRC initiated a review of terminated NRC licenses to determine whether sites had

been adequately decontaminated prior to termination and release of the site. As a result of this

effort, a number of sites were identified as lacking proper documentation of termination

activities, including disposition of materials. Some of these NRC formerly licensed sites were

determined to be located in Agreement States and to be the regulatory responsibility of the

State. In an effort to reduce the resource impacts on Agreement States, the NRC established a

grant program in 2001 for Agreement States to conduct file reviews and initial surveys of the

NRC formerly licensed sites. Fourteen sites were determined to be located in Massachusetts. 

The Commonwealth of Massachusetts submitted a grant proposal to the NRC and, on

June 5, 2002, was awarded a grant of $36,890.70 to review the 14 sites within the

Commonwealth. The Commonwealth completed the grant project, closed all the 14 site files,

and submitted a final report to the NRC in a letter dated November 19, 2002.

The final report includes the Commonwealth’s assessments and findings for each site file

reviewed. Based on review of the final report, the review team determined that the

Commonwealth conducted a through review of these NRC formerly licensed sites. The basis to

close each site file is well documented and supported by radiological status of the site including

survey results obtained during site visits of these formerly licensed sites.

The review team examined the licensees that the Program had determined met the criteria for

the increased controls, as per COMSECY-05-0028. Each applicable licensee was issued a

license amendment requiring increased controls, with exceptions discussed below, and will

continue to issue increased controls to any additional future licensees meeting the threshold

criteria.

The review team determined that the Program had correctly identified the licensees that require

increased controls based on this criteria except for about 20 licensees that were overlooked

due to a misinterpretation of COMSECY-05-0028. Specifically, certain reciprocity licensees and

some licensees that may temporarily possess sources exceeding quantity of concern, for

example, during the source exchange period, were not issued license amendments to include
Massachusetts Final Report Page 9

increased controls. The review team discussed this oversight with Program management and

staff, and the Program agreed to take action to address this finding. The review team

recommends that the Commonwealth address each of the licensing cases where increased

controls are needed by either issuing license amendments to decrease possession limits or

issuing license amendments to include increased controls.

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

that Massachusetts’ 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, the review

team examined the Program’s response to the questionnaire relative to this indicator, evaluated

selected incidents reported for Massachusetts in the Nuclear Material Events Database (NMED)

against those contained in the Program’s files, and evaluated the casework and supporting

documentation for 11 material incidents. A listing of the incident casework examined, with

case-specific comments, can be found in Appendix E. The review team also evaluated the

Program’s response to 13 allegations involving radioactive material received during the review

period, including three referred to the Commonwealth by the NRC.

The review team discussed the Program’s event and allegation procedures, tracking system,

file documentation, NMED, and notification of incidents to the NRC Headquarters Operations

Center with Program management and staff. The Program’s event procedures include

reporting requirements consistent with the Office of State and Tribal Programs (STP)

Procedure SA-300, “Reporting Material Events.”

The primary responsibility for coordination of all incidents and allegations rests with the Event

Coordinator. The initial response and follow up to incidents and allegations involving

radioactive materials are coordinated with the Licensing Supervisor and Radioactive Materials

Supervisor. A combined written procedure exists for handling all incidents and allegations. If

an inspection is warranted, the Inspection Supervisor is notified and an inspector is assigned to

handle the event. The Program conducts on-site investigations for all incidents that present a

potential or actual hazard to public health and safety. Prior to dispatching responders to the

site, Program management is advised of all incidents and allegations reported and the planned

response. Review of the casework indicated that this approach provides effective and

appropriate response actions and generally does not delay the response time.

The procedure and report forms are available to the staff when responding to any event,

accident or emergency involving radioactive materials. All events, as well as allegations, are

assigned individual docket numbers for tracking. The events are also entered into a local

events database and assigned a sequential event number. Completed events and allegation

docket files are placed in the corresponding licensee’s file.

The 11 incident files selected for review included the following categories: overexposure, loss

of radioactive material, medical, transportation, leaking source and fire. The review team found

that the Program’s response to events was generally complete and comprehensive except for

the two events discussed below. Initial responses were prompt and well-coordinated, and the

level of effort was commensurate with the health and safety significance. The Program
Massachusetts Final Report Page 10

dispatched inspectors for on-site investigations when appropriate and took suitable

enforcement and follow-up actions.

The review team found two events received by the Program in 2003 where they were not acted

on in a timely manner. One event involved a high dose-rate remote afterloader malfunction and

the other one involved a leaking sealed source. In both cases, the Program received the event

report, opened a case, but did not take any action to follow up or resolve the issue. The review

team discussed these two events with the Program. Program management indicated that they

plan to take follow-up action to close these two action items. Although the review team

concluded that these are two isolated cases and do not represent an overall performance issue

with respect to the Program’s handling of events, the review team believes that these cases

could have been identified and acted on if the Program effectively utilized its existing database,

which allows management to periodically track the Program’s action items. Specifically, the

Program staff periodically generates reports containing the status of all the essential action

items, including event opening and closing dates. The review team does not believe that the

Program has effectively used these reports to monitor the status of progress of each event and

close out the event in a timely manner. The review team further noted that a significant number

of events remained open. The review team recommends that the Commonwealth take

appropriate and timely follow-up actions commensurate with the potential health and safety

significance for all events.

The 2002 IMPEP review team identified that the Program was not reporting significant or

routine events in a timely manner as requested in STP Procedure SA-300. Prior to the on-site

review, the review team queried the NMED system and identified 33 NRC reportable events

over the review period. During the on-site review, the Program provided a list of 52 events

reported to NMED since June 2002. The review team noted that among the 52 events, some

are not NRC reportable events.

The review team evaluated the timeliness of the 33 NRC reportable events and noted that

approximately 35 percent of the these events were not reported in a timely manner as

requested in STP Procedure SA-300. The review team noted that routine and follow-up event

information was not reported to NMED on a monthly basis as requested in STP Procedure 

SA-300. The review team discussed the issue of reporting events and providing follow-up

event information with Program management and staff responsible for NMED data entry. 

Program management indicated that the poor performance in reporting and updating events

was due to the changeover in staff responsible for the Events Coordinator position and the

extra time and effort needed in learning the NMED software to enter information into the

database. Although the review team found that there has been some progress made in

reporting recent events to the NRC in accordance with STP Procedure SA-300, there were a

significant number of older events which had not been properly reported as required. Thus, as

discussed in Section 2 above, the recommendation from the 2002 IMPEP report remains open.

During the review period, the Program received 13 allegations including three referred to the

Commonwealth by the NRC. The review team evaluated all allegations received by the

Program. The review team noted that the Program promptly responded with appropriate

investigations, follow up, and closeout actions. All allegation files contained written closeout

correspondence to the alleger summarizing the Program’s actions regarding the concerns

raised. The review team also determined that the Program can protect an alleger’s identity. 

There were no performance issues identified from the review of the files or the documentation.
Massachusetts Final Report Page 11

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

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

Allegation Activities, was satisfactory, but needs improvement.

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 Massachusetts Agreement State Program does not cover uranium recovery

operations, so only the first three non-common performance indicators were applicable to this

review.

4.1 Compatibility Requirements

4.1.1 Legislation

Massachusetts became an Agreement State on March 21, 1997. The authority under which the

Program administers the Agreement is in Massachusetts General Law Chapter 111H and

Chapter 111. The statute authorizing the Governor to enter into the Agreement is contained in

Chapter 111H and the statute under which the Program operates is in Chapter 111. The

Department of Public Health is designated as the Commonwealth's radiation control agency. 

The review team noted that no new legislation, which would affect the Agreement State

program or its authority, was passed since the last review.

4.1.2 Program Elements Required for Compatibility

The Commonwealth regulations for the Program are located in Title105 of the Code of

Massachusetts Regulations Section 120, and apply to ionizing radiation, whether produced by

radionuclides or machines. Massachusetts requires a license for possession and use of

radioactive materials, including naturally occurring and accelerator-produced radionuclides.

The review team evaluated the Program’s response to the questionnaire relative to this

indicator, interviewed Program management and staff, reviewed the status of regulations

required to be adopted by the Commonwealth under the Commission’s adequacy and

compatibility policy and verified the adoption of regulations with data obtained from STP’s State

Regulation Status Data Sheet.

The review team examined the Program’s rulemaking process and found that, depending on

the number of regulations being processed, the amount of time to promulgate regulations from

the date regulations are drafted until the effective date of the regulations can take up to

approximately 18 months. Regulations are drafted by Program staff, reviewed by Program

management, and are then sent to the NRC for a compatibility review. Any comments received

by the NRC are evaluated, and the regulations are revised as necessary. The regulations,

revised to address NRC comments, are then reviewed by the Program’s legal counsel. The

time required for the legal counsel review ranges from one week to one year, depending on the

size of the rulemaking package. A memorandum containing the regulations, revised to reflect

legal counsel comments, is presented to the Department Commissioner for review. The

regulations are then presented to the Commonwealth’s Department of Public Health Council
Massachusetts Final Report Page 12

(the Council) for public publication approval. The regulations are published in two newspapers

and in the Commonwealth Register for a minimum of 30 days for public review and comment. 

Any comments received by the public are evaluated through comment analysis by the Program

staff, and the regulations are revised as necessary. The amount of time to complete the

comment analysis varies, but usually takes several months. The revised regulations are

reviewed by Program management and are submitted to the Council for promulgation. Once

the Council approves the regulations for promulgation, the Secretary of the Commonwealth

establishes an effective date, which is usually 30 days after the date of approval. A copy of the

final promulgated regulations are then sent to the NRC for review as final regulations.

The review team determined that 16 regulations have not been adopted within the three year

time frame. The review team noted that three of the 16 overdue regulations were identified as

overdue during the 2002 IMPEP review. During the 2002 IMPEP review, the Program indicated

an intent to promulgate the three overdue regulations in the next iteration of the regulation

anticipated for 2003. Program management indicated during this on-site review that the

reasons the three overdue regulations were not promulgated in 2003 were: (1) Program

management preferred to present to the Council a regulation package with significant changes,

such as changes to 10 CFR Part 35, that had an upcoming implementation date; (2) Program

management preferred to present for promulgation a larger regulation package instead of three

regulations which were otherwise provided for by other legal processes; and (3) the process to

put together the larger package changed the time lines.

The following 13 regulations including the three overdue regulations identified during the 2002

IMPEP review have not been adopted and are overdue:

! “Timeliness in Decommissioning Material Facilities,” 10 CFR Parts 30, 40, 70

amendments (59 FR 36026) that became effective August 15, 1997.

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

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

! “Radiation Protection Requirements: Amended Definitions and Criteria,” 10 CFR Parts

19, 20 amendments (60 FR 36038) that became effective August 14, 1998.

! “Clarification of Decommissioning Funding Requirements,” 10 CFR Parts 30, 40, 70

amendments (60 FR 38235) that became effective November 24, 1998.

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

amendments (62 FR 39057) that became effective August 20, 2000.

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

Radiographic Operations,” 10 CFR Part 34 amendment (63 FR 37059) that became

effective July 9, 2001.

! “Minor Corrections, Clarifying Changes and a Minor Policy Change,” 10 CFR Parts 20,

35, 36 amendments (63 FR 39347, 63 FR 45393) that became effective October 26,

2001.
Massachusetts Final Report Page 13

! “Transfer for Disposal and Manifests: Minor Technical Conforming Amendment,” 

10 CFR Part 20 amendments (63 FR 50127) that became effective November 20, 2001.

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

amendments (64 FR 54543, 64 FR 55524) that became effective on February 2, 2003.

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

10 CFR Part 39 amendments (65 FR 20337) that became effective on May 17, 2003.

! “New Dosimetry Technology,” 10 CFR Parts 34, 36 and 39 amendments (65 FR 63750)

that became effective on January 8, 2004.

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

became effective April 5, 2005.

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

(67 FR 20249) that became effective on April 24, 2005.

In addition, the review team noted that the Commonwealth used other forms of generic legally

binding requirements to address the following three regulations and one Order:

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

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

effective February 27, 2000.

! “Deliberate Misconduct by Unlicensed Persons,” 10 CFR Parts 30, 40, 61, 70, 71, 150

amendments (63 FR 1890, 63 FR 13773) that became effective on February 12, 2001.

! “Requirements for Certain Generally Licensed Industrial Devices Containing Byproduct

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

effective February 16, 2004.

! “Increased Controls for Risk-Significant Radioactive Sources,” NRC Order EA-05-090,

that became effective December 1, 2005.

All 16 overdue regulations have been submitted to the NRC, as proposed regulations, for

review and comment. NRC has reviewed the proposed regulations, and submitted comments

on 5 of the 16 regulations. The Program promulgated the 16 overdue regulations in July 2006

and plans to submit the final regulations to the NRC in August 2006. The review team noted

that of the license conditions being used in place of regulations or NRC Orders only the license

condition used to address NRC Order EA-05-090 has been submitted to the NRC for a

compatibility review.

As discussed in Section 2.0, the recommendation from the 2002 IMPEP review, that the

Commonwealth adopt regulations necessary for compatibility within the required three year time

frame and submit alternate forms of legally binding requirements for NRC review following the

guidance in SA-201, remains open.
Massachusetts Final Report Page 14

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

adopting alternate legally binding requirements:

! “Financial Assurance for Materials Licensees,” 10 CFR Parts 30, 40, 70 amendments

(68 FR 57327) that will become effective December 3, 2006.

! “Compatibility with IAEA Transportation Safety Standards and Other Transportation

Safety Amendments,” 10 CFR Part 71 amendment (69 FR 3697) that will become

effective October 1, 2007.

! “Medical Use of Byproduct Material - Recognition of Specialty Boards, “ 10 CFR Part 35

amendment (70 FR 16336, 71 FR 1926) that will become effective April 29, 2008.

! “Security Requirements for Portable Gauges Containing Byproduct Material,” 10 CFR

Part 30 amendment (70 FR 2001) that will become effective July 11, 2008.

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

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

satisfactory, but needs improvement.

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

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

performance regarding their SS&D Evaluation Program. These sub-indicators include: 

(1) Technical Staffing and Training; (2) Technical Quality of the Product Evaluation; and 

(3) Evaluation of Defects and Incidents Regarding SS&Ds.

In assessing the SS&D Evaluation Program, the review team examined information provided by

the Program in response to the IMPEP questionnaire relative to this indicator. A review of

selected new, amended, transferred, and inactivated SS&D evaluations and supporting

documents covering the review period was conducted. The review team noted the staff's use of

guidance documents and procedures, interviewed the staff and the supervisor involved in SS&D

evaluations, and verified the use of regulations, license conditions, and inspections to enforce

commitments made in the applications.

The Program completed 149 SS&D actions and six evaluations of events or failures involving

Massachusetts’ products since June 2002.

4.2.1 Technical Staffing and Training

The Program reported that currently two staff members and the Licensing Supervisor have

authority to sign SS&D evaluations, in addition to their responsibilities for materials licensing

casework and inspections. The review team examined the training and experience folders for

the two staff members. All had engineering backgrounds by education and attended the NRC

SS&D workshop. In addition to the courses attended for training, the training records had

detailed documentation of SS&D casework assignments, dates, and the name of the Program

mentor. Staff members were not permitted to work independently until the Licensing Supervisor

was satisfied that the individual had demonstrated adequate competency and recommended

working independently through a memorandum to the Radioactive Materials Supervisor. The
Massachusetts Final Report Page 15

review team found that the Program’s SS&D staff completed the casework within an average of

six to eight weeks and that there is no backlog of SS&D cases. The review team determined

that the current staffing level is adequate for conducting SS&D safety evaluations.

The review team also reviewed the Program’s qualification criteria for SS&D reviewers. The

document, used by the Program and made available to the review team, is entitled

“Qualification Criteria in the Radioactive Materials Regulatory Program Area,” dated 

December 10, 1997. The document specified only that the SS&D reviewers must attend the

SS&D Review Workshop and that any additional training will be determined by the individual’s

supervisor. According to the provisions of Management Directive 5.6, Part III(G)(1)(a)(ii), the

applicable IMPEP criterion specifies that the “[q]ualification criteria for reviewers are

established, implemented, and documented” for a training program to be satisfactory. The

review team found that the qualification requirements, left to the supervisor’s determination

without further written guidance, are not consistent with the provisions of the guidance. The

review team recommends that the Commonwealth develop and document a set of formal

qualification requirements for SS&D reviewers.

4.2.2 Technical Quality of the Product Evaluation Program

Seventeen SS&D case files were selected by the review team for review including work

performed by all reviewers. The cross-section sampling included a variety of the Program’s

SS&D manufacturers and distributors, with a range of products including the following types:

radiography exposure device, brachytherapy source, brachytherapy afterloader, liquid

scintillation counter, high energy beta source, x-ray fluorescence analyzer, gas chromatograph,

ordnance detection system, high energy photon source, ion mobility spectrometer, static

eliminator, and formation tester. The SS&D actions were also selected to represent a variety of

actions which included five new certificates, seven amendments, four inactivations, and

reactivation. A listing of the SS&D certificates evaluated by the review team, with case specific

comments, can be found in Appendix F.

The review team evaluated the conduct of the SS&D safety evaluations, deficiency

correspondence, and checklists for the SS&D cases within the review period. The SS&D

certificates were reviewed for accuracy, appropriateness of authorizations, tie-down statements,

and overall technical quality. Casework was evaluated for timeliness, adherence to good

radiation safety practices, acceptable engineering practices, references to appropriate

regulations, documentation of safety evaluation reports, manufacturing Quality

Assurance/Quality Control (QA/QC), supporting documents, peer or supervisory review as

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

documents and other supporting data.

Analysis of the casework and interviews with the staff confirmed that the Program followed the

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

Rev. 1. All applicable and pertinent regulations, industry standards, and applicable references

were available and used appropriately in performing the SS&D reviews. Appropriate review

checklists were used to assure that all relevant materials were submitted and reviewed. The

checklists were retained in the case files. The registration certificates summarized the product

evaluation and provided license reviewers with adequate information on areas requiring

additional attention to license the possession, use, and distribution of the products. The review

team’s comments in Appendix F did not identify any safety issues, and the comments are
Massachusetts Final Report Page 16

presented to show non-safety related variances from documentation traditional in SS&D

evaluations as described in NUREG-1556, Vol. 3.

The review team found that the SS&D files were maintained in an orderly manner and

correspondence was filed chronologically. The review team noted that the records filing system

is organized in a comprehensive manner to maintain all previous actions regarding the SS&D

registration certificates. Specifically, all actions ranging from initial approval through sequential

amendments, changes, and corrections to the latest action are maintained and stored in one

file. In the file, the individual actions are clearly separated from each other and fully

documented. As a result, the records filing system provides, for each SS&D registration, a

most readily accessible historical overview of all the current as well as the previous actions. 

The review team recommends that the Commonwealth’s filing system for SS&D casework files

be identified as a good practice.

The review team also noted that the Program performed, during the review period, a number of

other SS&D related actions that were beyond the scope of traditional SS&D safety evaluations. 

Specifically, the Program completed a number of equipment related actions, such as:

! Conducted a full safety evaluation of a device for the State of New Hampshire where no

qualified reviewers were available (Registration Certificate NH-1184-D-101-S).

! Reviewed an event, and followed up with a quality assurance inspection, involving a

source disconnect in an AEA Model 660 radiography camera, reported by the State of

Florida. As a result, the vendor issued a service bulletin and modified the maintenance

procedure.

! Identified, and followed up with a quality assurance inspection, connection issues

involving radiography sources that were distributed by the vendor, Industrial Nuclear,

Inc., in noncompliance with the SS&D specifications. As a result, the vendor modified

the fabrication procedures, and the QA program.

! Initiated an investigation, upon notification from the NRC and the Canadian Nuclear

Safety Commission, to determine the root cause of potential excessive S-tube wear

involving AEA Model 660B radiography cameras. The investigation was still open at the

time of the review.

The review team noted that the Program conducted the SS&D evaluations on the basis of the

standard operating procedure, dated June 16, 2000. In addition, the Program used a checklist

for each case to assure that all aspects of the safety evaluation had been satisfactorily

completed. Both reviewers initialed and dated the checklist. The review team noted that the

Licensing Supervisor also reviewed, initialed, and dated the checklist, thus, providing an

additional quality assurance check for the safety evaluation process. The review team

recommends that the Commonwealth’s use of initialed and dated checklists be identified as a

good practice.

In reviewing the case files, the review team noted that the Program issued a number of

inactivated registration certificates that did not contain the full text, but only a reference to

another registration certificate (e.g., MA-1059-S-905-S, MA-1059-S-919-S). The review team

noted that NRC also received a notification about this practice from another Agreement State
Massachusetts Final Report Page 17

stating that they noticed that all technical content was deleted in inactivated sheets and that

they would prefer the method of leaving all the original information in the inactivated sheet and

just adding the statement about ‘no longer distributed or serviced.’ The Program’s staff

explained to the review team that such short-form inactivated registrations referred only to

active ones which did contain the full text. By using a short format, the information is not readily

available to the users, and the referenced certificate, containing the full text, might be later

deleted from the National Sealed Source and Device Registry when the vendor discontinues

distribution of the product. It is the historical practice of the SS&D community nationwide that

the full text is retained in inactivated registrations. Furthermore, the applicable guidance in

NUREG-1556, Vol. 3, Rev. 1, Section 13.4, specifies that the inactivated certificate should

contain information sufficient to be used as the basis for continued licensing of the product. 

The review team recommends that the Commonwealth issue inactivated registration certificates

in the future with full text and, reissue the shortened certificates with full text, if practicable. If

the Commonwealth wishes to continue the practice of short forms, then the review team

recommends that the registration certificate, which is referenced in the short text, be attached

to the inactivated registration.

The review team discussed this issue with the Program and the Program management

indicated that they will issue future inactive certificates with full text, the previously issued

certificates will be revised, and the SS&D safety evaluation procedure will be expanded to

address the inactivation process.

4.2.3 Evaluation of Defects and Incidents Regarding SS&D

The review team examined all incidents during the review period for relevance to SS&D issues. 

Six incidents involved equipment failure or malfunction. The review team found that the

Program fully reviewed three of the six incidents, took appropriate follow-up actions, and

documented completion in the records. One incident is under timely review. Two of the six

incidents, both from 2003, were not closed out and are still open which are discussed in Section

3.5. The Program’s handling of SS&D related incidents is similar to that for other incidents

discussed in Section 3.5. Therefore, the conclusions presented in Section 3.5 apply.

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

might have taken place that were not registered by the Program staff. No additional incidents

related to malfunctioning devices or products were identified.

During the review period, the Program received no allegations related to the SS&D evaluation

program.

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

that Massachusetts’ performance with respect to the indicator, Sealed Source and Device

Evaluation Program, was satisfactory.

4.3 Low-Level Radioactive Waste (LLRW) Disposal Program

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

Discontinuance of NRC Regulatory Authority and Assumption Thereof by States Through

Agreement" to allow a State to seek an amendment for the regulation of LLRW as a separate

category. Those States with existing Agreements prior to 1981 were determined to have
Massachusetts Final Report Page 18

continued LLRW disposal authority without the need of an amendment. Although the

Massachusetts Agreement State Program has LLRW disposal authority, NRC has not required

States to have a program for licensing a LLRW disposal facility until such time as the State has

been designated as a host State for a LLRW disposal facility. When an Agreement State has

been notified or becomes aware of the need to regulate a LLRW disposal facility, they are

expected to put in place a regulatory program which will meet the criteria for an adequate and

compatible LLRW disposal program. There are no plans for a LLRW disposal facility in

Massachusetts. Accordingly, the review team did not review this indicator.

5.0 SUMMARY

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

satisfactory for five of the performance indicators reviewed. The review team found

Massachusetts performance to be satisfactory, but needs improvement for the following two

indicators: Technical Quality of Incident and Allegation Activities and Compatibility

Requirements. Accordingly, the review team recommended and the MRB agreed that the

Massachusetts Agreement State Program was 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 should be conducted

in approximately four years.

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

implementation, as appropriate, by the Commonwealth.

RECOMMENDATIONS:

1. The review team recommends that the Commonwealth pursue adequate funding to

support and implement the staffing plan which is needed to meet current program

demands as well as the projected increase in workload. (Section 3.1)

2. The review team recommends that the Commonwealth address each of the licensing

cases where increased controls are needed by either issuing license amendments to

decrease possession limits or issuing license amendments to include increased

controls. (Section 3.4)

3. The review team recommends that the Commonwealth take appropriate and timely

follow-up actions commensurate with the potential health and safety significance for all

events. (Section 3.5)

4. The review team recommends that the Commonwealth take necessary steps to ensure

that all reportable events are submitted and updated to NRC in accordance with STP

Procedure SA-300. (Open recommendation from 2002 IMPEP review) (Section 3.5)

5. The review team recommends that the Commonwealth adopt regulations necessary for

compatibility within the required three year time frame and submit alternate forms of

legally binding requirements for NRC review following the guidance in SA-201. (Open

recommendation from the 2002 IMPEP review) (Section 4.1.2)
Massachusetts Final Report Page 19

6. The team recommends that the Commonwealth make corrections to registration

certificate MA-0116-102-B. (Open recommendation, second part only, from the 2002

IMPEP review) (Section 2.0, Recommendation 4)

7. The review team recommends that the Commonwealth develop and document a set of

formal qualification requirements for SS&D reviewers. (Section 4.2.1)

8. The review team recommends that the Commonwealth issue inactivated registration

certificates in the future with full text and, reissue the shortened certificates with full text,

if practicable. If the Commonwealth wishes to continue the practice of short forms, then

the review team recommends that the registration certificate, which is referenced in the

short text, be attached to the inactivated registration. (Section 4.2.2)

GOOD PRACTICES:

1. The Program maintains a records filing system which provides, for each SS&D

registration, a most readily accessible historical overview of all the current as well as the

previous actions. Specifically, all actions ranging from initial approval through

consequential amendments, changes, and corrections to the latest action are

maintained and stored in one file. In the file, the individual actions are clearly separated

from each other and fully documented. (Section 4.2.2)

2. In performing the SS&D safety evaluations, the Program uses a checklist for each case

to assure that all aspects of the safety evaluation had been satisfactorily completed. 

Both reviewers initial and date the checklist, and in addition, the SS&D supervisor also

reviews, initials, and dates the checklist, thus, providing an additional quality assurance

check for the safety evaluation process. (Section 4.2.2)
LIST OF APPENDICES AND ATTACHMENTS

Appendix A IMPEP Review Team Members

Appendix B Massachusetts Organization Charts

Appendix C Inspection Casework Reviews

Appendix D License Casework Reviews

Appendix E Incident Casework Reviews

Appendix F SS&D Casework Reviews

Attachments Massachusetts’ Responses to Draft IMPEP Report
APPENDIX A

IMPEP REVIEW TEAM MEMBERS

Name Area of Responsibility

Kevin Hsueh, STP Team Leader

Technical Staffing and Training

Shawn Seeley, Maine Technical Quality of Inspections

Technical Quality of Incident and Allegation Activities

Inspector Accompaniments

Sheri Minnick, RI Technical Quality of Licensing Actions

Shawn Smith, STP Status of Materials Inspection Program

Compatibility Requirements

John Jankovich, NMSS Sealed Source and Device Evaluation Program
APPENDIX B

MASSACHUSETTS ORGANIZATION CHARTS

ADAMS: ML061710265
APPENDIX C

INSPECTION CASEWORK REVIEWS

NOTE: CASEWORK LISTED WITHOUT COMMENT ARE INCLUDED FOR COMPLETENESS

ONLY.

File No.: 1

Licensee: North Shore Medical Center License No.: 44-0161

Inspection Type: Routine, Unannounced Priority: 1

Inspection Dates: 1/10-11/06 Inspector: AC

File No.: 2

Licensee: New England Medical Specialists License No.: 67-0324

Inspection Type: Routine, Unannounced Priority: 5

Inspection Date: 4/6/06 Inspector: BP

Comment:

Incomplete report, supervisory review not within 30 days.

File No.: 3

Licensee: Brsitol-Myers Squibb License No.: 60-0088

Inspection Type: Routine, Unannounced Priority: 2

Inspection Date: 2/3/06 Inspector: AC

File No.: 4

Licensee: Bristol-Myers Squibb License No.: 60-0088

Inspection Type: Routine, Unannounced Priority: 2

Inspection Dates: 9/24-25/03 Inspectors: MW, JS

File No.: 5

Licensee: Neurophysics License No.: 55-0523

Inspection Type: Initial, Announced Priority: 5

Inspection Date: 4/6/06 Inspector: MI

File No.: 6

Licensee: Caritas Norwood Hospital License No.: 44-0008

Inspection Type: Routine, Unannounced Priority: 3

Inspection Date: 1/31/06, 2/3/06, 2/16/06 Inspector: BP

File No.: 7

Licensee: ABC Testing License No.: 19-7781

Inspection Type: Routine, Unannounced Priority: 1

Inspection Date: 12/7/04 Inspector: JD

Comment:

Wrong date referenced in correspondence to licensee. Should be 2/7/05 and not 2/7/04

as listed.
Massachusetts Final Report Page C.2

Inspection Casework Reviews

File No.: 8

Licensee: Baker Testing Services License No.: 19-0672

Inspection Type: Routine, Unannounced Priority: 1

Inspection Date: 1/13/06 Inspector: MI

File No.: 9

Licensee: TEI Analytical License No.: N/A

Inspection Type: Reciprocity Priority: 1

Inspection Date: 7/15/05 Inspector: MI

File No.: 10

Licensee: Varian License No.: 66-0111

Inspection Type: Reciprocity Priority: 5

Inspection Date: 3/9/06 Inspector: TC

File No.: 11

Licensee: Selectix Pharmaceuticals License No.: 55-0466

Inspection Type: Initial, Announced Priority: 3

Inspection Date: 2/23/05 Inspector: TC

File No.: 12

Licensee: Lowell General Hospital License No.: 44-0060

Inspection Type: Routine, Unannounced Priority: 3

Inspection Date: 4/5/06 Inspector: BG

Comment:

Supervisory review not within 30 days

INSPECTOR ACCOMPANIMENTS

In addition, the following inspection accompaniments were performed as part of the IMPEP

review.

Accompaniment No.: 1

Licensee: Lowell General Hospital License No.: 44-0060

Inspection Type: Routine, Unannounced Priority: 3

Inspection Date: 4/5/06 Inspector: BG

Comment:

Inspectors meter failed prior to inspection. Observed licensee surveys.

Accompaniment No.: 2

Licensee: Neurophysics License No.: 55-0523

Inspection Type: Initial, Unannounced Priority: 5

Inspection Date: 4/6/06 Inspector: MI
Massachusetts Final Report Page C.3

Inspection Casework Reviews

Accompaniment No.: 3

Licensee: New England Medical Specialists License No.: 67-0324

Inspection Type: Routine, Unannounced Priority: 5

Inspection Date: 4/6/06 Inspector: BP
APPENDIX D

LICENSE CASEWORK REVIEWS

NOTE: CASEWORK LISTED WITHOUT COMMENT ARE INCLUDED FOR COMPLETENESS

ONLY; NO SIGNIFICANT COMMENTS WERE IDENTIFIED BY THE IMPEP TEAM.

File No.: 1

Licensee: ABC Testing, Inc. License No.: 19-7781

Type of Action: Amendment Amendment No.: 7

Date Issued: 11/18/05 License Reviewers: JS, KT

File No.: 2

Licensee: Advance Testing Company, Inc. License No.: 48-0236

Type of Action: Renewal Amendment No.: 5

Date Issued: 10/23/03 License Reviewers: SL, BP

File No.: 3

Licensee: Beth Israel Deaconess Medical Center License No.: 44-0403

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

Date Issued: 8/2/02 License Reviewers: GS, KT

File No.: 4

Licensee: Beth Israel Deaconess Medical Center License No.: 44-0403

Type of Action: Amendment Amendment No.: 2

Date Issued: 11/21/05 License Reviewers: AC, MI

File No.: 5

Licensee: Baystate Health System, Inc. License No.: 60-0095

Type of Action: Renewal Amendment No.: 18

Date Issued: 7/5/05 License Reviewers: AC, MI

File No.: 6

Licensee: Clinomics Laboratories License No.: 55-0307

Type of Action: Amendment Amendment No.: 4

Date Issued: 4/4/05 License Reviewers: AC, KT

File No.: 7

Licensee: Cyclis Pharmaceuticals, Inc. License No.: 55-0409

Type of Action: Termination Amendment No.: 2

Date Issued: 10/9/03 License Reviewer: AC

File No.: 8

Licensee: Children’s Hospital, Boston License No.: 60-0137

Type of Action: Amendment Amendment No.: 12

Date Issued: 3/30/06 License Reviewers: MI, KT
Massachusetts Final Report Page D.2

License Casework Reviews

File No.: 9

Licensee: Beth Israel Deaconess Medical Center License No.: 60-0432

Type of Action: Amendment Amendment No.: 5

Date Issued: 11/18/05 License Reviewers: JS, KT

File No.: 10

Licensee: Eastern Isotopes License No.: 42-0473

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

Date Issued: 4/12/04 License Reviewer: AC

File No.: 11

Licensee: Dositec, Inc. License No.: 21-3261

Type of Action: Amendment Amendment No.: 9

Date Issued: 11/21/05 License Reviewers: JS, KT

File No.: 12

Licensee: Ratheon Company License No.: 01-1027

Type of Action: Renewal Amendment No.: 3

Date Issued: 6/23/05 License Reviewers: JD, AC

File No.: 13

Licensee: Raytheon Company License No.: 01-1027

Type of Action: Amendment Amendment No.: 4

Date Issued: 12/2/05 License Reviewers: JS, KT

File No.: 14

Licensee: Solutia, Inc. License No.: 00-5146

Type of Action: Renewal Amendment No.: 4

Date Issued: 6/6/05 License Reviewers: MI, AC

File No.: 15

Licensee: Unitech Services Group License No.: 03-5291

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

Date Issued: 3/29/05 License Reviewers: AC, MW

File No.: 16

Licensee: QSA Global, Inc. License No.: 12-8361

Type of Action: Financial Assurance Amendment No.: N/A

Date Issued: 2/16/06 License Reviewers: AC, KT

File No.: 17

Licensee: Tiax LLC License No.: 30-1121

Type of Action: Amendment Amendment No.: 3

Date Issued: 7/24/02 License Reviewers: KT, BW
APPENDIX E

INCIDENT CASEWORK REVIEWS

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS

ONLY.

File No.: 1

Licensee: AEA Technology Licensee No.: 12-8361

Date of Incident: 2/14/03 Incident Log No.: 02-3979

Investigation Date: assigned 2/19/03 Type of Incident: Leaking source

Type of Investigation: On-site/phone

Comment:

This is a reportable event and was not reported to the NRC.

File No.: 2

Licensee: NITON Licensee No.: 55-0238

Date of Incident: 10/14/04 Incident Log No.: 10-5189

Investigation Date: N/A Type of Incident: Leaking source

Type of Investigation: N/A

Comment:

This is a reportable event and was not reported to the NRC.

File No.: 3

Licensee: Perkin Elmer Licensee No.: 00-3205

Date of Incident: 1/30/06 Incident Log No.: 04-6276

Investigation Date: 3/10/06 Type of Incident: Transportation

Type of Investigation: On-site/phone

Comment:

This is a reportable event and was not reported to the NRC.

File No.: 4

Licensee: Brigham & Women’s Hospital Licensee No.: 44-0004

Date of Incident: 6/23/03 Incident Log No.: 06-4245

Investigation Date: N/A Type of Incident: Medical

Type of Investigation: N/A

Comments:

a) This is a 24-hour reportable event and was not reported to the NRC in a timely manner.

b) Event was not entered into NMED.

File No.: 5

Licensee: North Shore Medical Center Licensee No.: 44-0161

Date of Incident: 9/25/01 Incident Log No.:12-5245

Investigation Dates: 10/26/04, 11/18/04, 11/22/04 Type of Incident: Overexposure

Type of Investigation: On-site/phone
Massachusetts Final Report Page E.2

Incident Casework Reviews

File No.: 6

Licensee: Sverdrup Civil, Inc. Licensee No.: 48-0233

Date of Incident: 8/7/02 Incident Log No.:09-3644

Investigation Date: 9/9/02 Type of Incident: Unplanned fire

Type of Investigation: On-site/phone

Comment:

This is a reportable event and was not reported to the NRC.

File No.: 7

Licensee: Cardinal Health, LLC Licensee No.: 41-0366

Date of Incident: 6/3/04 Incident Log No.: 01-6064

Investigation Date: 6/7/04 Type of Incident: Overexposure

Type of Investigation: On-site/phone

Comments:

a) This is a reportable event and was not reported to the NRC.

b) Reassigned to another reviewer on 8/26/05.

File No.: 8

Licensee: Lahey Clinic Foundation Licensee No.: 44-0015

Date of Incident: 9/1/04 Incident Log No.: 09-5115

Investigation Date: 9/2/04 Type of Incident: Loss of material

Type of Investigation: On-site/phone

Comment:

Event not closed.

File No.: 9

Licensee: Level 1, Inc. Licensee No.: N/A

Date of Incident: 1/29/03 Incident Log No.: 01-3958

Investigation Date: 1/29/03 Type of Incident: Loss of material

Type of Investigation: Phone

Comments:

a) This is a reportable event and was not reported to the NRC.

b) Event was not entered into NMED.

File No.: 10

Licensee: Niton Corporation Licensee No.: 55-0238

Date of Incident: 12/3/03 Incident Log No.:10-5189

Investigation Date: 10/19/04 Incident: Leaking source

Type of Investigation: On-site/phone

Comments:

a) This is a reportable event and was not reported to the NRC.

b) Event was not entered into NMED.

c) Originally assigned 10/19/04, reassigned 1/14/05.
Massachusetts Final Report Page E.3

Incident Casework Reviews

File No.: 11

Licensee: Perkin Elmer Licensee No.: 00-3200

Date of Incident: 6/4/02 Incident Log No.: 06-3433

Investigation Date: 6/4/02 Type of Incident: Transportation

Type of Investigation: Phone

Comments:

a) This is a reportable event and was not reported to the NRC.

b) Event was not entered into NMED.
APPENDIX F

SEALED SOURCE AND DEVICE CASEWORK REVIEWS

NOTE: CASEWORK LISTED WITHOUT COMMENT IS INCLUDED FOR COMPLETENESS

ONLY.

File No.: 1

Registry No.: MA-1059-D-334-S SS&D Type: (A) Industrial Radiography

Manufacturer: AEA Technology QSA, Inc. Model No.: 880 Series

Date Issued: 2/12/04 Type of Action: Amendment

SS&D Reviewers: JED, JS

File No.: 2

Registry No.: MA-1059-D-334-S SS&D Type: (A) Industrial Radiography

Manufacturer: AEA Technology QSA, Inc. Model No.: 880 Series

Date Issued: 11/09/05 Type of Action: Amendment

SS&D Reviewers: JED, JS

File No.: 3

Registry No.: MA-1059-D-334-S SS&D Type: (A) Industrial Radiography

Manufacturer: AEA Technology QSA, Inc. Model No.: 880 Series

Date Issued: 7/13/04 Type of Action: Amendment

SS&D Reviewers: JED, JS

File No.: 4

Registry No.: MA-1216-S-101-S SS&D Type: (AA) Manual Brachytherapy

Manufacturer: RadioMed Corp. Model No.: Series 35, Series 80

Date Issued: 7/28/04 Type of Action: New

SS&D Reviewers: JS, JED

Comment:

FDA’s Form 510(k) was not in the file.

File No.: 5

Registry No.: MA-1142-D-102-G SS&D Type: (Y) Calibrators

Manufacturer: PerkinElmer Life Sciences, Inc. Model No.: Series 1200

Date Issued: 2/23/04 Type of Action: Amendment

SS&D Reviewers: JED, JS

Comment:

Meticulous records in file (phone logs, e-mails) to follow up with the licensee.
Massachusetts Final Report Page F.2

Sealed Source and Device Casework Reviews

File No.: 6

Registry No.: MA-1059-S-905-S SS&D Type: (E) Beta Gauges

Manufacturer: AEA Technology QSA, Inc. Model No.: SIF.D2

Date Issued: 8/31/04 Type of Action: Inactivation

SS&D Reviewers: JS, JED

Comments:

a) Inactivation questions (as specified in NUREG-1556, Vol. 3, Rev. 1, Section 13.4) were

not in the file.

b) The inactivated registration certificate did not contain the full text, but only reference to 

another registration, i.e., MA-1059-S-137-S.

File No.: 7

Registry No.: MA-8173-D-802-G SS&D Type: (Y) Calibrators

Manufacturer: Perkin Elmer Life Sciences, Inc. Model No.: Series 1200

Date Issued: 4/24/06 Type of Action: Inactivation

SS&D Reviewers: JED, JS

File No.: 8

Registry No.: MA-8154-D-803-B SS&D Type: (U) X-ray Fluorescence

Manufacturer: Oxford Instruments of America, Inc. Model No.: Lab-X 1000 Series

Date Issued: 2/05/05 Type of Action: Inactivation

SS&D Reviewers: JED, JS

Comment:

The inactivated registration certificate did not contain the full text, but only reference to

another registration, i.e., MA-8154-D-802-B.

File No.: 9

Registry No.: MA-8154-D-802-B SS&D Type: (U) X-ray Fluorescence

Manufacturer: Oxford Instruments of America, Inc. Model No.: Lab-X 1000 and 2000 Series

Date Issued: 9/27/04 Type of Action: Inactivation

SS&D Reviewers: JED/JS 

File No.: 10

Registry No.: MA-1234-D-101-G SS&D Type: (N) Ion Generators,

Chromatography

Manufacturer: ThermoEnvironmental Model No.: EGIS Defender

 Instruments, Inc.

Date Issued: 6/02/05 and 8/02/05 (correction) Type of Action: New

SS&D Reviewers: JS, JED

Comment:

The registration certificate was issued on the basis of a draft (instead of a final)

operations manual; thus, the vendor may change the manual after the issuance of the

certificate. The Program requested (in a telephone call on 05/16/06) a final version from

the vendor.
Massachusetts Final Report Page F.3

Sealed Source and Device Casework Reviews

File No.: 11

Registry No.: MA-1234-D-101-G SS&D Type: (N) Ion Generators,

Chromatography

Manufacturer: ThermoEnvironmental Model No.: EGIS Defender

 Instruments, Inc.

Date Issued: 8/02/05 Type of Action: Amendment

SS&D Reviewers: JS, JED

File No.: 12

Registry No.: MA-1229-D-101-S SS&D Type: (AF) Other Medical Uses

Manufacturer: Sirtex Wilmington LLC Model No.: SIR-Spheres

Date Issued: 5/6/05 Type of Action: New

SS&D Reviewers: JED, JS

Comments:

a) The distribution/fabrication of the device was transferred from one vendor to another,

and a statement in the Safety Analysis Summary references the registration of the

previous vendor (MA-1059-D-365-S). However, the documents in the file do not contain

information that would back up the cross-reference.

b) The records did not show that the reviewers verified that the new vendor accepted all

commitments made by the previous vendor, as specified by the guidance in NUREG1556, Vol.3, Rev. 1, Section 13.6, Item 6.

c) The label as approved does not show Sirtex’s address in the U.S. and the previously

used labels do not show a U.S. address, as specified by the guidance in NUREG-1556,

Vol. 3, Rev. 1, Section 5.5.

File No.: 13

Registry No.: MA-1218-D-103-S SS&D Type: (H) General Neutron

Source Applications

Manufacturer: Ancore Corp. Model No.: UXO-EDS-1

Date Issued: 4/21/05 Type of Action: New

SS&D Reviewers: JED, JS

Comment:

This is a custom registration for a user located in Massachusetts.

File No.: 14

Registry No.: MA-1059-S-250-S SS&D Type: (D) Gamma Gauging Source

Manufacturer: AEA Technology, Inc. Model No.: CKC.P1, CKC.P6

Date Issued: 10/22/02 Type of Action: Reactivation

SS&D Reviewers: JS, JED

Comments:

a) This is a reactivation of MA-1059-S-818-S.

b) The Model CKC.P6 was not in MA-1059-S-818-S, it was transferred from

MA-1059-344-S.
Massachusetts Final Report Page F.4

Sealed Source and Device Casework Reviews

File No.: 15

Registry No.: MA-0399-D-104-G SS&D Type: (N) Ion Generators, Chromatography

Manufacturer: GE Ion Track Model No.: 6 various models

Date Issued: 6/7/04 Type of Action: Amendment

SS&D Reviewers: JS, JED

File No.: 16

Registry No.: NH-1184-D-104-S SS&D Type: (O) Ion Generators, Static Eliminator

Manufacturer: BAE Systems Model No.: Laser System

Date Issued: 6/7/04 Type of Action: New

SS&D Reviewers: TMK, DPO

Comments:

a) The Program performed the SS&D review for the State of New Hampshire.

b) The Program issued a transmittal letter, dated 02/26/03, to New Hampshire with two

attachments: (1) draft SS&D registration certificate, and (2) deficiency questions for

New Hampshire to ask from the licensee. Attachment 2 was not in the file, it was

located during the review on the C:/ drive of one of the staff. Attachment 2 was placed

into the file.

c) The checklist left the following sections blank: Prototype Testing/Historical Use,

Radiation Profiles, Quality Assurance, Installation, Safety Instructions, Accompanying

Documentation.

d) The checklist was not signed and dated.

File No.: 17

Registry No.: MA-0399-D-104-G SS&D Type: (N) Ion Generators, Chromatography

Manufacturer: GE Ion Track Model No.: 6 various models

Date Issued: 5/5/03 Type of Action: Amendment

SS&D Reviewers: JS, JED
ATTACHMENTS

Massachusetts’ Responses to Draft IMPEP Report

July 21, 2006 Letter from Robert Walker

ADAMS: ML062050670

August 9, 2006 E-Mail from Robert Walker

ADAMS: ML062230246