Attached include final revisions based on SJC review. This is OK … · 2014-07-03 ·...

From: Daehler, Joshua (DPH)To: Katanic, JanineCc: Priest, Jack (DPH)Subject: FW: MA IMPEP Questionnnaire 2014 Priest Rev 1.docxDate: Wednesday, July 02, 2014 12:26:52 PMAttachments: MA IMPEP Questionnnaire 2014 Priest Rev 1.docx

Janine; Attached is our completed IMPEP Questionnaire. Please let us know if in case you have any additional questions. Thanks,Josh Joshua E. DaehlerRadioactive Materials Unit SupervisorMassachusetts Radiation Control ProgramSchrafft Center, Suite 1M2A529 Main StreetCharlestown, MA 02129Tel.: 617-242-3035 ext. 2015Fax: 617-242-3457

From: Priest, Jack (DPH) Sent: Wednesday, July 02, 2014 11:11 AMTo: Daehler, Joshua (DPH)Subject: MA IMPEP Questionnnaire 2014 Priest Rev 1.docx Attached include final revisions based on SJC review. This is OK to forward to the NRC. Please keep acopy.
mailto:[email protected]:[email protected]:[email protected]
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No. 3150-0183

Expires 11/30/2013

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM

QUESTIONNAIRE

Massachusetts Department of Public Health

Reporting Period: July 17, 2010 to August 1, 2014

AS OF JUNE 25, 2014

Note: If there has been no change in the response to a specific question since the last IMPEP questionnaire, the State or Region may copy the previous answer, if appropriate.

A. GENERAL

1. Please prepare a summary of the status of the State's or Region's actions taken in response to each of the open recommendations from previous IMPEP reviews.

Recommendation 1: The review team recommended 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. (Carryover from the 2006 IMPEP review)

Status: The Program is funded by licensing and registration fees. The funds are placed into a retained revenue account and the Program is allowed to retain a certain amount of the revenue from its annual fees and is capped at that point.

The Program is reviewing the need to increase the cap and evaluating the Program fees relative to NRC and other Agreement State fees.

Staffing level weaknesses identified during the last IMPEP included vacancies of clerical position, two or more technical positions and the Director position. The clerical position was filled October 11, 2011. Two technical positions were filled January 3, 2011 and May 13, 2013. The Director position was filled March 31, 2014. Two Environmental Engineer III technical positions became vacant recently due to promotions and are funded and in the process to be filled this quarter.

Recommendation 2: The review team recommended that the Commonwealth monitor and maintain accurate information in its database so it can be used by Program management and staff as a reliable planning and tracking tool to ensure that inspections are completed within the required timeframe.

Status: This recommendation was addressed prior to the 2011 periodic meeting. The Program has completed modifications to its database to more effectively monitor and track inspections as well as licensing actions. In addition, the Program modified the database to track assigned and unassigned inspections, flag inspections approaching their due dates, and identify potential data entry errors. Tickler reports of outstanding actions are sent to managers. Individual inspectors and license reviewers receive weekly tickler reports listing their respective outstanding actions. The Program, through its Radioactive Materials Unit Supervisor and Inspections Supervisor, check status of inspections on a weekly basis and make inspection assignments at least three months before the due date.

Recommendation 3: The review team recommended that the Commonwealth routinely perform accompaniments of each inspector, at least annually, to ensure quality and consistency in the inspection program.

Status: Supervisory accompaniments are performed to ensure quality and consistency in the inspection program and are documented on a supervisor accompaniment form which is monitored quarterly by the Radioactive Materials Unit Supervisor.

The Program completed all but one supervisory accompaniment in calendar year 2011. All supervisory accompaniments were completed in calendar year 2012 and in 2013.

For 2014, one supervisory accompaniment is complete and the remainders are scheduled to be completed.

Recommendation 4: The review team recommended that the Commonwealth take necessary steps to ensure that all reportable events are submitted and updated to NRC in accordance with FSME Procedure SA-300. (Carryover recommendation from the 2002 IMPEP review)

Status: The 2010 IMPEP review team determined that five out of 51 events were not reported to NRC in a timely manner and timely follow up information was not provided for nine events which were still open in the Nuclear Material Events Database (NMED).

Since the IMPEP review, the Program has addressed the open events in NMED.

The Program has reported 56 new events to NRC. Two of these events were not reported in a timely manner. Neither of these incidents involved significant health and safety or security issues and did not have generic implications.

Of those 56 new events reported since last IMPEP, 53 are closed. For the three that remain open, timely initial report and updates have been provided by the Program to NMED in accordance with SA-300.

Recommendation 5: The review team recommended that the Commonwealth adopt regulations necessary for compatibility within the required 3-year period. (Carryover from the 2006 IMPEP review; modified in the 2010 IMPEP review)

Status: Since last IMPEP, the Program has submitted 12 regulation amendments to NRC for review. The Program addressed comments that were received by NRC between June 23, 2010 and January 19, 2011 and promulgated final regulations that were published March 2, 2012 that addressed those comments. The as published regulations were sent to NRC and NRC performed a more detailed review resulting in 12 additional NRC comments. The Program addressed nine of those 12 comments through regulatory ammendment in 2013. Three remaining comments will be addressed through the submission to the Commonwealth’s Public Health Council in a future rulemaking. The Program currently has no overdue regulations.

Recommendation 6: The review team recommended that the Commonwealth reissue the certificate MA0555-S-102-S to contain a table indicating radiation levels under maximum loading conditions.

Status: Registration certificate MA-0555-S-102-S has been revised to include a table of radiation levels under maximum loading conditions. The revised certificate has been posted in the SS&D Registry.

Recommendation 7: The review team recommended that the Commonwealth make corrections to

registration certificate MA-0166-D-102-B. (Carryover recommendation from the 2002 and 2006 IMPEP reviews)

Status: The new registration certificate with the proper model number (HUB-77A) was completed on July 23, 2010. This certificate was posted in the SS&D Registry with the new registration number MA-1287-D-103-B and subsequently inactivated on September 2, 2010 and posted as MA-1287-D-801-B.

Recommendation 8: The review team recommended that the Commonwealth reissue registration certificate MA-8154-D-803-B with the complete text or equivalent form. (Carryover recommendation from the 2006 IMPEP review; modified in the 2010 IMPEP review)

Status: The Program provided, with letter to NRC dated January 28, 2011, copy of the reissued registration, equivalent form that includes cover page of the registration certificate NR-143-D-103-B and the inactivated certificate MA-8154-D-803-B for posting in the SS&D Registry. The specifics of this case are described in the letter and the reissued registration has been accepted by NRC and posted to the SS&D Registry.

COMMON PERFORMANCE INDICATORS

I. Technical Staffing and Training

2. Please provide the following organization charts, including names and positions:

(a) A chart showing positions from the Governor down to the Radiation Control Program Director;

Governor ► Secretary, Executive Office of Health and Human Services ► Commissioner, Department of Public Health ► Associate Commissioner, Bureau of Environmental Health ► Director, Radiation Control Program

(b) A chart showing positions of the radiation control program, including management; and

(c) Equivalent charts for sealed source and device evaluation, low-level radioactive waste and uranium recovery programs, if applicable.

Sealed source and device evaluations are performed by John Sumares, Kenath Traegde, and Joshua Daehler, their positions shown in the chart of the Radiation Control Program. Low-level radioactive waste fee and survey collection activities are performed by William Sellers, his position shown in the chart of the Radiation Control Program.

3. Please provide a staffing plan, or complete a listing using the suggested format below, of the professional (technical) full-time equivalents (FTE) applied to the radioactive materials program by individual. Include the name, position, and, for Agreement States, the fraction of time spent in the following areas: administration, materials licensing & compliance, emergency response, low-level radioactive waste, uranium recovery, other. If these regulatory responsibilities are divided between offices, the table should be consolidated to include all personnel contributing to the radioactive materials program.

If consultants were used to carry out the program's radioactive materials responsibilities, include their efforts. The table heading should be:

Name

Position

Area of Effort

FTE%

Jack Priest

Director

Administration

Emergency response

45

5

Joshua Daehler

Radioactive Materials Unit Supervisor (Promotion effective December 5, 2011)

Materials licensing & compliance

Emergency response

Other (SS&D)

Other (Regulations)

75

5

10

10

Kenath Traegde

Licensing Supervisor


Emergency response

Other (SS&D)

70

5

25

Anthony (Tony) Carpenito

Inspection Supervisor (Promotion effective June 16, 2014)


Emergency response

95

5

John Sumares

Radiation Control Officer


Emergency response

Other (SS&D)

50

5

45

Bruce Packard



Emergency response

95

5

Doug Cullen



Emergency response

95

5

Ed Salomon



Emergency response

95

5

Vacant



Emergency response

95

5

Vacant



Emergency response

95

5

Mario Iannaccone

Planning / Monitoring Unit Supervisor


Emergency response

15

10

Michael Whalen

Nonionizing / Industrial X-Ray / Accelerator Unit Supervisor


Emergency response

20

5

William Sellers

Program Coordinator

Other (General Licensing)

Other (Low-Level Radioactive Waste)

10

40

Judy Garbati

Materials Clerk

Other (Clerical)

100

Mark DeLorenzo

Clerk

Other (Clerical)

50

4. Please provide a listing of all new professional personnel hired into your radioactive materials program since the last review, indicate the date of hire; the degree(s) they received, if applicable; additional training; and years of experience in health physics or other disciplines, as appropriate.

Name

Date of Hire

Degree(s)

Additional Training

Years of Experience in Health Physics

Doug Cullen

January 3, 2011

M.S. in Oceanography

Extensive, see below

20

Edward Salomon

May 13, 2013

B.A in Biology


30

Jack Priest

March 31, 2014

B.S. in Radiological Health Physics

25

Doug Cullen’s additional training includes NRC Brachytherapy, Gamma Knife and other Medical Uses of Byproduct Material Course (H-313); Transportation of Radioactive Materials Course (H-308); NRC Materials Control & Security Systems & Principles (S-201); Inspection Procedures (G-108); Licensing Procedures (G-109); Industrial Radiography (H-305); 8 Hour Health & Safety Refresher Training for Hazardous Waste Site Activities per 29 CFR 1910.120; and on-the-job training.

Edward Salomon’s additional training includes Fundamental Health Physics I and II (H-122); Inspection Procedures (G-108); Licensing Procedures (G-109); Sealed Source and Device Workshop; 8 Hour Health & Safety Refresher Training for Hazardous Waste Site Activities per 29 CFR 1910.120; and on-the-job training.

5. Please list all professional staff who have not yet met the qualification requirements for a radioactive materials license reviewer or inspector. For each, list the courses or equivalent training/experience they need and a tentative schedule for completion of these requirements.

Edward Salomon; Courses or equivalent training/experience needed include Brachytherapy, Gamma Knife and other Medical Uses of Byproduct Material Course (H-313); Nuclear Medicine (H-304); Transportation of Radioactive Materials Course (H-308); NRC Materials Control & Security Systems & Principles (S-201); Radiography (H-305) and additional on-the-job training. Tentative schedule for completion of these requirements is March 2015.

6. Identify any changes to your qualification and training procedure that occurred during the review period.

No changes.

7. Please identify the technical staff that left your radioactive materials program during the review period and indicate the date they left.

Salifu Dakubu, Radioactive Materials Unit Supervisor; Retired on May 31, 2011.

Maureen Ingaharro, Radiation Control Officer; Resigned on April 30, 2012.

Robert (Bob) Gallaghar, Deputy Director; Resigned on November 9, 2012.

Michael Whalen, Jr., Inspection Supervisor; Promoted to Nonionizing / Industrial X-Ray / Accelerator Unit Supervisor on January 12, 2014. Michael continues to provide some support of our radioactive materials program.

Mario Iannaccone, Radiation Control Officer; Promoted to Planning / Monitoring Unit Supervisor on February 3, 2014. Mario continues to provide some support of our radioactive materials program.

Beverly Anderson, Interim Director; returned to a management position outside of Program on March 31, 2014.

8. List any vacant positions in your radioactive materials program, the length of time each position has been vacant, and a brief summary of efforts to fill the vacancy.

One position of Radiation Control Officer has been vacant since February 3, 2014 when Mario Iannaccone was promoted from Radiation Control Officer to Planning / Monitoring Unit Supervisor. One position of Radiation Control Officer became vacant effective June 16, 2014 when Tony Carpenito was promoted from Radiation Control Officer to Inspection Supervisor. The first position is funded and was posted with application deadline of June 9, 2014 with applicants being selected for interview. The second position is funded and was posted with application deadline of July 21, 2014. An additional oversight lead position reporting directly to the Director has been posted and expected to be filled during the third quarter of this year.

9. For Agreement States, does your program have an oversight board or committee which provides direction to the program and is composed of licensees and/or members of the public? If so, please describe the procedures used to avoid any potential conflict of interest.

No.

II. Status of Materials Inspection Program

10. Please identify individual licensees or categories of licensees the State is inspecting less frequently than called for in NRC’s Inspection Manual Chapter (IMC) 2800 and explain the reason for the difference. The list only needs to include the following information: license category or licensee name and license number, your inspection interval, and rationale for the difference.

None are inspected less frequently.

11. Please provide the number of routine inspections of Priority 1, 2, and 3 licensees, as defined in IMC 2800 and the number of initial inspections that were completed during each year of the review period.

2010 Beginning July 17, 2010: 23 routine Priority 1, 2, and 3; 7 initial.

2011: 39 routine Priority 1, 2, and 3; and 21 initial.




12. Please submit a table, or a computer printout, that identifies inspections of Priority 1, 2, and 3 licensees and initial inspections that were conducted overdue.

At a minimum, the list should include the following information for each inspection that was conducted overdue during the review period:

(1) Licensee Name

(2) License Number

(3) Priority (IMC 2800)

(4) Last inspection date or license issuance date, if initial inspection

(5) Date Due

(6) Date Performed

(7) Amount of Time Overdue

(8) Date inspection findings issued

Licensee Name

License Number

Priority

Last Insp. Date or Lic. Issuance Date

Date Due

Date Performed

Days > 25% Overdue or > 1 Year for Initial

Date Insp.

Findings Issued

Pharmalucence, Inc.

20-9734

2

10/14/2005

10/14/2007

9/24/2010

894

10/1/2010

Steward Saint Anne’s Hospital

44-0009

2

9/17/2009

9/17/2011

10/10/2012

207

10/30/2012

Cape Cod Hospital

44-0164

2

3/7/2008

3/7/2010

12/2/2011

453

2/15/2012

Beth Israel - Milton

44-0050

3

8/3/2005

8/3/2008

10/6/2010

520

10/8/2010

Lawrence General Hospital

44-0085

3

8/26/2005

8/26/2008

10/15/2010

506

10/22/2010

IBA Molecular North America

41-0618

2, Initial

12/18/2009

12/18/2009

1/10/2011

22

2/17/2011

13. Please submit a table or computer printout that identifies any Priority 1, 2, and 3 licensees and initial inspections that are currently overdue, per IMC 2800. At a minimum, the list should include the same information for each overdue inspection provided for Question 12 plus your action plan for completing the inspection. Also include your plan for completing the overdue inspections.

There are currently no overdue inspections for Priority 1, 2, and 3 licensees.

One initial inspection, though initiated, is currently overdue because the dredging vessel containing the licensed materials has been out to sea and we intended to include onsite inspection of licensed materials in vessel when next docked at its Massachusetts location authorized by the license instead of only completing a paperwork inspection for this case. The licensee is Cashman Dredging and Marine Contracting, License No. 48-0680, Priority 5, License issued on 2/5/2013.

14. Please provide the number of reciprocity licensees that were candidates for inspection per year as described in IMC 1220 and indicate the number of reciprocity inspections of candidate licensees that were completed each year during the review period.

Year

Candidates

Candidates Inspected

2010

15

4

2011

12

5

2012

12

6

2013

18

6

2014

12

4

III. Technical Quality of Inspections

15. What, if any, changes were made to your written inspection procedures during the reporting period?

Effective August 23, 2012, and though already implemented in practice, written policy was made for performance of increased controls inspections at same priority as for routine inspections and for inspection of NSTS (National Source Tracking System) requirements during increased controls inspections for licensees subject to increased controls and during routine inspection for licensees subject to NRC Orders instead of increased controls.

16. Prepare a table showing the number and types of supervisory accompaniments made during the review period. Include:

Inspector SupervisorLicense CategoryDate

M.I.

A.C.

03226

9/28-29/2010

A.C.

M.I.

02513; 02511

10/29&11/1/2010

A.C.

M.W.

03226

7/5/2011

M.I.

M.W.

03620

7/8/2011

M.I.

A.C.

02111

11/3&5/2010

B.P.

M.W.

03521

9/16/2011

J.S.

B.G.

03510

9/21/2011

M.I.

M.W.

03620

9/23/2011

J.D.

M.W.

03214; 03240

9/26/2011

M.W.

J.D.

02120

4/6/2012

B.P.

J.D.

03510

9/6/2012

A.C.

J.D.

03310; 03320

10/17&24/2012

J.S.

B.G.

03211

11/9/2012

M.I.

J.D.

02120

11/30/2012

D.C.

J.D.

03121

12/6&11/2012

D.C.

J.D.

03620

2/12/2013

A.C.

J.D.

03121

9/27/2013

J.S.

J.D.

03240; 03214

10/2/2013

B.P.

J.D.

03620

11/7&14/2013

M.W.

J.D.

03620

11/19/2013

M.I.

J.D.

03620

12/4/2013

D.C.

J.D.

02121

3/24/2014

17. Describe or provide an update on your instrumentation, methods of calibration, and laboratory capabilities. Are all instruments properly calibrated at the present time? Were there sufficient calibrated instruments available throughout the review period?

Typical instrumentation available to the Program is identified in the following table:

Survey Instruments used by inspectors are calibrated by persons specifically licensed by Agreement States to perform calibrations to include by Atlantic Nuclear of Massachusetts and Ludlum Measurements of Texas. Laboratory type instrumentation used at the Massachusetts Environmental Radiation Laboratory is calibrated in accordance with the model procedures contained in Appendix J of U.S. NRC NUREG-1556, Volume 7, Revision 1, Draft Report published January 2014.

All instruments actually in use by inspectors are properly calibrated at this time. There were sufficient calibrated instruments available throughout the review period.

IV. Technical Quality of Licensing Actions

18. How many specific radioactive material licenses does your program regulate at this time?

444.

19. Please identify any major, unusual, or complex licenses which were issued, received a major amendment, were terminated, decommissioned, submitted a bankruptcy notification or renewed in this period.

Major, unusual or complex licenses and SS&D registrations are identified below by Docket No.

Docket No. 12-9906: New license, major license requiring increased controls.

Docket No. 24-0562: Amended License, complex license for use authorization of specific registered model sealed sources not specifically approved in registration for specific model device.

Docket No. 20-0392: New license, unusual license requiring coordination with NRC for voluntary NRC Order.

Docket No. 03-9555: New license, major license, radioactive materials production using accelerators.

Docket No. 14-0070: Amended SS&D registration, complex registration that included addressing of NRC concern about an Agreement State industrial radiography licensee attaching an unapproved heavy collimator directly to a device where heavy collimator caused device adaptor part to fail and special inspection performed by Program (Docket No. 8361-15)

Docket No. 24-1101: New SS&D registration, major registration, new radiographic source changer.

Docket No. 23-1022: Renewed license, major license renewal in its entirety, medical broad scope.

Docket No. 17-0738: Terminated license, unusual license termination, last of its kind teletherapy unit in Massachusetts, included assistance provided by NSTS Helpdesk for removal of license from NSTS.

20. Discuss any variances in licensing policies and procedures or exemptions from the regulations granted during the review period.

Financial Surety Case: Exemption from decommissioning funding plan requirements of 105 CMR 120.125(C) was granted, to licensee (License No. 55-0692) for possession of up to 50 millicuries of germanium-68 contained in germanium-68/gallium-68 generator, in accordance with 105 CMR 120.006(A) and statements and representations made by licensee.

Timely Renewal Cases: Exemption from renewal application filing deadline requirements of 105 CMR 120.133(B) for non expiration of licenses was granted, to licensees (License Nos. 60-0096; 44-0042; 48-0574; 60-0055; 60-0037; 19-7610; 19-3841; 44-0085), extending application filing deadlines for periods of between 2 and 3 months, in accordance with 105 CMR 120.006(A) and statements and representations made by licensee.

21.What, if any, changes were made in your written licensing procedures (new procedures, updates, policy memoranda, etc.) during the reporting period?

Effective December 7, 2011, written policy was made for License and SS&D Reviewers to obtain review and written approval of completed new licenses, license terminations and new SS&D registrations from Radioactive Materials Unit Supervisor prior to issuance of new licenses, license terminations and new SS&D registrations.

22. Identify by licensee name and license number any renewal applications that have been pending for one year or more. Please indicate why these reviews have been delayed and describe your action plan to reduce the backlog.

None.

V. Technical Quality of Incident and Allegation Activities

23. For Agreement States, please provide a list of any reportable incidents not previously submitted to NRC (See Procedure SA-300, Reporting Material Events, for additional guidance, OMB clearance number 3150-0178). The list should be in the following format:

Licensee Name License # Date of Incident/Report Type of Incident

None.

24.Identify any changes to your procedures for responding to incidents and allegations that occurred during the period of this review.

Effective April 8, 2014, a written expectation was provided to the RCP staff. This expectation requires Director’s concurrence for review of reportable events prior to NRC notification. This expectation may be delegated allowing a timely notification and provide increased management oversight to ensure accurate information is communicated from the department to the NRC.

B. NON-COMMON PERFORMANCE INDICATORS

I. Compatibility Requirements

25. Please list all currently effective legislation that affects the radiation control program. Denote any legislation that was enacted or amended during the review period.

Massachusetts Department of Public Health Radiation Control Statutes: M.G.L. c. 111 §§2, 3, 4F, 5K, 5L, 5M, 5O, 5P, 5Q. Administrative Procedures Act: M.G.L. c. 30A. Conflict of Interest Law: M.G.L. c. 268A. Low-Level Radioactive Waste Law: M.G.L. c. 111H. Labor and Industry Statutes: M.G.L. c. 149.

26. Are your regulations subject to a "Sunset" or equivalent law? If so, explain and include the next expiration date for your regulations.

No.

27. Please review and verify that the information in the enclosed State Regulation Status (SRS) sheet is correct. For those regulations that have not been adopted by the State, explain why they were not adopted, and discuss actions being taken to adopt them. If legally binding requirements were used in lieu of regulations and they have not been reviewed by NRC for compatibility, please describe their use.

The SRS sheet enclosed with the questionnaire made part of NRC scheduling letter dated February 3, 2014 was revised and updated by NRC on March 6, 2014 to reflect 2013 final as published corrections made to 105 CMR 120.000.

28.If you have not adopted all amendments within three years from the date of NRC rule promulgation, briefly describe your State's procedures for amending regulations in order to maintain compatibility with the NRC, showing the normal length of time anticipated to complete each step.

The Program has adopted all amendments that had been overdue during last IMPEP period and has adopted within three years from the date of NRC rule promulgation all amendments that became due during this IMPEP period.

II.Sealed Source and Device (SS&D) Evaluation Program

29. Prepare a table listing new and amended (including transfers to inactive status) SS&D registrations of sources and devices issued during the review period. The table heading should be:

SS&DManufacturer,

Registry Distributor or Product Type Date Type of

NumberCustom Useror UseIssuedAction

Facility Name

SSD Number:

Docket No

1st Reviewer

2nd Reviewer

Action

Action Issued Date

THERMO SCIENTIFIC PORTABLE ANALYTICAL INSTRUMENTS INC.

MA-1303-D-102-G

02-9491

JS

JD

SSDAM

6/3/2011

QSA GLOBAL, INC.

MA-1059-S-271-S

12-9408

JD

JS

SSDAM

1/10/2011

QSA GLOBAL, INC.

MA-1059-S-204-S

06-9085

JD

JS

SSDAM

10/22/2010

QSA GLOBAL, INC.

MA-1059-D-334-S

01-9474

JD

JS

SSDAM

10/21/2011

BRUKER DETECTION CORPORATION

MA-1101-D-103-B

05-9637

JD

JS

SSDAM

6/14/2011

QSA GLOBAL, INC.

MA-1059-D-334-S

14-0070

JS

JD

SSDAM

10/11/2012

QSA GLOBAL, INC.

MA-1059-D-361-S

16-0206

JS

KT

SSDAM

2/19/2013

RADIATION MONITORING DEVICE, INC, RMD IN

MA-0573-D-103-B

17-0233

JS

JD

SSDAM

8/31/2012

QSA GLOBAL, INC.

MA-1059-D-362-S

14-0615

JS

JD

SSDAM

6/28/2013


MA-1159-D-101-B

18-0281

JS

KT

SSDAM

5/9/2013

QSA GLOBAL, INC.

MA-1059-S-271-S

12-9933

JS

JD

SSDAM

3/21/2012


MA-1159-D-102-B

21-0433

JS

KT

SSDAM

5/9/2013

QSA GLOBAL, INC.

MA-1059-5-158-S

14-0108

JS

JD

SSDAM

3/27/2012

QSA GLOBAL, INC.

MA-1059-S-128-S

14-0109

JS

JD

SSDAM

3/27/2012

QSA GLOBAL, INC.

MA-1059-S-278-S

14-0110

JS

JD

SSDAM

3/27/2012

QSA GLOBAL, INC.

MA-1059-S-349-S

14-0111

JS

JD

SSDAM

3/27/2012

QSA GLOBAL, INC.

MA-1059-S-154-S

14-0112

JS

JD

SSDAM

3/27/2012

QSA GLOBAL, INC.

MA-1059-S-163-S

14-0113

JS

JD

SSDAM

3/27/2012

QSA GLOBAL, INC.

MA-1059-S-271-S

19-0302

JS

KT

SSDAM

2/19/2013

THERMO FISHER SCIENTIFIC, INC.

MA-1303-D-102-G

23-0498

JS

KT

SSDAM

11/19/2012

THERMO EGS GAUGING, INC.

MA-1287-D-106-B

14-0672

JS

JD

SSDAM

6/28/2013


MA-1287-D-107-B

14-0673

JS

JD

SSDAM

6/28/2013

QSA GLOBAL, INC.

MA-1059-D-365-S

13-0578

JS

JD

SSDAM

6/28/2013

QSA GLOBAL, INC.

MA-1059-D-369-S

21-0950

JS

KT

SSDAM

12/9/2013

QSA GLOBAL, INC.

MA-1059-D-370-S

22-0999

JS

KT

SSDAM

2/4/2014

QSA GLOBAL, INC.

MA-1059-S-372-S

17-0758

JS

KT

SSDAM

8/22/2013


MA-0116-D-102-B

12-3859

JS

JD

SSDCR

8/2/2010

INDUSTRIAL NUCLEAR COMPANY, INC.

MA-0555-S-102-S

10-9324

JS

SSDCR

11/19/2010

QSA GLOBAL, INC.

MA-1059-S-371-S

17-0253

JS

SSDCR

7/3/2012

SIRTEX WILMINGTON LLC

MA-1229-D-101-S

21-0430

JS

SSDCR

12/10/2012

QSA GLOBAL, INC.

MA-1059-D-369-S

01-9437

JS

JD

SSDEV

7/20/2011

BRUKER DETECTION CORPORATION

MA-1101-D-103-B

08-9190

JS

JD

SSDEV

3/11/2011

THE CHARLES STARK DRAPER LABORATORY, INC.

MA-1340-D-101-G

02-9489

JS

JD

SSDEV

5/6/2011

QSA GLOBAL, INC.

MA-1059-D-370-S

09-9792

JS

JD

SSDEV

12/2/2011

QSA GLOBAL, INC.

MA-1059-S-371-S

12-9945

JS

KT

SSDEV

4/23/2012

QSA GLOBAL, INC.

MA-1059-S-372-S

16-0212

JS

KT

SSDEV

11/12/2012


MA-1287-D-107-B

18-0291

JS

KT

SSDEV

1/8/2013

QSA GLOBAL, INC.

MA-1059-S-375-S

19-0828

JS

KT

SSDEV

11/20/2013

PERKINELMER HEALTH SCIENCES, INC.

MA-1371-D-101-G

18-0812

JS

KT

SSDEV

10/10/2013

PERKINELMER HEALTH SCIENCES, INC.

MA-1371-D-101-G

18-0813

JS

KT

SSDEV

10/10/2013

QSA GLOBAL, INC.

MA-1059-D-377-S

24-1101

JS

KT

SSDEV

4/17/2014


MA-0116-D-104-B

07-9133

JS

JD

SSDIN

9/13/2010


MA-1287-D-103-B

07-9132

JS

JD

SSDIN

9/13/2010

SIONEX CORPORATION

MA-1233-D-101-G

02-9490

JS

JD

SSDIN

7/5/2011

ENVIRONMENTAL CHEMICALS CORPORATION

MA-1218-D-103-S

09-9242

JS

JD

SSDIN

11/19/2010

QSA GLOBAL, INC.

MA-1059-S-366-S

12-9946

JS

KT

SSDIN

5/29/2012

INDUSTRIAL NUCLEAR COMPANY, INC.

MA-0555-S-102-S

03-9536

JS

JD

SSDIN

6/3/2011

QSA GLOBAL, INC.

IL-0136-D-331-S

15-0164

JS

JD

SSDIN

9/13/2012

ABC TESTING INC.

NR-0136-D-234-S

15-0165

JS

JD

SSDIN

9/13/2012

QSA GLOBAL, INC.

NR-0136-S-167-S

15-0166

JS

JD

SSDIN

12/27/2012

QSA GLOBAL, INC.

NR-0136-S-235-S

15-0167

JS

JD

SSDIN

12/27/2012

QSA GLOBAL, INC.

NR-0136-D-217-S

15-0168

JS

JD

SSDIN

12/27/2012

QSA GLOBAL, INC.

NR-0136-S-110-U

15-0169

JS

JD

SSDIN

12/27/2012

PHOTOVAC, INC.

MA-1181-D-101-B

16-0185

JS

JD

SSDIN

5/21/2013

QSA GLOBAL, INC.

MA-1059-S-129-S

05-9619

JD

JS

SSDIN

7/18/2011

QSA GLOBAL, INC.

MA-1059-S-123-S

05-9620

JS

JD

SSDIN

7/18/2011


MA-0116-D-103-B

13-0055

JS

JD

SSDIN

7/3/2012

QSA GLOBAL, INC.

MA-1059-D-124-S

11-9861

JS

JD

SSDIN

3/14/2012

QSA GLOBAL, INC.

MA-1059-S-174-S

12-9934

JS

KT

SSDIN

5/31/2012

RMD INSTRUMENTS CORP. D/B/A DYNASIL PRODUCTS

MA-0573-D-103-B

14-1150

JS

KT

SSDAM

6/24/2014

PROTEC INSTRUMENT CORP.

MA-1383-D-101-B

17-1310

JS

KT

SSDEV

6/25/2014

SS&D product type and use codes are identified on each registration. The registration numbers on the listed SS&D registrations are those acted upon and in some cases, such as for in-activations, changed to a different number. The information is available in our files and also in the national Sealed Source and Device Registry.

30. Please include information on the following questions in Section A, as they apply to the SS&D Program:

Technical Staffing and Training - Questions 2-9

Technical Quality of Licensing Actions - Questions 18-22

Technical Quality of Incident and Allegation Activities - Questions 23-24

The SS&D program is part of the materials program and is integrated into all the sections of this questionnaire.

III. Low-level Radioactive Waste Disposal Program

31. Please include information on the following questions in Section A, as they apply to the Low-Level Radioactive Waste Disposal Program:


Status of Materials Inspection Program - Questions 10-14

Technical Quality of Inspections - Questions 15-17



IV. Uranium Recovery Program

32. Please include information on the following questions in Section A, as they apply to the Uranium Recovery Program:


Status of Materials Inspection Program - Questions 10-14

Technical Quality of Inspections - Questions 15-17



MATERIALS REQUESTED TO BE AVAILABLE FOR

THE ON-SITE PORTION OF AN IMPEP REVIEW

Please have the following information available for use by the IMPEP review team when they arrive at your office:

· List of open license cases, with date of original request, and dates of follow-up actions.

· List of licenses terminated during review period.

· Copy of current log or other document used to track licensing actions.

· List of all licensing actions completed during the review period (sorted by license reviewer, if possible).

· Copy of current log or other document used to track inspections.

· List of all inspections completed during the review period (sorted by inspector, if possible).

· List of inspection frequencies by license type.

· List of all allegations occurring during the review period. Show whether the allegation is open or closed and whether it was referred by NRC.

· List of all licenses that your agency has imposed additional security requirements upon.

ALSO, PLEASE HAVE THE FOLLOWING DOCUMENTS AVAILABLE:

·

Enclosure 1

· All State regulations

· Statutes affecting the regulatory authority

of the State program

· Standard license conditions

· Technical procedures for licensing,

model licenses, review guides

· SS&D review procedures, guides, and

standards

· Instrument calibration records

· Inspection procedures and guides

· Inspection report forms Documented training plan, if applicable

· Records of results of supervisory accompaniments of inspectors

· Emergency plan and communications list

· Procedures for investigating allegations

· Procedures for investigating incidents

· Enforcement procedures, including procedures for escalated enforcement, severity levels, civil penalties

(as applicable)

· Job description

Enclosure 1

Approved by OMB1

No. 3150-0183 Expires 11/30/2013

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM

QUESTIONNAIRE Massachusetts Department of Public Health Reporting Period: July 17, 2010 to August 1, 2014 AS OF JUNE 25, 2014 Note: If there has been no change in the response to a specific question since the last IMPEP

questionnaire, the State or Region may copy the previous answer, if appropriate.

A. GENERAL

1. Please prepare a summary of the status of the State's or Region's actions taken in response to each of the open recommendations from previous IMPEP reviews.

Recommendation 1: The review team recommended 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. (Carryover from the 2006 IMPEP review) Status: The Program is funded by licensing and registration fees. The funds are placed into a retained revenue account and the Program is allowed to retain a certain amount of the revenue from its annual fees and is capped at that point. The Program is reviewing the need to increase the cap and evaluating the Program fees relative to NRC and other Agreement State fees. Staffing level weaknesses identified during the last IMPEP included vacancies of clerical position, two or more technical positions and the Director position. The clerical position was filled October 11, 2011. Two technical positions were filled January 3, 2011 and May 13, 2013. The Director position was filled March 31, 2014. Two Environmental Engineer III technical positions became vacant recently due to promotions and are funded and in the process to be filled this quarter. Recommendation 2: The review team recommended that the Commonwealth monitor and maintain accurate information in its database so it can be used by Program management and staff as a reliable planning and tracking tool to ensure that inspections are completed within the required timeframe.

Status: This recommendation was addressed prior to the 2011 periodic meeting. The Program has completed modifications to its database to more effectively monitor and track inspections as well as licensing actions. In addition, the Program modified the database to track assigned and unassigned 1 This information request has previously been approved by OMB 3150-0183 and was resubmitted to OMB for review of continued approval of information collection. Estimated burden per response to comply with this voluntary collection request: 53 hours. Forward comments regarding burden estimate to the Records Management Branch (T-5 F52), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, and to the Paperwork Reduction Project (3150-0183), Office of Management and Budget, Washington, DC 20503. If an information collection does not display a currently valid OMB control number, NRC may not conduct or sponsor, and a person is not required to respond to, the information collection.

inspections, flag inspections approaching their due dates, and identify potential data entry errors. Tickler reports of outstanding actions are sent to managers. Individual inspectors and license reviewers receive weekly tickler reports listing their respective outstanding actions. The Program, through its Radioactive Materials Unit Supervisor and Inspections Supervisor, check status of inspections on a weekly basis and make inspection assignments at least three months before the due date.

Recommendation 3: The review team recommended that the Commonwealth routinely perform accompaniments of each inspector, at least annually, to ensure quality and consistency in the inspection program.

Status: Supervisory accompaniments are performed to ensure quality and consistency in the inspection program and are documented on a supervisor accompaniment form which is monitored quarterly by the Radioactive Materials Unit Supervisor.

The Program completed all but one supervisory accompaniment in calendar year 2011. All supervisory accompaniments were completed in calendar year 2012 and in 2013.

For 2014, one supervisory accompaniment is complete and the remainders are scheduled to be completed.

Recommendation 4: The review team recommended that the Commonwealth take necessary steps to ensure that all reportable events are submitted and updated to NRC in accordance with FSME Procedure SA-300. (Carryover recommendation from the 2002 IMPEP review)

Status: The 2010 IMPEP review team determined that five out of 51 events were not reported to NRC in a timely manner and timely follow up information was not provided for nine events which were still open in the Nuclear Material Events Database (NMED).

Since the IMPEP review, the Program has addressed the open events in NMED.

The Program has reported 56 new events to NRC. Two of these events were not reported in a timely manner. Neither of these incidents involved significant health and safety or security issues and did not have generic implications.

Of those 56 new events reported since last IMPEP, 53 are closed. For the three that remain open, timely initial report and updates have been provided by the Program to NMED in accordance with SA-300.

Recommendation 5: The review team recommended that the Commonwealth adopt regulations necessary for compatibility within the required 3-year period. (Carryover from the 2006 IMPEP review; modified in the 2010 IMPEP review)

Status: Since last IMPEP, the Program has submitted 12 regulation amendments to NRC for review. The Program addressed comments that were received by NRC between June 23, 2010 and January 19, 2011 and promulgated final regulations that were published March 2, 2012 that addressed those comments. The as published regulations were sent to NRC and NRC performed a more detailed review resulting in 12 additional NRC comments. The Program addressed nine of those 12 comments through regulatory ammendment in 2013. Three remaining comments will be addressed through the submission to the Commonwealth’s Public Health Council in a future rulemaking. The Program currently has no overdue regulations.

Recommendation 6: The review team recommended that the Commonwealth reissue the certificate MA0555-S-102-S to contain a table indicating radiation levels under maximum loading conditions.

Status: Registration certificate MA-0555-S-102-S has been revised to include a table of radiation levels under maximum loading conditions. The revised certificate has been posted in the SS&D Registry. Recommendation 7: The review team recommended that the Commonwealth make corrections to registration certificate MA-0166-D-102-B. (Carryover recommendation from the 2002 and 2006 IMPEP reviews) Status: The new registration certificate with the proper model number (HUB-77A) was completed on July 23, 2010. This certificate was posted in the SS&D Registry with the new registration number MA-1287-D-103-B and subsequently inactivated on September 2, 2010 and posted as MA-1287-D-801-B. Recommendation 8: The review team recommended that the Commonwealth reissue registration certificate MA-8154-D-803-B with the complete text or equivalent form. (Carryover recommendation from the 2006 IMPEP review; modified in the 2010 IMPEP review) Status: The Program provided, with letter to NRC dated January 28, 2011, copy of the reissued registration, equivalent form that includes cover page of the registration certificate NR-143-D-103-B and the inactivated certificate MA-8154-D-803-B for posting in the SS&D Registry. The specifics of this case are described in the letter and the reissued registration has been accepted by NRC and posted to the SS&D Registry. COMMON PERFORMANCE INDICATORS

I. Technical Staffing and Training

2. Please provide the following organization charts, including names and positions:

(a) A chart showing positions from the Governor down to the Radiation Control Program Director;

Governor ► Secretary, Executive Office of Health and Human Services ► Commissioner, Department of Public Health ► Associate Commissioner, Bureau of Environmental Health ► Director, Radiation Control Program

(b) A chart showing positions of the radiation control program, including management; and

(c) Equivalent charts for sealed source and device evaluation, low-level radioactive waste and uranium recovery programs, if applicable.

Sealed source and device evaluations are performed by John Sumares, Kenath Traegde, and Joshua Daehler, their positions shown in the chart of the Radiation Control Program. Low-level radioactive waste fee and survey collection activities are performed by William Sellers, his position shown in the chart of the Radiation Control Program.

3. Please provide a staffing plan, or complete a listing using the suggested format below, of the professional (technical) full-time equivalents (FTE) applied to the radioactive materials program by individual. Include the name, position, and, for Agreement States, the fraction of time spent in the following areas: administration, materials licensing & compliance, emergency response, low-level radioactive waste, uranium recovery, other. If these regulatory responsibilities are divided between offices, the table should be consolidated to include all personnel contributing to the radioactive materials program.

If consultants were used to carry out the program's radioactive materials responsibilities, include their efforts. The table heading should be:

Name Position Area of Effort FTE% Jack Priest Director Administration

Emergency response 45 5

Joshua Daehler Radioactive Materials Unit Supervisor (Promotion effective December 5, 2011)

Materials licensing & compliance Emergency response Other (SS&D) Other (Regulations)

75 5 10 10

Kenath Traegde Licensing Supervisor Materials licensing & compliance Emergency response Other (SS&D)

70 5 25

Anthony (Tony) Carpenito

Inspection Supervisor (Promotion effective June 16, 2014)

Materials licensing & compliance Emergency response

95 5

John Sumares Radiation Control Officer

Materials licensing & compliance Emergency response Other (SS&D)

50 5 45

Bruce Packard Radiation Control Officer


95 5

Doug Cullen Radiation Control Officer


95 5

Ed Salomon Radiation Control Officer


95 5

Vacant Radiation Control Officer


95 5

Vacant Radiation Control Officer


95 5

Mario Iannaccone Planning / Monitoring Unit Supervisor


15 10

Michael Whalen Nonionizing / Industrial X-Ray / Accelerator Unit Supervisor


20 5

William Sellers Program Coordinator Other (General Licensing) Other (Low-Level Radioactive Waste)

10 40

Judy Garbati Materials Clerk Other (Clerical) 100 Mark DeLorenzo Clerk Other (Clerical) 50

4. Please provide a listing of all new professional personnel hired into your radioactive materials program since the last review, indicate the date of hire; the degree(s) they received, if applicable; additional training; and years of experience in health physics or other disciplines, as appropriate.

Name Date of Hire Degree(s) Additional Training Years of

Experience in Health Physics

Doug Cullen January 3, 2011 M.S. in Oceanography


20

Edward Salomon May 13, 2013 B.A in Biology Extensive, see below

30

Jack Priest March 31, 2014 B.S. in Radiological Health Physics

25

Doug Cullen’s additional training includes NRC Brachytherapy, Gamma Knife and other Medical Uses of Byproduct Material Course (H-313); Transportation of Radioactive Materials Course (H-308); NRC Materials Control & Security Systems & Principles (S-201); Inspection Procedures (G-108); Licensing Procedures (G-109); Industrial Radiography (H-305); 8 Hour Health & Safety Refresher Training for Hazardous Waste Site Activities per 29 CFR 1910.120; and on-the-job training. Edward Salomon’s additional training includes Fundamental Health Physics I and II (H-122); Inspection Procedures (G-108); Licensing Procedures (G-109); Sealed Source and Device Workshop; 8 Hour Health & Safety Refresher Training for Hazardous Waste Site Activities per 29 CFR 1910.120; and on-the-job training.

5. Please list all professional staff who have not yet met the qualification requirements for a radioactive materials license reviewer or inspector. For each, list the courses or equivalent training/experience they need and a tentative schedule for completion of these requirements.

Edward Salomon; Courses or equivalent training/experience needed include Brachytherapy, Gamma Knife and other Medical Uses of Byproduct Material Course (H-313); Nuclear Medicine (H-304); Transportation of Radioactive Materials Course (H-308); NRC Materials Control & Security Systems & Principles (S-201); Radiography (H-305) and additional on-the-job training. Tentative schedule for completion of these requirements is March 2015.

6. Identify any changes to your qualification and training procedure that occurred during the review period.

No changes.

7. Please identify the technical staff that left your radioactive materials program during the review period and indicate the date they left.

Salifu Dakubu, Radioactive Materials Unit Supervisor; Retired on May 31, 2011. Maureen Ingaharro, Radiation Control Officer; Resigned on April 30, 2012. Robert (Bob) Gallaghar, Deputy Director; Resigned on November 9, 2012. Michael Whalen, Jr., Inspection Supervisor; Promoted to Nonionizing / Industrial X-Ray / Accelerator Unit Supervisor on January 12, 2014. Michael continues to provide some support of our radioactive materials program.

Mario Iannaccone, Radiation Control Officer; Promoted to Planning / Monitoring Unit Supervisor on February 3, 2014. Mario continues to provide some support of our radioactive materials program. Beverly Anderson, Interim Director; returned to a management position outside of Program on March 31, 2014.

8. List any vacant positions in your radioactive materials program, the length of time each position has been vacant, and a brief summary of efforts to fill the vacancy.

One position of Radiation Control Officer has been vacant since February 3, 2014 when Mario Iannaccone was promoted from Radiation Control Officer to Planning / Monitoring Unit Supervisor. One position of Radiation Control Officer became vacant effective June 16, 2014 when Tony Carpenito was promoted from Radiation Control Officer to Inspection Supervisor. The first position is funded and was posted with application deadline of June 9, 2014 with applicants being selected for interview. The second position is funded and was posted with application deadline of July 21, 2014. An additional oversight lead position reporting directly to the Director has been posted and expected to be filled during the third quarter of this year.

9. For Agreement States, does your program have an oversight board or committee which provides direction to the program and is composed of licensees and/or members of the public? If so, please describe the procedures used to avoid any potential conflict of interest.

No.

II. Status of Materials Inspection Program

10. Please identify individual licensees or categories of licensees the State is inspecting less frequently than called for in NRC’s Inspection Manual Chapter (IMC) 2800 and explain the reason for the difference. The list only needs to include the following information: license category or licensee name and license number, your inspection interval, and rationale for the difference.

None are inspected less frequently. 11. Please provide the number of routine inspections of Priority 1, 2, and 3 licensees, as

defined in IMC 2800 and the number of initial inspections that were completed during each year of the review period.

2010 Beginning July 17, 2010: 23 routine Priority 1, 2, and 3; 7 initial. 2011: 39 routine Priority 1, 2, and 3; and 21 initial. 2012: 42 routine Priority 1, 2, and 3; and 17 initial. 2013: 48 routine Priority 1, 2, and 3; and 11 initial. 2014: 16 routine Priority 1, 2, and 3; and 8 initial. 12. Please submit a table, or a computer printout, that identifies inspections of Priority 1, 2,

and 3 licensees and initial inspections that were conducted overdue. At a minimum, the list should include the following information for each inspection that

was conducted overdue during the review period:

(1) Licensee Name (2) License Number (3) Priority (IMC 2800)

(4) Last inspection date or license issuance date, if initial inspection (5) Date Due (6) Date Performed (7) Amount of Time Overdue (8) Date inspection findings issued

Licensee Name License

Number Priority Last Insp.

Date or Lic. Issuance Date

Date Due Date Performed

Days > 25% Overdue or > 1 Year for Initial

Date Insp. Findings Issued

Pharmalucence, Inc.

20-9734 2 10/14/2005 10/14/2007 9/24/2010 894 10/1/2010

Steward Saint Anne’s Hospital

44-0009 2 9/17/2009 9/17/2011 10/10/2012 207 10/30/2012

Cape Cod Hospital

44-0164 2 3/7/2008 3/7/2010 12/2/2011 453 2/15/2012

Beth Israel – Milton

44-0050 3 8/3/2005 8/3/2008 10/6/2010 520 10/8/2010

Lawrence General Hospital

44-0085 3 8/26/2005 8/26/2008 10/15/2010 506 10/22/2010

IBA Molecular North America

41-0618 2, Initial 12/18/2009 12/18/2009 1/10/2011 22 2/17/2011

13. Please submit a table or computer printout that identifies any Priority 1, 2, and 3 licensees and initial inspections that are currently overdue, per IMC 2800. At a minimum, the list should include the same information for each overdue inspection provided for Question 12 plus your action plan for completing the inspection. Also include your plan for completing the overdue inspections.

There are currently no overdue inspections for Priority 1, 2, and 3 licensees. One initial inspection, though initiated, is currently overdue because the dredging vessel containing the licensed materials has been out to sea and we intended to include onsite inspection of licensed materials in vessel when next docked at its Massachusetts location authorized by the license instead of only completing a paperwork inspection for this case. The licensee is Cashman Dredging and Marine Contracting, License No. 48-0680, Priority 5, License issued on 2/5/2013.

14. Please provide the number of reciprocity licensees that were candidates for inspection per year as described in IMC 1220 and indicate the number of reciprocity inspections of candidate licensees that were completed each year during the review period.

Year Candidates Candidates Inspected 2010 15 4 2011 12 5 2012 12 6 2013 18 6 2014 12 4

III. Technical Quality of Inspections

15. What, if any, changes were made to your written inspection procedures during the reporting period?

Effective August 23, 2012, and though already implemented in practice, written policy was made

for performance of increased controls inspections at same priority as for routine inspections and for inspection of NSTS (National Source Tracking System) requirements during increased controls inspections for licensees subject to increased controls and during routine inspection for licensees subject to NRC Orders instead of increased controls. 16. Prepare a table showing the number and types of supervisory accompaniments made

during the review period. Include:

Inspector Supervisor License Category Date M.I. A.C. 03226 9/28-29/2010 A.C. M.I. 02513; 02511 10/29&11/1/2010 A.C. M.W. 03226 7/5/2011 M.I. M.W. 03620 7/8/2011 M.I. A.C. 02111 11/3&5/2010 B.P. M.W. 03521 9/16/2011 J.S. B.G. 03510 9/21/2011 M.I. M.W. 03620 9/23/2011 J.D. M.W. 03214; 03240 9/26/2011 M.W. J.D. 02120 4/6/2012 B.P. J.D. 03510 9/6/2012 A.C. J.D. 03310; 03320 10/17&24/2012 J.S. B.G. 03211 11/9/2012 M.I. J.D. 02120 11/30/2012 D.C. J.D. 03121 12/6&11/2012 D.C. J.D. 03620 2/12/2013 A.C. J.D. 03121 9/27/2013 J.S. J.D. 03240; 03214 10/2/2013 B.P. J.D. 03620 11/7&14/2013 M.W. J.D. 03620 11/19/2013 M.I. J.D. 03620 12/4/2013 D.C. J.D. 02121 3/24/2014

17. Describe or provide an update on your instrumentation, methods of calibration, and laboratory capabilities. Are all instruments properly calibrated at the present time? Were there sufficient calibrated instruments available throughout the review period?

Typical instrumentation available to the Program is identified in the following table:

Survey Instruments used by inspectors are calibrated by persons specifically licensed by Agreement States to perform calibrations to include by Atlantic Nuclear of Massachusetts and Ludlum Measurements of Texas. Laboratory type instrumentation used at the Massachusetts Environmental Radiation Laboratory is calibrated in accordance with the model procedures contained in Appendix J of U.S. NRC NUREG-1556, Volume 7, Revision 1, Draft Report published January 2014. All instruments actually in use by inspectors are properly calibrated at this time. There were sufficient calibrated instruments available throughout the review period. IV. Technical Quality of Licensing Actions

18. How many specific radioactive material licenses does your program regulate at this time?

444. 19. Please identify any major, unusual, or complex licenses which were issued, received a

major amendment, were terminated, decommissioned, submitted a bankruptcy notification or renewed in this period.

Major, unusual or complex licenses and SS&D registrations are identified below by Docket No. Docket No. 12-9906: New license, major license requiring increased controls. Docket No. 24-0562: Amended License, complex license for use authorization of specific

registered model sealed sources not specifically approved in registration for specific model device.

Docket No. 20-0392: New license, unusual license requiring coordination with NRC for voluntary NRC Order.

Docket No. 03-9555: New license, major license, radioactive materials production using accelerators.

Docket No. 14-0070: Amended SS&D registration, complex registration that included addressing of NRC concern about an Agreement State industrial radiography licensee attaching an unapproved heavy collimator directly to a device where heavy collimator caused device adaptor part to fail and special inspection performed by Program (Docket No. 8361-15)

Docket No. 24-1101: New SS&D registration, major registration, new radiographic source changer.

Docket No. 23-1022: Renewed license, major license renewal in its entirety, medical broad scope.

Docket No. 17-0738: Terminated license, unusual license termination, last of its kind teletherapy unit in Massachusetts, included assistance provided by NSTS Helpdesk for removal of license from NSTS.

20. Discuss any variances in licensing policies and procedures or exemptions from the

regulations granted during the review period.

Financial Surety Case: Exemption from decommissioning funding plan requirements of 105 CMR 120.125(C) was granted, to licensee (License No. 55-0692) for possession of up to 50 millicuries of germanium-68 contained in germanium-68/gallium-68 generator, in accordance with 105 CMR 120.006(A) and statements and representations made by licensee.

Timely Renewal Cases: Exemption from renewal application filing deadline requirements of 105 CMR 120.133(B) for non expiration of licenses was granted, to licensees (License Nos. 60-0096; 44-0042; 48-0574; 60-0055; 60-0037; 19-7610; 19-3841; 44-0085), extending application filing deadlines for periods of between 2 and 3 months, in accordance with 105 CMR 120.006(A) and statements and representations made by licensee. 21. What, if any, changes were made in your written licensing procedures (new procedures,

updates, policy memoranda, etc.) during the reporting period?

Effective December 7, 2011, written policy was made for License and SS&D Reviewers to obtain review and written approval of completed new licenses, license terminations and new SS&D registrations from Radioactive Materials Unit Supervisor prior to issuance of new licenses, license terminations and new SS&D registrations.

22. Identify by licensee name and license number any renewal applications that have been pending for one year or more. Please indicate why these reviews have been delayed and describe your action plan to reduce the backlog.

None. V. Technical Quality of Incident and Allegation Activities

23. For Agreement States, please provide a list of any reportable incidents not previously submitted to NRC (See Procedure SA-300, Reporting Material Events, for additional guidance, OMB clearance number 3150-0178). The list should be in the following format:

Licensee Name License # Date of Incident/Report Type of Incident

None.

24. Identify any changes to your procedures for responding to incidents and allegations that

occurred during the period of this review. Effective April 8, 2014, a written expectation was provided to the RCP staff. This expectation requires Director’s concurrence for review of reportable events prior to NRC notification. This expectation may be delegated allowing a timely notification and provide increased management oversight to ensure accurate information is communicated from the department to the NRC. B. NON-COMMON PERFORMANCE INDICATORS I. Compatibility Requirements

25. Please list all currently effective legislation that affects the radiation control program. Denote any legislation that was enacted or amended during the review period.

Massachusetts Department of Public Health Radiation Control Statutes: M.G.L. c. 111 §§2, 3, 4F, 5K, 5L, 5M, 5O, 5P, 5Q. Administrative Procedures Act: M.G.L. c. 30A. Conflict of Interest Law: M.G.L. c. 268A. Low-Level Radioactive Waste Law: M.G.L. c. 111H. Labor and Industry Statutes: M.G.L. c. 149.

26. Are your regulations subject to a "Sunset" or equivalent law? If so, explain and include the next expiration date for your regulations.

No.

27. Please review and verify that the information in the enclosed State Regulation Status

(SRS) sheet is correct. For those regulations that have not been adopted by the State, explain why they were not adopted, and discuss actions being taken to adopt them. If legally binding requirements were used in lieu of regulations and they have not been reviewed by NRC for compatibility, please describe their use.

The SRS sheet enclosed with the questionnaire made part of NRC scheduling letter dated February 3, 2014 was revised and updated by NRC on March 6, 2014 to reflect 2013 final as published corrections made to 105 CMR 120.000.

28. If you have not adopted all amendments within three years from the date of NRC rule promulgation, briefly describe your State's procedures for amending regulations in order to maintain compatibility with the NRC, showing the normal length of time anticipated to complete each step.

The Program has adopted all amendments that had been overdue during last IMPEP period and has

adopted within three years from the date of NRC rule promulgation all amendments that became due during this IMPEP period.

II. Sealed Source and Device (SS&D) Evaluation Program

29. Prepare a table listing new and amended (including transfers to inactive status) SS&D registrations of sources and devices issued during the review period. The table heading should be:

SS&D Manufacturer, Registry Distributor or Product Type Date Type of Number Custom User or Use Issued Action

Facility Name SSD Number: Docket No 1st

Reviewer 2nd

Reviewer Action Action

Issued Date

THERMO SCIENTIFIC PORTABLE ANALYTICAL INSTRUMENTS INC. MA-1303-D-102-G 02-9491 JS JD SSDAM 6/3/2011 QSA GLOBAL, INC. MA-1059-S-271-S 12-9408 JD JS SSDAM 1/10/2011 QSA GLOBAL, INC. MA-1059-S-204-S 06-9085 JD JS SSDAM 10/22/2010 QSA GLOBAL, INC. MA-1059-D-334-S 01-9474 JD JS SSDAM 10/21/2011 BRUKER DETECTION CORPORATION MA-1101-D-103-B 05-9637 JD JS SSDAM 6/14/2011 QSA GLOBAL, INC. MA-1059-D-334-S 14-0070 JS JD SSDAM 10/11/2012 QSA GLOBAL, INC. MA-1059-D-361-S 16-0206 JS KT SSDAM 2/19/2013

RADIATION MONITORING DEVICE, INC, RMD IN MA-0573-D-103-B 17-0233 JS JD SSDAM 8/31/2012 QSA GLOBAL, INC. MA-1059-D-362-S 14-0615 JS JD SSDAM 6/28/2013

THERMO SCIENTIFIC PORTABLE ANALYTICAL INSTRUMENTS INC. MA-1159-D-101-B 18-0281 JS KT SSDAM 5/9/2013 QSA GLOBAL, INC. MA-1059-S-271-S 12-9933 JS JD SSDAM 3/21/2012

THERMO SCIENTIFIC PORTABLE ANALYTICAL INSTRUMENTS INC. MA-1159-D-102-B 21-0433 JS KT SSDAM 5/9/2013 QSA GLOBAL, INC. MA-1059-5-158-S 14-0108 JS JD SSDAM 3/27/2012 QSA GLOBAL, INC. MA-1059-S-128-S 14-0109 JS JD SSDAM 3/27/2012 QSA GLOBAL, INC. MA-1059-S-278-S 14-0110 JS JD SSDAM 3/27/2012 QSA GLOBAL, INC. MA-1059-S-349-S 14-0111 JS JD SSDAM 3/27/2012 QSA GLOBAL, INC. MA-1059-S-154-S 14-0112 JS JD SSDAM 3/27/2012 QSA GLOBAL, INC. MA-1059-S-163-S 14-0113 JS JD SSDAM 3/27/2012 QSA GLOBAL, INC. MA-1059-S-271-S 19-0302 JS KT SSDAM 2/19/2013 THERMO FISHER SCIENTIFIC, INC. MA-1303-D-102-G 23-0498 JS KT SSDAM 11/19/2012 THERMO EGS GAUGING, INC. MA-1287-D-106-B 14-0672 JS JD SSDAM 6/28/2013 THERMO EGS GAUGING, INC. MA-1287-D-107-B 14-0673 JS JD SSDAM 6/28/2013

Facility Name SSD Number: Docket No 1st

Reviewer 2nd

Reviewer Action Action

Issued Date QSA GLOBAL, INC. MA-1059-D-365-S 13-0578 JS JD SSDAM 6/28/2013 QSA GLOBAL, INC. MA-1059-D-369-S 21-0950 JS KT SSDAM 12/9/2013 QSA GLOBAL, INC. MA-1059-D-370-S 22-0999 JS KT SSDAM 2/4/2014 QSA GLOBAL, INC. MA-1059-S-372-S 17-0758 JS KT SSDAM 8/22/2013 THERMO EGS GAUGING, INC. MA-0116-D-102-B 12-3859 JS JD SSDCR 8/2/2010 INDUSTRIAL NUCLEAR COMPANY, INC. MA-0555-S-102-S 10-9324 JS SSDCR 11/19/2010 QSA GLOBAL, INC. MA-1059-S-371-S 17-0253 JS SSDCR 7/3/2012 SIRTEX WILMINGTON LLC MA-1229-D-101-S 21-0430 JS SSDCR 12/10/2012 QSA GLOBAL, INC. MA-1059-D-369-S 01-9437 JS JD SSDEV 7/20/2011 BRUKER DETECTION CORPORATION MA-1101-D-103-B 08-9190 JS JD SSDEV 3/11/2011

THE CHARLES STARK DRAPER LABORATORY, INC. MA-1340-D-101-G 02-9489 JS JD SSDEV 5/6/2011 QSA GLOBAL, INC. MA-1059-D-370-S 09-9792 JS JD SSDEV 12/2/2011 QSA GLOBAL, INC. MA-1059-S-371-S 12-9945 JS KT SSDEV 4/23/2012 QSA GLOBAL, INC. MA-1059-S-372-S 16-0212 JS KT SSDEV 11/12/2012 THERMO EGS GAUGING, INC. MA-1287-D-107-B 18-0291 JS KT SSDEV 1/8/2013 QSA GLOBAL, INC. MA-1059-S-375-S 19-0828 JS KT SSDEV 11/20/2013 PERKINELMER HEALTH SCIENCES, INC. MA-1371-D-101-G 18-0812 JS KT SSDEV 10/10/2013 PERKINELMER HEALTH SCIENCES, INC. MA-1371-D-101-G 18-0813 JS KT SSDEV 10/10/2013 QSA GLOBAL, INC. MA-1059-D-377-S 24-1101 JS KT SSDEV 4/17/2014 THERMO EGS GAUGING, INC. MA-0116-D-104-B 07-9133 JS JD SSDIN 9/13/2010 THERMO EGS GAUGING, INC. MA-1287-D-103-B 07-9132 JS JD SSDIN 9/13/2010 SIONEX CORPORATION MA-1233-D-101-G 02-9490 JS JD SSDIN 7/5/2011

ENVIRONMENTAL CHEMICALS CORPORATION MA-1218-D-103-S 09-9242 JS JD SSDIN 11/19/2010 QSA GLOBAL, INC. MA-1059-S-366-S 12-9946 JS KT SSDIN 5/29/2012 INDUSTRIAL NUCLEAR COMPANY, INC. MA-0555-S-102-S 03-9536 JS JD SSDIN 6/3/2011 QSA GLOBAL, INC. IL-0136-D-331-S 15-0164 JS JD SSDIN 9/13/2012 ABC TESTING INC. NR-0136-D-234-S 15-0165 JS JD SSDIN 9/13/2012 QSA GLOBAL, INC. NR-0136-S-167-S 15-0166 JS JD SSDIN 12/27/2012 QSA GLOBAL, INC. NR-0136-S-235-S 15-0167 JS JD SSDIN 12/27/2012 QSA GLOBAL, INC. NR-0136-D-217-S 15-0168 JS JD SSDIN 12/27/2012 QSA GLOBAL, INC. NR-0136-S-110-U 15-0169 JS JD SSDIN 12/27/2012 PHOTOVAC, INC. MA-1181-D-101-B 16-0185 JS JD SSDIN 5/21/2013 QSA GLOBAL, INC. MA-1059-S-129-S 05-9619 JD JS SSDIN 7/18/2011 QSA GLOBAL, INC. MA-1059-S-123-S 05-9620 JS JD SSDIN 7/18/2011 THERMO EGS GAUGING, INC. MA-0116-D-103-B 13-0055 JS JD SSDIN 7/3/2012 QSA GLOBAL, INC. MA-1059-D-124-S 11-9861 JS JD SSDIN 3/14/2012 QSA GLOBAL, INC. MA-1059-S-174-S 12-9934 JS KT SSDIN 5/31/2012 RMD INSTRUMENTS CORP. D/B/A DYNASIL PRODUCTS MA-0573-D-103-B 14-1150 JS KT SSDAM 6/24/2014 PROTEC INSTRUMENT CORP. MA-1383-D-101-B 17-1310 JS KT SSDEV 6/25/2014

SS&D product type and use codes are identified on each registration. The registration numbers on the listed SS&D registrations are those acted upon and in some cases, such as for in-activations, changed to a different number. The information is available in our files and also in the national Sealed Source and Device Registry.

30. Please include information on the following questions in Section A, as they apply to the SS&D Program:

Technical Staffing and Training - Questions 2-9 Technical Quality of Licensing Actions - Questions 18-22 Technical Quality of Incident and Allegation Activities - Questions 23-24

The SS&D program is part of the materials program and is integrated into all the sections of this questionnaire. III. Low-level Radioactive Waste Disposal Program

31. Please include information on the following questions in Section A, as they apply to the Low-Level Radioactive Waste Disposal Program:

Technical Staffing and Training - Questions 2-9 Status of Materials Inspection Program - Questions 10-14 Technical Quality of Inspections - Questions 15-17 Technical Quality of Licensing Actions - Questions 18-22 Technical Quality of Incident and Allegation Activities - Questions 23-24

IV. Uranium Recovery Program 32. Please include information on the following questions in Section A, as they apply to the

Uranium Recovery Program:

Technical Staffing and Training - Questions 2-9 Status of Materials Inspection Program - Questions 10-14 Technical Quality of Inspections - Questions 15-17 Technical Quality of Licensing Actions - Questions 18-22 Technical Quality of Incident and Allegation Activities - Questions 23-24

Attached include final revisions based on SJC review. This is OK … · 2014-07-03 ·...

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