ML18194A860

7/17/18 Letter to J. Priest Massachusetts 2018 Draft Impep Report

ML18194A860
Person / Time
Issue date:	07/17/2018
From:	Paul Michalak NRC/NMSS/DMSST/ASPB
To:	Priest J State of MA, Dept of Public Health, Radiation Control Program
Rakovan L
References
Download: ML18194A860 (23)

Text

[Type here]

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 July 17, 2018 Mr. Jack Priest, Director Radiation Control Program Commonwealth of Massachusetts Department of Public Health Schrafft Center Suite 1M2A 529 Main Street Charlestown, MA 02129

Dear Mr. Priest:

The U.S. Nuclear Regulatory Commission (NRC) uses the Integrated Materials Performance Evaluation Program (IMPEP) in the evaluation of Agreement State programs. Enclosed for your review is the draft IMPEP report, which documents the results of the Agreement State review held in Charlestown on June 11-15, 2018. The teams preliminary findings were discussed with you and your staff on the last day of the review. The review teams proposed recommendations are that the Massachusetts Agreement State Program be found adequate to protect public health and safety and compatible with the NRCs program.

The NRC conducts periodic reviews of Agreement State programs to ensure that public health and safety are adequately protected from the potential hazards associated with the use of radioactive materials and that Agreement State programs are compatible with the NRCs program. The process, titled IMPEP, employs a team of NRC and Agreement State staff to assess Agreement States and NRC Regional Offices radioactive materials programs. All reviews use common criteria in the assessment and place primary emphasis on performance.

The final determination of adequacy and compatibility of each program, based on the teams report, is made by a Management Review Board (MRB) composed of NRC managers and an Agreement State program manager who serves as a liaison to the MRB.

In accordance with procedures for implementation of IMPEP, we are providing you with a copy of the draft report for your review and comment prior to submitting the report to the MRB.

Comments are requested within 4 weeks from your receipt of this letter. This schedule will permit the issuance of the final report in a timely manner that will be responsive to your needs.

The team will review the response, make any necessary changes to the report, and issue it to the MRB as a proposed final report. The MRB meeting is scheduled for September 13, 2018, at 1:00 pm ET. The NRC will provide invitational travel for you or your designee to attend the MRB meeting at the NRC Headquarters in Rockville, Maryland. The NRC has video conferencing capability if it is more convenient for the Commonwealth to participate through this medium.

Please contact me if you desire to establish a video conference for the meeting.

J. Priest If you have any questions regarding the enclosed report, please contact me at 301-415-5804.

Thank you for your cooperation.

Sincerely,

/RA/

Paul Michalak, Chief Agreement State Programs Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards

Enclosure:

2018 Draft IMPEP Report

SUBJECT:

MASSACHUSETTS FY 2018 DRAFT IMPEP REPORT Date: July 17, 2018 Distribution:

JMiller, RI SSeeley, RI DPiccirrillo, RIII GWarren, RIII JPate, LA JTrapp, RI JNick, RI DCollins, MSST SAttack, MSST AStrainingandtravel.Resource@nrc.gov OAS Board ML18194A860 OFFICE TL ASPB:PM ASPB:BC NAME RErickson via LRakovan PMichalak email DATE 7/16/18 7/16/18 7/17/18 OFFICIAL RECORD COPY

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW OF THE MASSACHUSETTS AGREEMENT STATE PROGRAM JUNE 11-15, 2018 DRAFT REPORT Enclosure

EXECUTIVE

SUMMARY

This report presents the results of the Integrated Materials Performance Evaluation Program (IMPEP) review of the Massachusetts program. The review was conducted during the period of June 11-15, 2018, by a team comprised of technical staff members from the U.S. Nuclear Regulatory Commission (NRC) and the State of Louisiana.

Based on the results of this review, the Massachusetts Agreement State programs performance was found to be satisfactory for all the indicators evaluated.

The team did not make any new recommendations and determined that the recommendation from 2014 IMPEP review should be closed.

Accordingly, the team recommends that the Massachusetts Agreement State Program be found adequate to protect public health and safety and compatible with the NRCs program. The team recommends that the period of Monitoring be discontinued and that next IMPEP review take place in approximately 4 years with a periodic meeting in approximately 2 years.

Massachusetts Draft IMEP Report Page 1

1.0 INTRODUCTION

This report presents the results of the review of the Massachusetts Agreement State Program radioactive materials safety program. The review was conducted during the period of June 11-15, 2018, by a team comprised of technical staff members from the U.S. Nuclear Regulatory Commission (NRC) and the State of Louisiana. Team members are identified in Appendix A. The review was conducted in accordance with the Agreement State Program Policy Statement, published in the Federal Register on October 18, 2017, and NRC Management Directive (MD) 5.6, Integrated Materials Performance Evaluation Program (IMPEP), dated February 26, 2004. Preliminary results of the review, which covered the period of August 2, 2014, to June 15, 2018, were discussed with Massachusetts State Program managers on the last day of the review.

In preparation for the review, a questionnaire addressing the common performance indicators and applicable non-common performance indicators was sent to Massachusetts by electronic mail on January 29, 2018. Massachusetts provided its response to the questionnaire by electronic mail on May 23, 2018. A copy of the questionnaire response is available in the NRCs Agencywide Documents Access and Management System (ADAMS) using the Accession Number ML18151A555.

The Massachusetts Agreement State Program is administered by the Radiation Control Program (the Program) which is located within the Department of Public Health (the Department), Bureau of Environmental Health. Organization charts for Massachusetts are available in ADAMS using the Accession Number ML18151A579.

At the time of the review, the Massachusetts Agreement State Program regulated 413 specific licenses authorizing possession and use of radioactive materials. The review focused on the radioactive 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.

The team evaluated the information gathered against the established criteria for each common and the applicable non-common performance indicators and made a preliminary assessment of the Massachusetts Agreement State Programs performance.

2.0 PREVIOUS IMPEP REVIEW AND STATUS OF RECOMMENDATIONS The previous IMPEP review concluded on August 1, 2014. The final report is available in ADAMS using Accession Number ML14301A012. The results of the review and the status of the recommendation are as follows:

Technical Staffing and Training: Satisfactory Recommendation: None Status of Materials Inspection Program: Satisfactory Recommendation: None

Massachusetts Draft IMEP Report Page 2 Technical Quality of Inspections: Satisfactory but Needs Improvement Recommendation: None Technical Quality of Licensing Actions: Satisfactory but Needs Improvement Recommendation: None Technical Quality of Incident and Allegation Activities: Satisfactory but Needs Improvement Recommendation: The review team recommends that the Commonwealth strengthen its incident response program and take measures to ensure that the Programs evaluation of events is thorough, complete, properly documented to facilitate future follow-up, and undergoes appropriate management review prior to closeout. (Section 3.5 of the 2014 IMPEP report)

Status: The review team examined Massachusetts incident response program and found that inspectors assigned to follow up on each event worked closely with management to ensure that actions taken in response to incidents were thorough and comprehensive, and that inspectors reports were complete and properly documented.

Documentation of each incident reviewed by the team was found to be complete, demonstrated a thorough review of the incident, and contained clear descriptions of any findings to facilitate future follow-up. A tracking sheet included with each incident file documented the reviewer assignment, priority for response, and timely and appropriate management review of the response prior to close-out of the event. The team believes that this recommendation should be closed.

Compatibility Requirements: Satisfactory Recommendation: None Sealed Source and Device Evaluation Program: Satisfactory Recommendation: None Overall finding: Adequate to protect public health and safety, but needs improvement, and compatible with the NRC's program.

The review team also recommended, and the MRB agreed, that a period of Monitoring be initiated for Massachusetts. At the time of the review, the Program continued to be in Monitoring status.

3.0 COMMON PERFORMANCE INDICATORS Five common performance indicators are used to review the NRC regional and Agreement State radioactive materials programs. These indicators are: (1) Technical Staffing and Training; (2) Status of Materials Inspection Program; (3) Technical Quality of Inspections; (4) Technical Quality of Licensing Actions; and (5) Technical Quality of Incident and Allegation Activities.

Massachusetts Draft IMEP Report Page 3 3.1 Technical Staffing and Training The ability to conduct effective licensing and inspection programs is largely dependent on having a sufficient number of experienced, knowledgeable, well-trained technical personnel. Under certain conditions, staff turnover could have an adverse effect on the implementation of these programs, and could affect public health and safety. Apparent trends in staffing must be explored. Review of staffing also requires consideration and evaluation of the levels of training and qualification. The evaluation standard measures the overall quality of training available to, and taken by, materials program personnel.

a. Scope The team used the guidance in State Agreements procedure SA-103, Reviewing the Common Performance Indicator: Technical Staffing and Training, and evaluated Massachusetts performance with respect to the following performance indicator objectives:

• A well-conceived and balanced staffing strategy has been implemented throughout the review period.

• Agreement State training and qualification program is equivalent to NRC Inspection Manual Chapter (IMC) 1248, Formal Qualifications Program for Federal and State Material and Environmental Management Programs.

• Qualification criteria for new technical staff are established and are followed or qualification criteria will be established if new staff members are hired.

• Any vacancies, especially senior-level positions, are filled in a timely manner.

• There is a balance in staffing of the licensing and inspection programs.

• Management is committed to training and staff qualification.

• Individuals performing materials licensing and inspection activities are adequately qualified and trained to perform their duties.

• License reviewers and inspectors are trained and qualified in a reasonable period of time.

b. Discussion The Massachusetts Agreement State Program is comprised of 16 staff members which equals 9.2 full time equivalents for the radioactive materials program when fully staffed.

At the time of the review, there were no vacancies. During the review period, three staff members left the program and five staff members were hired. On average, positions were vacant from 7 to 9 months. All employees hired during this review period have science degrees with three having a master of science. Massachusetts has a training and qualification program compatible with the NRCs IMC 1248.

Department management is very supportive of the training program. The five most recent hires have attended a combined 50 NRC training courses since September 2014.

Continuing education is promoted and tracked by the Materials Unit Supervisor. The training qualification record that is used to track milestones directed toward qualification is comprehensive and includes in-house training, on the job instruction, and formal

Massachusetts Draft IMEP Report Page 4 courses. A mentoring program has been implemented where senior inspectors or license reviewers provide on the job training for more junior employees.

c. Evaluation The team determined that, during the review period, Massachusetts met the performance indicator objectives listed in Section 3.1.a., and recommends that, based on the criteria in MD 5.6, Massachusetts performance with respect to the indicator, Technical Staffing and Training, be found satisfactory.

d. MRB Decision The final report will present the MRBs conclusion regarding this indicator.

3.2 Status of Materials Inspection Program Periodic inspections of licensed operations are essential to ensure that activities are being conducted in compliance with regulatory requirements and consistent with good safety practices. The frequency of inspections is specified in IMC 2800, Materials Inspection Program, and is dependent on the amount and kind of material, the type of operation licensed, and the results of previous inspections. There must be a capability for maintaining and retrieving statistical data on the status of the inspection program.

a. Scope The team used the guidance in State Agreements procedure SA-101, Reviewing the Common Performance Indicator: Status of the Materials Inspection Program, and evaluated Massachusetts performance with respect to the following performance indicator objectives:

• Initial inspections and inspections of Priority 1, 2, and 3 licensees are performed at the frequency prescribed in IMC 2800.

• Candidate licensees working under reciprocity are inspected in accordance with the criteria prescribed in IMC 1220, Processing of NRC Form 241, Report of Proposed Activities in Non-Agreement States, Areas of Exclusive Federal Jurisdiction, and Offshore Waters, and Inspection of Agreement State Licensees Operating Under 10 CFR 150.20.

• Deviations from inspection schedules are normally coordinated between technical staff and management.

• There is a plan to perform any overdue inspections and reschedule any missed or deferred inspections; or a basis has been established for not performing any overdue inspections or rescheduling any missed or deferred inspections.

• Inspection findings are communicated to licensees in a timely manner (30 calendar days, or 45 days for a team inspection, as specified in IMC 0610, Nuclear Material Safety and Safeguards Inspection Reports).

Massachusetts Draft IMEP Report Page 5

b. Discussion Massachusetts inspection frequencies are the same for similar license types found in the NRCs IMC 2800. Massachusetts has implemented a stretch goal where no more than 10 percent of assigned inspections are performed beyond the due date. The Program performed 151 Priority 1, 2, and 3 inspections and 48 initial inspections over the review period, none of which were conducted overdue.

Initial inspections of new licenses were performed within 12 months of license issuance.

Each year of the review period, Massachusetts performed greater than 20 percent of candidate reciprocity inspections, with percentages ranging from 28 percent for 2014 to 54 percent for 2016.

Of the 23 inspection files reviewed, inspection findings were conveyed to licensees greater than 30 days after the inspection in only two instances. The late documentation was conveyed to the licensee in 45 and 60 days, respectively, after the completion of the inspection. In both cases, the delays were a result of transmission of findings around the holidays and the travel schedule of the manager.

c. Evaluation The team determined that, during the review period, Massachusetts met the performance indicator objectives listed in Section 3.2.a., and, based on the criteria in MD 5.6, recommends that Massachusetts performance with respect to the indicator, Status of Materials Inspection Program, be found satisfactory.

d. MRB Decision The final report will present the MRBs conclusion regarding this indicator.

3.3 Technical Quality of Inspections Inspections, both routine and reactive, provide assurance that licensee activities are carried out in a safe and secure manner. Accompaniments of inspectors performing inspections, and the critical evaluation of inspection records, are used to assess the technical quality of an Agreement States inspection program.

a. Scope The team used the guidance in State Agreements procedure SA-102, Reviewing the Common Performance Indicator: Technical Quality of Inspections, and evaluated Massachusetts performance with respect to the following performance indicator objectives:

• Inspections of licensed activities focus on health, safety, and security.

• Inspection findings are well-founded and properly documented in reports.

• Management promptly reviews inspection results.

Massachusetts Draft IMEP Report Page 6

• Procedures are in place and used to help identify root causes and poor licensee performance.

• Inspections address previously identified open items and violations.

• Inspection findings lead to appropriate and prompt regulatory action.

• Supervisors, or senior staff as appropriate, conduct annual accompaniments of each inspector to assess performance and assure consistent application of inspection policies.

• For programs with separate licensing and inspection staffs, procedures are established and followed to provide feedback information to license reviewers.

• Inspection guides are consistent with NRC guidance.

• An adequate supply of calibrated survey instruments is available to support the inspection program.

b. Discussion The team evaluated the inspection reports and enforcement documentation, and interviewed inspectors involved in materials inspections conducted during the review period. The casework reviewed included 23 inspections conducted by 11 of Massachusetts inspectors and covered medical, industrial, commercial, academic, research, service, security, and reciprocity licenses.

The team found that inspection documents were thorough, complete, consistent, and of acceptable technical quality with health, safety, and security issues properly addressed.

Inspection findings were clearly communicated to the licensee and violations were written with a direct link to a regulation or license condition. Inspection documentation received timely management review with no reviews taking longer than 30 days to complete. In the casework reviewed, every inspection addressed previously identified open items and violations.

A team member accompanied six program inspectors during the weeks of March 19-23 and May 21-24, 2018. No performance issues were noted during the inspector accompaniments. The inspectors were well-prepared and thorough, and assessed the impact of licensed activities on health, safety, and security. Inspector accompaniments are identified in Appendix B.

Supervisory accompaniments for each of the materials inspectors were performed in each year of the review period by the Materials Unit Supervisor. The accompaniments were well documented and the supervisor discussed the results of the evaluation with each employee.

The team verified that the Program maintains a wide variety of appropriately calibrated survey instruments to support the inspection program, and to respond to radioactive materials incidents and emergency situations. Detection instruments are available for gamma, beta, and alpha, as well as dose rates. The Program had several portable multi-channel analyzers for assessing and identifying unknown sources. The team

Massachusetts Draft IMEP Report Page 7 conducted a random instrumentation check and all meters were calibrated. A senior staff member manages the instrumentation program and assures that the calibrations are tracked and staggered so that appropriated instrumentation is available.

c. Evaluation The team determined that, during the review period, Massachusetts met the performance indicator objectives listed in Section 3.3.a., and recommends that, based on the criteria in MD 5.6, Massachusetts performance with respect to the indicator, Technical Quality of Inspections be found satisfactory.

d. MRB Decision The final report will present the MRBs conclusion regarding this indicator.

3.4 Technical Quality of Licensing Actions The quality, thoroughness, and timeliness of licensing actions can have a direct bearing on public health and safety, as well as security. An assessment of licensing procedures, actual implementation of those procedures, and documentation of communications and associated actions between the Massachusetts licensing staff and regulated community is a significant indicator of the overall quality of the licensing program.

a. Scope The team used the guidance in State Agreements procedure SA-104, Reviewing the Common Performance Indicator: Technical Quality of Licensing Actions, and evaluated Massachusetts performance with respect to the following performance indicator objectives:

• Licensing action reviews are thorough, complete, consistent, and of acceptable technical quality with health, safety, and security issues properly addressed.

• Essential elements of license applications have been submitted and elements are consistent with current regulatory guidance (e.g., financial assurance, increased controls, pre-licensing guidance).

• License reviewers, if applicable, have the proper signature authority for the cases they review independently.

• License conditions are stated clearly and can be inspected.

• Deficiency letters clearly state regulatory positions and are used at the proper time.

• Reviews of renewal applications demonstrate a thorough analysis of a licensees inspection and enforcement history.

• Applicable guidance documents are available to reviewers and are followed (e.g.,

NUREG-1556 series, pre-licensing guidance, regulatory guides, etc.).

• Licensing practices for risk-significant radioactive materials are appropriately implemented including increased controls and fingerprinting orders (Part 37 equivalent).

Massachusetts Draft IMEP Report Page 8

• Documents containing sensitive security information are properly marked, handled, controlled, and secured.

b. Discussion During the review period, Massachusetts performed 954 radioactive materials licensing actions. The team evaluated 23 of those licensing actions. The licensing actions selected for review included four new applications, nine amendments, seven renewals and three terminations. The team evaluated casework which included the following license types and actions: broad scope, medical diagnostic and therapy, accelerator, commercial manufacturing and distribution, industrial radiography, research and development, academic, nuclear pharmacy, self-shielded irradiators, service providers, decommissioning actions, financial assurance, and bankruptcies. The casework sample represented work from 12 license reviewers.

Licensing actions were well documented. Each completed licensing action was peer reviewed before submission to the Program Director for signature. The team noted that the incorporation of a licensing action peer review process has led to consistently high quality products.

The team evaluated the pre-licensing guidance and the pre-licensing site visit aspect of the new license application process. The Program conducted pre-licensing site visits for all unknown entities in accordance with the pre-licensing checklist. The Program issued a license only once the applicant had, as a minimum, adequate facilities and equipment, as well as a qualified radiation safety officer and materials users. In addition, a new applicant with licensed radioactive material quantity equal to or exceeding Category 2 quantities has to implement increased security measures in accordance with Massachusetts' requirement prior to the issuance of the new license. Moreover, any licensee at a new location that will possess Category 2 quantities and above of radioactive material is also required to implement increased security measures before the location will be authorized to possess the Category 2 quantities and above in the license.

c. Evaluation The team determined that, during the review period, Massachusetts met the performance indicator objectives listed in Section 3.4.a., and recommends that, based on the criteria in MD 5.6, Massachusetts performance with respect to the indicator, Technical Quality of Licensing Actions, be found satisfactory.

d. MRB Decision The final report will present the MRBs conclusion regarding this indicator.

3.5 Technical Quality of Incident and Allegation Activities The quality, thoroughness, and timeliness of response to incidents and allegations of safety concerns can have a direct bearing on public health and safety. An assessment

Massachusetts Draft IMEP Report Page 9 of incident response and allegation investigation procedures, actual implementation of these procedures, internal and external coordination, and investigative and followup actions, are a significant indicator of the overall quality of the incident response and allegation programs.

a. Scope The team used the guidance in State Agreements procedure SA-105, Reviewing the Common Performance Indicator: Technical Quality of Incident and Allegation Activities, and evaluated Massachusetts performance with respect to the following performance indicator objectives:

• Incident response, investigation, and allegation procedures are in place and followed.

• Response actions are appropriate, well-coordinated, and timely.

• On-site responses are performed when incidents have potential health, safety, or security significance.

• Appropriate followup actions are taken to ensure prompt compliance by licensees.

• Followup inspections are scheduled and completed, as necessary.

• Notifications are made to the NRC Headquarters Operations Center for incidents requiring a 24-hour or immediate notification to the Agreement State or NRC.

• Incidents are reported to the Nuclear Material Events Database (NMED).

• Allegations are investigated in a prompt, appropriate manner.

• Concerned individuals are notified of investigation conclusions.

• Concerned individuals identities are protected, as allowed by law.

b. Discussion During the review period, 37 incidents were reported to the NMED by Massachusetts.

The team selected 14 events to evaluate. The casework reviewed included: seven lost/stolen radioactive materials events; one potential fetal overexposure; two medical events; three leaking source events, two of which that were also categorized as damaged equipment events; and one contamination event. The team found that inspectors properly evaluated each event, interviewed involved individuals, and thoroughly documented their findings. Enforcement actions were taken where appropriate.

The team found that when an event is reported to the Program, it is evaluated to determine its health and safety significance and what the appropriate response should be. That response can range anywhere from responding immediately to reviewing the event during the next inspection. The Program responded immediately to each incident that it determined had potential health and safety significance, including dispatching inspectors for onsite follow up for six of the cases reviewed. The team also found that the Program responded to events in accordance with their established procedure.

During the review period, 14 allegations were received by Massachusetts. The team evaluated 11 of the allegations, including four allegations referred by NRC. All of the

Massachusetts Draft IMEP Report Page 10 allegations reviewed were appropriately closed, concerned individuals were notified of the actions taken, and allegers identities were protected whenever possible in accordance with Massachusetts law.

c. Evaluation The team determined that, during the review period, Massachusetts met the performance indicator objectives listed in Section 3.5.a., and recommends that, based on the criteria in MD 5.6, Massachusetts performance with respect to the indicator, Technical Quality of Incident and Allegation Activities, be found satisfactory.

d. MRB Decision The final report will present the MRBs conclusion regarding this indicator.

4.0 NON-COMMON PERFORMANCE INDICATORS Four non-common performance indicators are used to review Agreement State programs: (1) Compatibility Requirements; (2) Sealed Source and Device (SS&D)

Evaluation Program; (3) Low-Level Radioactive Waste Disposal (LLRW) Program; and (4) Uranium Recovery Program. The NRCs Agreement with Massachusetts retains regulatory authority for a low-level radioactive waste disposal program and a uranium recovery program; therefore, only the first two non-common performance indicators applied to this review.

4.1 Compatibility Requirements State statutes should authorize the State to establish a program for the regulation of agreement material and provide authority for the assumption of regulatory responsibility under the agreement. The statutes must authorize the State to promulgate regulatory requirements necessary to provide reasonable assurance of protection of public health, safety, and security. The State must be authorized through its legal authority to license, inspect, and enforce legally binding requirements, such as regulations and licenses.

NRC regulations that should be adopted by an Agreement State for purposes of compatibility or health and safety should be adopted in a time frame so that the effective date of the State requirement is not later than 3 years after the effective date of the NRC's final rule. Other program elements, as defined in Appendix A of State Agreements procedure SA-200, Compatibility Categories and Health and Safety Identification for NRC Regulations and Other Program Elements, that have been designated as necessary for maintenance of an adequate and compatible program, should be adopted and implemented by an Agreement State within 6 months following NRC designation.

a. Scope The team used the guidance in State Agreements procedure SA-107, Reviewing the Non-Common Performance Indicator: Compatibility Requirements, and evaluated Massachusetts performance with respect to the following performance indicator

Massachusetts Draft IMEP Report Page 11 objectives. A complete list of regulation amendments can be found on the NRC website at the following address: https://scp.nrc.gov/regtoolbox.html.

• The Agreement State program does not create conflicts, duplications, gaps, or other conditions that jeopardize an orderly pattern in the regulation of radioactive materials under the Atomic Energy Act, as amended.

• Regulations adopted by the Agreement State for purposes of compatibility or health and safety were adopted no later than 3 years after the effective date of the NRC regulation.

• Other program elements, as defined in SA-200 that have been designated as necessary for maintenance of an adequate and compatible program, have been adopted and implemented within 6 months of NRC designation.

• The State statutes authorize the State to establish a program for the regulation of agreement material and provide authority for the assumption of regulatory responsibility under the agreement.

• The State is authorized through its legal authority to license, inspect, and enforce legally binding requirements such as regulations and licenses.

• Impact of sunset requirements, if any, on the States regulations.

b. Discussion The Commonwealth of Massachusetts became an Agreement State on March 19, 1997.

The authority under which the Program administers the Agreement is located 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 is designated as the Commonwealths radiation control agency. The review team noted that no legislation which would affect the Agreement State program or its authority was passed during the review period. Massachusetts regulations are not subject to sunset review.

The Commonwealths regulations for the Program are located in Title 105 of the Code of Massachusetts Regulations Section 120, and apply to ionizing radiation, whether emitted from radionuclides or devices. Massachusetts requires a license for possession and use of radioactive material.

The review team examined the Programs rulemaking process. Regulations are drafted by the Program, reviewed by Program managers and staff, and then sent to the NRC for a compatibility review. After addressing any compatibility comments, the regulations are then reviewed by the Programs legal counsel. 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 Commonwealths Public Health Council (PHC), which meets monthly and approves the proposed regulations for public comment. Once comments are addressed, the revised regulations are submitted to the PHC for promulgation. After PHC approval, the final regulations are submitted to the Secretary of the Commonwealth, who establishes an effective date for the regulations. A copy of the final promulgated regulations is then sent to the NRC for a

Massachusetts Draft IMEP Report Page 12 compatibility review as final regulations. The rulemaking process takes approximately 9 months to complete.

During the review period, the Program submitted three final amendments that were overdue for State adoption at the time of submission to the NRC:

• Licenses, Certifications, and Approvals for Materials Licensees, 10 CFR Parts 30, 36, 39, 40, 70 and 150 amendment (76 FR 56951), that was due for Agreement State adoption on November 14, 2014. (RATS ID 2011-2)

• Advance Notification of Native American Tribes of Transportation of Certain Types of Nuclear Waste, 10 CFR Part 71 amendment (77 FR 34194), that was due for Agreement State adoption on August 10, 2015. (RATS ID 2012-2)

• Technical Corrections, 10 CFR Parts 30, 34, 40 and 71 amendment (77 FR 39899), that was due for Agreement State adoption on August 6, 2015.

(RATS ID 2012-3)

An additional three amendments are currently overdue. The first two were submitted to the NRC as proposed regulations for compatibility review nearly 1 year after the rules were due for adoption. The third was submitted as a proposed regulation approximately one month after the rule was due for adpotion:

• Decommissioning Planning, 10 CFR Parts 20, 30, 40 and 70 amendment (76 FR 35512), that was due for Agreement State adoption on December 17, 2015.

(RATS ID 2011-1)

• Requirements for Distribution of Byproduct Material, 10 CFR Parts 30, 31, 32, 40 and 70 amendment (77 FR 43666), that was due for Agreement State adoption on October 23, 2015. (RATS ID 2012-4)

• Distribution of Source Material to Exempt Persons and to General Licensees and Revision of General License and Exemptions, 10 CFR Parts 30, 40 and 70 amendment (78 FR 32310), that was due for Agreement State adoption on August 27, 2016. (RATS ID 2013-2)

c. Evaluation The team determined that, during the review period, Massachusetts met the performance indicator objectives listed in Section 4.1.a., and recommends that, based on the criteria in MD 5.6, Massachusetts performance with respect to the indicator, Compatibility Requirements, be found satisfactory.

d. MRB Decision The final report will present the MRBs conclusion regarding this indicator.

Massachusetts Draft IMEP Report Page 13 4.2 Sealed Source and Device (SS&D) Evaluation Program Adequate technical evaluations of SS&D designs are essential to ensure that SS&Ds will maintain their integrity and that the design is adequate to protect public health and safety. NUREG-1556, Volume 3, Consolidated Guidance about Materials Licenses:

Applications for Sealed Source and Device Evaluation and Registration, provides information on conducting SS&D reviews and establishes useful guidance for teams.

Under this guidance, three sub elements: Technical Staffing and Training, Technical Quality of the Product Evaluation Program, and Evaluation of Defects and Incidents Regarding SS&Ds, are evaluated to determine if the SS&D program is satisfactory.

Agreement States with authority for SS&D evaluation programs who are not performing SS&D reviews are required to commit in writing to having an SS&D evaluation program in place before performing evaluations.

a. Scope The team used the guidance in State Agreements procedure SA-108, Reviewing the Non-Common Performance Indicator: Sealed Source and Device Evaluation Program, and evaluated Massachusetts performance with respect to the following performance indicator objectives:

Technical Staffing and Training

• A well-conceived and balanced staffing strategy has been implemented throughout the review period.

• Qualification criteria for new technical staff are established and are being followed or qualification criteria will be established if new staff members are hired.

• Any vacancies, especially senior-level positions, are filled in a timely manner.

• Management is committed to training and staff qualification.

• Individuals performing SS&D evaluation activities are adequately qualified and trained to perform their duties.

• SS&D reviewers are trained and qualified in a reasonable period of time.

Technical Quality of the Product Evaluation Program

• SS&D evaluations are adequate, accurate, complete, clear, specific, and consistent with the guidance in NUREG-1556, Volume 3.

Evaluation of Defects and Incidents

• SS&D incidents are reviewed to identify possible manufacturing defects and the root causes of these incidents.

• Incidents are evaluated to determine if other products may be affected by similar problems. Appropriate action and notifications to the NRC, Agreement States, and others, as appropriate, occur in a timely manner.

Massachusetts Draft IMEP Report Page 14

b. Discussion Technical Staffing and Training At the time of the review, the Program had four staff qualified to perform SS&D evaluations with no vacancies. During the review period, one of the SS&D staff members retired from the Program and two new staff were hired as replacements.

The team noted that, over the review period, the Program was able to successfully plan for this retirement knowing in advance that their senior SS&D reviewer was going to retire. The Program was able to contract with the retired individual to return and train the two new staff members. The retired reviewer worked with the Program for 2 years, until both new staff members were fully qualified.

Massachusetts has a training program equivalent to NRC training requirements listed in the NRCs IMC 1248, Appendix D.

Technical Quality of the Product Evaluation Massachusetts has 58 SS&D registrations from 13 licensees. The Program completed 86 SS&D actions during the review period, which included 46 amendments, 10 new applications, 26 inactivations, and four corrected sheets. The team evaluated 71 of these actions and found that the registration sheets were complete, thorough and of acceptable technical quality.

Evaluation of Defects and Incidents Regarding SS&Ds The team evaluated one incident reported from another State during the review period involving a Massachusetts-registered nuclear gauge.

The Program evaluated the device which had a failure of the shutter to remain open.

The evaluation revealed that Loctite had not been used for two screws to hold a magnate in the correct position to maintain the shutters in an open position. The Program notified all facilities that had purchased the gauge to be aware of this potential problem and what to look for. This was determined to be a manufacturing quality control concern and not a design error. The device manufacturer retrained the targeted assembly workers about applying Loctite to the two screws during assembly. The Program determined that this concern was corrected.

c. Evaluation The team determined that, during the review period, Massachusetts met the performance indicator objectives listed in Section 4.2.a., and recommends that, based on the criteria in MD 5.6, Massachusetts performance with respect to the indicator, Sealed Source and Device Evaluation Program, be found satisfactory.

Massachusetts Draft IMEP Report Page 15

d. MRB Decision The final report will present the MRBs conclusion regarding this indicator.

4.3 Low-level Radioactive Waste Disposal Program In 1981, the NRC amended its Policy Statement, Criteria for Guidance of States and NRC in Discontinuance of NRC Authority and Assumption Thereof by States Through Agreement, to allow a State to seek an amendment for the regulation of low-level radioactive waste (LLRW) as a separate category. Those States with existing Agreements prior to 1981 were determined to have continued LLRW disposal authority without the need of an amendment. Although the Massachusetts Agreement State Program has authority to regulate a LLRW disposal facility, the NRC has not required States to have a program for licensing a 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, it is expected to put in place a regulatory program that will meet the criteria for an adequate and compatible LLRW program.

The Commonwealth does not have a LLRW disposal facility (i.e., it is not a host State) and is not required to have a program for licensing a disposal facility until such time as it becomes a host State. The team did, however, follow up on the Programs questionnaire response, which indicated that a Program Coordinator performs low-level radioactive waste fee and survey collection activities. The team discussed the referenced fees and activities with the Program. The Program collects fees from the Commonwealths Class A low-level waste generators, and these fees are deposited into a Massachusetts low-level waste fund. This money is used by the Commonwealth to monitor the low-level waste activities of the generators licensed by the Program. The generators work with a low-level waste processor to dispose of their material.

5.0

SUMMARY

As noted in Sections 3.0 and 4.0 above, Massachusetts performance was found to be satisfactory for all performance indicators reviewed. The team did not make any recommendations regarding program performance and determined that the recommendation from the 2014 IMPEP review should be closed.

Accordingly, the team recommends that the Massachusetts Agreement State Program be found adequate to protect public health and safety and compatible with the NRCs program. The team recommends that the period of Monitoring be discontinued and that next IMPEP review take place in approximately 4 years with a periodic meeting in approximately 2 years.

LIST OF APPENDICES Appendix A IMPEP Review Team Members Appendix B Inspection Accompaniments

APPENDIX A IMPEP REVIEW TEAM MEMBERS Name Areas of Responsibility Randy Erickson, Region IV Team Leader Status of Materials Inspection Program Compatibility Requirements John Miller, Region I Technical Staffing and Training Technical Quality of Inspections Shawn Seeley, Region I Technical Quality of Licensing Actions Inspector Accompaniments Darren Piccirillo, Region III Status of Materials Inspection Program (assist Erickson)

Geoffrey Warren, Region III Technical Quality of Incident and Allegation Activities Technical Quality of Inspections James Pate, LA Sealed Source & Device Evaluation Program

APPENDIX B INSPECTION ACCOMPANIMENTS The following inspection accompaniments were performed prior to the on-site IMPEP review:

Accompaniment No.: 1 License No.: 44-0020 License Type: Medical Written Directive Priority: 3 Inspection Date: 3/19/18 Inspector: HH Accompaniment No.: 2 License No.: 60-0095 License Type: Broad Medical Priority: 2 Inspection Date: 3/20-21/18 Inspector: TC / BL Accompaniment No.: 3 License No.: 42-0690 License Type: Distribution License Priority: 2 Inspection Date: 5/21/18 Inspector: BP Accompaniment No.: 4 License No.: 19-7781 License Type: Industrial Radiography (TJS) Priority: 2 Inspection Date: 5/22/18 Inspector: SW Accompaniment No.: 5 License No.: 30-A131 License Type: SS Irradiator Priority: 5 Inspection Date: 5/23/18 Inspector: ES