ML21316A135

11-19-2021 Letter to M Levine Re Draft Vermont Impep Report

ML21316A135
Person / Time
Issue date:	11/19/2021
From:	Brian Anderson NRC/NMSS/DMSST/ASPB
To:	Michael Levine State of VT, Dept of Health
Cook J
References
Download: ML21316A135 (19)

Text

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 November 19, 2021 Dr. Mark Levine, Commissioner Vermont Department of Health 108 Cherry Street P.O. Box 70, Drawer #43 Burlington, VT 05402-0070

Dear Dr. Levine:

The U.S. Nuclear Regulatory Commission (NRC) uses the Integrated Materials Performance Evaluation Program (IMPEP) in the review of Agreement State and NRC radiation control programs. Enclosed is the draft IMPEP report which documents the results of the Vermont Agreement State review conducted on October 4-6, 2021. The teams preliminary findings were discussed with your Vermont staff and managers on the last day of the review. The teams proposed recommendations are that the Vermont Agreement State Program be found satisfactory for all indicators reviewed and overall, be found adequate to protect public health and safety and compatible with the NRCs program.

The NRC conducts periodic reviews of radiation control 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 IMPEP process uses a team composed of Agreement State and NRC staff to perform the reviews. 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 the Chair of the Management Review Board (MRB) after receiving input from the MRB members. The MRB is composed of NRC senior managers and an Agreement State program manager.

In accordance with the 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.

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 to be conducted as a hybrid meeting on Thursday, January 13, 2022, 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 conference room location will be determined prior to the meeting and in-person attendance will be flexible. The NRC will also provide you with Microsoft Teams connection information prior to the meeting.

M. Levine If you have any questions regarding the enclosed report, please contact Ms. Jacqueline D. Cook, Team Leader at (817) 200-1132.

Thank you for your cooperation.

Sincerely, Signed by Anderson, Brian on 11/19/21 Brian C. Anderson, Chief State Agreement and Liaison Programs Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards

Enclosure:

2022 Vermont Draft IMPEP Report cc: William Irwin, Radiation Control Program Director

ML21316A135 OFFICE RIV/DMNS NMSS/MSST NMSS/MSST NAME JCook RJohnson BAnderson DATE 11/15/21 11/15/21 11/19/21 INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW OF THE VERMONT AGREEMENT STATE PROGRAM October 4-6, 2021 DRAFT REPORT Enclosure

EXECUTIVE

SUMMARY

The results of the Integrated Materials Performance Evaluation Program (IMPEP) review of the Vermont Agreement State Program are discussed in this report. The review was conducted in Burlington, Vermont, from October 4-6, 2021. In-person inspector accompaniments were conducted on July 21-22, 2021.

This is Vermonts first IMPEP review since becoming an Agreement State on September 30, 2019.

The team found Vermonts performance to be satisfactory for all performance indicators:

Technical Staffing and Training; Status of Materials Inspection Program; Technical Quality of Inspections; Technical Quality of Licensing Actions; Technical Quality of Incident and Allegation Activities; and Legislation, Regulations, and Other Program Elements.

The team did not make any recommendations.

In accordance with the NRCs Management Directive 5.6 Integrated Materials Performance Evaluation Program (IMPEP), the team recommends that the Vermont Agreement State Program be found adequate to protect public health and safety and compatible with the U.S. Nuclear Regulatory Commissions program. The team also recommends that a periodic meeting take place in approximately 2 years and the next IMPEP review take place in approximately 4 years.

Vermont Draft IMPEP Report Page 1

1.0 INTRODUCTION

The Vermont Agreement State Program (the Program) review was conducted from October 4-6, 2021, by a team of technical staff members from the U.S. Nuclear Regulatory Commission (NRC) and the State of Tennessee. Team members are identified in Appendix A. In-person inspector accompaniments were conducted on July 21-22, 2021. The review was conducted in accordance with the Agreement State Program Policy Statement, published in the Federal Register on October 18, 2017 (82 FR 48535), and NRC Management Directive (MD) 5.6, Integrated Materials Performance Evaluation Program (IMPEP), dated July 24, 2019. Preliminary results of the review, which covered the period of October 1, 2019 to October 8, 2021, were discussed with Vermont staff and 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 Vermont on September 10, 2021. Vermont provided its response to the questionnaire on September 19, 2021. A copy of the questionnaire response is available in the NRCs Agencywide Documents Access and Management System (ADAMS) using the Accession Number ML21267A454.

The Program is administered by the Radiological Health Program which is located within the Division of Environmental Health. The Division of Environmental Health is located within the Vermont Department of Health. No changes to the organizational structure of the Agreement State Program have occurred since the Agreement became effective on September 30, 2019. Organization charts for Vermont are available in ADAMS (Accession Number ML21270A037).

At the time of the review, Vermont regulated 33 specific licenses authorizing possession and use of radioactive materials. The review focused on the radiation control program as it is carried out under Section 274b. (of the Atomic Energy Act of 1954, as amended)

Agreement between the NRC and the State of Vermont.

The team evaluated the information gathered against the established criteria for each common and applicable non-common performance indicator and made a preliminary assessment of Vermonts performance.

2.0 PREVIOUS IMPEP REVIEW AND STATUS OF RECOMMENDATIONS This is Vermonts first IMPEP review since becoming an Agreement State on September 30, 2019; as such, there is not a previous IMPEP review or status of recommendations to discuss.

3.0 COMMON PERFORMANCE INDICATORS Five common performance indicators are used to review the NRC and Agreement State radiation control 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.

3.1 Technical Staffing and Training

Vermont Draft IMPEP Report Page 2 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 assessed. 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 Vermonts performance with respect to the following performance indicator objectives:

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

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.

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.

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 Vermont is comprised of two technical staff and one manager which equals 1.5 full-time equivalent (FTE) for the radiation control program when fully staffed. All staff are qualified to perform licensing reviews and inspections per Vermonts compatible procedure to IMC 1248. During the review period there was a balance in staffing of the licensing and inspection programs. Currently there are no vacancies. During the review period none of the staff members left the program and there were no new staff members hired. Vermont has a training and qualification program compatible with the NRCs IMC 1248 (Vermonts Radioactive Materials Program Procedure 5.1, Rev. 0 dated September 30, 2019).

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

d. MRB Chairs Determination The final report will provide the MRB Chairs determination regarding this indicator.

Vermont Draft IMPEP Report Page 3 3.2 Status of Materials Inspection Program Inspections of licensed operations are essential to ensure that activities are being conducted in compliance with regulatory requirements and consistent with good safety and security practices. The frequency of inspections is specified in IMC 2800, Materials Inspection Program, and is dependent on the amount and type of radioactive 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 Vermonts performance with respect to the following performance indicator objectives:

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

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.

Candidate licensees working under reciprocity are inspected in accordance with the criteria prescribed in IMC 2800 and other applicable guidance or compatible Agreement State Procedure.

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.

b. Discussion Vermont performed three routine Priority 1, 2, and 3 inspections, and one initial inspection during the review period. The team determined that Vermonts inspection frequencies are the same for similar license types in IMC 2800. One Priority 2 inspection was overdue at the time of the review. However, this was due to the COVID-19 pandemic; the licensee would not allow the inspector to enter the medical facility due to the issues associated with the pandemic. Temporary Instruction (TI) 003, Evaluating the Impacts of the COVID-19 Public Health Emergency as part of the Integrated Materials Performance Evaluation Program, states, in part, that for inspections that exceed the scheduling window as described in IMC 2800 with overdue dates falling inside the defined timeframe of the pandemic, the number of overdue inspections should be noted in the report but should not be counted in the calculation of overdue inspections, provided that the Program continues to maintain health, safety, and security. The team concluded that Vermont continued to maintain health, safety, and security during the pandemic. Therefore, the team did not include the overdue inspection in the calculation. Vermont kept in close contact with the licensee and has plans to inspect as soon as possible.

All Priority 1, 2, 3, and initial inspection findings were communicated to the licensees within Vermonts goal of 30 days after the inspection exit or 45 days after a team inspection exit.

Vermont Draft IMPEP Report Page 4 Vermont inspected 11 of the 17 reciprocity licenses during the review period, and more than 20 percent of candidates each year (100% percent in 2019, 40% percent in 2020, and 83% percent to date in 2021). Reciprocity inspections were conducted in the State of Vermont using the States internal guidance, which is similar to that previously outlined in the NRCs IMC 2800. The reciprocity inspections reviewed were consistent with the guidance in IMC 2800.

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

d. MRB Chairs Determination The final report will provide the MRB Chairs determination regarding this indicator.

3.3 Technical Quality of Inspections Inspections, both routine and reactive, provide reasonable 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 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 Vermonts 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.

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 compatible with NRC guidance.

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

Vermont Draft IMPEP Report Page 5

b. Discussion The team evaluated 11 inspection reports and interviewed the inspector involved in materials inspections conducted during the review period. The team reviewed casework for this inspector. The casework included medical, industrial, academic, research, and service provider licenses. Based on the review of inspection documentation, the team found that all inspections were well-documented, and inspection findings were consistent with inspection procedures and regulatory requirements.

During the pandemic, Vermont performed two Priority 1, 2, 3, and initial inspections through a virtual platform and email. As circumstances allowed, Vermont performed on-site inspections and asked for records upfront when needed. At the time of the review, Vermont had resumed in-person inspections and does not intend to conduct additional virtual inspections unless circumstances change.

A team member conducted an in-person inspector accompaniment with the inspector at two different Vermont licensee locations on July 21 and 22, 2021. No performance issues were noted during the accompaniments. The team found that the inspector was well-prepared and thorough, and assessed the impact of licensed activities on health, safety, and security. The inspector observed the use of radioactive materials and interviewed licensee staff. The inspector used open ended questions and determined that radioactive materials were being used safely and securely. Any findings observed were brought to the users attention at the time of the inspection and again to the licensees management during the inspection exit meeting. The inspector accompaniments are identified in Appendix B.

The team found that supervisory accompaniments were performed at least annually.

Accompaniments continued to be performed during the pandemic.

The team verified that Vermont has an adequate supply of properly calibrated radiation detection equipment to support the inspection program and respond to radioactive material incidents and emergency situations. Calibrations are performed appropriately, and records are maintained on file. Vermont also has laboratory services available for sample analysis, as needed.

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

d. MRB Chairs Determination The final report will provide the MRB Chairs determination regarding this indicator.

Vermont Draft IMPEP Report Page 6 3.4 Technical Quality of Licensing Actions The quality, thoroughness, and timeliness of licensing actions can have a direct bearing on public health, safety, and security. An assessment of licensing procedures, implementation of those procedures, and documentation of communications and associated actions between the Vermont 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 Vermonts 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., pre-licensing guidance, Title 10 Code of Federal Regulations (CFR) Part 37, financial assurance, etc.).

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 the physical protection of Category 1 and Category 2 quantities of radioactive material (10 CFR Part 37 equivalent).

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

b. Discussion Vermont completed 71 licensing actions during the review period. The team reviewed 10 licensing actions: 1 new application, 6 amendments, and 3 renewals. The team reviewed the work of the license reviewer during this review period. This casework included the following types of licenses: service providers, portable gauges, possession only license permanent shutdown, nuclear pharmacy, nuclear medicine, nuclear medicine with high dose rate remote afterloader and emerging technologies, and mobile nuclear medicine services. The team interviewed the license reviewer. The license reviewer was knowledgeable and used the most current pre-licensing guidance checklist and risk significant radioactive material checklist. Vermonts licenses containing security related information were properly marked and stored appropriately. New licenses and renewals are issued for 10 years.

The team noted that appropriate financial assurance instruments were properly submitted when required.

Vermont employs an effective approval and peer review process to ensure the adequacy of licensing reviews. The Radioactive Materials Program Manager (RMPM) is the primary materials license reviewer. Once the licensing review has been conducted, the

Vermont Draft IMPEP Report Page 7 RMPM and the Radiological Health Specialist (RHS) perform an administrative and technical review of the licensing actions. During the supervisory review, the Radiation Control Program Director (RCPD), the RMPM, and RHS review the documents together before the Health Commissioner signs the license.

Vermont has a self-imposed metric of 90 days for all types of licensing actions. During monthly meetings, the Program discusses the number of licensing actions open and the number of licensing actions open greater than 90 days. The team noted that there were no impacts seen for this indicator related to the pandemic.

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

d. MRB Chairs Determination The final report will provide the MRB Chairs determination 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, safety, and security. An assessment of incident response and allegation investigation procedures, actual implementation of these procedures, internal and external coordination, timely incident reporting, and investigative and follow-up 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 Vermonts performance with respect to the following performance indicator objectives:

Incident response 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 follow-up actions are taken to ensure prompt compliance by licensees.

Follow-up 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) and closed when all required information has been obtained.

Allegations are investigated in a prompt, appropriate manner.

Concerned individuals are notified within 30 days of investigation conclusions.

Concerned individuals identities are protected, as allowed by law.

Vermont Draft IMPEP Report Page 8

b. Discussion During the review period, five incidents were reported to Vermont. The team evaluated all of the reported radioactive materials incidents: three lost or stolen radioactive material events, one medical event, and one event involving a leaking source. Vermont dispatched inspectors for on-site follow-up for all five incidents. The team found that Vermonts evaluation of the incoming incident and their response to those incidents was thorough, well balanced, complete, and comprehensive.

The team also evaluated Vermonts reporting of incidents to the NRCs Headquarters Operations Center (HOC). The team noted that in three of the five cases requiring HOC notification, Vermont reported the incidents within the required timeframe. The remaining two incidents involving material found in landfills, were reported late. At the time of the initial receipt, Vermont was unsure if the incidents met the criteria for a reportable event as discussed in State Agreements procedure SA-300, Reporting Material Events, and did not report the incidents to the NRC. During the July 31, 2020, orientation meeting, NRC staff informed Vermont that these incidents met the criteria for reporting to the HOC. Subsequently, Vermont reported the two incidents to the HOC on August 5 and 6, 2020, respectively. This equated to the two incidents being reported three months and four months late, respectively.

During the review period, no allegations were received, and the NRC did not refer any allegations to Vermont. The team noted that there were no impacts to Vermont for this indicator related to the pandemic.

c. Evaluation The team determined that during the review period Vermont met the performance indicator objectives listed in Section 3.5.a, except for:

Two notifications were not made to the NRC HOC for incidents requiring a 24-hour or immediate notification to the Agreement State or NRC.

After discussing the incidents with NRC staff on July 31, 2020, and determining that they did meet the criteria to be reportable events, Vermont subsequently reported both events to the NRCs HOC. As a result of discussions at the Orientation Meeting Vermont, now recognizes the issue, took immediate actions after the Orientation Meeting, and revised the process to ensure reporting of these types of events, as appropriate. No additional incidents were reported late for the remainder of the review period.

Based on the IMPEP evaluation criteria in MD 5.6, the team recommends that Vermonts performance with respect to the indicator, Technical Quality of Incident and Allegation Activities be found satisfactory.

d. MRB Chairs Determination The final report will provide the MRB Chairs determination regarding this indicator.

Vermont Draft IMPEP Report Page 9 4.0 NON-COMMON PERFORMANCE INDICATORS Four non-common performance indicators are used to review Agreement State programs: (1) Legislation, Regulations, and Other Program Elements; (2) Sealed Source and Device (SS&D) Evaluation Program; (3) Low-Level Radioactive Waste (LLRW) Disposal Program; and (4) Uranium Recovery Program. The NRC retains regulatory authority for SS&D Evaluation, LLRW Disposal, and Uranium Recovery Program; therefore, only the first (1) Legislation, Regulations, and Other Program Elements non-common performance indicator applied to this review.

4.1 Legislation, Regulations, and Other Program Elements 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 States agreement with the NRC. The statutes must authorize the State to promulgate regulatory requirements necessary to provide reasonable assurance of adequate 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. The 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 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 Program Element Table indicating the Compatibility Categories for those program elements other than regulations can be found on the NRC Web site at the following address: https://scp.nrc.gov/regtoolbox.html.

a. Scope The team used the guidance in State Agreements procedure SA-107, Reviewing the Non-Common Performance Indicator: Legislation, Regulations, and Other Program Elements, and evaluated Vermonts performance with respect to the following performance indicator 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.

Sunset requirements, if any, do not negatively impact the effectiveness of the States regulations.

Vermont Draft IMPEP Report Page 10

b. Discussion Vermont became an Agreement State on September 30, 2019. The current effective statutory authority is contained in the Ionizing and Nonionizing Radiation Control Act contained in the Vermont Statute Title 18 Chapter 32. The Department of Health is designated as the States radiation control agency. No legislation affecting the radiation control program was passed during the review period.

Vermonts administrative rulemaking process takes approximately 5-9 months from drafting to finalizing a rule. The public, the NRC, other agencies, and potentially impacted licensees and registrants are offered an opportunity to comment during the process. Comments are considered and incorporated, as appropriate, before the regulations are finalized and approved. The team noted that Vermonts rules and regulations are not subject to sunset laws.

Vermont adopts NRC regulations required for compatibility by reference. Since the regulations are not tied to a specific date, whenever the NRC promulgates a rule change it becomes effective the same day in Vermont. Therefore, Vermonts regulations were immediately updated and effective and Vermont did not need to submit any proposed/final regulations or legally binding requirements to the NRC for review. The team determined that there were no amendments overdue for adoption; however, there were five outstanding comments from an NRC letter issued in May 2019 discussing NRCs review of Vermonts final regulations. Vermont committed to addressing these changes as soon as practicable in its response dated June 6, 2019. The team determined that during the review period Vermont had not address these comments.

The Program stated it was unable to address the comments due to restrictions on rulemaking that were put in place during the pandemic. Additionally, the team noted that these outstanding comments are discussed in Enclosure 2 - Staff Assessment of SECY-19-0085, Section 274b Agreement with the State of Vermont. In that enclosure, staff noted the five outstanding comments on adopted regulations and determined the Agreement State program was compatible with the NRCs program. Therefore, the team determined that Vermonts inability to address these comments during the review period did not affect its ability to regulate its licensees effectively. Vermont plans to draft changes to address the five outstanding comments and have them ready for the next legislative session (the legislative session runs January - May of each year).

The team reviewed guidance documents that Vermont uses to meet the requirements of other program elements (e.g., Pre-Licensing Guidance, Inspection Procedures, etc.) that the NRC has designated as necessary for the maintenance of an adequate and compatible program. The team found that all documents reviewed were compatible and adopted within the applicable time frame.

c. Evaluation The team determined that, during the review period, Vermont met the performance indicator objectives listed in Section 4.1.a. Based on the criteria in MD 5.6, the team recommends that Vermonts performance with respect to the indicator, Legislation, Regulations, and Other Program Elements be found satisfactory.

d. MRB Chairs Determination The final report will provide the MRB Chairs determination regarding this indicator.

Vermont Draft IMPEP Report Page 11 5.0

SUMMARY

Vermonts performance was found to be satisfactory for all performance indicators reviewed. The team did not make any recommendations.

Accordingly, the team recommends that the Vermont Agreement State Program be found adequate to protect public health and safety, and compatible with the NRC's program. Based on the results of the IMPEP review, the team recommends that a periodic meeting take place in approximately 2 years and the next full IMPEP review take place in approximately 4 years.

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

APPENDIX A IMPEP REVIEW TEAM MEMBERS Name Areas of Responsibility Jacqueline D. Cook, RIV Team Leader Technical Staffing and Training Technical Quality of Licensing Actions Beth Shelton, TN Status of Materials Inspection Program Technical Quality of Inspections Monica Ford, RI Inspector Accompaniments Technical Quality of Incident and Allegation Activities Legislation, Regulations, and Other Program Elements

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

Accompaniment No.: 1 License No.: 44-101970-04 License Type: Irradiator (Part 37) Priority: 5 Inspection Date: 07/21/21 Inspector: FO Accompaniment No.: 2 License No.: 44-30124-01MD License Type: Nuclear Pharmacy Priority: 2 Inspection Date: 07/22/21 Inspectors: FO