ML23289A168

Letter to C. Eldredge Re Florida Final Impep Report

ML23289A168
Person / Time
Issue date:	11/03/2023
From:	Catherine Haney NRC/EDO/DEDMRT
To:	Eldredge C State of FL, Dept of Health, Bureau of Radiation Control
Meyer K
References
Download: ML23289A168 (26)

Text

November 3, 2023 Clark Eldredge, Interim Bureau Chief Bureau of Radiation Control Division of Emergency Preparedness and Community Support 4052 Bald Cypress Way, SE, Bin C21 Tallahassee, FL 32399-1741

Dear Clark Eldredge:

On October 5, 2023, the Management Review Board (MRB), which consisted of the U.S.

Nuclear Regulatory Commission (NRC) senior managers and an Organization of Agreement States MRB member, met to consider the results of the Integrated Materials Performance Evaluation Program (IMPEP) review of the Florida Agreement State Program. The MRB Chair, in consultation with the MRB, found the Florida Agreement State Program adequate to protect public health and safety and not compatible with the NRCs program.

The enclosed final report documents the IMPEP teams findings and summarizes the results of the MRB meeting. Based on the results of the current IMPEP review, the MRB determined that the next periodic meeting take place in approximately 2 years with the next IMPEP review taking place in approximately 4 years.

I appreciate the courtesy and cooperation extended to the IMPEP team during the review. I also wish to acknowledge your continued support for the Agreement State program. I look forward to our agencies continuing to work cooperatively in the future.

Sincerely, Signed by Haney, Cathy on 11/03/23 Catherine Haney Deputy Executive Director for Materials, Waste, Research, State, Tribal, Compliance, Administration, and Human Capital Programs Office of the Executive Director for Operations

Enclosures:

1. 2023 Florida Final IMPEP Report

2. 2023 Florida MRB Meeting Participants cc: Santiago Rodriguez, Chief Radiation Control Bureau New Mexico Environment Department

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW OF THE FLORIDA AGREEMENT STATE PROGRAM JUNE 12-16, 2023 FINAL REPORT ENCLOSURE 1

EXECUTIVE

SUMMARY

The results of the Integrated Materials Performance Evaluation Program (IMPEP) review of the Florida Agreement State Program (Florida) are discussed in this report. The review was conducted June 12-16, 2023, in Tallahassee, FL. In-person inspector accompaniments were conducted between February and May 2023.

The team found Floridas performance satisfactory for the performance indicators: Technical Staffing and Training, Status of Materials Inspection Program, Technical Quality of Inspections, Technical Quality of Licensing Actions, Technical Quality of Incidents and Allegation Activities, and Sealed Source and Device Evaluation. The team found Floridas performance unsatisfactory for the performance indicator Legislation, Regulations, and other Program Elements.

The team recommended and the MRB Chair agreed to close the three recommendations from the 2019 IMPEP review, and opening a new recommendation related to the Legislation, Regulations, and other Program Elements performance indicator.

Accordingly, the team recommended and the MRB Chair agreed that the Florida Agreement State Program be found adequate to protect public health and safety and not compatible with the NRC's program. The team also recommended and the MRB Chair agreed that a periodic meeting take place in approximately 2 years with the next IMPEP review taking place in approximately 4 years.

Florida Final IMPEP Report Page 1

1.0 INTRODUCTION

The Florida Agreement State Program review was conducted from June 12-16, 2023, by a team of technical staff members from the U.S. Nuclear Regulatory Commission (NRC) and the States of Arizona, Illinois, Louisiana, and North Dakota. Team members are identified in Appendix A. The team completed 20 in-person materials inspector accompaniments between February and May of 2023. The inspector accompaniments are identified in Appendix B. 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 June 29, 2019, to June 16, 2023, were discussed with the Florida 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 Florida on May 8, 2023. Florida provided its response to the questionnaire on May 26, 2023. A copy of the questionnaire response is available in the NRCs Agencywide Documents Access and Management System (ADAMS) using the Accession Number ML23151A354.

The Florida Agreement State Program is administered by the Bureau of Radiation Control (the Bureau), which is designated as the States radiation control agency. The Bureau is in the Division of Emergency Preparedness and Community Support in the Department of Health. Organization charts for Florida are available in ADAMS ML23151A309.

The 2023 IMPEP team issued a draft report to Florida on July 28, 2023, for factual comment (ML23205A152). Florida responded to the draft report by letter dated August 24, 2023, from Mr. Clark Eldridge, Interim Chief, Bureau of Radiation Control(ML23237A479). The Management Review Board (MRB) was conducted on October 5, 2023, to discuss the teams findings and recommendations.

At the time of the review, the Bureau regulated 1,521 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 Florida.

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

2.0 PREVIOUS IMPEP REVIEW AND STATUS OF RECOMMENDATIONS The previous IMPEP review concluded on June 28, 2019. The final report is available in ADAMS ML19262D631. The results of the review are as follows:

Technical Staffing and Training: Satisfactory Recommendation: None

Florida Final IMPEP Report Page 2 Status of Materials Inspection Program: Satisfactory Recommendation: None Technical Quality of Inspections: Satisfactory but needs improvement.

Recommendation 1: The 2019 team recommended the outcome of previously identified inspection open items and violations be documented and communicated formally to the licensee.

Status of Recommendation 1: The 2023 team recommended that this recommendation be closed and the MRB Chair agreed. Details related to the work performed by Florida to address this recommendation and the 2023 IMPEP teams evaluation of that effort can be found in Section 3.3 of this report.

Technical Quality of Licensing Actions: Satisfactory Recommendation 2: The 2019 team recommended the Program consistently document the training completed by license reviewers, including the license types for which each reviewer has obtained signature authority.

Status of Recommendation 2: The 2023 team recommended that this recommendation be closed and the MRB Chair agreed. Details related to the work performed by Florida to address this recommendation and the 2023 IMPEP teams evaluation of that effort can be found in Section 3.4 of this report.

Technical Quality of Incident and Allegation Activities: Satisfactory Recommendation: None Legislation, Regulations, and Other Program Elements (formerly Compatibility Requirements): Unsatisfactory Recommendation 3: The 2019 team recommended that a plan be developed and implemented to address the overdue regulations, including how rules should be prioritized. The plan should also address instituting a knowledge management program for the staff involved in the rulemaking process.

Status of Recommendation 3: The 2023 team recommended and the MRB Chair agreed that this recommendation be closed based on the development of the plan and that a new recommendation be opened to address the remaining scope of work that needs to be completed.

Sealed Source and Device (SS&D) Evaluation Program: Satisfactory Recommendation: None Overall finding: Adequate to protect public health and safety but needs improvement and not compatible with the NRC's program.

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)

Florida Final IMPEP Report Page 3 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 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 (SA) procedure SA-103, Reviewing the Common Performance Indicator: Technical Staffing and Training, and evaluated Floridas 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 Florida is composed of 50 technical staff members, which includes 24 full-time equivalent (FTE) for the radiation control program when fully staffed. During the review period, 23 of the staff members left the program and 21 staff members were hired.

Currently, there are two vacancies. The positions were vacant from 60 to 120 days, except for one, which remained open for approximately 160 days. Florida assigned resources from other areas of the Bureau to supplement staffing demands. Senior level positions were filled in a timely manner. As a result, licensing and inspection work was completed successfully without any impact to public health and safety.

Florida initiated steps to be more successful in recruiting and retaining staff. The Environmental Specialist II (ESII) positions were upgraded to Environmental Specialist III (ESIII) positions, which included a pay increase. Future staff will be hired in at an ESIII position.

Florida Final IMPEP Report Page 4 Floridas training and qualification program is compatible with the NRCs IMC 1248. Four of the 21 employees hired during the review period had a masters degree in science, 10 had a bachelors degree in science, six had associate degrees in nuclear medicine or radiation technology and one had completed Navy Nuclear Power School. Florida used a combination of in-house training, NRC sponsored training, and on the job training for its license reviewers and inspectors. New inspectors were on probation for a year and were expected to demonstrate proficiency in performing nuclear gauge and nuclear medicine (no written directive required) inspections to successfully complete the probationary period. The team also confirmed that fully qualified license reviewers and inspectors completed and documented a minimum 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of refresher training every 2 years.

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

d. Management Review Board (MRB) Chairs Determination The MRB Chair agreed with the teams recommendation and found Floridas performance with respect to this performance indicator satisfactory.

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 SA-101, Reviewing the Common Performance Indicator:

Status of the Materials Inspection Program, and evaluated Floridas 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 (https://www.nrc.gov/materials/miau/mat-toolkits.html).

• 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.

Florida Final IMPEP Report Page 5

• 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 Florida performed 1,207 Priority 1, 2, 3, and initial inspections during the review period.

No Priority 1, 2, 3 or initial inspections were conducted overdue during the review period.

Floridas inspection frequencies are the same, or in some cases, more frequent than the frequencies listed in IMC 2800 for similar license types.

A sampling of 36 inspection reports indicated that inspection findings were communicated to the licensees within Floridas goal of 30 days after the inspection exit or 45 days after the team inspection exit.

Candidate licensees working under reciprocity were inspected in accordance with the criteria prescribed in IMC 2800 and other applicable guidance. For each year of the review period, Florida performed greater than 20 percent of candidate reciprocity inspections.

c. Evaluation Based on the IMPEP evaluation criteria in MD 5.6, the team recommends that Floridas performance with respect to the indicator, Status of Materials Inspection Program, be found satisfactory.

d. MRB Chairs Determination The MRB Chair agreed with the teams recommendation and found Floridas performance with respect to this performance indicator satisfactory.

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 SA-102, Reviewing the Common Performance Indicator:

Technical Quality of Inspections, and evaluated Floridas 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.

Florida Final IMPEP Report Page 6

• 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.

b. Discussion The team evaluated 34 inspection reports, reviewed enforcement documentation, and interviewed inspectors involved in materials inspections conducted during the review period. The team reviewed casework for inspections conducted by 31 current and former Florida inspectors and covered medical, industrial, commercial, academic, research, and service provider licenses.

The team completed 20 in-person materials inspector accompaniments between February 2023 and May 2023. The team found that the inspectors were well-prepared, thorough in their evaluation of each licensee, and assessed the impact of licensed activities on health, safety, and security. During interviews of licensee staff, inspectors used open-ended questions, and were able to develop a basis of confidence that radioactive materials were being used safely and securely. Any findings observed were brought to the licensee staff members attention at the time of the inspection. All findings and conclusions were well-founded and appropriately documented. The inspector accompaniments are identified in Appendix B.

The team noted that supervisory accompaniments were performed annually for most of the qualified inspectors in each year of the review period. Due to Floridas high staff turnover rate, lead inspectors spent time training new staff. This made it difficult for Florida management to complete all the required accompaniments of the lead inspectors in a timely manner. Floridas inspection program managers and lead inspectors were required to spend time training new inspection staff resulting in missing some of the lead inspector accompaniments. This did not affect Floridas ability to protect public health and safety.

The team identified that Floridas inspection results were well documented, and violations were well supported. Florida followed its own documented inspection and enforcement procedures. The team reviewed the Florida inspection procedures and found them to be compatible with NRC inspection procedures.

The 2019 IMPEP review team made one recommendation related to Floridas performance on the Technical Quality of Inspection performance indicator.

Recommendation 1: The outcome of previously identified inspection open items and violations be documented and communicated formally to the licensee.

Florida Final IMPEP Report Page 7 The 2023 team identified that in all inspection reports reviewed, Florida adequately identified all open inspection items and violations and communicated them formally to the licensee. Therefore, the 2023 team proposed closing this recommendation.

The 2023 team verified that Florida maintained an adequate supply of appropriate and calibrated survey instruments to support the inspection program and to respond to radioactive materials incidents.

c. Evaluation The team determined that during the review period Florida met the performance indicator objectives listed in Section 3.3.a, except for:

• Supervisors, or senior staff as appropriate, did not conduct annual accompaniments of each inspector to assess performance and assure consistent application of inspection policies.

The team conducted 20 inspector accompaniments of the 29 fully or partially qualified inspectors and found that all inspectors were well-prepared, thorough in their evaluation of each licensee, and adequately assessed the impact of licensed activities on health, safety, and security. Therefore, the team determined that missing some of the supervisory accompaniments did not affect Floridas ability to protect public health and safety.

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

d. MRB Chairs Determination The MRB Chair agreed with the teams recommendation and found Floridas performance with respect to this performance indicator satisfactory. The MRB Chair also agreed that the 2019 recommendation be closed.

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, implementation of those procedures, and documentation of communications and associated actions between the Florida 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 Floridas 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.

Florida Final IMPEP Report Page 8

• Essential elements of license applications have been submitted and elements are consistent with current regulatory guidance (e.g., pre-licensing guidance, Title 10 of the Code of Federal Regulation (10 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 (RSRM) 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 During the review period, Florida performed 7,877 radioactive materials licensing actions. The team evaluated 27 of those licensing actions. The licensing actions selected for review included 6 new applications, 14 amendments, 5 renewals, and 2 terminations. The team also reviewed 2 licensing actions that included security requirements and 2 that involved financial assurance. The team evaluated casework which included the following license types: broad scope, medical diagnostic and therapeutic, mobile medical, industrial radiography, veterinary, research and development, academic, nuclear pharmacy, portable and fixed gauges, panoramic and self-shielded irradiators, service provider, waste processor, and decommissioning licensees. The casework sample represented work from 13 current and former license reviewers.

Florida had 12 qualified license reviewers. Florida successfully processed a very large number of licensing actions in a timely manner. License reviewers benefited from comprehensive license application checklists developed based on the NUREG-1556 series, and emerging technologies guidance. These checklists also provide guidance to Floridas licensees on the necessary elements of a successful license application, thus reducing the need for requests for additional information.

Florida also benefited from the expertise of long-term staff who were highly qualified, using them to review actions performed by newer staff who had yet to obtain broad qualification. Florida implemented the RSRM and Pre-Licensing Guidance checklists for new licenses, and 100 percent of new license applicants receive pre-licensing visits. The team found that all documents containing sensitive security related or protected information were properly marked and secured in accordance with their procedures for controlling sensitive information.

The team reviewed decommissioning activities at two legacy decommissioning sites.

These legacy sites contained laboratory hazardous and radioactive wastes.

Decommissioning at the Tallahassee site was completed during this review period.

Florida Final IMPEP Report Page 9 Decommissioning at the Apalachicola National Forest legacy site was nearing completion at the time of the review. The team noted that the licensee was currently working with a contractor to ensure proper disposal of the waste. The team also determined that the two legacy sites will continue to be listed on the license until decommissioning is completed.

The 2019 IMPEP review team made a recommendation related to Floridas performance on the Technical Quality of Licensing Actions performance indicator.

Recommendation 2: Florida consistently document the training completed by license reviewers, including the license types for which each reviewer has obtained signature authority.

To assess Floridas work related to this recommendation, the 2023 IMPEP team reviewed license reviewer qualification journals and found that each license reviewer had a qualification journal that documented what type of license reviews they were qualified to perform independently. Therefore, the 2023 IMPEP team proposed closing this recommendation.

c. Evaluation Based on the criteria in MD 5.6, the team recommends that the State of Floridas performance with respect to the indicator, Technical Quality of Licensing Actions, be found satisfactory.

d. MRB Chairs Determination The MRB Chair agreed with the teams recommendation and found Floridas performance with respect to this performance indicator satisfactory. The MRB Chair also agreed that the 2019 recommendation be closed.

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 SA-105, Reviewing the Common Performance Indicator:

Technical Quality of Incident and Allegation Activities, and evaluated Floridas 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.

Florida Final IMPEP Report Page 10

• 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.

b. Discussion During the review period, 85 events were reported to the NMED database by Florida.

The team evaluated 18 radioactive materials events, which included 7 medical events, 5 events involving lost or stolen radioactive materials, 1 event involving an industrial radiography source disconnect, 1 fire event involving radioactive materials, 1 event involving medical waste setting off an alarm, 2 auto accidents involving radiopharmaceuticals, and 1 security event involving a delivery driver inadvertently attempting to enter an incorrect door. Florida dispatched inspectors for on-site follow-up for all cases reviewed.

When an event was reported to Florida, management evaluated it and determined its health and safety significance and then decided on the appropriate response. That response can range anywhere from responding immediately to reviewing the event during the next inspection. For each incident Florida staff determined to have potential health and safety significance, Florida responded immediately. Responses were appropriate, well-coordinated and timely. 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 also found that Florida responded to events in accordance with their established procedure.

The team evaluated Floridas reporting of events to the NRCs Headquarters Operations Officer (HOO). The team noted that in each case evaluated where HOO notification was required, Florida reported all events within the required timeframe.

During the review period, 18 allegations were received directly by Florida with 6 additional allegations referred by the NRC. The team evaluated 10 of the allegations and found that Florida took prompt and appropriate action in response to each of the concerns raised. The team determined that all allegations reviewed were appropriately closed, concerned individuals were notified timely of the actions taken, and allegers identities were protected whenever possible in accordance with State law. The team also found that Florida responded to allegations in accordance with their established procedure.

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

Florida Final IMPEP Report Page 11

d. MRB Chairs Determination The MRB Chair agreed with the teams recommendation and found Floridas performance with respect to this performance indicator satisfactory.

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) SS&D Evaluation Program; (3) LLRW Disposal Program; and (4) Uranium Recovery Program.

The NRC retains regulatory authority for Uranium Recovery Program; therefore, only the first three non-common performance indicators 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 website at the following address: https://scp.nrc.gov/regtoolbox.html.

a. Scope The team used the guidance in SA-107, Reviewing the Non-Common Performance Indicator: Legislation, Regulations, and Other Program Elements, and evaluated Floridas 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.

Florida Final IMPEP Report Page 12

• 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.

b. Discussion Florida became an Agreement State on July 1, 1964. Florida s current effective statutory authority is contained in the Florida Radiation Protection Act in Title XXIX, Chapter 404, of the State of Florida Statutes. The Bureau is designated as the States radiation control agency. The Bureau is in the Division of Emergency Preparedness and Community Support in the Department of Health. No legislation affecting the radiation control program was passed during the review period.

Floridas administrative rulemaking process takes approximately 12-18 months from drafting to finalizing a rule. The public, 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 by the Governor. The States rules and regulations are not subject to sunset laws.

To begin rule promulgation, Florida submits a Notice to Develop Rulemaking to the Department of Health (Department). The Department will then send the Notice to the Office of Program Policy Analysis and Government Accountability (OFARR) in the Governors Office for review and approval. Once permission is given, the Department publishes a Notice to Develop Rulemaking in the Florida Administrative Register (FAR) for a period of 21 days offering to hold a rule development workshop. If a workshop is requested, it is published in the FAR at least seven days prior to the workshop. The Notice of Proposed Rulemaking must be published within one year from the Notice of Rule Development. If the Notice is not published within one year, Florida is required to refile the Notice. Because of process delays, Florida filed the Notice for Rule Development in 2021 and had to file again in 2022. The filing included the overdue regulations amendments mentioned previously.

After the Notice was filed, the proposed regulations were reviewed by Floridas Departments Office of General Counsel (OGC). During the pandemic, Floridas OGC focused their review of proposed rules to those concerning emergency response to the pandemic, which caused a delay in reviewing Floridas rules. Floridas OGC also added levels of management review, extending the time required for OGC to complete their review.

During the review period, Florida submitted one proposed regulation amendment, no final regulation amendments, and two license conditions to the NRC for a compatibility review. The proposed regulation amendment, RATS ID 2015-3, was submitted overdue for State adoption at the time of submission.

At the time of the review, the following six amendments were overdue and had not been submitted to the NRC for review:

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• Revisions to Transportation Safety Requirements and Harmonization with International Atomic Energy Agency Transportation Requirements Part 71 (80 FR 33987), that was due for Agreement State adoption on August 15, 2020.

• Medical Use of Byproduct Material - Medical Event Definitions, Training and Experience, and Clarifying Amendments, 10 CFR Parts 30, 32 and 35, that was due for Agreement State adoption on January 14, 2022.

• Miscellaneous Corrections - Organizational Changes 10 CFR Parts 37,40.70, and 71, that was due for Agreement State adoption on December 21, 2021.

• Miscellaneous Corrections, 10 CFR Parts 1, 2, 34, 37, 50, 71, 73, and 140, that was due for Agreement state adoption, July 30, 2022.

• Miscellaneous Corrections, 10 CFR Parts 2, 21, 37, 50, 52, 73, and 110, that was due for Agreement State adoption on December 18, 2022

• Organizational Changes and Conforming Amendments, 10 CFR Parts 1, 2, 37, 40, 50, 51, 52, 55, 71, 72, 73, 74, 100, 140, and 150, that was due for Agreement State adoption on December 30, 2022.

In addition, Individual Monitoring Devices, 10 CFR Parts 34, 36, and 39, was not overdue at the time of the review but had not been submitted to the NRC for review. It became overdue on June 16, 2023, after the review period.

Florida used license conditions to enforce regulations that had not been promulgated so that no regulatory gaps were created which allowed Florida to maintain protection of public health and safety, including the regulations set forth in 10 CFR Parts 37 and 71.

Recommendation 3: The 2019 team recommended that a plan be developed and implemented to address the overdue regulations, including how rules should be prioritized. The plan should also address instituting a knowledge management program for the staff involved in the rulemaking process.

The team noted that Florida developed and implemented a plan to address the overdue regulations which included several members of the staff. Staff met periodically to address the status of overdue regulations. Although the plan had been established and included knowledge management, not all overdue regulations were adopted, and additional regulation amendments became overdue during this review period. The team recommended closing the 2019 recommendation because Florida developed and implemented a plan and addressed knowledge management. The implementation of the plan was not fully successful. Therefore the 2023 team made a new recommendation to address the chronic issues associated with the timely adoption of regulations; namely, improving the administrative review process.

The team also reviewed other program elements designated as necessary for the maintenance of an adequate and compatible program. The other program elements included, licensing guidance, inspection guidance, and new or revised medical guidance.

Program elements require adoption by Florida within 6 months of NRC issuance. The team determined that Florida implemented these program elements, as required.

Florida Final IMPEP Report Page 14

c. Evaluation The team determined that, during the review period, Florida met the performance indicator objectives listed in Section 4.1.a, except for:

• Regulations adopted by the Agreement State for purposes of compatibility or health and safety were adopted later than 3 years after the effective date of the NRC regulation.

The team found that a detailed, realistic timeline of regulation promulgation was not established and monitored by senior Division of Emergency Preparedness and Community Support management in the Department of Health. These actions would help to avoid cross-organizational challenges and support meeting the 3-year implementation deadline. While Florida implemented license conditions to ensure there was no adverse impact on public health and safety, the 2023 IMPEP team made a recommendation for Florida to address challenges with promulgating regulations, the 2023 IMPEP team proposed opening a new recommendation to have Florida:

• Manage implementation of the compatibility plan to establish realistic timelines and leverage senior Division of Emergency Preparedness and Community Support management engagement to ensure timely adoption of current and future regulations.

During the MRB, Florida mentioned that recently adopted meeting with their OGC every month to review the status of the rules.

Based on the IMPEP evaluation criteria in MD 5.6, the team recommends that Floridas performance with respect to the indicator, Legislation, Regulations, and Other Program Elements, be found unsatisfactory.

d. MRB Chairs Determination The MRB Chair agreed with the teams recommendation and found Floridas performance with respect to this performance indicator unsatisfactory. The MRB Chair also agreed that the 2019 recommendation be closed and a new recommendation be opened.

4.2 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 the SS&D reviews and establishes useful guidance for teams.

In accordance with MD 5.6, 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.

Florida Final IMPEP Report Page 15

a. Scope The team used the guidance in SA-108, Reviewing the Non-Common Performance Indicator: Sealed Source and Device Evaluation Program, and evaluated Floridas 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.

b. Discussion Technical Staffing and Training Florida has two qualified SS&D reviewers with two additional staff being trained. At the time of the review, there were no vacancies. During the review period, no SS&D reviewers left the program, and none were hired. Floridas training program is equivalent to NRCs IMC 1248, Appendix D.

Technical Quality of the Product Evaluation Florida has eight SS&D licensees. The team evaluated all seven SS&D actions processed during the review period. These actions included six amendments and one new application. These actions were thorough, adequate, accurate, complete, clear, specific, and consistent with the guidance in NUREG-1556, Volume 3.

Florida Final IMPEP Report Page 16 Evaluation of Defects and Incidents Regarding SS&Ds The team reviewed NMED for incidents involving SS&D registered products during the review period. The team did not identify any incidents related to manufacturing or design of the sources or devices manufactured or distributed by a licensee with a SS&D registered by Florida.

c. Evaluation The team determined that, during the review period, the State of Florida met the performance indicator objectives listed in Section 4.2.a. Based on the criteria in MD 5.6, the team recommends that Floridas performance with respect to the indicator, SS&D Evaluation Program, be found satisfactory.

d. MRB Chairs Determination The MRB Chair agreed with the teams recommendation and found Floridas performance with respect to this performance indicator satisfactory.

4.3 LLRW Disposal Program In 1981, the NRC amended its Policy Statement, Criteria for Guidance of States and NRC in Discontinuance of NRC Regulatory Authority and Assumption Thereof by States Through Agreement, to allow a State to seek an amendment for the regulation of LLRW as a separate category. Although Florida has authority to regulate a LLRW disposal, 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 disposal program. There are no plans for a LLRW disposal facility in Florida. Accordingly, the review team did not review this indicator.

5.0

SUMMARY

The team found Floridas performance satisfactory for the performance indicators:

Technical Staffing and Training, Status of Materials Inspection Program, Technical Quality of Inspections, Technical Quality of Licensing Actions, Technical Quality of Incidents and Allegation Activities, and SS&D Evaluation Program. The team found Floridas performance unsatisfactory for the performance indicator Legislation, Regulations, and other Program Elements.

The team proposed closing the three 2019 IMPEP review recommendations and the MRB Chair agreed. The team also proposed and the MRB Chair agreed to open a new recommendation to have Florida:

• Manage implementation of the compatibility plan to establish realistic timelines and leverage senior management engagement to ensure timely adoption of current and future regulations.

Florida Final IMPEP Report Page 17 Accordingly, the team recommended and the MRB Chair agreed that the Florida Agreement State Program be found adequate to protect public health and safety, and not compatible with the NRCs program. The team recommended and the MRB Chair agreed that the next periodic meeting take place in approximately 2 years and the next 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 Randy Erickson, Region IV Team Leader Technical Quality of Incident and Allegation Activities Inspector Accompaniments Darren Piccirillo, Region III Team Leader in Training David Stradinger, North Dakota Technical Staffing and Training Robin Muzzalupo, Illinois Status of the Materials Inspection Program Inspector Accompaniments Brian Goretzki, Arizona Technical Quality of Inspections Inspector Accompaniments Robin Elliott, Region I Technical Quality of Licensing Actions Farrah Gaskins, Region I Legislation, Regulations, and Other Program Elements James Pate, Louisiana Sealed Source and Device Evaluation Program Miranda Ross, NMSS Observer Trisha Gupta Sarma, NMSS Observer

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

Accompaniment No.: 1 License No.: 4723-8 License Type: Nuclear Pharmacy Priority: 2 Inspection Date: 2/6/2023 Inspectors initials: BC Accompaniment No.: 2 License No.: 3111-4 License Type: Gamma Knife Priority: 2 Inspection Date: 2/7/2023 Inspectors initials: MC Accompaniment No.: 3 License No.: 0014-6 License Type: Gamma Knife Priority: 2 Inspection Date: 2/27/2023 Inspectors initials: KM Accompaniment No.: 4 License No.: 4472-2 License Type: Industrial Radiography Priority: 1 Inspection Date: 2/28/2023 Inspectors initials: WG Accompaniment No.: 5 License No.: 2612-2 License Type: Industrial Radiography Priority: 1 Inspection Date: 3/2/2023 Inspectors initials: MV Accompaniment No.: 6 License No.: 3157-1 License Type: Medical - Written Directive (WD) Priority: 3 required Inspection Date: 3/3/2023 Inspectors initials: AC Accompaniment No.: 7 License No.: 1042-1 License Type: Medical - WD required Priority: 3 Inspection Date: 4/4/2023 Inspectors initials: RL Accompaniment No.: 8 License No.: 1099-1 License Type: Medical WD required Priority: 3 Inspection Date: 4/3/23 Inspectors initials: DG Accompaniment No.: 9 License No.: 3955-4 License Type: Industrial Radiography Priority: 1 Inspection Date: 4/4/23 Inspectors initials: NP

Accompaniment No.: 10 License No.: 0993-1 License Type: Medical WD required Priority: 3 Inspection Date: 4/5/23 Inspectors initials: EK Accompaniment No.: 11 License No.: 4239-1 License Type: Medical No WD required Priority: 5 Inspection Date: 4/6/23 Inspectors initials: ML Accompaniment No.: 12 License No.: 4764-5 License Type: High Dose-Rate Afterloader Priority: 2 Brachytherapy Device Inspection Date: 4/7/23 Inspectors initials: FN Accompaniment No.: 13 License No.: 2476-1 License Type: Medical - WD required Priority: 3 Inspection Date: 4/5/2023 Inspectors initials: LB Accompaniment No.: 14 License No.: 4388-1 License Type: Medical - No WD required Priority: 5 Inspection Date: 4/6/2023 Inspectors initials: JA Accompaniment No.: 15 License No.: 4203-4 License Type: Medical - No WD required Priority: 5 Inspection Date: 4/7/2023 Inspectors initials: RC Accompaniment No.: 16 License No.: 4104-1 License Type: Brachytherapy Priority: 3 Inspection Date: 5/22/2023 Inspectors initials: CC Accompaniment No.: 17 License No.: 4430-1 License Type: Pool Irradiator Priority: 2 Inspection Date: 5/23/2023 Inspectors initials: AO Accompaniment No.: 18 License No.: 0387-1 License Type: Medical - WD required Priority: 3 Inspection Date: 5/24/2023 Inspectors initials: CH Accompaniment No.: 19 License No.: 0549-3 License Type: High Dose-Rate Afterloader Priority: 2 Brachytherapy Device Inspection Date: 5/25/2023 Inspectors initials: SR

Management Review Board (MRB) Meeting Participants - October 5, 2023 Management Review Board:

Cathy Haney, MRB Chair, OEDO Mohammed Shuaibi, Region III Jessica Bielecki, OGC Santiago Rodriguez, the OAS MRB Rep.,

John Lubinski, NMSS from the State of New Mexico IMPEP Team Members:

Robing Elliot, RI Robin Muzzalupo, IL Randy Erickson, RIV Darren Piccirillo, RIII Farrah Gaskins, RI James Pate, LA Brian Goretzki, AZ David Stradinger, ND State of Florida:

Clark Eldridge Ryan Hill Kevin Kunder Jorge Laguna Leo Bakersmith Giovanna Manning Ken Barnhart Mike Stephens NRC Staff:

Huda Akhavannik, NMSS Karen Meyer, NMSS Jaun Ayala, RI Kathy Modes, NMSS Jackie Cook, Region IV Jessie Quichocho, Region I Suzanne Dennis, OCM Soly Soto, EDO Ken Erwin, MSST Kelli Trotter, NRAN Sherrie Flaherty, SLPB, MSST Lee Smith, SLPB, MSST Monica Ford, Region I Duncan White, SLPB, MSST Adelaide Giantelli, SLPB, MSST Kevin Williams, MSST Robert Johnson, MSST Members of the Public:

James Albright, NC Matt Greenwood, Tennessee Louis Brayboy, NC Chinwe Ekwuribe, NC Travis Cartoski, NC Stevie Norcross, UT Keish Cornelius, Oklahoma Mesfin Redeat, NC Randy Crowe, NC Caleb A. Smith, NC Adam Gause, South Carolina There were no comments from Members of the Public. The meeting began at approximately 1:00 p.m. (ET) and was adjourned at approximately 2:06 p.m. (ET)

Enclosure 2

Ltr ML23289A168 OFFICE OEDO/DEDM NAME CHaney CH DATE Nov 3, 2023