UNITED STATES

NUCLEAR REGULATORY COMMISSION 

WASHINGTON, D.C. 20555-0001 

June 25, 2015 

Celeste Philip, M.D., MPH

Deputy Secretary for Health

Florida Department of Health 

4025 Esplanade Way 

Room 110A, Bin A-06 

Tallahassee, FL 32399-1722 

Dear Dr. Phillip: 

On June 4, 2015, the Management Review Board (MRB) met to consider the proposed final 

Integrated Materials Performance Evaluation Program (IMPEP) report on the Florida Agreement 

State Program. The MRB found the Florida program adequate to protect public health and 

safety, and compatible with the U.S. Nuclear Regulatory Commission’s program. 

Section 5.0, page 14, of the enclosed final report contains a summary of the IMPEP team’s 

findings. Based on the results of the current IMPEP review, the next full review of the Florida 

Agreement State Program will take place in approximately 4 years, with a periodic meeting 

tentatively scheduled for March 2017. 

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, 

 /RA/ 

 Michael F. Weber 

 Deputy Executive Director for Materials, 

 Waste, Research, State, Tribal and 

 Compliance Programs 

 Office of the Executive Director for Operations 

Enclosure: 

Florida Final IMPEP Report 

cc: See next page
cc: 

Debra Shults, TN 

Organization of Agreement States 

 Liaison to the MRB 

Cindy E. Dick, MBA, EFO, Director 

Division of Emergency Preparedness 

 and Community Support 

Cynthia Becker, MPH, Chief 

Bureau of Radiation Control 
June 25, 2015 

Celeste Philip, M.D., MPH

Deputy Secretary for Health

Florida Department of Health 

4025 Esplanade Way 

Room 110A, Bin A-06 

Tallahassee, FL 32399-1722 

Dear Dr. Phillip: 

On June 4, 2015, the Management Review Board (MRB) met to consider the proposed final 

Integrated Materials Performance Evaluation Program (IMPEP) report on the Florida Agreement 

State Program. The MRB found the Florida program adequate to protect public health and 

safety, and compatible with the U.S. Nuclear Regulatory Commission’s program. 

Section 5.0, page 9, of the enclosed final report contains a summary of the IMPEP team’s 

findings. Based on the results of the current IMPEP review, the next full review of the Florida 

Agreement State Program will take place in approximately 4 years, with a periodic meeting 

tentatively scheduled for March 2017. 

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, 

 /RA/ 

 Michael F. Weber 

 Deputy Executive Director for Materials, 

 Waste, Research, State, Tribal and 

 Compliance Programs 

 Office of the Executive Director for Operations 

Enclosure: 

Florida Final IMPEP Report 

cc: see next page 

Distribution: (SP05) see next page

ML15159B035 

OFC MSTR/ASPB MSTR/ASPB RIV:TL NMSS/MSTR Tech Ed NMSS EDO 

NAME LDimmick CEinberg RErickson 

via email

JPiconne / 

PJH for

CPoland CHaney MWeber 

DATE 06/09/15 06/11/15 06/11/15 06/12/15 06/12/15 06/19/15 06/ 25 /15 

OFFICIAL RECORD COPY 
Letter to C. Phillip from M. Weber dated: June 25, 2015 

SUBJECT: FLORIDA FY2015 FINAL IMPEP REPORT 

DISTRIBUTION: (SP05) 

RidsEdoMailCenter 

JFoster, OEDO 

RidsOgcMailCenter 

JOlmstead, OGC 

RidsRgn3MailCenter 

DRoberts, RIII 

RidsRgn1MailCenter 

DCollins, RI 

JNick, RI 

RidsNmmsOd 

RidsSecyCorrespondenceMailCenter Chairman Burns 

JPiccone, MSTR Commissioner Svinicki 

PHenderson, MSTR Commissioner Ostendorff 

DJanda, RI/RSAO Commissioner Baran 

KLambert, RIII SECY 

MArribas-Colon, NMSS 

AWilbers, KY 

JBai, FL 

MStephens, FL 

OAS Board 

JWeil, OCA 
Enclosure 

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM 

REVIEW OF THE FLORIDA AGREEMENT STATE PROGRAM 

MARCH 9–13, 2015 

FINAL REPORT
EXECUTIVE SUMMARY 

This report presents the results of the Integrated Materials Performance Evaluation Program 

(IMPEP) review of the Florida Agreement State Program. The review was conducted during the 

period of March 9–13, 2015, by a review team composed of technical staff members from the 

U.S. Nuclear Regulatory Commission (NRC) and the Commonwealth of Kentucky.

Based on the results of this review, Florida’s performance was found satisfactory for all 

indicators reviewed. The review team did not make any recommendations for the State. 

Accordingly, the review team recommended, and the Management Review Board (MRB) 

agreed, that the Florida Agreement State Program is adequate to protect public health and 

safety and is compatible with the NRC's Program. The review team recommended, and the 

MRB agreed, that the next IMPEP review take place in approximately 4 years and that a 

periodic meeting be held in 2 years. 
Florida Final IMPEP Report Page 1 

1.0 INTRODUCTION 

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

The review was conducted during the period of March 9-13, 2015, by a review team 

composed of technical staff members from the U.S. Nuclear Regulatory Commission 

(NRC) and the Commonwealth of Kentucky. Team members are identified in 

Appendix A. The review was conducted in accordance with the “Implementation of the 

Integrated Materials Performance Evaluation Program and Rescission of Final General 

Statement of Policy,” published in the Federal Register on October 16, 1997, and NRC 

Management Directive 5.6 (MD 5.6), “Integrated Materials Performance Evaluation 

Program (IMPEP),” dated February 26, 2004. Preliminary results of the review, which 

covered the period of April 2, 2011– March 13, 2015, were discussed with Florida 

managers on the last day of the review. 

In preparation for the review, a questionnaire addressing the common and applicable 

non-common performance indicators was sent to the State on December 1, 2014. The 

State provided its response to the questionnaire by electronic mail on February 23, 

2015. A copy of the questionnaire response can be found in the NRC’s Agencywide 

Documents Access and Management System (ADAMS) using the Accession Number 

ML15056A122. 

A draft of this report was issued to Florida on April 9, 2015, for factual comment. Florida 

responded to the findings and conclusions of the review by electronic mail dated May 11, 

2015. A copy of the State’s response can be found in ADAMS using the Accession 

Number ML15131A383. The Management Review Board (MRB) met on June 4, 2015, 

to consider the proposed final report. The MRB found the Florida Agreement State 

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

program. 

The Florida Agreement State Program is administered by the Bureau of Radiation 

Control (the Bureau) which is located within the Division of Emergency Preparedness 

and Community Support (the Division). The Division is part of the Department of Health 

(the Department). Organization charts for the State can be found in ADAMS using the 

Accession Number ML15097A299. 

At the time of the review, the Florida Agreement State Program regulated 1,659 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 State of 

Florida. 

The review 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 Florida Agreement State Program’s performance. 

 
Florida Final IMPEP Report Page 2 

2.0 PREVIOUS IMPEP REVIEW AND STATUS OF RECOMMENDATIONS 

The previous IMPEP review concluded on April 1, 2011. The final report is available in 

ADAMS using the Accession Number ML111661400. The results of that review were as 

follows: 

Technical Staffing and Training: Satisfactory 

Recommendation: None 

Status of Materials Inspection Program: Satisfactory 

Recommendation: None 

Technical Quality of Inspections: Satisfactory 

Recommendation: None 

Technical Quality of Licensing Actions: Satisfactory 

Recommendation: None 

Technical Quality of Incident and Allegation Activities: Satisfactory 

Recommendation: None 

Compatibility Requirements: Satisfactory, but needs Improvement 

Recommendation: None 

Sealed Source and Device Evaluation Program: Satisfactory 

Recommendation: None 

Overall finding: Adequate to protect public health and safety and Compatible with the 

NRC’s program. 

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. 

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, and well-trained technical 

personnel. Under certain conditions, staff turnover could have an adverse effect on the 

implementation of these programs, and thus could affect public health and safety. 

Apparent trends in staffing must be explored. Review of this indicator also requires a 

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. 
Florida Final IMPEP Report Page 3 

a. Scope

The review team used the guidance in State Agreements procedure SA-103, “Reviewing 

the Common Performance Indicator: Technical Staffing and Training,” and evaluated 

Florida’s 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 Inspection 

Manual Chapter (IMC) 1248. 

• Qualification criteria for new technical staff are established and are being followed. 

• 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 Florida Agreement State Program is composed of 68 staff members with 20 full-time 

equivalents (FTE) allocated to the radioactive materials program. There are currently 

three vacancies. During the review period, 15 staff members left the Bureau and 12 staff 

members were hired. On average, each vacancy was only open for two months. The 

review team found that Florida’s training and qualification program is equivalent to the 

NRC’s training program. 

c. Evaluation

The review team determined that during the review period the Florida program met the 

performance indicator objectives listed in Section 3.1.a. 

The review team discussed the staff turnover rate with Bureau management, including 

management’s view regarding the causes for the turnover, any impacts resulting from 

the staff losses, and measures which were implemented to deal with the losses. Based 

on the discussion, the review team found that at least half of those who left the Bureau 

had reached retirement age and left the Bureau for that reason. Given the age of the 

current staff, the Bureau expects a trend of attrition due to retirements continuing for the 

next few years. The Department is working on strategies to address these upcoming 

anticipated losses. The other staff, who departed, left for various reasons. Bureau 

management believes that, in large part, low salaries were a contributing factor to some 

of the staff departures. To compensate for low salaries, both the Department and 

Bureau have been implementing strategies to retain staff with incentives such as 

full-time home basing, electronic work submission, flexibility in work schedules, and 

providing State vehicles. 
Florida Final IMPEP Report Page 4 

The review team determined that the staff losses had minimal impact on the Bureau’s 

performance over the review period. This is due in large part to the Bureau’s in-house 

training program. The Bureau developed its own comprehensive training program. With 

this program, the Bureau is able to quickly train newly hired new staff instead of waiting 

on NRC course availability. The training program focuses on those modalities that 

comprise the bulk of Florida’s licensee base. This training includes self-directed 

modules, and on the job training overseen by the new employee’s supervisor. The NRC 

training courses are also attended as the classes become available. This training 

program shortens the time in which new inspection staff can be qualified and work 

independently. While the impact of the staff turnover on licensing, inspection and 

incident response activities was minimal, the review team did observe a lapse in the 

timely reporting of events which was attributed to staff losses in the emergency response 

program (Section 3.5 of this report). The Bureau took action to address this oversight. 

d. Results

Based on the IMPEP evaluation criteria in MD 5.6, the review team recommended, and 

the MRB agreed, that Florida’s performance with respect to the indicator, Technical 

Staffing and Training, be found satisfactory. 

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 NRC Inspection Manual 

Chapter (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 review team used the guidance in State Agreements procedure SA-101, “Reviewing 

the Common Performance Indicator: Status of Materials Inspection Program,” and 

evaluated Florida’s 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 NRC 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 coordinated between technical staff and 

management. 
Florida Final IMPEP Report Page 5 

• 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”). 

b. Discussion

Florida’s inspection frequency is more frequent than similar license types found in 

IMC 2800. The Bureau performed a total of 2,944 Priority 1, 2, 3 and initial inspections 

over the review period of which none were conducted overdue. Initial inspections of new 

licenses were performed within 12 months of license issuance. A sampling of 28 

inspection reports indicated that none of the inspection findings were communicated to 

the licensees beyond Florida’s goal of 30 days following the inspection exit. In each 

year of the review period, Florida performed more than 20 percent of candidate 

reciprocity inspections. 

c. Evaluation

The team determined that during the review period Florida met the performance 

indicator objectives listed in Section 3.2.a. 

d. Results

Based on the IMPEP evaluation criteria in MD 5.6, the review team recommended, and 

the MRB agreed, that Florida’s performance with respect to the indicator, Status of 

Materials Inspection Program, be found satisfactory. 

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 a program’s inspection capability. 

a. Scope

The review team used the guidance in State Agreements procedure SA-102, “Reviewing 

the Common Performance Indicator: Technical Quality of Inspections,” and evaluated 

Florida’s 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 conduct annual accompaniments of each inspector to assess 

performance and assure consistent application of inspection policies. 

• For programs with separate licensing and inspection staffs, to verify that procedures 

are established and followed to provide feedback information to license reviewers. 

• For Agreement States, to determine if inspection guides are consistent with NRC 

guidance. 

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

inspection program. 

b. Discussion

The review team interviewed inspectors and evaluated a sampling of inspection reports 

and enforcement documentation for 28 of the 2,944 Priority 1, 2, 3 and initial inspections 

conducted during the review period. The casework reviewed included inspections 

conducted by 23 of Florida’s 32 inspectors and covered medical, industrial, commercial, 

academic, research, and service provider licenses. 

Accompaniments of 17 inspectors were conducted by two review team members in 

January and February 2015. The inspectors were found to be well-prepared, thorough, 

and conducted performance-based inspections. The inspections were adequate to 

assess radiological health, safety and security. 

The review team noted that the Bureau has a policy of performing annual supervisory 

accompaniments for each of the materials inspectors. The review team found that over 

the review period a total of 193 inspector accompaniments had been performed with 

only two being missed. The review team noted that in these two instances, during the 

year when the inspector was not accompanied, they had been accompanied the 

preceding and following years. The Bureau believed the oversight occurred due to the 

manner in which it was tracking accompaniments. To correct this, in 2014 the Bureau 

developed a new spreadsheet to ensure that supervisory accompaniments of all 

inspectors were performed annually. 

c. Evaluation

The team determined that during the review period Florida met the performance 

indicator objectives listed in Section 3.3.a. 

d. Results

Based on the IMPEP evaluation criteria in MD 5.6, the review team recommended, and 

the MRB agreed, that Florida’s performance with respect to the indicator, Technical 

Quality of Inspections, be found satisfactory. 

 
Florida Final IMPEP Report Page 7 

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, and security. An assessment of licensing procedures, 

actual implementation of these procedures, and documentation of communications and 

associated actions between the State licensing staff and the regulated community will be 

a significant indicator of the overall quality of the program. 

a. Scope

The review team used the guidance in State Agreements procedure SA-104, “Reviewing 

the Common Performance Indicator: Technical Quality of Licensing Actions,” and 

evaluated Florida’s 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 meet 

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 are inspectable. 

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

• Reviews of renewal applications demonstrate a thorough analysis of a licensee’s 

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). 

• Documents containing sensitive security information are properly marked, handled, 

controlled and secured. 

b. Discussion

During the review period, Florida performed 7,820 licensing actions. The review team 

evaluated 26 of these licensing actions which included casework for eight current and 

former license reviewers. The casework reviewed included new applications, 

amendments, renewals and terminations. The review team evaluated casework for the 

following license types and actions: broad scope, medical diagnostic and therapy, 

veterinary, research and development, academic, gauges, panoramic and self-shielded 

irradiators, service providers, waste brokers, decommissioning actions, financial 

assurance, and bankruptcies. 

 
Florida Final IMPEP Report Page 8 

c. Evaluation

The team determined that during the review period Florida met the performance 

indicator objectives listed in Section 3.4.a. 

d. Results

Based on the IMPEP evaluation criteria in MD 5.6, the review team recommended, and 

the MRB agreed, that Florida’s performance with respect to the indicator, Technical 

Quality of Licensing Actions, be found satisfactory. 

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 

of incident response and allegation investigation procedures, actual implementation of 

these procedures, internal and external coordination, and investigative and follow-up 

procedures and actions will be a significant indicator of the overall quality of the 

program. 

a. Scope

The review team used the guidance in State Agreements procedure SA-105, “Reviewing 

the Common Performance Indicator: Technical Quality of Incident and Allegation 

Activities,” and evaluated Florida’s 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 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). 

• 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, a total of 226 incidents were reported to Florida which in turn 

the Bureau reported to NMED. The review team screened the incidents reported to 

NMED and noted that 125 of these incidents were waste/scrap alarms that would not 

need to be reported to the NRC. Of the remainder reported to NMED, the review team 
Florida Final IMPEP Report Page 9 

evaluated the casework for 21 radioactive materials incidents which included 5 

lost/stolen radioactive materials events, 2 potential overexposures, 9 medical events, 

and 5 damaged equipment incidents. Florida dispatched inspectors for onsite follow-up 

for 16 of the cases reviewed. 

During the review period, Florida received 19 allegations. The review team evaluated 

10 allegations, including 5 allegations that the NRC referred to the State during the 

review period. 

c. Evaluation

The team determined that during the review period Florida met the performance 

indicator objectives listed in Section 3.5.a. with the exception of the requirement for 

timely notification of incidents to the NRC. 

The review team identified seven incidents that were reported to NMED but were not 

reported to the NRC Headquarters Operations Center as required (i.e., the incidents 

required a 24-hour or immediate notification to the NRC). In August 2014, the Bureau 

participated in the NRC-sponsored NMED training course and subsequently determined 

that reporting of incidents was not being performed as established in State Agreements 

procedure SA-300, “Reporting Material Events.” In October 2014, the Bureau reported 

29 materials events to NMED including 6 of the 7 incidents that had not been reported to 

the NRC Headquarters Operations Center. The remaining incident had been previously 

reported to NMED in August 2011. The Bureau determined that the reporting lapse was 

due to staff turnover in the emergency response program. Based on a review of the 

events reported in October 2014, the review team determined that, although the 

reporting requirements were inadvertently overlooked, the Bureau responded to the 

incidents in an effective manner. Florida has since been reporting events to the NRC in 

a timely manner. 

d. Results

Although Florida did not report some events to the NRC in accordance with the 

timeliness guidelines established in SA-300 the review team determined that the Bureau 

responded to each incident in a manner commensurate with its health and safety 

significance. 

Based on the IMPEP evaluation criteria in MD 5.6, the review team recommended, and 

the MRB agreed, that Florida’s performance with respect to the indicator, Technical 

Quality of Incident and Allegation Activities, be found satisfactory. 

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 Evaluation 

Program, (3) Low-Level Radioactive Waste Disposal Program, and (4) Uranium 

Recovery Program. The NRC’s Agreement with Florida does not relinquish regulatory 

authority for uranium recovery programs, and Florida does not have an active low-level 
Florida Final IMPEP Report Page 10 

waste disposal program. 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 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 review team used the guidance in State Agreements procedure SA-107, “Reviewing 

the Non-Common Performance Indicator: Compatibility Requirements,” and evaluated 

Florida’s performance with respect to the following performance indicator objectives 

• 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 State’s regulations. 

A complete list of regulation amendments can be found on the NRC website at the 

following address: http://nrc-stp.ornl.gov/rss_regamendents.html. 

 
Florida Final IMPEP Report Page 11 

b. Discussion

Florida became an Agreement State on July 1, 1964. The Florida Agreement State 

Program‘s current effective statutory authority is contained in the Florida Radiation 

Protection Act in Title XXIX, Chapter 404 of the Florida Statutes. The Bureau’s 

rulemaking process is governed by the Administrative Procedure Act in Title X, Chapter 

120, of the Florida Statutes. The Department is designated as the State’s radiation 

control agency and the Bureau implements the radiation control program. No legislation 

affecting the radiation control program was passed during the review period. 

The State’s administrative rulemaking process takes approximately 12 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 by the agency. The review team noted that the 

State’s rules and regulations are not subject to “sunset” laws. 

During the review period, Florida submitted revisions to five final regulation amendments 

to the NRC for compatibility review. These revisions were in response to the NRC 

generated comments on these previously submitted final regulation amendments. In 

addition, Florida submitted three proposed regulation amendments for a compatibility 

review. The three regulation amendments were overdue for State adoption at the time 

of submission. The Bureau addressed the NRC generated comments and finalized 

these proposed regulation amendments, but did not send them to the NRC for review. 

On March 11, 2015, while the review team was on site, the Bureau sent the final 

regulations to the NRC for review. 

c. Evaluation

The team determined that during the review period Florida met the performance 

indicator objectives listed in Section 3.4.1.a. 

d. Results

The review team compared the status of the Compatibility indicator in the 2011 IMPEP 

review with its current status and evaluated the progress made in completing the 

outstanding amendments. Using the evaluation criteria in MD 5.6, the review team 

recommended, and the MRB agreed, that Florida’s performance with respect to the 

indicator, Compatibility Requirements, be found satisfactory. 

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 review 

teams. Three sub elements, technical staffing and training, technical quality of the 
Florida Final IMPEP Report Page 12 

product evaluation program, and evaluation of defects and incidents regarding SS&D’s, 

will be 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 review team used the guidance in State Agreements procedure SA-108, “Reviewing 

the Non-Common Performance Indicator: Sealed Source and Device Evaluation 

Program,” and evaluated Florida’s 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. 

• Any vacancies 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 NUREG 1556, Volume 3. 

Evaluation of Defects and Incidents

• SS&D incidents are reviewed to detect 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 NRC, Agreement States, and 

others, as appropriate, should occur in a timely manner. 

b. Discussion

Technical Staffing and Training

The Bureau had six qualified reviewers over the review period. Two reviewers retired, 

one reviewer left the Bureau, and one new reviewer was qualified. The Bureau currently 

has four individuals qualified as SS&D reviewers. There are no vacancies at the present 

time. The review team determined that current staffing levels are adequate for the 

Bureau’s SS&D program. The Bureau’s training program is equivalent to the training 

requirements identified in Appendix D to IMC 1248 which includes attending NRC’s 
Florida Final IMPEP Report Page 13 

SS&D Workshop. Due to the small number of applications and amendment requests 

received, the Bureau primarily uses on-the-job training for new reviewers with oversight 

from a senior SS&D reviewer. 

Technical Quality of the Product Evaluation

Florida has 6 SS&D licensees and processed 10 SS&D actions over the review period. 

The review team evaluated each of the 10 actions which included 9 amendments and 

1 transfer from the State of Maryland. 

Evaluation of Defects and Incidents Regarding SS&Ds

The review team did not identify any incidents involving SS&D registered products 

during the review period. There were also no incidents identified which related to 

manufacturing or design of the sources/devices manufactured or distributed by a 

licensee with an SS&D registered by Florida. 

c. Evaluation

The team determined that during the review period Florida met the performance 

indicator objectives listed in Section 4.2.a. 

d. Results

Based on the IMPEP evaluation criteria in MD 5.6, the review team recommended, and 

the MRB agreed, that Florida’s performance with respect to the indicator, Sealed Source 

and Device Evaluation Program, be found satisfactory. 

4.3 Low-level Radioactive Waste (LLRW) Disposal Program 

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

NRC in Discontinuance of NRC Regulatory Authority and Assumption Thereof by States 

Through Agreement," to allow a State to seek an amendment for the regulation of LLRW 

as a separate category. Although the Florida Agreement State Program has LLRW 

disposal authority, NRC has not required States to have a program for licensing a LLRW 

disposal facility until such time as the State has been designated as a host State for a 

LLRW disposal facility. When an Agreement State has been notified or becomes aware 

of the need to regulate a LLRW disposal facility, they are expected to put in place a 

regulatory program which will meet the criteria for an adequate and compatible LLRW 

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

Accordingly, the review team did not review this indicator. 

 
Florida Final IMPEP Report Page 14 

5.0 SUMMARY

As noted in Sections 3.0 and 4.0 above, Florida’s performance was found satisfactory for 

all the performance indicators reviewed. The review team did not make any 

recommendations regarding program performance by the State. 

Accordingly, the review team recommended, and the MRB agreed, that the Florida 

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 current IMPEP review, 

the review team recommended, and the MRB agreed, that the next full IMPEP review 

take place in approximately 4 years. 
LIST OF APPENDICES 

Appendix A IMPEP Review Team Members 

Appendix B Inspection Accompaniments 
APPENDIX A 

IMPEP REVIEW TEAM MEMBERS 

Name Area of Responsibility

Randy Erickson, Region IV Team Leader 

 Technical Staffing and Training 

 Compatibility Requirements 

 Inspector Accompaniments 

Donna Janda, Region I Technical Quality of Incident and 

 Allegation Activities 

Kenneth Lambert, Region III Technical Quality of Inspections 

 Inspector Accompaniments 

Maria Arribas-Colon, NMSS Status of Materials Inspection Program 

 Sealed Source and Device Evaluation Program 

Angela Wilbers, Technical Quality of Licensing Actions 

Commonwealth of Kentucky 
APPENDIX B 

INSPECTION ACCOMPANIMENTS 

The following inspection accompaniments were performed prior to the on-site IMPEP review: 

Accompaniment No.: 1 License No.: 1319-3 

License Type: Gamma Knife & HDR Priority: 2 

Inspection Date: 1/20/15 Inspector: EK 

Accompaniment No.: 2 License No.: 1319-2 

License Type: Self Shielded & Panoramic Irradiator Priority: 1 

Inspection Date: 1/20/15 Inspector: FN 

Accompaniment No.: 3 License No.: 2941-1 

License Type: Industrial Radiography Priority: 1 

Inspection Date: 1/21/15 Inspector: JS 

Accompaniment No.: 4 License No.: 3279-2 

License Type: HDR Priority: 2 

Inspection Date: 1/22/15 Inspector: RL 

Accompaniment No.: 5 License No.: 3825-22 

License Type: HDR Priority: 2 

Inspection Date: 1/23/15 Inspector: LP 

Accompaniment No.: 6 License No.: 4332-1 

License Type: Diagnostic Nuclear Medicine Priority: 5 

Inspection Date: 1/26/15 Inspector: HS 

Accompaniment No.: 7 License No.: 1669-1 

License Type: Teletherapy Priority: 2 

Inspection Date: 1/27/15 Inspector: LB 

Accompaniment No.: 8 License No.: 4162-2 

License Type: HDR Priority: 2 

Inspection Date: 1/28/15 Inspector: RC 

Accompaniment No.: 9 License No.: 4220-2 

License Type: HDR Priority: 2 

Inspection Date: 1/29/15 Inspector: DD 

Accompaniment No.: 10 License No.: 3287-1 

License Type: Nuclear Pharmacy Priority: 2 

Inspection Date: 1/30/15 Inspector: MV 

Accompaniment No.: 11 License No.: 1367-1 

License Type: Diagnostic & Therapeutic Nuclear Medicine Priority: 3 

Inspection Date: 2/3/15 Inspector: BC 
Florida Final IMPEP Report Page B.2 

Inspection Accompaniments 

Accompaniment No.: 12 License No.: 4432-1 

License Type: Nuclear Pharmacy Priority: 2 

Inspection Date: 2/4/15 Inspector: JJ 

Accompaniment No.: 13 License No.: 3453-13 

License Type: Nuclear Pharmacy Priority: 2 

Inspection Date: 2/5/15 Inspector: RL 

Accompaniment No.: 14 License No.: 0319-8 

License Type: Self Shielded Irradiator Priority: 5 

Inspection Date: 2/6/15 Inspector: KB 

Accompaniment No.: 15 License No.: 4071-1 

License Type: HDR Priority: 2 

Inspection Date: 2/6/15 Inspector: SR 

Accompaniment No.: 16 License No.: 1275-1 

License Type: Diagnostic & Therapeutic Nuclear Medicine Priority: 3 

Inspection Date: 2/9/15 Inspector: GH 

Accompaniment No.: 17 License No.: 3362-2 

License Type: Diagnostic & Therapeutic Nuclear Medicine Priority: 3 

Inspection Date: 2/10/15 Inspector: DB