May 1, 2003

Bonita Sorensen, M.D., M.B.A.

Deputy State Health Officer

Department of Health

4052 Bald Cypress Way, Bin A07

Tallahassee, FL 32399-1708

Dear Dr. Sorensen:

On April 15, 2003, 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 Nuclear Regulatory Commission’s (NRC) program. 

No recommendations were made by the review team.

Based on the results of the current IMPEP review, the next full review will be in approximately

four 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 Radiation Control Program and the

excellence in program administration demonstrated by your staff as reflected in the team’s

findings. I look forward to our agencies continuing to work cooperatively in the future.

Sincerely,

/RA/

Carl J. Paperiello 

Deputy Executive Director 

 for Materials, Research and State Programs

Enclosure:

As stated

cc: Daniel Parker, Senior Management Analyst II

Acting Director, Division of Environmental Health

William A. Passetti, Chief

Bureau of Radiation Control

Department of Health

Pearce O’Kelley, SC

OAS Liaison to the MRB
Bonita Sorensen, M.D., M.B.A. May 1, 2003

Deputy State Health Officer

Department of Health

4052 Bald Cypress Way, Bin A07

Tallahassee, FL 32399-1708

Dear Dr. Sorensen:

On April 15, 2003, 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 Nuclear Regulatory Commission’s (NRC) program. 

No recommendations were made by the review team.

Based on the results of the current IMPEP review, the next full review will be in approximately

four 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 Radiation Control Program and the

excellence in program administration demonstrated by your staff as reflected in the team’s

findings. I look forward to our agencies continuing to work cooperatively in the future.

Sincerely,

/RA/

Carl J. Paperiello 

Deputy Executive Director 

 for Materials, Research and State Programs

Enclosure:

As stated

cc: Daniel Parker, Senior Management Analyst II

Acting Director, Division of Environmental Health

William A. Passetti, Chief

Bureau of Radiation Control bcc: Chairman Diaz

Department of Health Commissioner Dicus

Commissioner McGaffigan

Pearce O’Kelley, SC Commissioner Merrifield

OAS Liaison to the MRB

Distribution: See next page.

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DATE 4/18/03 4/18/03 4/18/03 05/01/03

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Bonita Sorensen

2 May 1, 2003

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Florida File
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM

REVIEW OF FLORIDA AGREEMENT STATE PROGRAM

February 3-7, 2003

FINAL REPORT

U.S. Nuclear Regulatory Commission
Florida Final 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 February 3-7, 2003, by a review team consisting of

technical staff members from the Nuclear Regulatory Commission (NRC) and the Agreement

State of Ohio. Team members are identified in Appendix A. The team was accompanied by

two representatives from the U.S. General Accounting Office. The review was conducted in

accordance with the "Implementation of the Integrated Materials Performance Evaluation

Program and Rescission of a Final General Statement of Policy," published in the Federal

Register on October 16, 1997, and the November 5, 1999, NRC Management Directive 5.6,

"Integrated Materials Performance Evaluation Program (IMPEP)." Preliminary results of the

review, which covered the period of February 26, 1999, to February 7, 2003, were discussed

with Florida management on February 7, 2003.

A draft of this report was issued to Florida for factual comment on March 6, 2003. The State

responded by electronic letter dated March 18, 2003. The Management Review Board (MRB)

met on April 15, 2003 to consider the proposed final report. The MRB found the Florida

radiation control program adequate to protect public health and safety and compatible with

NRC’s program.

The Florida Agreement State program is administered by the Bureau of Radiation Control (the

Bureau). The Bureau Chief reports to the Director of the Division of Environmental Health (the

Division) located in the Department of Health (the Department). The Bureau consists of five

sections managed by the Bureau Chief. Three sections within the Bureau, Radioactive

Materials, Field Operations, and Environmental Radiation Labs have responsibilities for

radioactive materials under the Agreement. The Department is the designated radiation

control agency (See Section 4.1). Organization charts are included in Appendix B. At the time

of the review, the Florida Agreement State program regulated 1383 specific licenses

authorizing Agreement and non-Atomic Energy Act materials. The review focused on the

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. 

In preparation for the review, a questionnaire addressing the common and non-common

performance indicators was sent to the Bureau on October 31, 2002. The Bureau provided a

response to the questionnaire on January 17, 2003. During the review, the review team

identified areas in the questionnaire response that needed to be modified. The State provided

an amended questionnaire response on February 12, 2003. Copies of the questionnaire

responses may be found on NRC’s Agencywide Document Access and Management Systems

using the Accession Numbers ML030300287 and ML030510559.

The review team's general approach for conduct of this review consisted of: (1) examination of

Florida’s responses to the questionnaire; (2) review of applicable Florida statutes and

regulations; (3) analysis of quantitative information from the radiation control program licensing

and inspection data base; (4) technical review of selected licensing and inspection actions;

(5) field accompaniments of nine Bureau inspectors; and (6) interviews with staff and

management to answer questions or clarify issues. The review team evaluated the information

that it gathered against the IMPEP performance criteria for each common and applicable
Florida Final Report Page 2

non-common performance indicators and made a preliminary assessment of the Florida

Agreement State program’s performance.

Section 2 below discusses the State’s actions in response to recommendations made following

the previous IMPEP review and the team’s conclusions regarding close-out of the

recommendation. Results of the current review for the IMPEP common performance indicators

are presented in Section 3. Section 4 discusses results of the applicable non-common

performance indicators, and Section 5 summarizes the review team's findings. 

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS

During the previous IMPEP review, which concluded on February 26, 1999, three

recommendations were made and transmitted to Ms. Sharon Heber, M.P.H., Director, Division

of Environmental Health, on May 25, 1999. The team’s review of the current status of the

recommendations are as follows:

1. The review team recommends that the Bureau incorporate the field notes for the

inspection of waste processing and panoramic irradiator licensees in their inspection

procedures manual. (Section 3.2)

Current Status: Copies of the field notes for the inspection of waste processing and

panoramic irradiator licensees were provided to the review team. The Bureau has

incorporated the field notes into their electronic inspection procedures manual. The

review team noted that the hard copy inspection procedures manual referred inspectors

to the electronic manual to obtain copies of these infrequently used field notes. This

recommendation is closed. 

2. The review team recommends that the Bureau revise their incident and allegation

procedures to document all existing State practices and to incorporate appropriate

elements of OSP Procedure SA-300, “Handbook on Nuclear Event Reporting in the

Agreement States” and NRC Management Directive 8.8, “Management of Allegations,”

particularly the required documentation and management approval for closing out

incidents and allegations. (Section 3.5)

Current Status: Copies of the Bureau Standard Operating Procedure (SOP) 1 dated

October 2002 were provided to the review team. Additions to the SOP since the

previous IMPEP review include thorough documentation of incident and allegation

response procedures, as well as additional information on reporting of events to the

NRC. Incident response files are closed out with proper management approval. This

recommendation is closed.

3. The review team recommends that the State complete adoption of the revisions to

Part 20 to correct discrepancies identified in NRC letter dated November 24, 1997. 

(Section 4.1.2)

Current Status: The review team found that the State corrected the minor

discrepancies in the State’s adoption of the 10 CFR Part 20 equivalent regulations

effective October 8, 2000. This recommendation is closed.
Florida Final Report Page 3

3.0 COMMON PERFORMANCE INDICATORS

IMPEP identifies five common performance indicators to be used in reviewing both NRC

Regional and Agreement State 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) Response to Incidents and Allegations. 

3.1 Technical Staffing and Training

Issues central to the evaluation of this indicator include the Bureau’s staffing level and staff

turnover, as well as the technical qualifications and training histories of the staff. To evaluate

these issues, the review team examined the Bureau’s questionnaire responses relative to this

indicator, interviewed Bureau management and staff, reviewed job descriptions and training

records, and considered any possible workload backlogs.

The Bureau is managed from the Central office located in Tallahassee. The Radioactive

Materials Administrator is responsible for materials licensing and compliance activities. The

Field Operations Administrator is responsible for coordinating the inspection activities, which

are conducted primarily by the six field offices and under contract with two counties, Polk and

Broward. The Environmental Radiation Lab Administrator, located in Orlando, is responsible

for the Bureau’s laboratory and emergency response activities.

At the time of the review, there were 58 individuals with various degrees of involvement with

the Florida radioactive materials program with a total of 20 full time equivalents (FTE) assigned

to implement the materials licensing and inspection program. This staffing level does not

include administrative support staff. Fifteen staff were located in the Central office, including

five managers. Thirty-four staff were inspectors distributed among the six field offices and the

two counties under contract. Nine staff were involved with emergency response and

laboratory services in the Orlando office.

The Bureau had a total of 21 turnovers in staff during the review period, equivalent to 6 FTE

assigned to the Agreement program. The Bureau’s turnover was due primarily to competition

with local industry for qualified staff. Nevertheless, the Bureau has generally been able to fill

vacancies in an expedient manner. At the time of the review, the Bureau had four vacancies,

one in the Central office and three in the Miami office. Bureau management does not intend to

fill one of the vacancies in the Miami office due to their current workload. The review team

concluded that the Bureau has a well balanced staff, and a sufficient number of trained

personnel to carry out regulatory duties.

The Bureau has a documented training and qualification program for licensing and inspection

staff that is based on the NRC/Organization of Agreement States Joint Working Group report. 

Adequate qualification is determined through a combination of education and experience,

formal classroom training, and on-the-job training. The technical staff are classified as

Environmental Scientists and Specialists. Staff members are required to have a bachelors

degree or equivalent experience in the physical sciences. The license evaluators and

inspectors are required to maintain individual Qualification Journals. The staff must document

completion of each module and receive management sign off prior to being authorized to

independently perform assigned tasks. The team observed that the Bureau has exhibited a
Florida Final Report Page 4

strong commitment to training. The Bureau recently posted and filled a new position, Training

Coordinator, dedicated to developing an in-house training program. The Bureau’s goal is to

develop a task oriented training program using available resources within the State. The MRB

acknowledged the initiatives involving in-house training.

The review team noted that the Bureau has experienced stable funding during the review

period. The Bureau is authorized to charge and collect fees for specific and general licenses

and for the registration of radiation machines. In addition, Florida licensees are assessed an

annual licensing and inspection fee. All monies collected by the Bureau are deposited in the

Radiation Protection Trust Fund which is held and applied solely for the expenses incurred in

implementing and enforcing the radiation control program. 

The Advisory Council on Radiation Protection of the State of Florida, as constituted under the

law, acts in an advisory role to the Bureau. Meetings of the Council are infrequent. 

Based on the IMPEP evaluation criteria, the review team recommended and the MRB agreed

that Florida’s performance with respect to the indicator, Technical Staffing and Training, is

satisfactory.

3.2 Status of Materials Inspection Program

The team focused on five factors in reviewing this indicator: inspection frequency, overdue

inspections, initial inspection of new licenses, the timely dispatch of inspection findings to

licensees, and the performance of reciprocity inspections. The evaluation is based on the

Bureau’s questionnaire responses relative to this indicator, data gathered independently from

the Bureau’s licensing and inspection data tracking system, the examination of completed

licensing and inspection casework, and interviews with managers and staff.

The Bureau uses a database (VARCO) to track all inspection data. A list of inspections due is

provided to each field office on a quarterly basis. The Bureau considers inspections timely if

performed by the end of the calendar quarter in which the due date falls regardless of the

priority. A monthly status report is provided to all field office managers that tracks the status of

all assigned inspections, inspection data, enforcement actions, reciprocity inspections, and any

new, terminated, or revoked licenses.

The team’s review of the Bureau’s inspection priorities verified that inspection frequencies for

various types of licenses are at least as frequent as, or more frequent than, similar license

types listed in NRC Inspection Manual Chapter (IMC) 2800. Twenty-nine of the 41 license

categories established by the State are inspected more frequently than similar license types

listed in IMC 2800. The Bureau’s maximum inspection interval is four years. 

In their response to the questionnaire, the Bureau indicated that there were no inspections

currently overdue by more than 25% of the NRC frequency. This information was verified by

review of the inspection data provided to the team. The Bureau performs approximately

600 routine inspections annually. The team determined that there were no core routine

inspections currently overdue and that only four core routine inspections were conducted

overdue during the review period.
Florida Final Report Page 5

With respect to initial inspections of new licensees, the Bureau requires that Priority 1

licensees be inspected within one month of issuance date, and new licensees of all other

priorities be inspected within six months of the license issuance date. The Bureau has a policy

of assigning inspections on a quarterly basis and considers inspections timely if performed by

the end of the assigned calendar quarter. Furthermore, the Bureau conducts pre-licensing

visits of all new licenses. Chapter 404 of the Florida Statutes requires that a new license be

issued if a licensee undergoes a change in ownership or controlling interest. These licensees

were also inspected as new licensees and included in the initial inspection data. At the April

15, 2003 MRB meeting, the MRB noted that promptly inspecting a licensee whose license

authority has been transferred to a new owner not only protected public health and safety, but

also promoted the common defense and security of materials. The MRB found this policy a

good practice.

The review team examined the Bureau’s initial inspection data and determined that of the 345

new licenses issued during the review period, only six were overdue for inspection at the time

the inspection was conducted. The 1999 IMPEP team determined, and the Management

Review Board (MRB) concurred, that the Bureau’s alternative policy for inspecting and

evaluating the initial use of radioactive material by a licensee more than adequately addressed

public health and safety concerns. Based on the results of this review, the review team

continues to agree with the 1999 MRB’s determination.

During the review period, the Bureau granted 223 reciprocity permits, of which, 220 permits

were core licensees based on IMC 1220. The review team noted that the Bureau’s reciprocity

inspection policy requires that 50 percent of Priority 1, 2, and 3 licensees, 30 percent of

Priority 4 licensees, and 25 percent of Priority 5 licensees be inspected each year. The review

team discussed NRC’s current reciprocity inspection goal of inspecting 20 percent of candidate

core licensees operating under reciprocity each year. The team determined that the Bureau

met and exceeded the IMC 1220 criteria for the entire review period. 

The timeliness of the issuance of inspection findings was evaluated during the inspection

casework review. The Bureau requires all inspection correspondence to licensees to be

issued within 30 days following the date of the inspection. For 57 routine inspection files

examined, all inspection findings were sent to the licensees within 30 days. 

Based on the IMPEP evaluation criteria, the review team recommended and the MRB agreed

that Florida’s performance with respect to the indicator, Status of Materials Inspections

Program, is satisfactory.
Florida Final Report Page 6

3.3 Technical Quality of Inspections

The team evaluated the inspection reports, enforcement documentation, and inspection field

notes, and interviewed staff for 57 radioactive materials inspections conducted during the

review period. The casework reviewed included inspections by 32 materials license inspectors

from eight field offices, and covered inspections of various types including: medical institution,

medical private practice, high dose-rate afterloader, gamma stereotactic unit, mobile nuclear

medicine, fixed and portable gauges, industrial radiography, academic broad scope, nuclear

pharmacy, service provider, waste processor, veterinary use, and uranium products. 

Appendix C lists the inspection casework files reviewed for completeness and adequacy with

case-specific comments.

All inspections were performed by inspectors operating out of six field offices and two county

offices. All inspectors performed radioactive materials inspections and x-ray inspections, and

were available to respond to radioactive materials incidents. The Bureau’s inspection

procedures were consistent with NRC inspection procedures.

Based on the casework file reviews, the review team found that routine inspections covered all

aspects of the licensee’s radiation protection program. Inspection reports were thorough,

complete, consistent, and of high quality, with sufficient documentation to ensure acceptable

performance with respect to health and safety by the licensee. Exit interviews were held with

appropriate licensee personnel. Team inspections were performed when appropriate and for

training purposes.

Inspectors prepared an inspection report of two or more pages, which included basic

information about the licensee, a summary of the inspection, and the apparent violations with

supporting documentation. The inspector also prepared field notes, which provided more

details about the inspection. These documents were reviewed and signed by the field office

manager, then sent to the Radioactive Materials section in the Central office. The inspection

report and field notes were reviewed by an Inspection Coordinator in the Central office, who

prepared a letter to the licensee documenting compliance with Bureau regulations, or a letter

of non-compliance listing violations. Bureau representatives stated that about 50 percent of

the routine inspections result in letters of non-compliance, which was confirmed by the

casework reviewed by the team. Prior to issuing a letter of non-compliance, telephone

discussions were held among Bureau staff if additional information or clarification was

required. All letters were reviewed and concurred on by the Radioactive Materials

Administrator before being sent to the licensee. 

The inspection documentation usually supported the cited violations, recommendations made

to licensees, unresolved safety issues, and discussions held with the licensee during exit

meetings. The review team noted a few instances of violations that lacked support as written

(e.g., citing a regulation instead of license condition, lack of regulatory basis, vague or general

language), some of which were contested by the licensee. The review team also noted a few

instances of inadequate review of the licensee’s response (e.g., responses did not address the

violation, no corrective actions were provided in several contested cases). However, these

appeared to be isolated cases with no common cause, and were not representative of the

overall quality of inspection documentation.
Florida Final Report Page 7

All licensee correspondence describing corrective actions to violations, or contesting violations,

was reviewed by the Inspection Coordinator. Of the casework selected, the review team

identified a number of cases in which licensees contested violations. Bureau staff stated that

contested violations were discussed with the appropriate inspector prior to determining if a

violation would be upheld or rescinded. The Inspection Coordinator prepared letters

responding to the licensees, stating if corrective actions were sufficient, and in the case of

contested violations, if the violations were upheld or rescinded. The Radioactive Materials

Administrator concurred on all response letters prior to being sent to the licensees. Currently,

the Bureau tracks only one type of contested violations. The review team discussed

expanding the tracking system to include all inspections that result in contested violations, in

order to determine if the number of contested violations is appropriate for their program and

Bureau management agreed. In addition, Bureau management plans to review the contested

violations to determine if any consistent cause can be identified and corrected, if necessary.

The review team accompanied nine materials inspectors from seven field offices during the

periods of January 6-10, 2003, and January 27-31, 2003. The inspections included: medical

institution, medical private practice, brachytherapy, high dose-rate afterloader, nuclear

pharmacy, and industrial radiography. The facilities inspected are identified in Appendix C. 

During the accompaniments, the inspectors demonstrated appropriate performance-based, risk

informed inspection techniques and knowledge of the regulations. Inspectors were well

prepared and thorough in their reviews of the licensees' radiation safety programs. The review

team noted that each inspector performed appropriate surveys during the inspections, using

survey instruments which were calibrated and operable. Overall, the technical performance of

the inspectors was excellent, and their inspections were adequate to assess radiological health

and safety at the licensed facilities.

During the review period, Bureau staff performed audits and accompaniments of all individuals

who performed materials inspections. The Bureau differentiated audits, which are performed

to evaluate staff performance, from accompaniments which included evaluation but primarily

served as cross-training. Audits were performed of each inspector by each field office

manager, prior to approval of the inspector to perform independent inspections of various

types of licensee programs. Each field office manager was audited by the Field Operations

Administrator during the review period. Accompaniments of new inspectors were performed by

senior inspectors, and by field office managers with inspectors. Cross training of staff was

accomplished by licensing staff accompanying inspection staff. The audit and accompaniment

reports contained sufficient details to document the areas covered.

The Bureau maintained an adequate number and variety of survey instruments to perform

radiological surveys of materials licensees. Most survey meters used by Bureau inspectors

were calibrated by the Radiation Surveillance section of the Bureau’s Environmental Radiation

Lab in Orlando, with sources that were National Institute of Standards and Technology

traceable. Because instrument calibrations were performed in self-contained shielded

calibration devices, survey instruments which did not fit the devices were sent directly from the

field offices for outside calibration. The Environmental Radiation Lab also maintained a large

number and variety of calibrated instruments for incident response, such as GM detectors, ion

chambers, microR meters, and scintillation detectors. A database was used to track each

instrument calibrated at the facility, its current location, and when the instrument must be

returned to the facility for calibration. During the review period, instruments were adequately
Florida Final Report Page 8

and appropriately calibrated for the field offices, and an effective tracking system ensured that

calibrated instruments were always available for inspectors.

Based on the IMPEP evaluation criteria, the review team recommended and the MRB agreed

that Florida’s performance with respect to the indicator, Technical Quality of Inspections, is

satisfactory.

3.4 Technical Quality of Licensing Actions

The review team examined completed licensing casework and interviewed license evaluators

for 20 specific licenses. Licensing actions were reviewed for completeness, consistency,

proper radioisotopes and quantities used, qualifications of authorized users, adequate facilities

and equipment, and operating and emergency procedures sufficient to establish the basis for

licensing actions. Licenses were evaluated for overall technical quality including accuracy,

appropriateness of the license, its conditions, and tie-down conditions. Casework was

evaluated for timeliness; adherence to good health physics practices, reference to appropriate

regulations, documentation of safety evaluation reports, product certifications or other

supporting documentation, consideration of enforcement history on renewals, pre-licensing

visits, peer or supervisory review as indicated, and proper signature authority. The files were

checked for retention of necessary documents and supporting data.

Licensing casework was selected to provide a representative sample of licensing actions that

were completed during the review period. The sampling included the following types of

licenses: academic, irradiator, industrial radiography, portable gauge, medical institution,

medical private practice, radioisotope and sealed source radiotherapy and nuclear pharmacies. 

Licensing actions selected for evaluation included six new licenses, four renewals, five

amendments and five termination files. A listing of the licenses evaluated with case-specific

comments can be found in Appendix D.

Overall, the review team found that the licensing actions were thorough, complete, consistent,

and of acceptable quality with health and safety issues properly addressed. License tie-down

conditions were stated clearly, backed by information contained in the file, and inspectable. 

The licensee’s compliance history was taken into account when reviewing renewal applications

and amendments. The exemptions noted in the questionnaire responses were determined to

be appropriate and well documented by license conditions. The license evaluators

appropriately used the Bureau’s licensing guides and policies and standard licensing

conditions.

Each licensing action is technically reviewed by a license evaluator. The Radioactive Materials

Administrator or a Radioactive Materials Licensing Manager performs a technical and

supervisory review on all licensing actions before each licensing action is issued. License

evaluators have signature authority for licensing actions. The Bureau issues licenses for a fiveyear period under a timely renewal system. 

The review team evaluated financial assurance and decommissioning activities conducted by

the Bureau. The team concluded that the Bureau handles financial assurance appropriately. 

The team found that terminated licensing actions were well documented. The files included

the appropriate material transfer records and survey records. Confirmatory surveys for license
Florida Final Report Page 9

terminations were conducted when appropriate. There were no performance issues identified

with the handling of financial assurance or decommissioning by the Bureau. 

As discussed in Section 3.2, Florida Statutes require a new license be issued if a licensee

undergoes a change in ownership or controlling interest. The review team noted that

termination actions resulting from this change specifically provided a reference to the new

license. However, the new license did not provide a reference to the terminated license. The

team discussed with Bureau management the potential loss of, or difficulty in retrieving, sitespecific history that may be important to decommissioning the site in the future. Bureau

management agreed to explore options with the State’s legal counsel to ensure that the history

of a site can be tracked when a new license is issued for a specific site.

Based on the IMPEP evaluation criteria, the review team recommended and the MRB agreed

that Florida's performance with respect to the indicator, Technical Quality of Licensing Actions,

is satisfactory.

3.5 Response to Incidents and Allegations

In evaluating the effectiveness of the Bureau’s actions in responding to incidents, the review

team examined the Bureau’s responses to the questionnaire relative to this indicator, reviewed

the incident reports for Florida in the Nuclear Material Events Database (NMED) against those

contained in the Bureau’s files, and evaluated reports and supporting documentation for

12 incidents. A list of the incident casework examined with case-specific comments is included

in Appendix E. The review team also reviewed the Bureau’s response to eight allegations

involving radioactive material, including five allegations referred to the Bureau by the NRC

during the review period. 

The incidents selected for review included the following categories: misadministration,

lost/stolen material, overexposure, leaking sources, transportation, contamination, loss of

control, and damaged equipment. The review team found that the Bureau’s response to

incidents was complete and comprehensive. Initial responses were prompt and wellcoordinated, and the level of effort was commensurate with the health and safety significance. 

The Bureau dispatched inspectors for on-site investigations when appropriate, and took

suitable enforcement and follow-up actions. 

When notification of an incident or an allegation is received, the Incident Response

Coordinator and staff at the Environmental Radiation Lab in Orlando discuss what level of

initial response is appropriate and contact the appropriate field office. After the investigation is

completed, the pertinent information is forwarded to the Radioactive Materials section in the

Central office for close out approval and appropriate follow-up/enforcement actions.

The review team identified 397 incidents in NMED for Florida during the review period,

including 110 incidents that required reporting. The Bureau reports incidents that require

immediate notification to the NRC within 24 hours of notification, and incidents that require

notification to the NRC within 30 days at the end of each month. Monthly reports and follow-up

information are provided by extracting information from the State’s Access incident database. 

The review team clarified with program staff what information should be reported to the NRC

for inclusion in NMED, specifically when the information pertains to an allegation. Any event
Florida Final Report Page 10

that meets a reporting requirement should be reported, regardless of how the Bureau was

informed of the event. When a reportable event is discovered due to an allegation, the Bureau

reports the information to NRC for inclusion in NMED only after the allegation has been

substantiated, fully investigated, and closed. Even then, the Bureau is careful to exclude any

language in the information reported that reveals that the incident was associated with an

allegation.

In evaluating the effectiveness of Florida's actions responding to allegations, the review team

examined the Bureau’s questionnaire responses relative to this indicator. The casework for

the five allegations referred by the NRC was reviewed as well as the case work for four

additional allegations reported directly to the State. The Bureau evaluates each allegation and

determines the proper level of response. The review of the casework and the Bureau files

indicated that the Bureau took prompt and appropriate action in response to the concerns

raised. All of the allegations reviewed were appropriately closed and appropriate parties were

notified of the actions taken. The review team noted that allegations were treated and

documented internally in the same manner as incidents. There were no performance issues

identified from the review of the casework documentation. 

The review team noted that Florida law requires that public documents be made available

upon request. The State makes every effort to protect an alleger’s identity, but it cannot be

guaranteed. During the initial telephone contact, the alleger is advised that their anonymity

cannot be guaranteed.

Based on the IMPEP evaluation criteria, the review team recommended and the MRB agreed

that Florida's performance with respect to the indicator, Response to Incidents and Allegations,

is satisfactory.

4.0 NON-COMMON PERFORMANCE INDICATORS

IMPEP identifies four non-common performance indicators to be used in reviewing Agreement

State programs: (1) Legislation and Program Elements Required for Compatibility; (2) Sealed

Source and Device Evaluation Program; (3) Low-Level Radioactive Waste Disposal Program; 

and (4) Uranium Recovery Program. Florida’s Agreement does not authorize uranium

recovery, so only the first three non-common performance indicators were applicable to this

review.

4.1 Legislation and Program Elements Required for Compatibility

4.1.1 Legislation

In addition to their response to the questionnaire, the Bureau provided the review team with

the opportunity to review copies of legislation that affect the radiation control program. The

current effective statutory authority is contained in the Florida Radiation Protection Act in Title

XXIX, Chapter 404 of the Florida Statutes. The Department is designated as the State’s

radiation control agency. The Bureau of Radiation Control within the Division of Environmental

Health in the Department implements the radiation control program. The review team noted

that no legislation affecting the radiation control program was passed during the review period.
Florida Final Report Page 11

4.1.2 Program Elements Required for Compatibility

The State’s regulations for control of radiation are located in Chapter 64E-5 of the Florida

Administrative Code (FAC) and apply to all ionizing radiation. Florida requires a license for

possession and use of all radioactive material including naturally occurring materials, such as

radium, and accelerator-produced radionuclides. Florida also requires registration of all

equipment designed to produce x-rays or other ionizing radiation. 

The Department’s rulemaking is governed by the Administrative Procedure Act in Title X,

Chapter 120 of the Florida Statutes. The administrative process for regulation adoption is

provided in Chapter 1S-1 of the Florida Administrative Code. The review team examined the

State’s administrative rulemaking process and found that the process takes three to six months

from the development stage to the final filing with the Secretary of State, after which the rule

becomes effective in twenty days. After the Bureau drafts the proposed regulations, they must

publish a notice of proposed rule development in the Florida Administrative Weekly offering to

hold a workshop. After the workshop, if held, the Bureau publishes another notice in the

Florida Administrative Weekly of proposed rulemaking, including an offer to conduct a public

hearing. Concurrently, the Bureau must prepare and send an initial rule review file to the Joint

Administrative Procedures Committee. This is a legislative committee which oversees

rulemaking by all State agencies. If there are no objections or changes needed, the Bureau

prepares the final regulation and files it with the Florida Secretary of State. The review team

noted that the State’s rules and regulations are not subjected to “sunset” laws. The State can

also adopt other agency’s regulations by reference and has the authority to issue legally

binding requirements (e.g., license conditions) in lieu of regulations until compatible regulations

become effective.

The review team evaluated the Bureau’s responses to the questionnaire, reviewed the status

of regulations required to be adopted by the State under the Commission’s adequacy and

compatibility policy, and verified the adoption of regulations with data obtained from the Office

of State and Tribal Program’s (STP) State Regulation Status Data Sheet. 

During the on-site review, the team found that the following regulation, due February 2, 2003,

had not been adopted. 

! “Respiratory Protection and Controls to Restrict Internal Exposures,” 10 CFR Part 20

amendment (64 FR 54543; 64 FR 55524) that became effective February 2, 2000.

The Bureau has a draft of the proposed regulations and anticipates sending them to NRC for

comment in May 2003. Currently, the Bureau does not have a licensee requiring a respiratory

program. However, Bureau management stated that they would adopt alternate legally binding

requirements if needed.

The State will need to address the following five regulations in upcoming rulemakings or by

adopting alternate legally binding requirements:

! “Energy Compensation Sources for Well Logging and Other Regulatory Clarifications,”

10 CFR Part 39 amendments (65 FR 20337) that became effective on May 17, 2000. 

The Bureau is currently working on a draft of the proposed regulations.
Florida Final Report Page 12

! “New Dosimetry Technology,” 10 CFR Parts 34, 36, and 39 amendments (65 FR

63749) that became effective January 8, 2001. The Bureau has chosen to specifically

identify new dosimetry technology in their regulations and has added optically

stimulated luminescence (OSL) dosimeters to applicable sections.

! “Requirements for Certain Generally Licensed Industrial Devices Containing Byproduct

Material,” 10 CFR Parts 30, 31, and 32 amendments (65 FR 79162) that became

effective February 16, 2001. 10 CFR 32.52(a) and 32.52(b) amendments were to be

implemented by States within 6 months, August 16, 2001. The Bureau addressed this

amendment by adding a license condition to affected licenses prior to August 16, 2001. 

The Bureau also provided copies of the license condition to NRC for information in

response to All Agreement State Letter STP-01-028, dated March 2001. NRC has

reviewed these conditions and determined that they meet the compatibility

requirements. The remaining portion of this amendment is due February 16, 2004.

! “Revision of the Skin Dose Limit,” 10 CFR Part 20 amendment (67 FR 16298) that

became effective April 5, 2002.

! “Medical Use of Byproduct Material,” 10 CFR 20, 32, and 35 amendments (67 FR

20249) that became effective April 24, 2002.

Based on IMPEP evaluation criteria, the review team recommended and the MRB agreed that

Florida’s performance with respect to the indicator, Legislation and Program Elements

Required for Compatibility, is satisfactory.

4.2 Sealed Source and Device (SS&D) Evaluation Program

In conducting this review, three sub-indicators were used to evaluate the Bureau’s

performance regarding their SS&D Evaluation Program. These sub-indicators include: (1)

Technical Quality of the Product Evaluation; (2) Technical Staffing and Training; and (3)

Evaluation of Defects and Incidents Regarding SS&Ds. 

In assessing the Bureau's SS&D Evaluation Program, the review team examined information

provided by the Bureau in response to the IMPEP questionnaire on this indicator. A review of

all new and amended SS&D evaluations and supporting documents covering the review period

was conducted. The team observed the staff's use of guidance documents and procedures,

interviewed the two managers involved in SS&D evaluations, and verified the use of

regulations, license conditions, and inspections to enforce commitments made in the

applications.

4.2.1 Technical Quality of the Product Evaluation Program

The Bureau processed 13 SS&D actions since the last IMPEP review, including four

inactivations. The review included all amendments, supporting documentation, licenses, and

inspections associated with each of the registrations processed by the Bureau since the last

review and represented cases completed by all reviewers. The SS&D certificates evaluated by

the review team are listed with case-specific comments in Appendix F.
Florida Final Report Page 13

Analysis of the casework and interviews with the staff confirmed that the Bureau follows the

recommended guidance from the NRC SS&D training workshops and NUREG-1556, Volume

3, issued July 1998. Appropriate review checklists were used to assure all relevant materials

had been submitted and reviewed. The checklists were retained in the registration files. All

pertinent American National Standards Institute standards, Regulatory Guides, and applicable

references were confirmed to be available and were used when performing SS&D reviews.

The registration files contained all correspondence, photographs, engineering drawings,

radiation profiles, and details of the applicant’s quality assurance and quality control (QA/QC)

program. The registrations clearly summarized the product evaluation to provide license

reviewers with adequate information to license the possession and use of the product. 

Deficiency letters clearly stated regulatory positions and all health and safety issues were

properly addressed. The review team determined that the product evaluations were thorough,

complete, consistent, of acceptable technical quality, and adequately addressed the integrity

of the products during use and in the event of an accident.

The team also reviewed the specific licenses associated with the SS&D casework and

determined that they were thorough, complete, and of good technical quality. The team noted

that the Bureau lists the Florida radioactive materials license number that authorizes

manufacturing and distribution of the device in the SS&D registration certificate for reference. 

In addition, the Bureau incorporates the SS&D registry certificate and associated documents

by license condition in the manufacturing and distribution license. Bureau management stated

that incorporating the registry certificate by license condition in the specific license legally

authorizes them to enforce the requirements of the registration certificate. 

During inspections of the SS&D facilities, the Bureau supplements their inspection record with

a detailed “Sealed & Unsealed Radioactive Material” inspection form that also serves as the

inspection procedure. The team evaluated this form by comparing it with the NRC Inspection

Procedure (IP) 87125, “Materials Processor/Manufacturer Programs.” The team noted that the

Bureau’s inspection record did not address the source or device review, or the QA/QC

inspection elements found in the NRC procedure. Inspection of these elements assure that

the licensee’s products are being manufactured and distributed in accordance with the SS&D

certificates, and that the licensee’s QA/QC programs have been fully implemented. Through

discussions with Bureau staff, the review team determined that the Bureau was inspecting

these elements during inspections of SS&D facilities, but not documenting their findings. 

Bureau management agreed to modify their inspection field notes in order to document the

inspection of the source or device review, and the QA/QC program of the device manufacturer.

4.2.2 Technical Staffing and Training

The Materials Licensing Manager is the principal SS&D reviewer and has authority to sign the

registration certificates. The Manager has a Bachelor of Science degree, many years of

experience in health physics, licensing, inspection, and several years experience conducting

SS&D evaluations. The Manager has completed all of the training modules for the materials

program, and received SS&D training under the direct supervision of the Radioactive Materials

Administrator. However, he has not attended NRC’s SS&D workshop.
Florida Final Report Page 14

The Radioactive Materials Administrator performs a concurrence review which is also an

independent evaluation. The Administrator has advanced degrees in physics, completed all of

the modular training for the materials program, and many years experience in health physics

and materials licensing. The Administrator has attended several SS&D workshops.

The Bureau is committed to maintaining a high standard of quality in their SS&D reviews. 

Bureau management indicated that they would like to sponsor a SS&D workshop in the State

of Florida similar to the one scheduled this year in California. If a workshop can be arranged,

the Bureau intends to provide training to their entire licensing staff and invite other Agreement

States to participate.

4.2.3 Evaluation of Defects and Incidents Regarding SS&Ds

No incidents related to malfunctioning devices or products authorized by Florida SS&D

certificates were reported during the review period. The review team verified that no incidents

had occurred by searching the NMED system and making inquires of both Florida and NRC

staff.

Based on the IMPEP evaluation criteria, the review team recommended and the MRB agreed

that Florida’s performance with respect to the indicator, Sealed Source and Device Evaluation

Program, is 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. Those States with existing Agreements prior to 1981 were determined to have

continued LLRW disposal authority without the need of an amendment. 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.

5.0 SUMMARY

As noted in Sections 3 and 4 above, Florida’s performance was found to be satisfactory for all

seven performance indicators. Accordingly, the review team recommended and the MRB

agreed in finding the Florida Agreement State program to be adequate to protect public health

and safety and compatible with NRC's program. Based on the results of the current IMPEP

review, the review team recommended and the MRB concurred that the next full review should

be in approximately 4 years. The review team made no recommendations.
Florida Final Report Page 15

GOOD PRACTICE:

Chapter 404 of the Florida Statutes requires that a new license be issued if a licensee

undergoes a change in ownership or controlling interest. These licensees were also inspected

as new licensees and included in the initial inspection data. At the April 15, 2003 MRB

meeting, the MRB noted that promptly inspecting a licensee whose license authority has been

transferred to a new owner or has a change in controlling interest, not only protected public

health and safety, but also promoted the common defense and security of materials. 
LIST OF APPENDICES AND ATTACHMENTS

Appendix A IMPEP Review Team Members

Appendix B Florida Organization Charts

Appendix C Inspection Casework Reviews

Appendix D License Casework Reviews

Appendix E Incident Casework Reviews

Appendix F Sealed Source and Device Casework Reviews

Attachment March 18, 2003 E-mail from Mr. William Passetti

Florida’s Response to Draft IMPEP Report
APPENDIX A

IMPEP REVIEW TEAM MEMBERS

Name Area of Responsibility

Vivian Campbell, Region IV Team Leader

Technical Staffing and Training

Richard Woodruff, Region II Status of Materials Inspection Program

Sealed Source and Device Evaluation

Inspector Accompaniments

Elizabeth Ullrich, Region I Technical Quality of Inspections 

Inspector Accompaniments

Lance Rakovan, STP Response to Incidents and Allegations

Shawn Smith, STP Legislation and Program Elements Required for

Compatibility

Michael Snee, Ohio Technical Quality of Licensing Actions
APPENDIX B

FLORIDA ORGANIZATION CHARTS

ML030440681







ATTACHMENT

March 18, 2003 E-mail from Mr. William Passetti

Florida’s Response to Draft IMPEP Report

ML030840217