DATED: MAY 25, 1999; SIGNED BY: FRANK J. MIRAGLIA, JR.

Sharon Heber, M.P.H., Director

Division of Environmental Health

Florida Department of Health

2020 Capital Circle, SE, Bin #A08

Tallahassee, FL 32399-1709

Dear Ms. Heber:

On May 20, 1999, 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 assure public health and safety

and compatible with NRC’s program. 

Section 5.0, page 15, of the enclosed final report presents the IMPEP team’s recommendations. 

We received your April 6, 1999 letter which described your actions taken in response to the

recommendations in the draft report. We request no additional information.

Based on the results of the current IMPEP review, the next full review will be in approximately 4

years.

I appreciate the courtesy and cooperation extended to the IMPEP team during the review and your

support of the Radiation Control Program. I look forward to our agencies continuing to work

cooperatively in the future.

Sincerely,

Frank J. Miraglia, Jr.

Deputy Executive Director

 for Regulatory Programs

Enclosure:

As stated

cc: William A. Passetti, Chief

Bureau of Radiation Control
Sharon Heber, M.P.H., Director

Division of Environmental Health

Florida Department of Health

2020 Capital Circle, SE, Bin #A08

Tallahassee, FL 32399-1709

Dear Ms. Heber:

On May 20, 1999, 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 assure public health and safety

and compatible with NRC’s program. 

Section 5.0, page 15, of the enclosed final report presents the IMPEP team’s recommendations. 

We received your April 6, 1999 letter which described your actions taken in response to the

recommendations in the draft report. We request no additional information.

Based on the results of the current IMPEP review, the next full review will be in approximately 4

years.

I appreciate the courtesy and cooperation extended to the IMPEP team during the review and your

support of the Radiation Control Program. I look forward to our agencies continuing to work

cooperatively in the future.

Sincerely,

Frank J. Miraglia, Jr.

Deputy Executive Director

 for Regulatory Programs

Enclosure:

As stated

cc: William A. Passetti, Chief

Bureau of Radiation Control

bcc: Chairman Jackson

Commissioner Dicus

Commissioner Diaz

Commissioner McGaffigan

Commissioner Merrifield

Distribution: See next page

DOCUMENT NAME: G:\IMPEP\99FNLTR.FL

To receive a copy of this document, indicate in the box: "C" = Copy without attachment/enclosure "E" = Copy with attachment/enclosure "N" = No copy

OFFICE RI/RSAO OSP DEDR

NAME DWhite:gd PHLohaus FJMiraglia

DATE 05/ /0 05/ /0 05/ /0

OSP FILE CODE: SP-AG-6
Sharon Heber, M.P.H. - 2 -

Distribution: 

DIR RF

EDO RF DCD (SP01)

SDroggitis PDR (YES/)

TCombs, OCA

R. Woodruff, RII

TO’Brien, OSP

JDeCicco, NMSS

SGavitt, NYSDH

DWhite, RI

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Florida File

OSP FILE CODE: SP-AG-6
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM

REVIEW OF FLORIDA AGREEMENT STATE PROGRAM

February 22 - 26, 1999

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 radiation control program. The review

was conducted during the period February 22-26, 1999 by a review team comprised of technical

staff members from the Nuclear Regulatory Commission (NRC) and the Agreement State of New

York. Review 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 a Final General Statement of Policy," published in the Federal Register on

October 16, 1997, and the November 25, 1998, revised NRC Management Directive 5.6,

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

which covered the period March 4, 1995 to February 21, 1999, were discussed with Florida

management on February 26, 1999

A draft of this report was issued to Florida for factual comment on March 19, 1999. The State

responded in a letter dated April 6, 1999. The Management Review Board (MRB) met on May 20,

1999, to consider the proposed final report. The MRB found the Florida radiation control program

was 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 (BRC)

located in the Department of Health (DOH). The BRC consists of five sections managed by a

Chief. Three sections within BRC have responsibilities for radioactive materials under the

Agreement, which includes inspectors in six field offices and two counties under contract. The

Administrators of the Field Operations Section, Environmental Radiation Labs Section and

Radioactive Materials Section report to the Chief, BRC. Organization charts for the BRC and DOH

are included as Appendix B. The Florida program regulates approximately 1,169 specific licenses

authorizing agreement 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 State on November 13, 1998. The State provided a

response to the questionnaire on January 21, 1999. A copy of the questionnaire is included in

Appendix G of the draft report.

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

Florida's response to the questionnaire; (2) review of applicable Florida statutes and regulations;

(3) analysis of quantitative information from the BRC licensing and inspection database; (4)

technical review of selected licensing and inspection actions; (5) field accompaniments of six

Florida 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 criteria for

each common and applicable non-common performance indicator and made a preliminary

assessment of the BRC’s performance. 
Florida Final Report Page 2

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

previous review. 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 and recommendations. 

Recommendations made by the review team are comments that relate directly to program

performance by the State. 

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS

The previous review of the Florida radiation control program concluded on March 3, 1995. 

The review consisted of an evaluation of 30 program indicators per the 1992 Policy Statement.

During the last review, two recommendations were made in the May 18, 1995 letter to Dr. Richard

Hunter, Deputy State Health Officer, Department of Health and Rehabilitative Services. Both items

were discussed in the NRC’s February 14, 1996 letter to Florida based on the State’s June 28,

1995 response letter. The team’s review of the current status of the open recommendations is as

follows:

1. We recommend that the pre-license inspection reports and the routine inspection reports

include documentation on the method(s) used for verifying that rooms in licensee facilities

are under negative pressure (when required), and the results of any measurements

performed by the inspector.

Current Status: The State’s pre-licensing and routine inspection reports now include the

means to document methods used for verifying that rooms in licensee facilities are under

negative pressure and the results of any measurements performed by the inspector. The

review team noted during this review that inspectors were documenting independent

measurements in the inspection reports. This recommendation is closed.

2. We recommend that a confirmatory survey be performed on the OTPO Mechanik, Inc.

facility in Melbourne, Florida to determine if the former licensed facility can be released for

unrestricted use.

Current Status: The OTPO Mechanik, Inc. facility requested termination of their license in

November 1995 which included a closeout survey of the facility. The State performed a

confirmatory survey in December 1995 at the facility. Based on the information provided by

the licensee and the State’s confirmatory survey, the license was terminated on January

17, 1996 and the facility released for unrestricted use. This recommendation is closed.

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) Status of Materials Inspection Program;

(2) Technical Quality of Inspections; (3) Technical Staffing and Training; 

(4) Technical Quality of Licensing Actions; and (5) Response to Incidents and Allegations.
Florida Final Report Page 3

3.1 Status of Materials Inspection Program

The team focused on four factors in reviewing the status of the materials inspection program:

inspection frequency, overdue inspections, initial inspection of new licensees, and the timely

dispatch of inspection findings to licensees. The evaluation is based on the Florida questionnaire

responses relative to this indicator, data gathered from reports generated from the licensee

databases, examination of inspection reports, and interviews with BRC staff.

Evaluation of Florida’s inspection priorities for the materials program indicated that the maximum

period for an inspection interval is four years, and 25 of the 41 licensee categories established by

the State have a higher inspection frequency than similar type categories listed in NRC Inspection

Manual Chapter (IMC) 2800. None of the State categories had a lower frequency of inspection. It

was noted that the State uses discretion to increase inspection frequency (decrease inspection

interval) based on licensee history and performance, but did not decrease inspection frequency for

good performance.

The BRC currently uses a dBase IV software application for tracking inspection frequency, but will

be converting to a latter generation database application in the near future. Currently, most staff

have access to the database information, but updates to, and reports from the database are

generated by the Radioactive Materials Section. Therefore, the Radioactive Materials Section at

the Tallahassee office generates, on a quarterly basis, the schedule for the inspection groups in

the field offices. A monthly status report to the Field Operations Administrator in Tallahassee

reflects a statistical update of inspections performed and those due for the quarter, and

emphasizes any past due by field office and licensee name.

Inspectors in the six state and two county field offices perform inspections according to the

quarterly scheduling report generated by the Tallahassee office. A policy exists for establishing the

date for the next scheduled inspection based on the date of the last inspection and the inspection

priority. BRC considers the inspection timely if it is performed by the end of the calendar quarter in

which the due date falls (regardless of the priority interval). Since the inspection frequencies for

routine inspections are more frequent or as frequent as those required by the NRC, the scheduling

of inspections does not fall outside of NRC requirements. 

In their response to the questionnaire, the State indicated that they had no inspections overdue by

more than 25% of the NRC frequency. During the review, the team verified that there were no

inspections that were overdue by this criteria. 

With respect to initial inspections, BRC assigns the inspection due date six months from the

issuance of a new license. Since inspectors are given until the end of the calendar quarter to

perform the inspection due in that quarter, this has resulted in several initial inspections being

conducted outside of the six month period required by IMC 2800. Of the 30 initial inspections

reviewed, nine were completed within six months, 20 were inspected between seven and nine

months, and one was within 10 months. However, the existing scheduling system maintained by

BRC appears to be very efficient in tracking and scheduling initial inspections. The team
Florida Final Report Page 4

considered this data and noted that the State has an established policy of performing pre-licensing

visits by licensing staff and/or inspectors. This mechanism for inspecting and evaluating the initial

use of radioactive material by a licensee more than adequately addresses the public health and

safety concerns.

With respect to reciprocity, BRC issues a general license to all out-of-State licensees that desire to

operate within Florida. Holders of out-of-State licenses are required to provide three days

notification of any planned use of radioactive material at a temporary job site in Florida. The

review team noted that the inspection of Priority 1 and 2 licensees granted reciprocity during the

review period fell short of the goals indicated in IMC 1220. However, inspection of teletherapy,

high dose afterloaders (HDR) and irradiator source services, and Priority 3 reciprocity licensees,

met the IMC 1220 goal in 1998. 

The BRC identified that this inspection shortfall resulted from these licensees (i.e., radiographers)

entering the State to conduct licensed activities for a short time, usually 1 or 2 days. Field sites

were sometimes located in remote areas of the State, making inspection of these licensees difficult. 

The review team noted, though, that in mid-1998, management placed emphasis on the urgency of

performing reciprocity inspections, ranking them just below incident response in importance, and

began tracking these inspections separately from the routine inspection to place more importance

on their completion. 

Timeliness of inspection correspondence issuance was evaluated during the inspection casework

review. Of 53 inspection letters reviewed by the team, 31 were issued to the licensee within 30

days, 20 were issued between 31 and 35 days, one at 49 days, and one at 59 days. The 49 day

report was delayed because of communications with the licensee between the inspection and the

final report, and the 59 day report was considered an outlier because of a difficulty created by a

mis-transfer of field notes. The review team considered the issuing of inspection correspondence

timely, noting that BRC conducts approximately 500 inspections annually, and the Tallahassee

office coordinates inspection correspondence from eight field offices that serves to ensure

consistency for compliance of licensed activities across the State.

Based on the IMPEP evaluation criteria, the review team recommends that Florida’s performance

with respect to the indicator, Status of Materials Inspections, be found satisfactory.

3.2 Technical Quality of Inspections

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

inspectors for 24 radioactive material inspections conducted during the review period. The

casework included at least one inspector from each of the eight field offices and covered

inspections of various types including: medical institutions, industrial radiography, nuclear

pharmacy, irradiator, academic broad scope, medical broad scope, waste processing,

transportation, mobile nuclear medicine, HDR and reciprocity. Appendix C lists the inspection

casework reviewed for completeness and adequacy with case-specific comments.
Florida Final Report Page 5

Currently there are 24 radioactive material inspectors operating out of six state field offices and two

county offices. All inspectors are trained to perform x-ray and radioactive materials inspections,

and respond to radioactive materials incidents and incidents at nuclear power facilities.

Florida’s inspection procedures are consistent with NRC procedures. The BRC tries to conduct

inspections unannounced, but a majority of the time, inspections are announced a few days before

the inspection. The review team noted that, of the 24 inspections evaluated, 11 were

unannounced. According to the BRC annual report, 32% of the inspections were unannounced

during 1998.

Based on casework, the review team noted that the routine inspections covered all aspects of the

licensees’ radiation programs. The review team found that inspection reports were thorough,

complete, consistent, and of high quality, with sufficient documentation to ensure that licensee’s

performance with respect to health and safety was acceptable. The documentation supported

violations, recommendations made to the licensee, unresolved safety issues, and discussions held

with the licensee during exit interviews. Team inspections were performed when appropriate and

for training purposes.

The inspectors fill out a report of two or more pages. The first page is the contact form and

contains licensee data, persons contacted, type of inspection, time spent for the inspection,

inspector’s and supervisor’s signature, and other administrative information. The second and

subsequent pages of the inspection report are summary sheets denoting violations of regulations

or license conditions, documentation to support the violations, recommendations made to the

licensee, unresolved or licensing issues, and exit interview discussions and comments. This

report, along with the inspection field notes, is sent to the Tallahassee Radioactive Materials

Section within 15 days of the inspection.

The inspection report and field notes are reviewed and signed by the field office manager. Once

received in Tallahassee, the inspection coordinator reviews the inspection findings and prepares

appropriate correspondence to the licensee. The inspection coordinator contacts the inspector or

office manager for clarification of the inspection findings if necessary. The Radioactive Materials

Administrator reviews and concurs on all inspection correspondence. Subsequent correspondence

between the licensee and the BRC is conducted with the Tallahassee office.

Inspection findings, including escalated enforcement actions, are routinely sent to the licensee

around thirty days with licensee responses returned in a timely manner. Boilerplate language is

used to generate compliance letters and violations to ensure consistency. Responses are

reviewed and replied to in a timely manner. The inspection files were generally found to be

complete and in good order. The review team noted that in two cases, the inspection

documentation maintained in Tallahassee did not include field notes or the inspection report. 

In one case, the inspection report was prepared by the field office but was not sent to the

Tallahassee office along with the contact form and in the second case, no field notes were

prepared by the field office. As noted in the previous section, this mis-transfer affected the timely

preparation of inspection correspondence to the licensee. The review team discussed the field

offices timely transmittal of field notes to Tallahassee to facilitate the preparation of

correspondence to the licensee.
Florida Final Report Page 6

Field notes have been developed to cover most types of inspections that are conducted by the

BRC. These field notes provide documentation for the scope of the licensees’ program and cover

all areas that need to be reviewed. The information contained in the field notes is comparable with

NRC’s Inspection Procedure 87100.

The review team noted during the review of casework that the Jacksonville and Polk County offices

developed their own field notes for the inspection of a waste processor and a panoramic irradiator,

respectively. Other field offices are using existing field notes customized by each inspector for

panoramic irradiators. BRC’s inspection procedure manual does not include field notes for these

types of licenses due to the small number of licensees in the State. The review team recommends

that BRC incorporate the field notes for the inspection of waste processing and panoramic

irradiator licensees in their inspection procedures manual.

Inspection accompaniments are most frequently performed by the field office manager. Senior

inspectors also accompany less experienced inspectors, particularly for training purposes. In

addition, the review team noted that the Field Operations Administrator will accompany field office

managers. Field office managers are required to perform a minimum number of x-ray and material

inspections each year to maintain proficiency. The review team noted that inspectors are

accompanied at least once a year.

The Field Operations Administrator visits a field office each quarter on a rotating basis to attend a

quarterly staff meeting and if necessary perform an annual office audit. Otherwise, the field office

manager performs this annual field office audit. 

The BRC has an adequate supply of survey instruments to support the current inspection program. 

Appropriate, calibrated survey instrumentation such as GM meters, scintillation detectors, ion

chambers, and micro-R meters were observed to be available in the Field Offices and in the

Orlando Environmental Laboratory. The Environmental Laboratory provides support to the

program through radiological analyses of environmental samples and samples taken by inspectors

during inspection activities, and environmental dosimetry around nuclear facilities. The laboratory

also has a calibration facility that provides low and high range calibration of portable

instrumentation used by local governments during emergency exercises, and portable

instrumentation utilized by the BRC inspectors. Instrument repair and calibration are also available

from the instrument manufacturers as needed. Instrumentation and a mobile laboratory are also

available for responding to incidents as needed. The program has the capability for analyzing all

types of environmental media, and evaluation of all types of radiation.

During the weeks of February 1 and 15, 1999, a review team member performed six

accompaniments with inspectors from each of the State’s field offices. The inspections included a

private nuclear cardiology facility, two radiopharmacies, a private brachytherapy facility with an

HDR unit, and two institutional nuclear medicine facilities. These accompaniments are also

identified in Appendix C. During the accompaniments, the Florida inspectors conducted

performance based inspections and demonstrated thorough knowledge of the regulations. The

inspectors were well prepared and thorough in their reviews of the licensees' radiation safety

programs. Overall, the technical performance of the inspectors was excellent, and their inspections

were adequate to assess radiological health and safety at the licensed facilities.
Florida Final Report Page 7

Based on the IMPEP evaluation criteria, the review team recommends that Florida’s performance

with respect to the indicator, Technical Quality of Inspections, be found satisfactory.

3.3 Technical Staffing and Training

Issues associated with this indicator include the radioactive material program 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 State’s questionnaire responses related to this indicator,

conducted interviews with BRC management and staff, and reviewed workload for backlog.

The BRC staffing level was stable over the review period. There are currently 54 people with

various degrees of involvement with the Florida radioactive materials program, equivalent to about

20 FTEs to the Agreement program. This staffing level does not include clerical support staff. Of

the 15 people in the Tallahassee central office, 10 individuals are involved with licensing full time,

with the remaining five persons in management and support contributing about 30% of their time to

the materials program. The remaining 39 persons are distributed among six field offices throughout

the State. The inspectors spend about 18% of their time performing materials inspections, with the

balance of time dedicated to x-ray equipment inspections. During the review period, three people

left the Tallahassee office and two new people were hired. For the field offices, 13 positions were

vacated and 10 of those positions were filled during the review period. Currently, three field office

positions are vacant, and there is no intent to fill them in the immediate future, justified by the

decreased frequency of required x-ray equipment inspections. 

The BRC also has contracts with Polk and Broward Florida counties to perform material and x-ray

inspections. Three inspectors are employed by the two counties. The counties are paid for each

inspection they perform and receive a portion of the annual fee for each licensee in the county. 

Although the BRC does not direct administrative control over these inspectors, they receive the

same training and are required to follow the same inspection and incidence response guidance as

the State field offices.

Due to the relatively low turnover rate for a program this size, the staff consists of experienced

personnel, with newer personnel mostly in the inspection area. Among the materials program staff,

there are three with associate degrees, with the remainder having bachelor degrees or higher, with

several people with multiple degrees. A recent re-designation of the health physicist positions to

environmental specialist positions re-evaluated staff qualifications because the new positions

require a bachelor degree or equivalent; the incumbents with associate degrees and experience

were found to be bachelor degree equivalent. 

Based on the lack of backlogs and the quality of the licensing actions and inspection reports, the

team concluded that the number and distribution of staff appear to be adequate to maintain the

program.
Florida Final Report Page 8

Training for licensing and inspection staff is similar to recommendations developed by the NRC -

Organization of Agreement State Joint Working Group. Because a majority of staff has been with

the BRC for a number of years beyond the review period, training records reviewed showed

extensive accumulation of both NRC and BRC training courses. New personnel receive a

combination of training modalities as they become available. For instance, general health physics

training is provided through home study courses, in-house training material, computer-based

training, university-based training (Universities of Florida and North Carolina), licensee and vendorbased training (i.e., cancer institutes, Syncor, Troxler), and professional meetings. BRC also uses

NRC courses, depending on availability of courses and training funds. 

Before performing an inspection independently, inspectors visit licensees’ sites to observe

inspections and become a lead inspector with an accompanying senior inspector or supervisor. 

Since each field office inspection team has a manager and a senior inspector, lead inspectors are

accompanied frequently, often several times in one year, on various categories of licensees. 

A good practice noted by the review team consisted of a basic health physics training module that

was assembled and presented by the BRC staff. Because of the large and diversified staffing of

the Florida program, BRC selected several staff members to submit topics in health physics for a

five-day training program for BRC staff. Preparation consisted of video recording the instructor

practice sessions, for self-critique and improvement on the course presentation.

Based on the IMPEP evaluation criteria, the team recommends that Florida’s performance with

respect to the indicator, Technical Staffing and Training, be found satisfactory.

3.4 Technical Quality of Licensing Actions

The review team examined completed licenses and casework for 25 licensing actions, representing

the work of eight license reviewers. The license reviewers and Radioactive Materials

Administrator were interviewed to supply additional information regarding licensing decisions or file

contents.

Licensing actions were evaluated for completeness, consistency, proper isotopes 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

reviewed for accuracy, appropriateness of the license and of its conditions and tie-down

conditions, and overall technical quality. Casework was evaluated for adherence to good health

physics practices, reference to appropriate regulations, supporting documents, peer or supervisory

review, and proper signature authorities. The files were checked for retention of necessary

documents and supporting data.

The licensing actions reviewed included the following types of licenses: academic, medical and

research and development (both broad scope and specific), industrial radiography, radiopharmacy,

commercial service, large irradiator; self-shielded irradiator; portable and fixed gauges; and

HDR/teletherapy. Licensing actions included three new licenses, twelve amendments, seven

renewals, and three terminations. A list of these licenses with case-specific comments may be

found in Appendix D.
Florida Final Report Page 9

All licensing actions are logged into a computer tracking system, assigned a control number, and

reviewed by the Radioactive Materials Administrator who assigns each action. Monthly tracking

reports are generated and reviewed. After an initial review, each licensing action, including the

cover letter, is printed in draft, and then reviewed by a second, qualified reviewer or manager, and

then by the Radioactive Materials Administrator. Reviews are documented (initialed) on the draft

and sent to the Administrative Assistant. The Administrative Assistant confirms the proper review,

prints the final for signature, and mails the license to the licensee. Each manager and the

Radioactive Materials Administrator keeps documentation of the reviews. Boilerplate licenses as

well as standard conditions for each type of amendment are used to generate all licenses and

amendments thus ensuring a standard license/amendment. For all renewals, program staff verify

corporate status via internet connection to the Florida Department of Corporations. All license

reviewers have signature authority. 

The review team found that the licensing actions were thorough, complete, consistent, and of high

quality, with health and safety issues properly addressed. Tie-down conditions are backed by

information contained in the file, and are inspectable. Deficiency letters clearly state regulatory

positions, are used at the proper time, and identify deficiencies in the licensees' documents. 

Terminated licensing actions are well-documented, showing appropriate transfer and survey

records. License files are complete and well organized. The program uses a combination of NRC

and State regulatory guides. In addition, a number of additional guidance documents are used. 

Checklists for each category of license are used and kept with the license file. These documents

are complete, well organized, available to reviewers, and appear to be followed.

Except for new licenses that only involve a change in ownership, pre-licensing inspections are

conducted for all new applicants. These inspections are conducted normally within five days after

the applicant is prepared to receive material or when the licensing action is complete. After the

pre-licensing visit, the license is normally issued within a few days after the receipt of the contact

form in the Tallahassee office from the inspector. If there are unresolved issues, the licensing

section will address them with the applicant and reschedule the pre-licensing visit.

The program processed 5381 licensing actions during the review period. These consisted of 436

terminations, 482 new license applications, 571 renewals, and 3,892 amendments. Based on the

files reviewed, actions were completed in a timely manner and complete. The review team noted

that three license renewals and one termination that have been pending for extended periods

without a written response by the program. This matter was discussed with BRC management to

ensure that these actions are given higher priority to ensure timely completion.

Based on the IMPEP evaluation criteria, the review team recommends that Florida’s performance

with respect to the indicator, Technical Quality of Licensing, be found satisfactory.

3.5 Response to Incidents and Allegations

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

examined the State’s response to the questionnaire regarding this indicator, evaluated selected

incidents reported for Florida in the “Nuclear Material Events Database” (NMED) against those

contained in the Florida files, and evaluated the casework and supporting documentation for 12

material incidents. A list of incident casework examined, along with case specific comments, is
Florida Final Report Page 10

contained in Appendix E. The team also evaluated the State’s response to 10 materials

allegations, five of which were referred to the State by NRC during the review period.

The review team discussed the State's incident and allegation process, file documentation, the

State’s equivalent to the Freedom of Information Act, NMED, and notification of incidents to the

NRC Operations Center with BRC management and staff in Tallahassee and personnel in the

Emergency Response Group under the Environmental Radiation Labs Section in Orlando. 

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

Manager and staff at the Orlando office discuss the initial response and the need for an on-site

investigation. The safety significance of the incident/allegation is evaluated to determine the type

of response that BRC will take and to ensure that the appropriate field office is notified. After the

investigation is completed, the pertinent information is forwarded to the Radioactive Materials

Section at the Tallahassee office for close out approval and appropriate follow-up/enforcement

actions.

The BRC has written guidance (SOP 1) for handling incidents and allegations. Although the State

had no specific guidance for reporting to NMED or reference to the “Handbook on Nuclear Event

Reporting in the Agreement States” in SOP 1, the staff was familiar with and followed the guidance

contained in the Handbook. After a review of the incidents and discussions with staff, the review

team found that all reportable materials events were appropriately reported to the NRC Operations

Center. Approximately 575 other incidents that also occurred in the review period were voluntarily

reported to the NMED system. SOP 1 also contains guidance on the handling of allegations. 

Although this guidance lacks the level of detail that is in NRC Management Directive 8.8, (e.g., the

State has no definition specified for the term “allegation”) the State does take prompt and

appropriate action in response to the concerns raised.

The 12 incidents selected for review, out of the 136 submitted as reportable incidents, included

radiation alarm events at waste facilities and steel recyclers, damaged portable gauge equipment,

stolen radioactive material, loss of control of radioactive material, misadministrations, and a

radiographer overexposure. The review team found that the State’s responses to incidents were

complete and comprehensive. Initial responses were prompt and well-coordinated. The level of

effort was commensurate with the health and safety significance. Inspectors were dispatched for

on-site investigations when appropriate and the State took suitable enforcement action. The

review team found the documentation of the response and follow-up to incidents consistent and

that incidents were followed up at the next inspection or in a timely fashion. The team did note that

the documentation of incident close out was not consistent. The majority of the incident close out

memoranda did not contain a management signature or date.

During the review period, there were five materials allegations referred to the State by the NRC

and numerous other allegations reported directly to the program. The review of the State’s

allegation files indicates that the State took prompt and appropriate action in response to the

concerns raised. All of the allegations reviewed were appropriately closed, however the

documentation of the closure was inconsistent in the same manner as that for incident close out. 

The review team also noted that allegations were treated and documented in the same manner as

incidents. The team noted that, in accordance with State law, no measures exist to protect

allegation related information except for medical records and social security numbers.
Florida Final Report Page 11

The review team recommends that BRC 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. 

Based on the IMPEP evaluation criteria, the review team recommends that Florida’s performance

with respect to the indicator, Response to Incidents and Allegations, be found 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 cover the uranium recovery

program, 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 

Along with their response to the questionnaire, the State provided the review team with the

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

currently effective statutory authority is contained in Chapter 404 of the Florida Statutes. The

statutes were revised in 1997 to designate the Florida Department of Health as the State's

radiation control agency. The BRC, Division of Environmental Health, DOH implements the

radiation control program.

4.1.2 Program Elements Required for Compatibility 

The Florida Control of Radiation Hazard Regulations, Chapter 64E-5, Florida Administrative Code

(FAC), applies to all ionizing radiation. Florida requires a license for possession and use of all

radioactive material including naturally occurring materials, such as radium, and acceleratorproduced radionuclides. Florida also requires registration of all equipment designed to produce xrays or other ionizing radiation.

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 rules become effective in twenty days. The regulation adoption process is

provided in Chapter 1S-1 of the FAC. The public, the NRC, other agencies, and all 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,

approved, and filed with the Secretary of State. The State can adopt other agency regulations by

reference which has been done with respect to transportation regulations adopted by the U.S.

Department of Transportation, the NRC, and the U.S. Postal Service regulations that were in effect

on May 15, 1996. The State also has the authority to issue legally binding requirements (e.g.,

license conditions) in lieu of regulations until compatible regulations become effective.
Florida Final Report Page 12

The team evaluated Florida’s response to the questionnaire and reviewed the status of regulations

required to be adopted by the State during the review period. The review team noted that following

the Agency’s reorganization under the Health Department, the regulations were recodified on July

17, 1997 as the Control of Radiation Hazard Regulations (CRHR), Chapter 64E-5, FAC. Following

the recodification, the CRHR regulations were updated on May 18, 1998 to be compatible with

NRC regulations with the adoption of NRC regulations as follows: 

“Timeliness in Decommissioning of Materials Facilities,” 10 CFR Parts 30, 40, and 70

amendments (59 FR 36026) that became effective August 15, 1994.

“Frequency of Medical Examinations for Use of Respiratory Protection Equipment,” 10 CFR

Part 20 amendment (60 FR 7900) that became effective March 13, 1995. 

“Low-Level Waste Shipment Manifest Information and Reporting,” 10 CFR Parts 20 and 61

amendments (60 FR 15649 and 25983) that became effective March 1, 1998. The

Agreement States are to promulgate their regulations no later than March 1, 1998 so that

NRC and the State would require this national system to be effective at the same time. 

"Performance Requirements for Radiography Equipment," 10 CFR Part 34 amendment (60

FR 28323) that became effective June 30, 1995.

The team identified the following regulation changes and adoptions that are needed, and the State

related that the regulations would be addressed in upcoming rulemakings or by adopting alternate

legally binding requirements:

NRC’s letter to the State dated November 24, 1997 identified two comments from the

review of Florida’s adoption of the 10 CFR Part 20 requirements. These comments related

to: (1) the State’s definition of “Occupational dose” [64E-5.101(93)]; and (2) the State’s use

of the term “planned exposure” instead of “planned special exposure” in the Occupational

Dose Limits for Adults (64E-5.304(b)(2). 

“Preparation, Transfer for Commercial Distribution, and Use of Byproduct Material for

Medical Use,” 10 CFR Parts 30, 32, and 35 amendments (59 FR 61767 and 65243) that

became effective January 1, 1995. 

“Resolution of Dual Regulation of Airborne Effluents of Radioactive Materials; Clean Air

Act,” 10 CFR Part 20 amendment (61 FR 65119) that became effective January 9, 1997.
Florida Final Report Page 13

“Recognition of Agreement State Licenses in Areas Under Exclusive Federal Jurisdiction

Within an Agreement State,” 10 CFR Part 150 amendment (62 FR 1662) that became

effective February 27, 1997.

“Criteria for the Release of Individuals Administered Radioactive Material,” 10 CFR Parts

20 and 35 amendments (62 FR 4120) that became effective May 29, 1997.

“Licenses for Industrial Radiography and Radiation Safety - Requirements for Industrial

Radiography Operations,” 10 CFR Parts 30, 34, 71, and 150 amendments (62 FR 28948)

that became effective June 27, 1997.

“Radiological Criteria for License Termination,” 10 CFR Parts 20, 30, 40, and 70

amendments (62 FR 39057) that became effective August 20, 1997.

“Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon-14 Urea,”

10 CFR Part 30 amendment (62 FR 63634) that became effective January 2, 1998.

“Deliberate Misconduct by Unlicensed Persons,” 10 CFR Parts 30, 40, 61, 70, and 150

amendments (63 FR 1890 and 13773) that became effective February 12, 1998.

“License for Industrial Radiography and Radiation Safety Requirements for Industrial

Radiographic Operations; Clarifying Amendments and Corrections,” 10 CFR Part 34

amendment (63 FR 37059) that became effective July 9, 1998.

“Minor Corrections, Clarifying Changes, and a Minor Policy Change,” 10 CFR Parts 20, 32,

35, 36, and 39 amendments (63 FR 393477 and 63 FR 45393) that became effective

October 26, 1998.

“ Transfer for Disposal and Manifest; Minor Technical Conforming Amendments,” 10 CFR

Part 20 amendment (63 FR 50127) that became effective November 20, 1998.

The State acknowledged in a letter dated December 23, 1997 that the Part 20 equivalent

regulations were oversights and that their regulations would be amended. During the review, the

State related that the above regulations were being developed as a package and that the adoption

process would be initiated during this calendar year. The State has deferred the medical

regulation update until the final version of 10 CFR Part 35 is published which is expected by June

1999. The team noted that except for the OSP letter concerning minor discrepancies on the

State’s adoption of the 10 CFR Part 20 equivalent regulations and the medical regulations due in

1998, that the State has adopted all regulations and elements needed for compatibility. 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. 
Florida Final Report Page 14

It is noted that Management Directive 5.9, Handbook, Part V, (1)(C)(III) provides that regulations

required prior to September 3, 1997, should be adopted by the State as expeditiously as possible,

but not later than three years after the September 3, 1997 effective date of the Commission Policy

Statement on Adequacy and Compatibility, i.e., September 3, 2000.

Based on the IMPEP evaluation criteria, the review team recommends that Florida’s performance

with respect to the indicator, Legislation and Program Elements Required for Compatibility, be

found satisfactory.

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

4.2.1 Technical Quality of the Product Evaluation Program

During the review period, three Sealed Source and Device (SS&D) certificates were issued by the

State. One certificate was for non-Atomic Energy Act (AEA) material and the other two SS&D

certificates were reviewed and are identified in Appendix F.

Review of the files and interviews with the staff confirms that Florida follows the recommended

guidance from the NRC SS&D training workshops. The registration files contain all

correspondence, photographs, engineering drawings, radiation profiles, and results of tests

conducted by the applicant. In addition, the SS&D review checklist received at the NRC SS&D

workshop is used to help assure all relevant materials are submitted and reviewed. The checklist

is contained in the registration file. The State indicated that the guidance in NUREG-1556, V.3,

issued September 1997 will be utilized for any future reviews. All pertinent American National

Standards Institute (ANSI Standards), Regulatory Guides, and workshop references were

confirmed to be available and are used when performing SS&D reviews. The Radioactive

Materials Administrator related that non-AEA reviews are performed in the same procedural manner

and using the same references as used for AEA sources and devices.

4.2.2 Technical Staffing and Training

The Radioactive Materials Administrator conducts the SS&D reviews and is in the process of

training other staff in the review of sealed sources and devices. The Radioactive Materials

Administrator and the BRC Chief both have attended the SS&D workshops sponsored by NRC and

both individuals have had many years of experience reviewing license applications. The

Radioactive Materials Administrator also has advanced degrees in physics and both managers

have many years of experience and training in health physics. Both individuals are considered fully

trained for licensing and inspection under the common performance indicator, Technical Staffing

and Training. The team found that the SS&D reviewers work together closely when conducting a

review and discuss issues and concerns they have identified in an application. The BRC is

committed to maintaining a high degree of quality in their SS&D reviews and would, if necessary,

send their reviewers for additional training or seek assistance from outside sources. 
Florida Final Report Page 15

4.2.3 Evaluation of Defects and Incidents Regarding SS&Ds

No incidents related to SS&Ds occurred during the review period, nor were there any defects

reported.

Based on the IMPEP evaluation criteria, the review team recommends 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 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 Florida 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, the review team found Florida’s performance to be satisfactory

for all of the indicators. Accordingly, the review team recommended and the MRB concurred in

finding the Florida Agreement State program to be adequate to protect public health and safety and

compatible with NRC's program. 

Below is a summary list of recommendations, as mentioned in earlier sections of the report, for

implementation and evaluation, as appropriate, by the State. Also, the “good practice” noted in the

report is identified. 

RECOMMENDATIONS:

1. The review team recommends that BRC incorporate the field notes for the inspection of

waste processing and panoramic irradiator licensees in their inspection procedures manual. 

(Section 3.2)

2. The review team recommends that BRC 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)
Florida Final Report Page 16

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)

GOOD PRACTICE:

1. A good practice noted by the review team consisted of a basic health physics training

module that was assembled and presented by the BRC staff that included the use of video

recording the instructor practice sessions, for self-critique and improvement on the course

presentation. (Section 3.3)
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 Florida’s Response to Draft IMPEP Report 

 Dated April 6, 1999
APPENDIX A

IMPEP REVIEW TEAM MEMBERS

Name Area of Responsibility

Duncan White, Region I Team Leader

Technical Quality of Inspections

Joseph DeCicco, NMSS Status of Materials Inspection Program

Technical Staffing and Training

Steven Gavitt, New York State Health Technical Quality of Licensing Actions

Thomas O’Brien, OSP Response to Incidents and Allegations

Richard Woodruff, Region II Legislation and Program Elements Required for 

Compatibility

Sealed Source and Device Evaluation Program

Inspection Accompaniments
APPENDIX B

STATE OF FLORIDA

DEPARTMENT OF HEALTH

and

BUREAU OF RADIATION CONTROL

ORGANIZATION CHARTS