In 1964, the Atomic Energy Commission (now the U.S. Nuclear Regulatory Commission) and Florida signed an agreement empowering the state to license and regulate radioactive materials users.
Today the program licenses more than 1,800 users, including hospitals, universities, industrial facilities, doctors, roofing companies, a food irradiator, and a medical product irradiator. The radioactive material employed by these users may be contained in a medical pharmaceutical or inside an industrial device such as a moisture density gauge or a static eliminator. The license is a dynamic document. Each year the program issues over 2,100 license amendments, or changes requested by the licensee, to accommodate the licensees’ needs and industry’s changing needs in the use of radioactive materials.
Each materials license is valid for 5 years. Program staff inspects each licensee periodically from every 6 months to every 5 years depending on the type of license. During the inspection, which may take 100 hours or more at a large facility, the inspector takes direct radiation readings and interviews and observes personnel. The inspector also reviews records, and if necessary, collects samples from equipment surfaces and the general environment which are later analyzed for contamination at the department’s radiation laboratory.
The inspector then discusses the preliminary inspection findings with the licensee during an exit interview and, within 30 days of the inspection, program staff sends a letter requiring corrective action of any deficiencies. If the licensee has significant violations or fails to correct the deficiencies, the department may impose an administrative fine or modify, suspend, or revoke the license.
The U.S. Nuclear Regulatory Commission audits agreement state programs. Florida’s audit results are available online.
Radioactive Material Forms and Documents
Forms and Checklists
Form DH 1054, December 2009 (DOC) (Incorporated by reference in 64E-5.207, F.A.C.)
Non-human use radioactive materials license application
Non-Human Use Application Checklist (DOC) (Use with form 1054)
Non-human use radioactive materials application checklist
Portable Gauge Checklist (DOC) (Use with form 1054)
Portable gauge license application checklist
Fixed Gauge Checklist (DOC) (Use with form 1054)
Fixed gauge license application checklist
Reciprocity License Notification
Used by out of state licensees seeking reciprocal recognition of their license to be able to use radioactive materials in Florida.
Model Radioactive Material Inventory Form (DOC)
Inventory form – Use to document performance of sealed source inventory. Has columns for recording additional descriptive information not required by chapter 64E-5
Form DH 1322, December 2009 (DOC) (Incorporated by reference in64E-5.207, F.A.C.)
Human use radioactive materials license application (for medical applicants only)
HDR Application Checklist (DOC)(Use with HDR Regulatory Guide 1.60 and DH Form 1322)
Checklist for high dose-rate (HDR) remote afterloading license application
Renewal, Renewal Attestation and Instructions
Radioactive materials license renewal, renewal attestation, and instructions (Use for both human and non human licenses).
Form DH 360 (DOC)
Certificate – In Vitro Testing
Form DH 361 (DOC)
Certificate – Medical Use Of Radioactive Material Under General License
Form DH 1059 (DOC)
Certificate – disposition of radioactive materials
Form DH 1622 (DOC)
Occupational exposure record for a monitoring period
Form DH 1623 (DOC)
Cumulative occupational exposure history
Emergency Notification Poster (DOC) – Instructions (DOC)
Designed to be printed in color on yellow or canary colored paper
Transfers of Industrial Devices Report – April, 2007
Report used to document transfers of generally licensed industrial devices
Bond Risk Factors Calculation Worksheet – March 2014
(Incorporated by reference in 64E-5.2167, F.A.C., July 1, 2015)
Regulatory Guides
Fees for Radioactive Material Licenses (DOC)
Regulatory Guide 6.20, Revision 5 – Fees for radioactive material licenses
Fixed Gauge Guide (Individual documents)
Regulatory Guide 1.20, Revision 2, February 2008 – For the preparation of applications for use of sealed sources in fixed gauges. also contains an application for non-human use of radioactive materials. Revision 1 should be used for new license applications, license renewals and amendments as applicable. This regulatory guide is made up of multiple individual documents provided together as a single PDF file. The documents are also available individually.
Gamma Stereotactic Radiosurgery Regulatory Guide (DOC)
Regulatory Guide 1.70, June 2012 – Guide for the preparation of applications for gamma stereotactic radiosurgery units including gamma knife devices. This regulatory guide is made up of multiple individual documents, provided together as a single file.
HDR Regulatory Guide (DOC)
Regulatory Guide 1.60, October 2011 – Guide for the preparation of applications for high dose rate remote afterloaders. This regulatory guide is made up of multiple individual documents, provided together as a single file. An HDR application checklist is also available.
Industrial Radiography Regulatory Guide (DOC)
Regulatory Guide 1.40, June 2013 – Guide for the preparation of applications for industrial radiography. This regulatory guide is made up of multiple individual documents, provided together as a single file.
Instructions for Recording and Reporting Occupational Radiation Exposure Data (DOC)
Regulatory Guide 6.7, Revision 1 – Instructions for recording and reporting occupational radiation exposure data
Medical Use Guide (DOC)
Regulatory Guide 1.30, Revision 5, August 2014 – For the preparation of applications for a medical use license. Includes license application form. This regulatory guide is made up of multiple individual documents, provided together as a single file.
Monitoring Criteria and Methods to Calculate Occupational Radiation Doses (DOC)
Regulatory Guide 3.34, Revision 2 – Monitoring criteria and methods to calculate occupational radiation doses
Portable Gauge Guide (Individual documents)
Regulatory Guide 1.10, Revision 6, December 2017 – For the preparation of applications for use of sealed sources in portable gauge devices. This regulatory guide is made up of multiple individual documents provided together as a single PDF file. The documents are also available individually.
Preceptor Attestation for Medical Authorized Users Guide (DOC)
Regulatory Guide 3.50, Revision 2, August 2014 – A required guide to document a physician’s training and experience with radioactive materials to become an authorized user listed on a human-medical use radioactive materials license. This regulatory guide is made up of multiple individual documents provided together as a single PDF file. Some of the documents are available individually.
Procedures for Radioactive Materials Enforcement Actions – May 2000
(Incorporated by reference in 64E-5.201 (3), F.A.C., October 8, 2000)
Radiation Dose to the Embryo/Fetus (DOC)
Regulatory Guide 3.36, Revision 1 – Radiation dose to the embryo/fetus
Unsealed or Sealed Sources Guide (non-human use) (Individual documents)
Regulatory Guide 1.50, July 2013 – Instructions for preparing applications for radioactive materials licenses authorizing unsealed and/or sealed sources. This regulatory guide is made up of 30 individual documents, provided together as a single PDF file. The documents are also available individually.
Regulatory Guide
1.10 Sections
- Cover and Introduction
- MOP Dose Limit Compliance Study — Appendix A
- ALARA Policy — Appendix B
- Duties and Responsibilities of the RSO — Appendix C
- Radiation Safety Training Program — Appendix D
- Personnel Monitoring Procedures — Appendix E
- Operating Procedures — Appendix F
- Emergency Procedures — Appendix G
- Ordering, Opening and Shipping RAM Packages — Appendix H
- Posting Procedure — Appendix I
- Record Retention Procedure — Appendix J
- Leak Test Procedure — Appendix K
- Inventory Procedure — Appendix L
- Notification and Reporting — Appendix M
- Transfer and Disposal — Appendix N
- Sample Facility Diagram — Exhibit A
- Sealed Source Inventory Form — Exhibit B
- Portable Gauge Utilization Log — Exhibit C
- Model Shipping Paper, Private Use Shipment — Exhibit D1
- Model Shipping Paper, Common Carrier Shipment — Exhibit D2
- Portable Gauge Emergency Response Information — Exhibit E
- Radiation Protection Program Audit Checklist — Exhibit F
- Instructions for Women Working With Radiation — Exhibit G
- Declaration of Pregnancy — Exhibit H
- Instructions for Declared Pregnant Women — Exhibit I
- Delegation of Authority — Exhibit J
- Non-Human Use Application Form — Supplement A
- List of Attachments — Supplement B
- License Application Checklist — Supplement C
- Guide to SI Units for Radiation Protection — Supplement D
- Outline for Radiation Safety Training Program — Supplement E
Regulatory Guide
1.20 Sections
- Introduction
- MOP Dose Limit Compliance Study — Appendix A
- ALARA Policy — Appendix B
- Duties and Responsibilities of the RSO — Appendix C
- Radiation Safety Training Program — Appendix D
- Operating Procedures — Appendix E
- Personnel Monitoring Procedures — Appendix F
- Release from Personnel Monitoring Requirements — Appendix G
- Posting Procedure — Appendix H
- Lock-Out Procedure — Appendix I
- Emergency Procedures — Appendix J
- Ordering, Opening and Shipping RAM Packages — Appendix K
- Leak Test Procedure — Appendix L
- Inventory Procedure — Appendix M
- Record Retention Procedure — Appendix N
- Notification and Reporting Procedures — Appendix O
- Transfer/Disposal Procedure — Appendix P
- Sealed Source Inventory Form — Exhibit A
- Fixed Gauge Survey Form — Exhibit B
- Model Shipping Paper — Private Use Shipment — Exhibit C
- Emergency Response Information — Exhibit D
- Instructions for Women Working With Radiation — Exhibit E
- Instructions for Declared Pregnant Women — Exhibit F
- Declaration of Pregnancy Form — Exhibit G
- Delegation of Authority to Make Legally Binding Statements — Exhibit H
- Fixed Gauge License Application Cover Page — Supplement A
- Application for Non-Human Use of RAM — Supplement A2
- List of Attachments — Supplement B
- Fixed Gauge License Application Checklist — Supplement C
Regulatory Guide
1.50 Sections
- Cover and Introduction
- MOP Dose Limit Compliance Study — Appendix A
- ALARA Policy — Appendix B
- Duties and Responsibilities of the RSO — Appendix C
- Radiation Safety Training Program — Appendix D
- Personnel Monitoring Procedures — Appendix E
- Operating Procedures — Appendix F
- Ordering, Opening and Shipping RAM Packages — Appendix G
- General Rules of Use of Unsealed Sources — Appendix H
- Contamination Control — Appendix I
- In-Vivo Thyroid Bioassay — Appendix J
- In-Vitro Urinalysis Bioassay — Appendix K
- Emergency Procedures — Appendix L
- Leak Testing Procedure — Appendix M
- Leak Test Analysis — Appendix N
- Inventory Procedure — Appendix O
- Record Retention Procedure — Appendix P
- Notification and Reporting Procedure — Appendix Q
- Radiation Detection Instrument Calibration Procedure — Appendix R
- Transfer/Disposal Procedure — Appendix S
- Inventory Form — Exhibit A
- Shipping Paper — Private Use Shipment — Exhibit B
- Emergency Response Information — Exhibit C
- Instructions for Women Working With Radiation — Exhibit D
- Instructions to Declared Pregnant Women — Exhibit E
- Declaration of Pregnancy — Exhibit F
- Delegation of Authority to Make Legally Binding Statements — Exhibit G
- Non-Human Use Application Form — Supplement A
- List of Attachments — Supplement B
- License Application Checklist — Supplement C
Regulatory Guide
3.50 Appendices
Security Advisories
Security Advisory 2024-19 – Attempts to Acquire Sensitive Information from Licensee Staff
(ML24337A215)
Information Notices
Information Notice 2024-2
Renewal and Renewal Attestation
Information Notice 2024-1
Technetium 99m shortage and the calibration of dose calibrators
Information Notice 2014-1 – Information Notice 2014-1
Revision 12 filing instructions: Changes to Chapter 64E-5, F.A.C. The first file contains only the information notice, while the second file contains the notice plus the actual replacement pages for revision 12
Information Notice 2013-1
Establishment and Maintenance of a Positive Safety Culture
Information Notice 2012-1
Authorization for aerosols in diagnostic nuclear medicine
Information Notice 2010-3
Industrial radiography reporting requirements (Clarification of the 24 hour notification requirement for an event in which the sealed source assembly did not return to the fully shielded position within the exposure device)
Information Notice 2010-2
Technetium 99m shortage and the calibration of dose calibrators
Information Notice 2010-1 – Information Notice 2010-1
Revision 10 filing instructions: Changes to Chapter 64E-5, F.A.C. The first file contains only the information notice, while the second file contains the notice plus the actual replacement pages for revision 10.
Information Notice 2009-2
Notice of proposed changes in 64E-5, F.A.C. Majority of changes are regarding the medical use of radioactive materials
Information Notice 2009-1
Varian Medical Systems Varisource high dose-rate remote afterloader events: Source retraction problems
Information Notice 2008-3
Voluntary security enhancements for self-contained irradiators containing cesium chloride sources
Information Notice 2008-2 – Information Notice 2008-2
Revision 8 filing instructions: Changes to chapter 64E-5, F.A.C. The first file contains only the information notice, while the second file contains the Notice plus the actual replacement pages for Revision 8.
Information Notice 2008-1
Nuclear medicine procedure verification
Information Notice 2007-6
Radioactive material license categories and fee revisions
Information Notice 2007-5 – Information Notice 2007-5
Revision 7 filing instructions: Changes to chapter 64E-5, F.A.C. The first file contains only the information notice, while the second file contains the notice plus the actual replacement pages for Revision 7.
Information Notice 2007-3
Opportunity to Dispose of Unused Radioactive Sources
Information Notice 2007-2
Additional requirements for licensees who possess or transfer certain generally licensed (GL) devices
Information Notice 2007-1 – Information Notice 2007-1
Revision 6 filing instructions: Changes to chapter 64E-5, F.A.C. The first file contains only the information notice, while the second file contains the notice plus the actual replacement pages for revision 6.
Information Notice 2006-4
Portable gauge additional security requirements, Effective 01-01-07
Information Notice 2006-2
Leak testing frequency for troxler portable gauges
Information Notice 2005-1
Medical physicists – Requirements for medical physicists for brachytherapy procedures
Information Notice 2004-1
Overnight mail delivery address
Information Notice 2003-1
HAZMAT training requirements for radioactive material licensees (Replaces information notice 99-3). Includes new USDOT requirements for security awareness training and security plans (if applicable)
Information Notice 2002-9
Am-241/Pu-238 disposal – Provides contact information for licensees who wish to dispose of unwanted or obsolete Am-241 or Pu-238 sources
Information Notice 2002-8
Y-90 Zevalin human use radiopharmaceutical therapy – Contains information needed to amend licenses for medical use of Yttrium-90 (Y-90) as a radiopharmaceutical therapy procedure
Information Notice 2001-6
Changes to 64E-5, F.A.C.; Revision 5 Filing Instructions
Information Notice 2001-4
Changes to 64E-5, F.A.C.; Revision 3 and revision 4 filing instructions
Information Notice 2001-3 (DOC)
Panama misadministration information
Information Notice 2001-2 (DOC)
Specific license applications for amendments, renewals, terminations, and new licenses
Information Notice 2000-3 (DOC)
Licensing requirements for the performance of coronary brachytherapy procedures
Information Notice 2000-2 (DOC)
Changes to chapter 64E-5, F.A.C.; Revision 2 filing instructions
Information Notice 2000-1 (DOC)
Change of bureau’s mailing address and phone number
Information Notice 99-5 (DOC)
Problems encountered when manually editing treatment data on the nucletron microselectron-HDR (new) model 105.999
Information Notice 99-4 (DOC)
Unplanned radiation exposures to radiographers resulting from failure to follow proper radiation safety procedures
Information Notice 99-2 (DOC)
Guidance on the use of a new dose-calculation formalism and revised air-kerma strength standard for Iodine-125 sealed sources
Information Notice 99-1 (DOC)
Requirements and responsibilities of authorized users in medical facilities
Information Notice 98-6 (DOC)
Requirements for advance notification for the shipment of low level radioactive waste
Information Notice 98-5 (DOC)
Changes to chapter 64E-5, F.A.C.; Filing instructions
Information Notice 98-3 (DOC)
Requirements for possession, transfer and record retention for generally licensed devices
Information Notice 98-2 (DOC)
Notice of exemption – Carbon 14 Urea breath test to detect presence of H. Pylori bacteria
Information Notice 98-1 (DOC)
Additional controls for transport of the Amersham model 660 series radiographic exposure devices
Information Notice 97-3 (DOC)
Failure of high dose rate (HDR) remote afterlloading device source guide tubes, catheters, and applicators
Information Notice 97-1 (DOC)
To high dose rate (HDR) licensees regarding treatment planning errors
Information Notice 96-6 (DOC)
Procedures for incident reporting requirements
Information Notice 96-2 (DOC)
Failure of safety systems on self-shielded irradiators because of inadequate maintenance and training
Model Procedures
ALARA Model Procedures (DOC)
ALARA – Model procedures for both sealed and unsealed Sources
MOP Dose – Main Instructions (DOC)
MOP main instructions – Model procedures for conducting a member-of-public (MOP) dose compliance study (Use for all MOP studies)
MOP Dose – Appendix A (DOC)
MOP TEDE – Model procedures for conducting a member-of-public dose compliance study – Appendix A (Use for all MOP studies)
MOP Dose – Appendix B (DOC)
MOP DDE – Model procedures for conducting a member-of-public dose compliance study – Appendix B (Use for all MOP studies)
MOP Dose – Appendix C (DOC)
MOP CEDE non-medical facilities – Model procedures for conducting a member-of-public dose compliance study – Appendix C (Use for all non-medical MOP studies with potential for internal exposure)
MOP Dose – Appendix D (DOC)
MOP CEDE medical facilities – Model procedures for conducting a member-of-public dose compliance study – Appendix D (Use for all medical MOP studies with potential for internal exposure)
Resources
Code of Federal Regulations
Title 49 CFR, which contains regulations for transporting hazardous material, can be found here along with other CFR Titles. This site is maintained by the National Archives and Records Administration.
Additional Protocol (AP) forms for Radioactive Material Licensees to assist in meeting International Atomic Energy Agency (IAEA) treaty obligations – In accordance with 10 CFR 110.54(a)(1), reports of exports of nuclear facilities, equipment, and certain non-nuclear materials shipped by licensees under general license or specific license during the previous quarter, must be submitted by October 15, 2022, to BIS on DOC/NRC Forms AP-M or AP-13, and associated forms. The reports must contain information on all nuclear facilities, equipment, and nonnuclear materials listed in Annex II of the AP.
Conference of Radiation Control Program Directors
A nonprofit organization of state and local government employees who regulate the use of radiation. CRCPD’s mission is “to promote consistency in addressing and resolving radiation protection issues, to encourage high standards of quality in radiation protection programs, and to provide leadership in radiation safety and education.”
U.S. Nuclear Regulatory Commission
- NRC Generic Communications – Contains NRC information notices, generic letters, circulars, bulletins, and administrative letters.
- NRC Office of State and Tribal Programs – Information about NRC activities that directly impact states.
U.S. Nuclear Regulatory Commission Notices and Information
NRC Order Suspending General License Authority To Export Radioactive Material and Deuterium to the Russian Federation
The U.S. Nuclear Regulatory Commission (NRC) is issuing an Order suspending the general license authority under NRC regulations to export radioactive material, and deuterium for nuclear end use, to the Russian Federation.
NRC Information Notice 2019-11
Strontium-82/Rubidium-82 Generator Elution Events and Issues
NRC Medical-Related Communications
Patients recently received Sr-82 and Sr-85 levels well in excess of the breakthrough limits for Sr-82/Rb-82 generators because of elution with Ringer’s lactate solution.
NRC Information Notice 2019-07
Methods to Prevent Medical Events (9/25/2019)
NRC Information Notice 2019-06
Patient Skin Contamination Events Associated with I-131 MetaIodoBenzylGuanidine During Neuroblastoma Treatments (9/25/2019)
NRC Information Notice 2019-05
Potential Over-Pressurization of High Specific-Activity Alphaemitting Radioactive Sources (9/25/2019)
Florida Notices and Recalls
Reminder to Florida licensees that they are required to follow manufacturer instructions, 2019 FDA DARRTS Reference ID # 4425113 or 2019 FDA DARRTS Reference ID # 4425127 and other requirements regarding the use of these generators.