Notice of Development of Rulemaking

DEPARTMENT OF HEALTH
Division of Environmental Health
RULE NO: RULE TITLE
64E-5.101: Definitions
64E-5.1301: Sealed or Unsealed Sources of Radioactive Material
64E-5.207: Filing Application for Specific Licenses
64E-5.210: Special Requirements for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material
64E-5.213: Specific Terms and Conditions of License
64E-5.216: Reciprocal Recognition of Licenses for Byproduct, Source, Naturally Occurring and Accelerator Produced Radioactive Material, and Special Nuclear Material in Quantities Not Sufficient to Form a Critical Mass
64E-5.301: Standards for Protection Against Radiation
64E-5.312: Dose Limits for Individual Members of the Public
64E-5.324: Exceptions to Posting Requirements
64E-5.331: Disposal of Specific Wastes
64E-5.340: Records of Waste Disposal or Transfers
64E-5.344: Notification of Incidents
64E-5.345: Reports of Exposures, Radiation Levels, Concentrations of Radioactive Material Exceeding the Constraints or Limits, and Misadministrations
64E-5.601: License Required
64E-5.602: License Amendments
64E-5.603: Notification
64E-5.604: ALARA Program
64E-5.605: Radiation Safety Officer
64E-5.606: Radiation Safety Committee
64E-5.607: Authority and Responsibilities
64E-5.608: Supervision
64E-5.609: Visiting Authorized User
64E-5.610: Mobile Nuclear Medicine Service Requirements
64E-5.611: Quality Management Program and Notifications, Records and Reports of Misadministrations
64E-5.612: Suppliers
64E-5.613: Quality Control of Diagnostic Instrumentation
64E-5.614: Possession, Use, Calibration, and Check of Dose Calibrators
64E-5.615: Use, Calibration and Check of Survey Instruments
64E-5.616: Assay of Radiopharmaceutical Dosages
64E-5.617: Authorization for Calibration and Reference Sources
64E-5.618: Requirements for Possession of Sealed Sources and Brachytherapy Sources
64E-5.619: Syringe Shields and Labels
64E-5.620: Vial Shields and Labels
64E-5.621: Surveys for Contamination and Ambient Radiation Dose Rate
64E-5.622: Release of Patients Containing Radiopharmaceuticals or Permanent Implants
64E-5.623: Storage of Volatiles and Gases
64E-5.624: Decay in Storage
64E-5.625: Safety Instruction and Precautions for Radiopharmaceutical Therapy, Brachytherapy, and Teletherapy
64E-5.626: Use of Radiopharmaceuticals for Uptake, Dilution, or Excretion Studies
64E-5.627: Use of Radiopharmaceuticals, Generators, and Reagent Kits for Imaging and Localization Studies
64E-5.628: Permissible Molybdenum 99 Concentration
64E-5.629: Control of Aerosols and Gases
64E-5.630: Use of Radiopharmaceuticals for Therapy
64E-5.631: Use of Sealed Sources for Diagnosis
64E-5.632: Use of Sources for Brachytherapy
64E-5.633: Brachytherapy Sources Inventory
64E-5.634: Use of Sealed Source in a Teletherapy Unit
64E-5.635: Maintenance and Repair Restrictions
64E-5.636: Amendments
64E-5.637: Doors, Interlocks, and Warning Systems
64E-5.638: Radiation Monitoring Devices
64E-5.639: Viewing Systems
64E-5.640: Dosimetry Equipment
64E-5.641: Full Calibration Measurements
64E-5.642: Periodic Spot-Checks
64E-5.643: Radiation Surveys for Teletherapy Facilities
64E-5.644: Safety Spot-Checks for Teletherapy Facilities
64E-5.645: Modification of Teletherapy Unit or Room Before Beginning a Treatment Program
64E-5.646: Reports of Teletherapy Surveys, Checks, Tests, and Measurements
64E-5.647: Five Year Inspection
64E-5.648: Radiation Safety Officer
64E-5.649: Training for Uptake, Dilution, or Excretion Studies
64E-5.650: Training for Imaging and Localization Studies
64E-5.651: Training for Therapeutic Use of Radiopharmaceuticals
64E-5.652: Training for Therapeutic Use of Brachytherapy Sources
64E-5.653: Training for Ophthalmic Use of Strontium 90
64E-5.654: Training for Use of Sealed Sources for Diagnosis
64E-5.655: Training for Teletherapy
64E-5.656: Training for Teletherapy Physicist
64E-5.657: Training for Experienced Authorized Users or Radiation Safety Officers
64E-5.658: Recentness of Training
PURPOSE AND EFFECT: The purpose of this proposed rule development is to maintain compatibility with the U.S. Nuclear Regulatory Commission by updating the department rules for the medical use of radioactive materials and temporary jobsite requirements. The proposed rule will also clarify how the department recognizes out of state licenses that use radioactive materials in the State of Florida. The substantive changes will establish new rules and change some existing rules regarding training and experience requirements for users, requirements for use and calibration of high dose rate remote afterloaders, and gamma stereotactic radiosurgery units.
SUBJECT AREA TO BE ADDRESSED: The substantive changes will be in the training and experience requirements for users, requirements for use and calibration of high dose rate remote afterloaders, and gamma stereotactic radiosurgery units. This rule development will review most of the rules in Chapter 64E-5, F.A.C., pertaining to the medical use of radioactive materials. This rule will also address a minor U.S. Nuclear Regulatory Commission wording issue regarding temporary job sites and how the department recognizes out of state licenses that use radioactive materials under reciprocity.
SPECIFIC AUTHORITY: 404.051, 404.061, 404.071, 404.081, 404.141, 404.022, 404.042 FS.
LAW IMPLEMENTED: 404.031, 404.061(2)(3), 404.20, 404.22, 404.30, 404.022, 404.051(1)(2)(4)(5)(6)(8)(9)(10)(11), 404.141, 404.081(1), 404.181(1)(b), 404.042, 404.071(1), 404.051, 404.061, 404.081 FS.
IF REQUESTED IN WRITING AND NOT DEEMED UNNECESSARY BY THE AGENCY HEAD, A RULE DEVELOPMENT WORKSHOP WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW:
TIME AND DATE: October 22, 2008, 10:30 a.m. – 12:00 Noon
PLACE: Room 240P, 4042 Bald Cypress Way, Tallahassee, FL 32399
Pursuant to the provisions of the Americans with Disabilities Act, any person requiring special accommodations to participate in this workshop/meeting is asked to advise the agency at least 7 days before the workshop/meeting by contacting: Michael Stephens; (850)245-4266. If you are hearing or speech impaired, please contact the agency using the Florida Relay Service, 1(800)955-8771 (TDD) or 1(800)955-8770 (Voice).
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT, IF AVAILABLE, IS: Michael Stephens, Bin C21, 4052 Bald Cypress Way, Tallahassee, FL 32399-1741

THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS NOT AVAILABLE.