Notice of Development of Rulemaking

DEPARTMENT OF HEALTH
Division of Environmental Health
RULE NO: RULE TITLE
64E-5.101: Definitions
64E-5.103: Records
64E-5.106: Units of Exposure and Dose
64E-5.1601: Definitions
64E-5.1602: Administrative Requirements
64E-5.1603: Training and Education
64E-5.1604: General Technical Requirements for Electronic Brachytherapy Facilities
64E-5.501: Definitions
64E-5.502: General Requirements
64E-5.507: Therapeutic X-Ray Systems of Less Than 1 MeV
64E-5.508: X-Ray and Electron Therapy Systems with Energies of 1 MeV and Above
64E-5.511: Registration of Radiation Machines
64E-5.801: Registration Requirements
64E-5.802: General Requirements for the Issuance of a Registration Certificate for Particle Accelerators
64E-5.803: Particle Accelerators for Therapeutic Use on Humans
64E-5.804: Limitations
64E-5.805: Shielding and Safety Design Requirements
64E-5.806: Particle Accelerator Controls and Interlock Systems
64E-5.807: Warning Devices
64E-5.808: Operating Procedures
64E-5.809: Radiation Monitoring Requirements
64E-5.810: Ventilation Systems
PURPOSE AND EFFECT: There have been no substantive changes to the rules affecting radiation therapy in at least 13 years. In that time, the use of such machines has changed, and new technologies, such as the miniature x-ray tubes used in electronic brachytherapy, have been created. The purpose of this development is to review those rules and amend and/or adopt new rule language as necessary to address radiation therapy practices, procedures, personnel, and equipment, and also to ensure compliance with current statutory requirements. A new Part XVI will be established for therapeutic radiation machines, and most existing rules in other parts of Chapter 64E-5, F.A.C., that are related to therapeutic radiation machines or radiation therapy will be amended or moved to Part XVI.
SUBJECT AREA TO BE ADDRESSED: Radiation therapy machines and associated devices and equipment; treatment planning & simulation; computer systems; installation, maintenance & repair; general administrative and facility requirements; shielding and safety design; technical requirements; safety & operating procedures; radiation protection devices and monitoring; personnel licensure, education, training and supervision; quality assurance/management; authorized users, operators & medical physicists; radiation safety committee; radiation safety officer; radiation protection program, including authority and responsibilities; surveys and survey instruments; calibration; definitions; forms; fees; registration; records; notifications; reporting; medical & recordable events; signage; posting; written & oral directives; mobile services; radiation dose & dosimetry; particle accelerator controls and interlock systems; ventilation systems; and warning devices.
SPECIFIC AUTHORITY: 404.022, 404.051, 404.071, 404.081, 404.131, 404.141, 404.22, 404.061 FS.
LAW IMPLEMENTED: 404.022, 404.031, 404.051, 404.071, 404.081, 404.091, 404.101, 404.131, 404.141, 404.161, 404.162, 404.163, 404.22, 404.061 FS.
IF REQUESTED IN WRITING AND NOT DEEMED UNNECESSARY BY THE AGENCY HEAD, A RULE DEVELOPMENT WORKSHOP WILL BE NOTICED IN THE NEXT AVAILABLE FLORIDA ADMINISTRATIVE WEEKLY.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT, IF AVAILABLE, IS: James Futch, Bin C21, 4052 Bald Cypress Way, Tallahassee, FL 32399-1741