6189975, 64E-5.101 - Florida Administrative Rules, Law, Code, Register

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Florida Department of State and Division of Library and Information Services

Notice: 6189975

Notice of Development of Rulemaking

Department:

DEPARTMENT OF HEALTH

Division:

Division of Environmental Health

Chapter:

CONTROL OF RADIATION HAZARDS

Overview

RULE:

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, Medical Events and Dose to an Embryo/Fetus or a Nursing Child
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, Visiting Authorized Medical Physicist, or Visiting RSO
64E-5.610	Mobile Medical Service Requirements
64E-5.611	Quality Management Program and Notifications, Records and Reports of Medical Events
64E-5.612	Suppliers
64E-5.613	Quality Control of Diagnostic Instrumentation
64E-5.614	Possession, Use, Calibration, and Check of Dose Calibrators in the Use of Unsealed Radiopharmaceuticals
64E-5.615	Use, Calibration and Check of Survey Instruments
64E-5.616	Determination of Dosages of Unsealed Radioactive Material for Medical Use
64E-5.617	Authorization for Calibration, Transmission 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 or Human Research Subjects Treated with Radiopharmaceuticals, Implants or Remote Afterloader Units
64E-5.623	Storage of Volatiles and Gases
64E-5.624	Decay in Storage
64E-5.625	Safety Instructions and Precautions for Liquid Iodine, Radiopharmaceutical Therapy, Manual Brachytherapy, Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery
64E-5.626	Use of Radiopharmaceuticals for Uptake, Dilution, or Excretion Studies
64E-5.627	Use of Unsealed Radiopharmaceuticals, Generators, and Reagent Kits for Imaging and Localization Studies
64E-5.628	Generators
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 Manual Brachytherapy
64E-5.633	Manual Brachytherapy Sources Inventory and Surveys
64E-5.634	Use of a Sealed Source in a Remote Afterloader Unit, Teletherapy Unit, or Gamma Sterotactic Radiosurgery Unit
64E-5.635	Installation, Adjustment, Maintenance and Repair Restrictions
64E-5.636	Safety Procedures and Instructions for Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units
64E-5.637	Safety Precautions for Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units
64E-5.638	Radiation Monitoring Devices
64E-5.639	Viewing Systems
64E-5.640	Dosimetry Equipment Used With Remote Afterloading Units, Teletherapy Units, or Gamma Stereotactic Radiosurgery Units
64E-5.641	Full Calibration Measurements on Teletherapy Units
64E-5.642	Periodic Spot-Checks or Teletherapy Units
64E-5.643	Radiation Surveys for Teletherapy Facilities
64E-5.644	Radiation Surveys for Remote Afterloader and Gamma Stereotactic Radiosurgery Facilities
64E-5.645	Remote Afterloader, Gamma Stereotactic, and Teletherapy Therapy-Related Computer Systems
64E-5.646	Reports of Teletherapy Surveys, Checks, Tests, and Measurements
64E-5.647	Five Year Inspection for Teletherapy and Gamma Stereotactic Radiosurgery Units
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 for Which a Written Directive Is Not Required
64E-5.651	Training for Therapeutic Use of Radiopharmaceuticals (Repealed)
64E-5.652	Training for Use of Manual 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 Use of Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units
64E-5.656	Training for and Authorized Medical Physicist
64E-5.657	Training for Experienced RSO, Teletherapy or Medical Physicist, Authorized Medical Physicist, Authorized User, Nuclear Pharmacist, and Authorized Nuclear Pharmacist
64E-5.658	Recentness of Training

PURPOSE:

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:

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.

RULEMAKING AUTHORITY:

404.051, 404.061, 404.071, 404.081, 404.141, 404.022, 404.042 FS.

LAW:

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.

PRINT PUBLISH DATE:

10/3/2008 Vol. 34/40

RELATED STATUTES
AND LAWS:

404.051, 404.061, 404.071, 404.081, 404.141, 404.022, 404.042 FS., 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.

OVERSIGHT COMMITTEE:

Joint Administrative Procedures Committee
Florida Administrative Law Central Online Network (F.A.L.C.O.N.)

RELATED COURT CASES:

Division of Administrative Hearings

FEDERAL eRULEMAKING
WEB PORTAL:

Regulations.gov

HOW TO LINK TO
THIS NOTICE:

http://www.flrules.org/gateway/ruleno.asp?id=64E-5.101&PDate=10/3/2008&Section=1

REFERENCE MATERIALS:

No reference(s).

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