7692020, 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: 7692020

Notice of Proposed Rule

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-5.1320	Bioassy Program
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-5.312	Dose Limits for Individual Members of the Public
64E-5.331	Disposal of Specific Wastes
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-5.6011	Definitions
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-5.614	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-5.621	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-5.624	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-5.6251	Manual Brachytherapy Therapy Related Computer Systems
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-5.6331	Calibration Measurements of Manual Brachytherapy Sources
64E-5.6332	Decay of Strontium-90 Sources for Ophthalmic Treatments
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-5.6411	Full Calibration Measurements on Remote Afterloader Units
64E-5.6412	Full Calibration Measurements on Gamma Stereotactic Radiosurgery Units
64E-5.642	Periodic Spot-Checks or Teletherapy Units
64E-5.6421	Periodic Spot-Checks for Remote Afterloader Units
64E-5.6422	Periodic Spot-Checks for Gamma Stereotactic Radiosurgery Units
64E-5.6423	Additional Technical Requirements for Mobile Remote Afterloader 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-5.647	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
64E-5.659	Training for an Authorized Nuclear Pharmacist
64E-5.660	Training for Use of Unsealed Radioactive Material for Which A Written Directive is Required in Rule 63E-5.626, 64E-5.627 or 64E-5.630, F.A.C.
64E-5.661	Training for the Oral Administration of Sodium Iodide I-131 Requiring A Written Directive in Quantities Less Than or Equal to 1.22 Gigabecquerels (33 Millicuries)
64E-5.662	Training for the Oral Administration of Sodium Iodide I-131 Requiring A Written Directive in Quantities Greater Than 1.22 Gigabecquerels (33 Millicuries)
64E-5.663	Training for the Parenteral Administration of Unsealed Radioactive Material Requiring a Written Directive
64E-5.664	Other Medical Uses of Radioactive Material or Radiation From Radioactive Material

PURPOSE:

The purpose of these proposed rule changes is to maintain required compatibility with the U.S. Nuclear Regulatory Commission by updating department rules for the medical use of radioactive materials and temporary jobsite requirements. Some proposed rule amendments will clarify how the department recognizes out of state licenses that use radioactive materials in the State of Florida. Other 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.

SUMMARY:

Proposed rule amendments maintain compatibility with U.S. Nuclear Regulatory Commission requirements by updating department rules for the medical use of radioactive materials and temporary jobsite requirements. These rules were reviewed by the Advisory Council on Radiation Protection. The Council consists of physicians who use radioactive materials for diagnostic and therapeutic uses, medical physicists, nuclear medicine and radiation technologists, consultants in the use of radioactive materials and private citizens.

RULEMAKING AUTHORITY:

404.042, 404.051(4), (11), 404.061(2), 404.071, 404.081(1), 404.141, 404.022 FS.

LAW:

404.031, 404.051(1), (2), (4), (5), (6), (8), (9), (10), (11), 404.061(2), (3), 404.20, 404.22, 404.022, 404.081(1), 404.141, 404.071(1), (3), 404.30 FS.

PRINT PUBLISH DATE:

10/2/2009 Vol. 35/39

COMMENTS:

From 10/2/2009 To 10/23/2009 (21 Days)
The public comment period for this notice has already expired.

REFERENCE MATERIALS:

No reference(s).

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