The purpose of these proposed rule changes is to maintain required compatibility with the U.S. Nuclear Regulatory Commission by updating department rules for use of radioactive materials or radiation from radioactive materials. Changes will also ...

 

DEPARTMENT OF HEALTH
Division of Environmental Health

RULE NO.: RULE TITLE:
64E-5.101: Definitions
64E-5.1115: Subsurface Tracer Studies
64E-5.1312: Training and User Requirements
64E-5.1313: Training and User Requirements
64E-5.1317: Storage and Control of Volatiles and Gases
64E-5.1419: Radiation Surveys
64E-5.1420: Detection of Leaking or Contaminated Sources
64E-5.1501: Purpose and Scope
64E-5.1502: Transportation of Radioactive Material
64E-5.203: Radioactive Material Other Than Source Material - Exemptions
64E-5.204: Types of Licenses
64E-5.206: General Licenses - Radioactive Material Other Than Source Material
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-5.304: Occupational Dose Limits for Adults
64E-5.306: Determination of External Dose from Airborne Radioactive Material
64E-5.307: Determination of Internal Exposure
64E-5.313: Compliance with Dose Limits for Individual Members of the Public
64E-5.315: Conditions Requiring Individual Monitoring of External and Internal Occupational Dose
64E-5.326: Exemptions to Labeling Requirements
64E-5.330: Discharge by Release into Sanitary Sewerage
64E-5.331: Disposal of Specific Wastes
64E-5.344: Notification of Incidents
64E-5.350: Reports of Transactions Involving Nationally Tracked Sources
64E-5.351: Nationally Tracked Source Thresholds
64E-5.6011: Definitions
64E-5.607: Authority and Responsibilities
64E-5.609: Visiting Authorized User, Visiting Authorized Medical Physicist, or Visiting RSO
64E-5.614: Possession, Use, Calibration, and Check of Dose Calibrators in the Use of Unsealed Radiopharmaceuticals
64E-5.6251: 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-5.629: Control of Aerosols and Gases
64E-5.630: Use of Radiopharmaceuticals for Therapy
64E-5.632: Use of Sources for Manual Brachytherapy
64E-5.633: Manual Brachytherapy Sources Inventory and Surveys
64E-5.6412: Full Calibration Measurements on Gamma Stereotactic Radiosurgery Units
64E-5.6422: Periodic Spot-Checks for Gamma Stereotactic Radiosurgery Units
64E-5.643: Radiation Surveys for Teletherapy Facilities
64E-5.645: Therapy-Related Computer Systems
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-5.652: 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-5.660: 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
64E-5.810: Ventilation Systems

PURPOSE AND EFFECT: The purpose of these proposed rule changes is to maintain required compatibility with the U.S. Nuclear Regulatory Commission by updating department rules for use of radioactive materials or radiation from radioactive materials. Changes will also include the use of discrete sources of radium 226, naturally occurring radioactive material or accelerator produced radioactive materials and use of radioactive materials within the State of Florida. Some of the proposed rule changes will provide exemptions and general licenses for the use of radioactive materials and specify requirements for preparation and distribution of radioactive materials for medical use in humans.

SUBJECT AREA TO BE ADDRESSED: The substantive changes will be in providing relaxations in training and experience requirements for authorized users for human medical use and daily spot checks of gamma stereotactic radiosurgery units containing radioactive materials; provide exemptions and general licenses for use of discrete sources of radium 226, naturally occurring radioactive materials or accelerator produced radioactive materials; changes to definitions; adding accelerator produced Nitrogen 13 and Oxygen 15 isotopes to the table of allowable radiation doses to occupational workers via oral and inhalation pathways, and maximum concentrations released into the environment via air, water and sewers (ALI-DAC Tables); clarifies how out of state licenses that use radioactive materials in the State of Florida may dispose of radioactive materials in the State of Florida; the preparation and distribution of radioactive materials for human medical use; require a permanent location within the State of Florida to be issued a specific radioactive materials license; and other subjects encompassed by the above-cited rules.

These rule changes will also address minor wording changes identified by the U.S. Nuclear Regulatory Commission and the department to clarify the use of radioactive materials or radiation from radioactive materials to maintain compatibility with the U.S. Nuclear Regulatory Commission.

RULEMAKING AUTHORITY: 404.051, 404.061, 404.071, 404.081, 404.131, 404.141, 404.20 FS.

LAW IMPLEMENTED: 404.022, 404.031, 404.051, 404.061, 404.071(1), (3), 404.081(1), 404.141, 404.20(1), 404.22 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: Brenda Andrews, 4052 Bald Cypress Way, Bin C21, Tallahassee, FL 32399-1741, [phone], [e-mail]

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