11987956, 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: 11987956

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-5.1115	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	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-5.629	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	Remote Afterloader, Gamma Stereotactic, and Teletherapy 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:

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:

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:

404.022, 404.031, 404.051, 404.061, 404.071(1), (3), 404.081(1), 404.141, 404.20(1), 404.22 FS.

PRINT PUBLISH DATE:

9/14/2012 Vol. 38/37

RELATED STATUTES
AND LAWS:

404.051, 404.061, 404.071, 404.081, 404.131, 404.141, 404.20 FS., 404.022, 404.031, 404.051, 404.061, 404.071(1), (3), 404.081(1), 404.141, 404.20(1), 404.22 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://flrules.org/gateway/ruleno.asp?id=64E-5.101&PDate=9/14/2012&Section=1

REFERENCE MATERIALS:

No reference(s).

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