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 NOS.:RULE TITLES:
64E-5.101Definitions
64E-5.1115Subsurface Tracer Studies
64E-5.1317Storage and Control of Volatiles and Gases
64E-5.1419Radiation Surveys
64E-5.1420Detection of Leaking or Contaminated Sources
64E-5.1501Purpose and Scope
64E-5.1502Transportation of Radioactive Material
64E-5.203Radioactive Material Other Than Source Material - Exemptions
64E-5.204Types of Licenses
64E-5.206General Licenses - Radioactive Material Other Than Source Material
64E-5.210Special Requirements for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material
64E-5.213Specific Terms and Conditions of License
64E-5.216Reciprocal 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-5.304Occupational Dose Limits for Adults
64E-5.306Determination of External Dose from Airborne Radioactive Material
64E-5.307Determination of Internal Exposure
64E-5.313Compliance with Dose Limits for Individual Members of the Public
64E-5.315Conditions Requiring Individual Monitoring of External and Internal Occupational Dose
64E-5.326Exemptions to Labeling Requirements
64E-5.330 Discharge by Release into Sanitary Sewerage
64E-5.331Disposal of Specific Wastes
64E-5.344Notification of Incidents
64E-5.350Reports of Transactions Involving Nationally Tracked Sources
64E-5.351Nationally Tracked Source Thresholds
64E-5.6011Definitions
64E-5.607Authority and Responsibilities
64E-5.609Visiting Authorized User, Visiting Authorized Medical Physicist, or Visiting RSO
64E-5.614Possession, Use, Calibration, and Check of Dose Calibrators in the Use of Unsealed Radiopharmaceuticals
64E-5.6251Therapy Related Computer Systems
64E-5.626Use of Radiopharmaceuticals for Uptake, Dilution, or Excretion Studies
64E-5.627Use of Unsealed Radiopharmaceuticals, Generators, and Reagent Kits for Imaging and Localization Studies
64E-5.629Control of Aerosols and Gases
64E-5.630Use of Radiopharmaceuticals for Therapy
64E-5.632Use of Sources for Manual Brachytherapy
64E-5.633Manual Brachytherapy Sources Inventory and Surveys
64E-5.6412Full Calibration Measurements on Gamma Stereotactic Radiosurgery Units
64E-5.6422Periodic Spot-Checks for Gamma Stereotactic Radiosurgery Units
64E-5.643Radiation Surveys for Teletherapy Facilities
64E-5.645Therapy-Related Computer Systems
64E-5.649Training for Uptake, Dilution, or Excretion Studies
64E-5.650Training for Imaging and Localization Studies for Which a Written Directive Is Not Required
64E-5.652Training for Use of Manual Brachytherapy Sources
64E-5.653Training for Ophthalmic Use of Strontium 90
64E-5.654Training for Use of Sealed Sources for Diagnosis
64E-5.655Training for Use of Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units
64E-5.656Training for and Authorized Medical Physicist
64E-5.660Training 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-5.661Training 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-5.662Training for the Oral Administration of Sodium Iodide I-131 Requiring A Written Directive in Quantities Greater Than 1.22 Gigabecquerels (33 Millicuries)
64E-5.663Training for the Parenteral Administration of Unsealed Radioactive Material Requiring a Written Directive
64E-5.810Ventilation 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 for the use of radioactive materials and specify requirements for preparation and distribution of radioactive materials for medical use in humans.
SUMMARY: 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 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.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:
The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the agency.
The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: The majority of the proposed changes to the regulations are to maintain required compatibility with the U.S. Nuclear Regulatory Commission regulations for the possession and use of radioactive materials and are generally revenue neutral or provide regulatory relief to licensees. Therefore this rulemaking will not have an adverse impact or regulatory costs in excess of $1 million within five years as established in s.120.541(2)(a), F.S.
Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
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 WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Brenda Andrews, 4052 Bald Cypress Way, Bin C21, Tallahassee, FL 32399-1741, (850)245-4266, Brenda_Andrews@doh.state.fl.us

THE FULL TEXT OF THE PROPOSED RULE IS:

64E-5.101 Definitions.

As used in these rules, these terms have the definitions set forth below. Additional definitions used only in a certain part are defined in that respective part.

(1) through (9) No change.

(10) “Airborne radioactivity area” means a room, enclosure or operating area in which airborne radioactive materials exist in concentrations:

(a) In excess of the derived air concentrations (DACs) specified in State of Florida Bureau of Radiation Control ALIs, DACs, and Effluent Concentrations, June 2012 July 1993, which is herein incorporated by reference and which can be obtained from the internet at is available _________ or at http://www.doh.state.fl.us/environment/radiation/regs/64e-5tab.htm from the Department, or

(b) No change.

(11) through (13) No change.

(14) “Annual limit on intake” (ALI) means the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year. ALI is the smaller value of intake of a given radionuclide in a year by Reference Man that would result in a committed effective dose equivalent of 5 rem (0.05 sievert) or a committed dose equivalent of 50 rem (0.5 sievert) to any individual organ or tissue. ALI values for intake by ingestion and by inhalation of selected radionuclides are given in State of Florida Bureau of Radiation Control ALIs, DACs, and Effluent Concentrations, June 2012 July 1993, Table I, Columns 1 and 2.

(15) through (20) No change.

(21) “Byproduct material” means:

(a) No change.

(b) No change.

(c)1. Any discrete source of radium-226 that is produced, extracted, or converted after extraction for use for a commercial, medical, or research activity; or

2. Any material that meets the following:

a. Has been made radioactive by use of a particle accelerator; and

b. Is produced, extracted, or converted after extraction for use for a commercial, medical, or research activity; and

(d)Any discrete source of naturally occurring radioactive material, other than source material, that meets the following:

1. The NRC, in consultation with the Administrator of the Environmental Protection Agency, the Secretary of Energy, the Secretary of Homeland Security, and the head of any other appropriate Federal agency, determines would pose a threat similar to the threat posed by a discrete source of radium-226 to the public health and safety or the common defense and security; and

2. Is extracted or converted after extraction for use in a commercial, medical, or research activity.

(22) through (36) No change.

(37) “Derived air concentration” (DAC) means the concentration of a given radionuclide in air which, if breathed by Reference Man for a working year of 2,000 hours under conditions of light work, results in an intake of one ALI. For purposes of these rules, the condition of light work is an inhalation rate of 1.2 cubic meters of air per hour for 2,000 hours in a year. DAC values are given in State of Florida Bureau of Radiation Control ALIs, DACs, and Effluent Concentrations, June 2012 July 1993, Table I, Column 3.

(38) No change.

(39) “Dose” is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, or total effective dose equivalent. For the purposes of these rules, “radiation dose” is an equivalent term.

(40) through (76) No change.

(77) “Low specific activity material (LSA)” means that as defined in 49 C.F.R. 173.403. (Pursuant to Section 120.54(6), F.S., subsection 64E-5.101(79), F.A.C., is substantively identical to 49 CFR 173.403 published on 10/01/2007.).

(78) through (84) No change.

(85) “Medical event” means the administration of:

(a) No change.

(b) Radioactive materials or radiation from radioactive materials not requiring a written directive that result in either of the following:

1. No change.

2. A dose that exceeds 0.05 Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose equivalent to the skin; and

a. through c. No change.

d. An administration of a dose or dosage delivered by the wrong mode of treatment; or

e. A leaking sealed source where the patient or human research subject is contaminated;.

f. A dose to the skin or an organ or tissue other than the treatment site that exceeds by 0.5 Sv (50 rem) to an organ or tissue and 50 percent or more of the dose expected from the administration defined in the written directive (excluding, for permanent implants, seeds that were implanted in the correct site but migrated outside the treatment site); or

g3. Any medical use that results or will result in unintended permanent functional damage to an individual’s organ or a physiological system, as determined by a physician.

(86) through (95) No change.

(96) “Package” means that as defined in 49 C.F.R. 173.403 (Pursuant to Section 120.54(6), F.S., subsection 64E-5.101(100), F.A.C., is substantively identical to 49 CFR 173.403 published on 10/01/2007).

(97) through (117) No change.

(118) “Radiographic exposure device” means any instrument containing a sealed source, fastened or contained therein, in which the sealed source or shielding thereof may be moved, or otherwise changed from a shielded position to an unshielded position for the purpose of making a radiographic exposure. It also is known as a camera or a projector. (Pursuant to Section 120.54(6), F.S., subsection 64E-5.101(122), F.A.C., is substantively identical to 10 CFR 34.3 published on 01/01/2007.)

(119) through (128) No change.

(129) “Sealed source” means radioactive material that is encased in a capsule designed to prevent release or escape of the radioactive material. (Pursuant to Section 120.54(6), F.S., subsection 64E-5.101(133), F.A.C., is substantively identical to 10 CFR 30.4 published on 01/01/2007.)

(130) through (150) No change.

(151) “Total effective dose equivalent” (TEDE) means the sum of the effective deep dose equivalent for external exposures and the committed effective dose equivalent for internal exposures.

(152) through (188) No change.

(189) “Nationally tracked source” means a sealed source containing a quantity equal to or greater than Category 1 or Category 2 levels of any radioactive material listed in Rule 64E-5.351, F.A.C. In this context a sealed source is defined as radioactive material that is sealed in a capsule or closely bonded, in a solid form, and which is not exempt from regulatory control. It does not mean material encapsulated solely for disposal, or nuclear material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. Category 1 nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the Category 1 threshold. Category 2 nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the Category 2 threshold but less than the Category 1 threshold. (Pursuant to Section 120.54(6), F.S., subsection 64E-5.101(194), F.A.C., is substantively identical to 10 CFR 20.1003 published on 01/01/2007.)

(190) through (194) No change.

(195) “Discrete source” means a radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities.

(196) “Positron Emission Tomography (PET) radionuclide production facility” means a facility operating a cyclotron or accelerator for the purpose of producing PET radionuclides.

(197) “Consortium” means an association of medical use licensees and a PET radionuclide production facility in the same geographical area that jointly own or share in the operation and maintenance cost of the PET radionuclide production facility that produces PET radionuclides for use in producing radioactive drugs within the consortium for noncommercial distributions among its associated members for medical use. The PET radionuclide production facility within the consortium must be located at an educational institution or a Federal facility or a medical facility.

(198) “Waste” or “Radioactive Waste” means those low-level radioactive wastes containing source, special nuclear or other radioactive material that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level radioactive waste means radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or radioactive material as defined in subsections 64E-5.101(21)(b), (c) and (d).

Rulemaking Authority 404.042, 404.051, 404.061 FS. Law Implemented 404.031, 404.051, 404.061, 404.20, 404.22, FS. History–New 7-17-85, Amended 4-4-89, 5-12-93, 1-1-94, 5-15-96, Formerly 10D-91.102, Amended 5-18-98, 10-8-00, 8-6-01, 9-11-01, 12-18-01, 9-28-06, 8-16-07, 2-28-08, 2-11-10,________.

64E-5.203 Radioactive Material Other Than Source Material - Exemptions.

(1) Exempt Concentrations.

(a)1. Except as provided in this section, any person is exempt from this part to the extent that such person receives, possesses, uses, transfers, owns or acquires products containing radioactive material introduced in concentrations not in excess of those listed in Schedule A.

2. A manufacturer, processor, or producer of a product or material is exempt from the requirements for a license to the extent that this person transfers radioactive material contained in a product or material in concentrations not in excess of those specified in Schedule A and introduced into the product or material by a licensee holding a specific license issued by the NRC expressly authorizing such introduction. This exemption does not apply to the transfer of radioactive material contained in any food, beverage, cosmetic, drug, or other commodity or product designed for ingestion or inhalation by, or application to, a human being.

(b) No person may introduce radioactive material into a product or material knowing or having reason to believe that it will be transferred to persons exempt under (1)(a), above, or equivalent regulations of the NRC, an Aagreement Sstate or Licensing State, except in accordance with a specific license issued by the NRC pursuant to 10 CFR 32.11. Rule 64E-5.210, F.A.C., or the general license provided in Rule 64E-5.216, F.A.C.

(2) Exempt Quantities.

(a) Except as provided in (2)(b) through (d) and (c), below, any person is exempt from these regulations to the extent that such person receives, possesses, uses, transfers, owns or acquires radioactive material in individual quantities each of which does not exceed the applicable quantity set forth in Schedule B.

(b) through (c) No change.

(d) No person may, for purposes of producing an increased radiation level, combine quantities of byproduct material covered by this exemption so that the aggregate quantity exceeds the limits set forth in Schedule B, except for radioactive material combined within a device placed in use before May 3, 1999, or as otherwise permitted by the regulations in this part.

(e) 1. Any person, who possesses radioactive material received or acquired before September 25, 1971, under the then existing general license issued to transfer, receive, acquire, own, possess, use and import quantities of radioactive materials listed in subparagraph 64E-5.203(2)(e)2., F.A.C., Table of General Licensed Quantities prior to September 25, 1971 below, or similar general license of a State, or provided that no person shall at any one time possess or use, pursuant to the general license provisions of this section, more than a total of ten such quantities.

2. Below is the Table of General Licensed Quantities prior to September 25, 1971:

	Radioactive material	Column No. I Not as a sealed source (microcuries)	Column No. III As a sealed source (microcuries)
a	Antimony (Sb 124)	1	10
b	Arsenic 76 (As 76)	10	10
c	Arsenic 77 (As 77)	10	10
d	Barium 140 – Lanthanum 140 (Ba La 140)	1	10
e	Beryllium 7 (Be 7)	50	50
f	Cadmium 109 – Silver 109 (Cd Ag 109)	10	10
g	Calcium 45 (Ca 45)	10	10
h	Carbon 14 (C 14)	50	50
i	Cerium 144 – Praseodymium (Ce Pr 144)	1	10
j	Cesium – Barium 137 (Cs Ba 137)	1	10
k	Chlorine 36 (Cl 36)	1	10
l	Chromium 51 (Cr 51)	50	50
m	Cobalt 60 (Co 60)	1	10
n	Copper 64 (Cu 64)	50	50
o	Europium 154 (Eu 154)	1	10
p	Fluorine 18 (F 18)	50	50
q	Gallium 72 (Ga 72)	10	10
r	Germanium 71 (Ge 71)	50	50
s	Gold 198 (Au 198)	10	10
t	Gold 199 (Au 199)	10	10
u	Hydrogen 3 (Tritium) (H 3)	250	250
v	Indium 114 (In 114)	1	10
w	Iodine 131 (I-131)	10	10
x	Iridium 192 (Ir 192)	10	10
y	Iron 55 (Fe 55)	50	50
z	Iron 59 (Fe 59)	1	10
aa	Lanthanum 140 (La 140)	10	10
bb	Manganese 52 (Mn 52)	1	10
cc	Manganese 56 (Mn 56)	50	50
dd	Molybdenum 99 (Mo 99)	10	10
ee	Nickel 59 (Ni 59)	1	10
ff	Nickel 63 (Ni 63)	1	10
gg	Niobium 95 (Nb 95)	10	10
hh	Palladium 109 (Pd 109)	10	10
ii	Palladium 103 – Rhodium 103 (Pd-Rh 103)	50	50
jj	Phosphorus 32 (P 32)	10	10
kk	Polonium 210 (Po 210)	0.1	1
ll	Potassium 42 (K 42)	10	10
mm	Praseodymium 143 (Pr 143)	10	10
nn	Promethium 147 (Pm 147)	10	10
oo	Rhenium 186 (Re 186)	10	10
pp	Rhodium 105 (Rh 105)	10	10
qq	Rubidium 86 (Rb 86)	10	10
rr	Ruthenium 106 – Rhodium 106 (Ru Rh 106)	1	10
ss	Samarium 153 (Sm 153)	10	10
tt	Scandium 46 (Sc 46)	1	10
uu	Silver 105 (Ag 105)	1	10
vv	Silver 111 (Ag 111)	10	10
ww	Sodium 22 (Na 22)	10	10
xx	Sodium 24 (Na 24)	10	10
yy	Strontium 89 (Sr 89)	1	10
zz	Strontium 89 – Yttrium 90 (Sr Y 90)	0.1	1
aaa	Sulfur 35 (S 35)	50	50
bbb	Tantalum 182 (Ta 182)	10	10
ccc	Technetium 96 (Tc 96)	1	10
ddd	Technetium 99 (Tc 99)	1	10
eee	Tellurium 127 (Te 127)	10	10
fff	Tellurium 129 (Te 129)	1	10
ggg	Thallium 204 (Tl 204)	50	50
hhh	Tin 112 (Sn 113)	10	10
iii	Tungsten 185 (W 185)	10	10
jjj	Vanadium 48 (V 48)	1	10
kkk	Yttrium 90 (Y 90)	1	10
lll	Yttrium 91 (Y 91)	1	10
mmm	Zinc 65 (Zn 65)	10	10
nnn	Beta or Gamma emitting radioactive material not listed above	1	10

(3) Exempt Items.

(a) Certain Items Containing Radioactive Material. Except for persons who apply radioactive material to, or persons who incorporate radioactive material into, the following products, any person is exempt from these regulations to the extent that he receives, possesses, uses, transfers, owns or acquires the following products. Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing byproduct material whose subsequent possession, use, transfer and disposal by all other persons are exempted from regulatory requirements may be obtained only from the NRC U.S. Nuclear Regulatory Commission, Washington, D.C. 20555:

1. Timepieces, hands or dials containing not more than the following specified quantities of radioactive material and not exceeding the following specified amount of radioactive material or dose rate, as applicable:

a. through g. No change.

h. One microcurie (37 kBq) of radium 226 per timepiece in intact timepieces manufactured acquired prior to November 30, 2007 January 1, 1989.

2. Ionization chamber smoke detectors containing not more than 1 microcurie (µCi) of americium-241 per detector in the form of a foil and designed to protect life and property from fires Lock illuminators containing not more than 15 millicuries (555 MBq) of tritium or not more than 2 millicuries (74 MBq) of promethium 147 installed in automobile locks. The radiation dose rate from each lock illuminator containing promethium 147 will not exceed 1 millirad (10 uGy) per hour at 1 centimeter from any surface when measured through 50 milligrams per square centimeter of absorber.

3. Precision balances containing not more than 1 millicurie (37 MBq) of tritium per balance or not more than 0.5 millicurie (18.5 MBq) of tritium per balance part manufactured before December 17, 2007.

4. Marine compasses containing not more than 750 millicuries (27.8 GBq) of tritium gas and other marine navigational instruments containing not more than 250 millicuries (9.25 GBq) of tritium gas manufactured before December 17, 2007 Automobile shift quadrants containing not more than 25 millicuries (925 MBq) of tritium.

5. Marine compasses containing not more than 750 millicuries (27.8 GBq) of tritium gas and other marine navigational instruments containing not more than 250 millicuries (9.25 GBq) of tritium gas.

6. Thermostat dials and pointers containing not more than 25 millicuries (925 MBq) of tritium per thermostat.

7. and 8. Renumbered 5. and 6.

5.7. Electron tubes, including spark gap tubes, power tubes, gas tubes including glow lamps, receiving tubes, microwave tubes, indicator tubes, pick-up tubes, radiation detection tubes and any other completely sealed tube that is designed to conduct or control electrical currents; provided, that the radiation dose rate from each electron tube containing radioactive material shall not exceed 1 millirad (10 uGy) per hour at 1 centimeter from any surface when measured through 7 milligrams per square centimeter of absorber, and that each tube does not contain more than one of the following specified quantities of radioactive material:

a. through f. No change.

6.8. Ionizing radiation measuring instruments containing, for purposes of internal calibration or standardization, one or more sources of radioactive material, provided that:

a. through c. No change.

9. Spark gap irradiators containing not more than 1 microcurie (37 kBq) of cobalt 60 per spark gap irradiator for use in electrically ignited fuel oil burners having a firing rate of at least 3 gallons (11.4 l) per hour.

(b) No change.

1. Except for persons who manufacture, process, or produce, or initially transfer for sale or distribution gas and aerosol detectors containing radioactive material, any person is exempt from these regulations to the extent that such person receives, possesses, uses, transfers, owns or acquires radioactive material in gas and aerosol detectors designed to protect life or property from fires and airborne hazards, provided that detectors containing radioactive material shall have been manufactured, processed, produced, imported or initially transferred in accordance with a specific license issued by the NRCU.S. Nuclear Regulatory Commission pursuant to Section 32.26 of 10 C.F.R. Part 32; or a Licensing State pursuant to subsection 64E-5.210(3), F.A.C., which authorizes the transfer of the detectors to persons who are exempt from regulatory requirements. Authority to transfer possession or control by the manufacturer, processor or producer of any equipment, device, commodity or other product containing byproduct material whose subsequent possession, use, transfer and disposal by all other persons are exempted from regulatory requirements may be obtained only from the NRC U.S. Regulatory Commission, Washington, D.C., 20555.

2. This exemption also covers gas and aerosol detectors manufactured or distributed before November 30, 2007 in accordance with a specific license issued by a State under comparable Section 32.26 of 10 CFR, Part 32 authorizing distribution to persons exempt from regulatory requirements. Gas and aerosol detectors previously manufactured and distributed to general licensees in accordance with a specific license issued by an agreement state shall be considered exempt under (3)(c)1., above, provided that the device is labeled in accordance with the specific license authorizing distribution of devices under a general license, and provided further that they meet the requirements of subsection 64E-5.210(3), F.A.C.

3. Gas and aerosol detectors containing NARM previously manufactured and distributed in accordance with a specific license issued by a Licensing State shall be considered exempt under (3)(c)1., above, provided that the device is labeled in accordance with the specific license authorizing distribution, and provided further that they meet the requirements of subsection 64E-5.210(3), F.A.C.

(d) Resins Containing Scandium 46 and Designed for Sand Consolidation in Oil Wells. Any person is exempt from these regulations to the extent that such person receives, possesses, uses, transfers, owns or acquires synthetic plastic resins containing scandium 46 which are designed for sand consolidation in oil wells. Such resins shall have been manufactured or imported in accordance with a specific license issued by the U.S. Nuclear Regulatory Commission, or shall have been manufactured in accordance with the specifications contained in a specific license issued by the Department or any agreement state to the manufacturer of such resins pursuant to licensing requirements equivalent to those in Sections 32.16 and 32.17 of 10 C.F.R. Part 32. This exemption does not authorize the manufacture of any resins containing scandium 46.

(4) No change.

Rulemaking Authority 404.051, 404.061, 404.141 FS. Law Implemented 404.022, 404.051(1), (4), (10), 404.141 FS. History–New 7-17-85, Amended 4-4-89, Formerly 10D-91.303, Amended 10-8-00,________.

64E-5.204 Types of Licenses.

Licenses for radioactive materials are of two types: general and specific.

(1) No change.

(2) Specific licenses require the submission of an application to the Ddepartment and the issuance of a licensing document by the Ddepartment. The licensee is subject to all applicable portions of these regulations as well as any limitations specified in the licensing document. The licensee is subject to the payment of fees as authorized under Section 404.131, F.S., and as outlined below:

(a) through (d) No change.

(e) Below is the schedule of fees for specific radioactive materials licenses:

1. through 4. No change.
5. Medical use:
a.(I) Teletherapy or gamma stereotactic radiosurgery including gamma knife devices;	$1,838	$1,791
(II) High, medium, low or pulsed dose rate remote afterloader afterloading devices;	$1,697		$1,654
(III) High, medium, low or pulsed dose rate remote afterloader afterloading devices and gamma stereotactic radiosurgery including gamma knife devices or teletherapy devices;	$1,838		$1,791
b. through e. No change.
f.(I) No change.
f.(II) Mobile high, medium, low or pulsed dose rate remote afterloader afterloading therapy device when the treatment is only performed on the mobile vehicle.	$2,970		$3,308
6. through 7. No change.

Rulemaking Authority 404.051, 404.061, 404.131 FS. Law Implemented 404.031, 404.051, 404.061, 404.081, 404.131, 404.141 FS. History–New 7-17-85, Amended 9-9-90, 8-25-91, 5-12-93, 11-6-94, Formerly 10D-91.304, Amended 5-18-98, 9-28-06, 8-16-07,_________.

64E-5.206 General Licenses – Radioactive Material Other Than Source Material.

(1) through (3) No change.

(4) Certain Measuring, Gauging and Controlling Devices.

(a) through (b) No change.

(c) Any person who owns, receives, acquires, possesses, uses, or transfers radioactive material in a device pursuant to the general license in paragraph (4)(a), above;

1. through 6. No change.

7. Except as provided in subparagraph (4)(c)8., below, shall transfer or dispose of the device containing radioactive material only by export as provided by paragraph 15 below, transfer to a specific licensee of the Ddepartment, the NRC, or an Agreement State, whose specific license authorizes him to receive the device, and within 30 days after transfer of a device to a specific licensee or export, shall furnish to the Ddepartment a report containing identification of the device by manufacturer’s or initial transferor’s name and model number and serial number, the name, address, license number, where applicable, of the person receiving the device, and the date of the transfer;

8. through 9. No change.

10. Shall be required to obtain written Ddepartment authorization before transferring the device to any other specific license not specifically identified in subparagraph 64E-5.206(4)(c)7., F.A.C. A holder of a specific license may transfer a device for possession and use under its own specific license without prior approval if the specific license holder satisfies the following requirements: The Department authorization is granted provided the specific license identifies the device.

a. Verifies that the specific license authorizes the possession and use, or applies for and obtains an amendment to the license authorizing the possession and use;

b. Removes, alters, covers, or clearly and unambiguously augments the existing label otherwise required by subparagraph 64E-5.206(4)(c)1., F.A.C., so that the device is labeled in compliance with Rule 64E-5.325, F.A.C., provided the manufacturer, model number, and serial number is retained;

c. Obtains manufacturer’s or initial transferor’s information concerning maintenance that would be applicable under the specific license such as leak testing procedures;

d. Reports the transfer under subparagraph 64E-5.206(4)(c)7, F.A.C.

11. through 16. No change.

(d) through (e) No change.

(5) through (6) No change.

(7) Medical Diagnostic Uses.

(a) No change.

(b) No physician shall receive, possess, use or transfer radioactive material pursuant to the general license established by paragraph (7)(a), above, until he has submitted the original and one copy of the completed information requested on form DH DOH Form 361 10/12, entitled “Certificate – Medical Use of Radioactive Material under General License”, which is herein incorporated by reference effective date of rule 7-17-85, with the Department and received from the Department a validated copy of this form with a certification number assigned. DH 361 10/12, entitled, “Certificate – Medical Use of Radioactive Material under General License,” is herein incorporated by reference and can be obtained from the internet at ________ or at http://www.doh.state.fl.us/environment/radiation/matform.htm.

(8) General License for Use of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing.

(a) No change.

(b) No person shall receive, acquire, possess, use or transfer radioactive material pursuant to the general license established by (8)(a), above until he has submitted, the original and one copy of the completed in triplicate, the information requested on form DH DOH Form 360 10/12, entitled “Certificate – In Vitro Testing with Radioactive Material under General License, which is herein incorporated by reference, effective 7-17-85, with the Department and received from the Department a validated copy of the “Certificate – In Vitro Testing with Radioactive Material under General License” this form with a certification number assigned. DH 360 10/12 entitled, “Certificate – In Vitro Testing with Radioactive Material under General License” is herein incorporated by reference and can be obtained from the internet at ________ or at http://www.doh.state.fl.us/environment/radiation/matform.htm.

(9) through (10) No change.

Rulemaking Authority 404.051, 404.061, 404.071, 404.081 FS. Law Implemented 404.022, 404.051(1), (4), (6), (8), (9), (10), (11), 404.061(2), 404.071(1), (3), 404.081(1), 404.141 FS. History–New 7-17-85, Amended 4-4-89, 1-1-94, Formerly 10D-91.306, Amended 9-28-06, 2-28-08,________.

64E-5.210 Special Requirements for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material.

(1) Licensing the Distribution of Radioactive Material in Exempt Concentrations. Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity or other product containing by-product material whose subsequent possession, use, transfer and disposal by all other persons are exempted from regulatory requirements may be obtained only from the NRC, Washington, D.C. 20555. No person may introduce radioactive materials into a product or material knowing or having reason to believe that it will be transferred to persons exempt under subsection 64E-5.203(1), F.A.C., NRC or equivalent regulations of an Agreement State, except in accordance with a license issued by the NRC under 10 CFR 32.11. Licensing the Introduction of Radioactive Material into Products in Exempt Concentrations.

(a) In addition to the requirements set forth in Rule 64E-5.208, F.A.C., a specific license authorizing the introduction of radioactive material into a product or material owned by or in the possession of the licensee or another to be transferred to persons exempt under paragraph 64E-5.203(1)(a), F.A.C., will be issued if:

1. The applicant submits a description of the product or material into which the radioactive material will be introduced, intended use of the radioactive material and the product or material into which it is introduced, method of introduction, initial concentration of the radioactive material in the product or material, control methods to assure that no more than the specified concentration is introduced into the product or material, estimated time interval between introduction and transfer of the product or material, and estimated concentration of the radioactive material in the product or material at the time of transfer; and

2. The applicant provides reasonable assurance that the concentrations of radioactive material at the time of transfer will not exceed the concentrations in Schedule A of this part, that reconcentration of the radioactive material in concentrations exceeding those in Schedule A is not likely, that use of lower concentrations is not feasible, and that the product or material is not likely to be incorporated in any food, beverage, cosmetic, drug or other commodity or product designed for ingestion or inhalation by, or application to, a human being.

(b) Each person licensed under this subsection shall file an annual report with the Department which shall identify the type and quantity of each product or material into which radioactive material has been introduced during the reporting period; name and address of the person who owned or possessed the product or material, into which radioactive material has been introduced, at the time of introduction; the type and quantity of radionuclide introduced into each such product or material; and the initial concentrations of the radionuclide in the product or material at time of transfer of the radioactive material by the licensee. If no transfers of radioactive material have been made pursuant to this subsection during the reporting period, the report shall so indicate. The report shall cover the year ending June 30, and shall be filed within 30 days thereafter.

(2) Licensing the Distribution of Radioactive Material in Exempt Quantities. Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity or other product containing byproduct material whose subsequent possession, use, transfer and disposal by all other persons are exempted from regulatory requirements may be obtained only from the NRC U.S. Nuclear Regulatory Commission, Washington, D.C. 20555. No person may introduce radioactive materials into a product or material knowing or having reason to believe that it will be transferred to persons exempt under subsection 64E-5.203(1), F.A.C., NRC or equivalent regulations of an Agreement State, except in accordance with a license issued by the NRC under 10 CFR 32.11.

(a) An application for a specific license to distribute NARM to persons exempted from these regulations pursuant to subsection 64E-5.203(2), F.A.C., will be approved if:

1. The radioactive material is not contained in any food, beverage, cosmetic, drug, or other commodity designed for ingestion or inhalation by, or application to, a human being;

2. The radioactive material is in the form of processed chemical elements, compounds, or mixtures, tissue samples, bioassay samples, counting standards, plated or encapsulated sources, or similar substances, identified as radioactive and to be used for its radioactive properties, but is not incorporated into any manufactured or assembled commodity, product, or device intended for commercial distribution; and

3. The applicant submits copies of prototype labels and brochures and the Department approves such labels and brochures, subject to the provisions of subparagraph (2)(b)3., below, and requirements herein.

(b) The license issued under paragraph (2)(a), above, is subject to the following conditions:

1. No more than 10 exempt quantities shall be sold or transferred in any single transaction. However, an exempt quantity may be composed of fractional parts of one or more of the exempt quantity provided the sum of the fractions shall not exceed unity.

2. Each exempt quantity shall be separately and individually packaged. No more than 10 such packaged exempt quantities shall be contained in any outer package for transfer to persons exempt pursuant to subsection 64E-5.203(2), F.A.C. The outer package shall be such that the dose rate at the external surface of the package does not exceed 0.5 millirem (5 µSv) per hour.

3. The immediate container of each quantity or separately packaged fractional quantity of radioactive material shall bear a durable, legible label which:

a. Identifies the radionuclide and the quantity of radioactivity, and

b. Bears the words “Radioactive Material”.

4. In addition to the labeling information required by subparagraph (2)(b)3., above, the label affixed to the immediate container, or accompanying brochure, shall:

a. State that the contents are exempt from Licensing State requirements,

b. Bear the words “Radioactive Material – Not for Human Use – Introduction into Foods, Beverages, Cosmetics, Drugs or Medicinals, or into Products Manufactured for Commercial Distribution is Prohibited – Exempt Quantities Should Not Be Combined,” and

c. Set forth appropriate additional radiation safety precautions and instructions relating to the handling, use, storage and disposal of the radioactive material.

(c) Each person licensed under subsection (2), above, shall maintain records identifying, by name and address, each person to whom radioactive material is transferred for use under subsection 64E-5.204(2), F.A.C., or the equivalent regulations of a Licensing State, and stating the kinds and quantities of radioactive material transferred. An annual summary report stating the total quantity of each radionuclide transferred under the specific license shall be filed with the Department. Each report shall cover the year ending June 30, and shall be filed within 30 days thereafter. If no transfers of radioactive material have been made pursuant to (2), above, during the reporting period, the report shall so indicate.

(3) Licensing the Distribution of Radioactive Material in Exempt Items. Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity or other product containing by-product material whose subsequent possession, use, transfer and disposal by all other persons are exempted from regulatory requirements may be obtained only from the NRC, Washington, D.C. 20555. No person may introduce radioactive materials into a product or material knowing or having reason to believe that it will be transferred to persons exempt under subsection 64E-5.203(1), F.A.C., NRC or equivalent regulations of an Agreement State, except in accordance with a license issued by the NRC under 10 CFR 32.11. Licensing the Incorporation of Naturally Occurring and Accelerator-Produced Radioactive Material (NARM) into Gas and Aerosol Detectors. An application for a specific license authorizing the incorporation of NARM into gas or aerosol detectors to be distributed to persons exempt under paragraph 64E-5.203(3)(c), F.A.C., will be approved if the application satisfies the requirements of this part and Parts I, III, IX and XV. The maximum quantity of radium 226 in each device shall not exceed 0.1 microcurie (3.7 kBq).

(4) Licensing the Manufacture and Distribution of Devices to General Licensees Under subsection 64E-5.206(4), F.A.C.

(a) through (g) No change.

(h) Each person licensed under subsection 64E-5.210(4), F.A.C., shall comply with the following reporting and record keeping requirements.

1. Report all transfers of devices to persons for use under the general license described in subsection 64E-5.206(4), F.A.C., and all receipts of devices from persons licensed under subsection 64E-5.206(4), F.A.C., to the Ddepartment. This report must be submitted at intervals not to exceed 3 months and contain all of the information described in “Transfers of Industrial Devices Report 04/2007” which is herein incorporated by reference and is available at the address listed in paragraph 64E-5.204(2)(b), F.A.C., or can be obtained from the internet at ________or at http://www.doh.state.fl.us/environment/radiation/ http://www.doh.state.fl.us/environment/radiation/regs/64e-5tab.htm.

2. through 7. No change.

(i) through (j) No change.

(5) through (7) No change.

(8) Manufacture and Distribution of Radioactive Material for Certain in In Vitro Clinical or Laboratory Testing Under General License. An application for a specific license to manufacture or distribute radioactive material for use under the general license of subsection 64E-5.206(8), F.A.C., will be approved if:

(a) through (e) No change.

(f) The applicant satisfies the requirements specified in paragraph 64E-5.210(10)(b), F.A.C.

(9) No change.

(10) Manufacture and Distribution of Radiopharmaceuticals Containing Radioactive Material for Medical Use. An application for a specific license to manufacture and distribute radiopharmaceuticals containing radioactive material for use by persons licensed pursuant to Part VI for the uses listed in Rules 64E-5.626, 64E-5.627, 64E-5.630 and 64E-5.664, F.A.C., will be approved if:

(a) through (b) No change.

(c) The applicant submits information on the radionuclide, chemical and physical form, the packaging including maximum activity per vial, syringe, generator, or other container of the radioactive drug package, and shielding provided by the packaging of the radioactive material which is appropriate for safe handling and storage of radiopharmaceuticals by medical use licensees;

(d) through (e) No change.

(f) An application from a medical facility, educational institution, or Federal facility to produce Positron Emission Tomography (PET) radiopharmaceuticals containing for noncommercial transfer to licensees in its consortium licensed for medical pursuant to Part VI, or equivalent Agreement State, or NRC rules will be approved if:

1. The requirements of paragraphs 64E-5.210(10)(a), (b), and (e), F.A.C., are satisfied;

2. The information required of paragraphs 64E-5.210(10)(c) and (d), F.A.C., indicates the PET drugs to be noncommercially transferred to members of its consortium.

(11) through (13) No change.

(14) A licensee, manufacturer or an initial distributor of a sealed source or device containing a sealed source whose product contains exempt NARM or is intended for use under a general or specific license must submit a request for an evaluation of the sealed source or device containing a sealed source and obtain a registration from the Ddepartment.

(a) through (b) No change.

(c) The Ddepartment shall use criteria and standards sufficient to ensure that the radiation safety properties of the sealed source or device are adequate to protect public health, safety and property. Criteria and standards used by the Ddepartment in evaluating a sealed source or device include:

1. U.S. Department of Health and Human Services Publication FDA 81-8025 June 1981, Guides for Naturally Occurring and Accelerator-Produced Radioactive Materials (NARM), which is herein incorporated by reference and can be obtained from the internet at ________ or at http://www.doh.state.fl.us/environment/radiation/matform.htm which is available from the department.

2. NRC U.S. Nuclear Regulatory Commission Regulatory Guide 10.10 March 1987, Guide for the Preparation of Applications for Radiation Safety Evaluations and Registration of Devices Containing Byproduct Material, which is herein incorporated by reference and can be obtained from the internet at ________ or at http://pbadupws.nrc.gov/docs/ML0037/ML003740220.pdf or at http://www.doh.state.fl.us/environment/radiation/ and which is available from the department.

3. NRC U.S. Nuclear Regulatory Commission Regulatory Guide 10.11 June 1987, Guide for the Preparation of Applications for Radiation Safety Evaluations of Sealed Sources Containing Byproduct Material, which is herein incorporated by reference and can be obtained from the internet at ________ or at http://pbadupws.nrc.gov/docs/ML0037/ML003740233.pdf or at http://www.doh.state.fl.us/environment/radiation/ and which is available from the department.

4. American National Standards Institute (ANSI) Standard, ANSI-HPS N43.8-2008 N538, Classification of Industrial Ionizing Radiation Gauging Devices October 1979, which is herein incorporated by reference and can be obtained from the internet at http://hps.org/hpssc/documents/ansi_standards_order_form.pdf and which is available from the department.

5. ANSI American National Standards Institute Standard, ANSI-HPS N43.4-2005N540, Classification of Radioactive Self-Luminous Light Sources January 1976, which is herein incorporated by reference and can be obtained from the internet at http://hps.org/hpssc/documents/ansi_standards_order_form.pdf which is available from the department.

6. ANSI American National Standards Institute Standard N432-1980, NBS Handbook 136, Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography, which is herein incorporated by reference and can be obtained from the internet at ________ or at http://pbadupws.nrc.gov/docs/ML0508/ML050840139.pdf or at http://www.doh.state.fl.us/environment/radiation/matform.htm which is available from the department.

7. ANSI American National Standards Institute Standard, ANSI-HPS N43.6-2007 N542, Sealed Radioactive Sources Classification July 1978, which is herein incorporated by reference and can be obtained from the internet at http://hps.org/hpssc/documents/ansi_standards_order_form.pdf which is available from the department.

(d) through (e) No change.

(15) Each licensee who manufactures a nationally tracked source after February 6, 2007 shall assign a unique serial number to each nationally tracked source. Serial numbers must be composed only of alpha-numeric characters. (Pursuant to Section 120.54(6), F.S., subsection 64E-5.210(15), F.A.C., is substantively identical to 10 CFR 32.201 published on 01/01/2007.)

Rulemaking Authority 404.051, 404.061, 404.071, 404.081, 404.141 FS. Law Implemented 404.022, 404.051, 404.061, 404.081, 404.141 FS. History–New 7-17-85, Amended 8-25-91, 5-12-93, 1-1-94, 5-15-96, Formerly 10D-91.311, Amended 8-6-01, 9-28-06, 8-16-07, 2-28-08, 2-11-10,________.

64E-5.213 Specific Terms and Conditions of License.

(1) through (3) No change.

(4)(a) Each person licensed by the Department pursuant to this part shall confine use and possession of the material licensed to the locations and purposes authorized in the license.

(b) Each person specifically licensed by the Department shall maintain a fixed facility located within the state of Florida.

(5) through (7) No change.

(8) A licensee shall apply and receive a license amendment or Ddepartment approval:

(a) through (f) No change.

(g) Identifying all sources or devices by manufacturer and model number as registered by the sealed source and device registry or for sources or devices not registered by the sealed source and device registry provide the information in subsection 64E-5.210(14), F.A.C.

Rulemaking Authority 404.051, 404.061, 404.141 FS. Law Implemented 404.051(1), (4), 404.061(2), (3), 404.081(1), 404.141 FS. History–New 7-17-85, Amended 4-4-89, 5-12-93, 8-29-94, Formerly 10D-91.314, Amended 5-18-98, 9-28-06, 2-11-10,_________.

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.

(1) Subject to these regulations, any person who holds a specific license from the NRC, or an Aagreement Sstate and issued by the agency having jurisdiction where the licensee maintains an office for directing the licensed activity and at which radiation safety records are normally maintained, will be granted a general license by the Department to conduct the activities authorized in such licensing document within the State of Florida, except for areas of exclusive federal jurisdiction, for a period not in excess of 180 consecutive days provided that:

(a) through (c) No change.

(d) The out-of-state licensee shall not transfer or dispose of radioactive material possessed or used under the general license provided in this section except by transfer to a person who is specifically licensed by the Department, by the NRC, an Agreement State or a Licensing State to receive such material.

1. Specifically licensed by the Department, by the NRC, an agreement state or a Licensing State to receive such material, or

2. Exempt from the requirements for a license for such material under paragraph 64E-5.203(1)(a), F.A.C.

(e) No change.

(2) through (3) No change.

Rulemaking Authority 404.051(4), (11), 404.061(2), 404.081(1), 404.141 FS. Law Implemented 404.051(1), (2), (4), (6), (11), 404.061(2), 404.081(1) FS. History–New 7-17-85, Amended 4-4-89, Formerly 10D-91.321, Amended 10-8-00, 2-28-08, 2-11-10,_______.

64E-5.304 Occupational Dose Limits for Adults.

(1) through (2) No change.

(3) When the external exposure is determined by measurement with an external personal monitoring device, the deep-dose equivalent must be used in place of the effective dose equivalent, unless the effective dose equivalent is determined by a dosimetry method approved by the Department. The assigned deep dose equivalent must be for the part of the body receiving the highest exposure. The assigned shallow dose equivalent must be the dose averaged over the contiguous 10 square centimeters of skin receiving the highest exposure. The deep dose equivalent, lens dose equivalent and shallow dose equivalent may be assessed from surveys or other radiation measurements to demonstrate compliance with the occupational dose limits if the individual monitoring device was not in the region of highest potential exposure or the results of individual monitoring are unavailable.

(4) Derived air concentration (DAC) and annual limit on intake (ALI) values are presented in State of Florida Bureau of Radiation Control ALIs, DACs, and Effluent Concentrations, June 2012 July 1993, Table I, and can be used to determine the individual’s dose and to demonstrate compliance with the occupational dose limits. See Rule 64E-5.339, F.A.C.

(5) In addition to the annual dose limits, the licensee shall limit the soluble uranium intake by an individual to 10 milligrams in a week in consideration of chemical toxicity. See footnote 3 of State of Florida Bureau of Radiation Control ALIs, DACs, and Effluent Concentrations, June 2012 July 1993.

(6) No change.

Rulemaking Authority 404.051, 404.081 FS. Law Implemented 404.022, 404.051(1), (4), 404.081 FS. History–New 1-1-94, Formerly 10D-91.435, Amended 10-8-00, 9-28-06,________.

64E-5.306 Determination of External Dose from Airborne Radioactive Material.

(1) Licensees shall include the contribution to the deep dose equivalent, eye dose equivalent, and shallow dose equivalent from external exposure to the radioactive cloud when determining the dose from airborne radioactive material. See State of Florida Bureau of Radiation Control ALIs, DACs, and Effluent Concentrations, June 2012 July 1993, footnotes 1 and 2.

(2) No change.

Rulemaking Authority 404.051, 404.081 FS. Law Implemented 404.022, 404.051(1), (4), 404.081 FS. History–New 1-1-94, Formerly 10D-91.437, Amended________.

64E-5.307 Determination of Internal Exposure.

(1) through (2) No change.

(3) When specific information on the physical and biochemical properties of the radionuclides taken into the body or the behavior of the material in an individual is known, the licensee is permitted to:

(a) through (b) No change.

(c) Separately assess the contribution of fractional intakes of Class D, W, or Y compounds of a given radionuclide to the committed effective dose equivalent. See State of Florida Bureau of Radiation Control ALIs, DACs, and Effluent Concentrations, June 2012 July 1993.

(4) No change.

(5) If the identity and concentration of each radionuclide in a mixture are known, the fraction of the DAC applicable to the mixture for use in calculating DAC-hours shall be either:

(a) The sum of the ratios of the concentration to the appropriate DAC value, that is D, W, or Y, from State of Florida Bureau of Radiation Control ALIs, DACs, and Effluent Concentrations, June 2012 July 1993, for each radionuclide in the mixture; or

(b) No change.

(6) through (7) No change.

(8) When determining the committed effective dose equivalent, the following information can be considered:

(a) No change.

(b) For an ALI and the associated DAC determined by the nonstochastic organ dose limit of 50 rem (0.5 sievert), the intake of radionuclides that would result in a committed effective dose equivalent of 5 rem (0.05 sievert), that is, the stochastic ALI, as listed in parentheses in State of Florida Bureau of Radiation Control ALIs, DACs, and Effluent Concentrations, June 2012 July 1993, Table I. The licensee can use the stochastic ALI to determine committed effective dose equivalent as a simplifying assumption. However, if the licensee uses the stochastic ALI, the licensee shall also demonstrate that the limit in subparagraph 64E-5.304(1)(a)2., F.A.C., is met.

Rulemaking Authority 404.051, 404.081 FS. Law Implemented 404.022, 404.051(1), (4), 404.081 FS. History–New 1-1-94, Formerly 10D-91.438, Amended________.

64E-5.313 Compliance with Dose Limits for Individual Members of the Public.

(1) No change.

(2) A licensee or registrant shall show compliance with the annual dose limit in Rule 64E-5.312, F.A.C., by:

(a) No change.

(b) Demonstrating that:

1. The annual average concentrations of radioactive material released in gaseous and liquid effluents at the boundary of the unrestricted area do not exceed the values specified in State of Florida Bureau of Radiation Control ALIs, DACs and Effluent Concentrations, June 2012 July 1993, Table II; and

2. No change.

(3) Upon approval from the Ddepartment, the licensee can adjust the effluent concentration values in State of Florida Bureau of Radiation Control ALIs, DACs, and Effluent Concentrations, June 2012 July 1993, for members of the public to take into account the actual physical and chemical characteristics of the effluents, such as aerosol size distribution, solubility, density, radioactive decay equilibrium, and chemical form.

(4) through (5) No change.

Rulemaking Authority 404.051, 404.081 FS. Law Implemented 404.022, 404.051(1), (4), 404.081 FS. History–New 1-1-94, Amended 11-20-94, 5-15-96, Formerly 10D-91.444, Amended_________.

64E-5.315 Conditions Requiring Individual Monitoring of External and Internal Occupational Dose.

Each licensee or registrant shall monitor exposures from sources of radiation at levels sufficient to demonstrate compliance with the occupational dose limits of this part. As a minimum:

(1) No change.

(2) Each licensee shall monitor to determine compliance with Rule 64E-5.307, F.A.C., the occupational intake of radioactive material by and assess the committed effective dose equivalent to:

(a) Adults likely to receive in 1 year an intake in excess of 10 percent of the applicable ALI in State of Florida Bureau of Radiation Control ALIs, DACs, and Effluent Concentrations June 2012 July 1993, Table I, Columns 1 and 2; and

(b) No change.

Rulemaking Authority 404.051, 404.081, FS. Law Implemented 404.022, 404.051(1), (4), 404.081 FS. History–New 1-1-94, Formerly 10D-91.446, Amended 10-8-00,________.

64E-5.326 Exemptions to Labeling Requirements.

A licensee is not required to label:

(1) No change.

(2) Containers holding licensed material in concentrations less than those specified in State of Florida Bureau of Radiation Control ALIs, DACs, and Effluent Concentrations, June 2012 July 1993, Table III;

(3) through (6) No change.

Rulemaking Authority 404.051, 404.081 FS. Law Implemented 404.022, 404.051(1), (4), 404.081 FS. History–New 1-1-94, Formerly 10D-91.459, Amended 10-8-00,________.

64E-5.330 Discharge by Release into Sanitary Sewerage.

(1) A licensee can discharge licensed material into sanitary sewerage if each of the following conditions is satisfied:

(a) No change.

(b) The quantity of licensed radioactive material that the licensee releases into the sewer in 1 month divided by the average monthly volume of water released into the sewer by the licensee does not exceed the concentration listed in State of Florida Bureau of Radiation Control ALIs, DACs, and Effluent Concentrations, June 2012 July 1993, Table III;

1. The licensee shall determine the fraction of the limit in State of Florida Bureau of Radiation Control ALIs, DACs, and Effluent Concentrations, June 2012 July 1993, Table III represented by discharges into sanitary sewerage by dividing the actual monthly average concentration of each radionuclide released by the licensee into the sewer by the concentration of that radionuclide listed in State of Florida Bureau of Radiation Control ALIs, DACs, and Effluent Concentrations, June 2012 July 1993, Table III; and

2. No change.

(d) No change.

(2) No change.

Rulemaking Authority 404.051, 404.081 FS. Law Implemented 404.022, 404.051(1), (4), 404.081 FS. History–New 1-1-94, Formerly 10D-91.463, Amended________.

SUBPART J WASTE MANAGEMENT

64E-5.331 Disposal of Specific Wastes.

(1) A licensee can dispose of the following licensed material without regard to its radioactivity:

(a) through (c) No change.

(d) Licensed material as defined in paragraphs 64E-5.101(21)(c) and (d), F.A. C., may be disposed of at a licensed low-level radioactive waste disposal facility, even though it is not defined as low-level radioactive waste provided the requirements of Rule 64E-5.332, F.A.C., are satisfied or at a disposal facility authorized to dispose of such material in accordance with any Federal or State solid or hazardous waste law, including the Solid Waste Disposal Act, as authorized under the Energy Policy Act of 2005.

(2) through (3) No change.

Rulemaking Authority 404.051, 404.081 FS. Law Implemented 404.022, 404.051(1), (4), 404.081 FS. History–New 1-1-94, Formerly 10D-91.465, Amended 2-11-10,________ .

SUBPAR L REPORTS

64E-5.344 Notification of Incidents.

(1) through (6) No change.

(7) Twenty-four hour report. Each licensee shall notify the Ddepartment within 24 hours after the discovery of any of the following events involving licensed material:

(a) An unplanned contamination event that:

1. No change.

2. Involves a quantity of material greater than five times the lowest annual limit on intake of materials as specified in State of Florida Bureau of Radiation Control ALIs, DACs, and Effluent Concentrations, June 2012 July 1993; and

3. No change.

(b) through (c) No change.

(d) An unplanned fire or explosion damaging any licensed material or any device, container, or equipment containing licensed materials when:

1. The quantity of material involved is five times the lowest annual limit on intake for material specified in State of Florida Bureau of Radiation Control ALIs, DACs, and Effluent Concentrations, June 2012 July 1993; and

2. No change.

(e) through (f) No change.

(8) No change.

Rulemaking Authority 404.051, 404.081 FS. Law Implemented 404.022, 404.051(1), (4), 404.081 FS. History–New 1-1-94, Amended 5-15-96, Formerly 10D-91.481, Amended 10-8-00, 2-11-10,________.

64E-5.350 Reports of Transactions Involving Nationally Tracked Sources.

Each licensee who manufactures, transfers, receives, disassembles, or disposes of a nationally tracked source shall complete and submit to the NRC a National Source Tracking Transaction Report as specified in paragraphs (1) through (5) of this section for each type of transaction. (Pursuant to Section 120.54(6), F.S., Rule 64E-5.350, F.A.C., except subsection 64E-5.350(8), F.A.C., as noted below, is substantively identical to 10 CFR 20.2207 effective 02/06/2007.)

(1) through (7) No change.

(8) Each licensee that possesses Category 1 nationally tracked sources shall report its initial inventory of Category 1 nationally tracked sources to the National Source Tracking System by January 31, 2009 or as specified in 10 C.F.R. 20.2207(h), whichever is the latest. Each licensee that possesses Category 2 nationally tracked sources shall report its initial inventory of Category 2 nationally tracked sources to the National Source Tracking System by January 31, 2009 or as specified in 10 C.F.R. 20.2207(h), whichever is the latest. The information may be submitted by using any of the methods identified by paragraphs (6)(a) through (6)(e) of this section. The initial inventory report must include the following information: (Pursuant to Section 120.54(6), F.S., subsection 64E-5.350(8), F.A.C., is substantively identical to 10 CFR 20.2207(h) effective 10/19/2007.)

(a) through (f) No change.

Rulemaking Authority 404.051, 404.081 FS. Law Implemented 404.022, 404.051, 404.081 FS. History–New 2-28-08, Amended________.

64E-5.351 Nationally Tracked Source Thresholds.

The nationally tracked source thresholds are listed in table 1 below with the Terabecquerel (TBq) values as the regulatory standard. The curie (Ci) values specified are obtained by converting from the TBq value. The curie values are provided for practical usefulness only and are rounded after conversion. (Pursuant to Section 120.54(6), F.S., Rule 64E-5.351, F.A.C., is substantively identical to Appendix E to 10 CFR Part 20 effective 02/06/2007.)

Table 1 No change.

Rulemaking Authority 404.051, 404.081 FS. Law Implemented 404.022, 404.051, 404.081 FS. History–New 2-28-08, Amended________.

64E-5.6011 Definitions.

(1) No change.

(2) “Authorized user” means:

(a) A physician, dentist, or podiatrist who meets the requirements in Rule 64E-5.658 and subsection 64E-5.649(1) 64E-5.549(1), 64E-5.550(1), 64E-5.660(1), 64E-5.661(1), 64E-5.662(1), 64E-5.652(1), 64E-5.654(1) or 64E-5.655(1), F.A.C.; or

(b) No change.

(3) through (20) No change.

Rulemaking Authority 404.051, 404.061 FS. Law Implemented 404.031, 404.061(2), 404.20, 404.22, 404.30 FS. History–New 2-11-10, Amended________.

64E-5.607 Authority and Responsibilities.

(1) A licensee shall provide sufficient authority and organizational freedom to the radiation safety officer and the radiation safety committee to:

(a) No change.

(b) Initiate, recommend, or provide solutions; and

(d) Stop unsafe operations.

(2) through (4) No change.

Rulemaking Authority 404.022, 404.051, 404.061, 404.071, 404.081, 404.141 FS. Law Implemented 404.022, 404.051(1), (4), (5), (6), (8), (9), (10), (11), 404.061(2), (3), 404.071(1), 404.081, 404.141 FS. History–New 8-25-91, Amended 5-12-93, Formerly 10D-91.713, Amended 2-11-10,________ .

64E-5.609 Visiting Authorized User, Visiting Authorized Medical Physicist, or Visiting RSO.

(1) through (5) No change.

(6) Licensee records shall include a copy of the record described in Rule 64E-5.657, F.A.C., or some other form of documentation that verifies the individual has met the respective perspective training and experience requirements listed in Subpart I. A licensee shall retain copies of the records specified in Rule 64E-5.609, F.A.C., for 3 years after the last visit.

SUBPART B GENERAL TECHNICAL REQUIREMENTS

64E-5.614 Possession, Use, Calibration, and Check of Dose Calibrators in the Use of Unsealed Radiopharmaceuticals.

(1) No change.

(2) A licensee shall check each dose calibrator before use each day of use, or during an assigned shift for facilities operating continuously, for constancy with a dedicated check source. The check shall be performed on a frequently used setting with a sealed source of not less than 10 microcuries (370 kBq) of radium 226 or 50 microcuries (1.85 MBq) of any other photon-emitting radionuclide with a half-life greater than 90 days. A record shall be made of each check, which shall include:

(a) through (f) No change.

(g) The name or initials of the individual who performing performed the check.

(3) through (9) No change.

64E-5.6251 Manual Brachytherapy Therapy Related Computer Systems.

The licensee shall perform acceptance testing on the treatment planning system of manual brachytherapy therapy-related computer systems in accordance with published protocols accepted by nationally recognized bodies. At a minimum, the acceptance testing must include, as applicable, verification of:

(1) through (4) No change.

Rulemaking Authority 404.051, 404.061, 404.081, 404.141 FS. Law Implemented 404.022, 404.051(1), (4), (6), (10), (11), 404.061(2), (3), 404.081, 404.141 FS. History–New 2-11-10, Amended________.

SUBPART C UPTAKE, DILUTION, AND EXCRETION

64E-5.626 Use of Radiopharmaceuticals for Uptake, Dilution, or Excretion Studies.

A licensee is allowed to use any unsealed radioactive material in a radiopharmaceutical for a diagnostic use involving measurements of uptake, dilution, or excretion for medical use under the following conditions:

(1) When a written directive is not required by subsection 64E-5.607(3), F.A.C., the licensee must satisfy the following:

(a) through (c) No change

(d) Radioactive material is prepared by:

1. through 2. No change.

3. An individual under the supervision of a physician who is an authorized user under subparagraph 64E-5.626(1)(d)2., F.A.C., and as specified in paragraphs 64E-5.601(3)(a) and (b), 64E-5.607(3)(e), or subsection 64E-5.608(1), F.A.C., or;

(e) No change.

(2) When a written directive is required by subsection 64E-5.607(3), F.A.C., the licensee must satisfy the following:

(a) through (c) No change.

(d) Radioactive material is prepared by:

1. No change.

2. A For sodium iodide I-131 in quantities greater than 30 microcuries (1.11 MBq), a physician who is an authorized user and meets the training requirements specified in Rule 64E-5.650 or 64E-5.660, F.A.C.; or

(e) No change.

Rulemaking Authority 404.022, 404.051, 404.061, 404.071, 404.081, 404.141 FS. Law Implemented 404.022, 404.051(1), (4), (5), (6), (8), (9), (10), (11), 404.061(2), (3), 404.071(1), 404.081, 404.141 FS. History–New 8-25-91, Formerly 10D-91.733, Amended 8-6-01, 2-11-10,__________.

SUBPART D IMAGING AND LOCALIZATION

64E-5.627 Use of Unsealed Radiopharmaceuticals, Generators, and Reagent Kits for Imaging and Localization Studies.

A licensee is allowed to use any radioactive material in a diagnostic radiopharmaceutical, or any generator, or reagent kit, for preparation and diagnostic use of a radiopharmaceutical containing radioactive material for medical use under the following conditions:

(1) When a written directive is not required by subsection 64E-5.607(3), F.A.C., the licensee must satisfy the following:

(a) through (c) No change.

(d) Radioactive material is prepared by:

1. No change.

2. Except for sodium iodide I-131 in quantities greater than 30 microcuries (1.11 MBq), a physician who is an authorized user and meets the training requirements specified in Rules 64E-5.650 or, 64E-5.660 and sub-subparagraph 64E-5.650(3)(a)2.g., F.A.C.; or

(e) No change.

(2) When a written directive is required by subsection 64E-5.607(3), F.A.C., the licensee must satisfy the following:

(a) through (c) No change.

(d) Radioactive material is prepared by:

1. No change.

2. A For sodium iodide I-131 in quantities greater than 30 microcuries (1.11 MBq) a physician who is an authorized user and meets the training requirements specified in Rule 64E-5.650 or 64E-5.660, F.A.C.; or

3. An individual under the supervision of a physician who is an authorized user under subparagraph 64E-5.627(2)(d)2., F.A.C., and as specified in paragraphs 64E-5.601(3)(a) and (b), 64E-5.607(3)(e) or subsection 64E-5.608(1), F.A.C.

(e) No change.

(3) For Only for oral administration of sodium iodide I-131 in quantities less than or equal to 33 millicuries (1.22 gigabecquerels) and when a written directive is required by subsection 64E-5.607(3), F.A.C., the licensee must satisfy the following:

(a) through (c) No change.

(d) Radioactive material is prepared by:

1. No change.

3. An individual under the supervision of a physician who is an authorized user under subparagraph 64E-5.627(1)(d)2., F.A.C., and as specified in paragraphs 64E-5.601(3)(a) and (b), 64E-5.607(3)(e), or subsection 64E-5.608(1), F.A.C., or;

(e) No change.

(4) No change.

64E-5.629 Control of Aerosols and Gases.

(1) A licensee shall only administer radioactive aerosols or gases when airborne concentrations are within the limits prescribed by State of Florida Bureau of Radiation Control ALIs, DACs, and Effluent Concentrations, June 2012 July 1993, Table I, Column 3, and Table II.

(2) through (3) No change.

(4) Before receiving, using, or storing radioactive gas, the licensee shall calculate the time needed after a release to reduce the concentration in the area of use to the occupational limit listed in State of Florida Bureau of Radiation Control ALIs, DACs, and Effluent Concentrations, June 2012 July 1993. The calculation shall be based on the highest activity of gas handled in a single container and the measured available air exhaust rate.

(5) through (7) No change.

Rulemaking Authority 404.022, 404.051, 404.061, 404.071, 404.081, 404.141 FS. Law Implemented 404.022, 404.051(1), (4), (5), (6), (8), (9), (10), (11), 404.061(2), (3), 404.071(1), 404.081, 404.141 FS. History–New 8-25-91, Amended 1-1-94, Formerly 10D-91.737, Amended 2-11-10,________.

SUBPART E RADIOPHARMACEUTICALS FOR THERAPY

64E-5.630 Use of Radiopharmaceuticals for Therapy.

A licensee is allowed to use any unsealed radioactive material in a radiopharmaceutical that requires a written directive as described in subsection 64E-5.607(3), F.A.C., and for a therapeutic medical use provided the following is met:

(1) For any unsealed radiopharmaceutical including parenteral use listed in subsection 64E-5.630(4), F.A.C., and sodium iodide I-131 use listed in subsections 64E-5.630(2) and (3), F.A.C., the licensee must satisfy the following:

(a) through (c) No change.

(d) Radioactive material is prepared by:

1. through 2. No change.

3. An individual under the supervision of a physician who is an authorized user under subparagraph 64E-5.630(1)(d)2., F.A.C., as specified in paragraphs 64E-5.601(3)(a) and (b), 64E-5.607(3)(e) or subsection 64E-5.608(1), F.A.C.

(e) No change.

(2) For Only for oral administration of sodium iodide I-131 in quantities less than or equal to 33 millicuries (1.22 gigabecquerels) the licensee must satisfy the following:

(a) through (c) No change.

(d) Radioactive material is prepared by:

1. through 2. No change.

(e) No change.

(3) For Only for oral administration of sodium iodide I-131 in quantities greater than 33 millicuries (1.22 gigabecquerels) the licensee must satisfy the following:

(a) through (c) No change.

(d) Radioactive material is prepared by:

1. through 2. No change.

(e) No change.

(4) For Only for parenteral use of radioactive materials the licensee must satisfy the following:

(a) through (c) No change

(d) Radioactive material is prepared by:

1. through 2. No change.

(e) No change.

SUBPART G SOURCES FOR BRACHYTHERAPY

64E-5.632 Use of Sources for Manual Brachytherapy.

The licensee is allowed to use the brachytherapy sources listed below, provided they are approved by and used as specified in, the Sealed Source and Device Registry, for diagnostic medical uses, or in research in accordance with an active IDE application accepted by the FDA and the requirements of Rule 64E-5.612, F.A.C., are met.

(1) through (11) No change.

64E-5.633 Manual Brachytherapy Sources Inventory and Surveys.

(1) The licensee shall maintain accountability at all times for all manual brachytherapy sources in storage or use. As soon as possible each time brachytherapy sources are returned to an area of storage from an area of use, the licensee shall immediately count or otherwise verify the number returned to ensure that all sources taken from the storage area have been returned.

(a) As soon as possible each time brachytherapy sources are returned to an area of storage from an area of use, the licensee shall immediately count or otherwise verify the number returned to ensure that all sources taken from the storage area have been returned; and

(b) As soon as possible after removing the sources from a patient or a human research subject, the licensee shall immediately count or otherwise verify the number of sources and return them to a secure storage area.

(2) through (4) No change.

64E-5.6412 Full Calibration Measurements on Gamma Stereotactic Radiosurgery Units.

(1) No change.

(2) Full calibration measurements of the gamma stereotactic radiosurgery unit shall include the determination of:

(a) through (d) No change.

(e) On-off errors timers;

(f) through (j) No change.

(3) through (7) No change.

64E-5.6422 Periodic Spot-Checks for Gamma Stereotactic Radiosurgery Units.

(1) No change.

(2) To satisfy the requirements of paragraph 64E-5.6422(1)(a), F.A.C., spot-checks Spot-checks shall include the determination of:

(a) through (b) No change.

(3) through (8) No change.

64E-5.643 Radiation Surveys for Teletherapy Facilities.

(1) The licensee shall perform radiation surveys with an operable radiation survey instrument calibrated as provided in Rule 64E-5.615, F.A.C., before medical use, after each installation of a teletherapy source;, following repairs to the source(s) driving unit, or other electronic or mechanical component that could expose the source(s), reduce shielding around the source(s), or compromise the radiation safety of the unit or the source(s); and after making any change for which an amendment is required by Rule 64E-5.636, F.A.C.

(a) The maximum and average radiation levels from the surface of the main source(s) safe with the source(s) in the shielded position do not exceed the levels stated in the Sealed Source and Device Registry at 1 meter from the teletherapy source with the source in the off position and the collimators set for a normal treatment field shall not exceed 10 millirems (100 µSv) per hour and 2 millirems (20 µSv) per hour.

(b) No change.

(2) through (3) No change.

Rulemaking Authority 404.022, 404.051, 404.061, 404.071, 404.081, 404.141 FS. Law Implemented 404.022, 404.051(1), (4), (5), (6), (8), (9), (10), (11), 404.061(2), (3), 404.071(1), 404.081, 404.141 FS. History–New 8-25-91, Amended 1-1-94, Formerly 10D-91.762, Amended 10-8-00, 2-11-10,________.

64E-5.645 Remote Afterloader, Gamma Stereotactic, and Teletherapy Therapy-Related Computer Systems.

The licensee shall perform acceptance testing on the treatment planning system of high, medium, low, pulsed dose-rate remote afterloaders, gamma stereotactic, and teletherapy therapy-related computer systems in accordance with published protocols accepted by nationally recognized bodies. An example of a nationally recognized body is the American Association of Physicists in Medicine. At a minimum, the acceptance testing must include, as applicable, verification of the following:

(1) through (5) No change.

Rulemaking Authority 404.022, 404.051, 404.061, 404.071, 404.081, 404.141 FS. Law Implemented 404.022, 404.051(1), (4), (5), (6), (8), (9), (10), (11), 404.061(2), (3), 404.071(1), 404.081, 404.141 FS. History–New 8-25-91, Amended 1-1-94, Formerly 10D-91.764, Amended 10-8-00, 2-11-10,________.

SUBPART I TRAINING AND EXPERIENCE REQUIREMENTS

64E-5.649 Training for Uptake, Dilution, or Excretion Studies.

Except as provided in Rule 64E-5.657, F.A.C., the licensee shall require the authorized user of a radiopharmaceutical listed in subsection 64E-5.626(1), F.A.C., to:

(1) No change.

(2) Be an authorized user under Rule 64E-5.650 or 64E-5.660, F.A.C., or equivalent NRC or Aagreement Sstate requirements; or

(3)(a) Have completed 60 hours of training and experience, including a minimum of 8 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material for uptake, dilution, and excretion studies. The training and experience must include the following:

1. Classroom and laboratory training in the following areas:

a. through c. No change

d. Chemistry of radioactive material for medical use; and

e. Radiation biology; and

2. Work experience, under the supervision of an authorized user who meets the requirements in Rule 64E-5.657, 64E-5.649, 64E-5.650 or 64E-5.660, F.A.C., NRC or equivalent Aagreement Sstate requirements, involving the following:

a. through f. No change.

(b) Have obtained written attestation, signed by a preceptor authorized user or a residency program director who represents a consensus of residency program faculties (as long as at least one member of the residency program faculty is an authorized individual in the same category designated by the applicant seeking authorized status) who meets the requirements in Rule 64E-5.657, 64E-5.649, 64E-5.650 or 64E-5.660, F.A.C., NRC or equivalent Aagreement Sstate requirements, that the individual has satisfactorily completed the requirements in paragraph 64E-5.649(1)(a) or 64E-5.649(3)(a), F.A.C., of this section and has demonstrated the ability to function independently as an authorized user to fulfill the radiation safety related duties for medical uses authorized under subsection 64E-5.626(1), F.A.C.

64E-5.650 Training for Imaging and Localization Studies for Which a Written Directive Is Not Required.

Except as provided in Rule 64E-5.657, F.A.C., the licensee shall require the authorized user specified in subsection 64E-5.627(1), F.A.C., to:

(1) No change.

(2) Be an authorized user under Rule 64E-5.660, F.A.C., and meet the requirements in sub-subparagraph 64E-5.650(3)(a)2.g., F.A.C., NRC or equivalent Aagreement Sstate requirements; or paragraph 64E-5.650(3)(a), F.A.C.; or

(3)(a) Have completed 700 hours of training and experience, including a minimum of 80 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material for imaging and localization studies. The training and experience must include, at a minimum the following:

1. No change.

2. Work experience, under the supervision of an authorized user who meets the requirements in Rule 64E-5.657, 64E-5.650 or 64E-5.660, and sub-subparagraph 64E-5.650(3)(a)2.g., and Rule 64E-5.660, F.A.C., NRC or equivalent Aagreement Sstate requirements, involving the following:

a. through g. No change

(b) Have obtained written attestation, signed by a preceptor authorized user or a residency program director who represents a consensus of residency program faculties (as long as at least one member of the residency program faculty is an authorized individual in the same category designated by the applicant seeking authorized status) who meets the requirements in Rules 64E-5.657, 64E-5.650, 64E-5.660, and sub-subparagraph 64E-5.650(3)(a)2.g., F.A.C., NRC or equivalent Aagreement Sstate requirements, that the individual has satisfactorily completed the requirements in paragraph 64E-5.650(1)(a) or 64E-5.650(3)(a), F.A.C., of this section and has demonstrated the ability to function independently as an authorized user to fulfill the radiation safety related duties for medical uses authorized under subsections 64E-5.626(1) and 64E-5.627(1), F.A.C.

64E-5.652 Training for Use of Manual Brachytherapy Sources.

Except as provided in Rule 64E-5.657, F.A.C., the licensee shall require the authorized user of a brachytherapy source specified in Rule 64E-5.632, F.A.C., to:

(1) No change.

(2)(a) Have completed a structured educational program in basic radionuclide handling techniques applicable to the use of manual brachytherapy sources that includes:

1. No change.

2. 500 hours of work experience, under the supervision of an authorized user who meets the requirements in Rule 64E-5.657 or 64E-5.652, F.A.C., NRC or equivalent Aagreement Sstate requirements at a medical institution, clinic, or private practice facility, involving the following:

a. through f. No change.

(b) Have completed 3 years of supervised clinical experience in radiation oncology, under an authorized user who meets the requirements in Rule 64E-5.657 or 64E-5.652, F.A.C., NRC or equivalent Aagreement Sstate requirements, as part of a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Committee on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required by subparagraph 64E-5.652(2)(a)2., F.A.C., of this section; and

(c) Have obtained written attestation, signed by a preceptor authorized user or a residency program director who represents a consensus of residency program faculties (as long as at least one member of the residency program faculty is an authorized individual in the same category designated by the applicant seeking authorized status) who meets the requirements in Rule 64E-5.657 or 64E-5.652, F.A.C., NRC or equivalent Aagreement Sstate requirements, that the individual has satisfactorily completed the requirements in paragraph 64E-5.652(1)(a) or 64E-5.652(2)(a) and 64E-5.652(2)(b), F.A.C., of this section and have demonstrated the ability to function independently as an authorized user to fulfill the radiation safety related duties for medical uses of manual brachytherapy sources authorized under Rule 64E-5.632, F.A.C.

64E-5.653 Training for Ophthalmic Use of Strontium 90.

Except as provided in Rule 64E-5.657, F.A.C., the licensee shall require the authorized user of only strontium 90 for ophthalmic radiotherapy to:

(1) Be authorized user under Rule 64E-5.652, F.A.C., NRC or equivalent Aagreement Sstate requirements; or

(2)(a) Have completed 24 hours of classroom and laboratory training applicable to the medical use of strontium-90 for ophthalmic radiotherapy. The training must include the following:

1. through 4. No change.

(b) No change.

(c) Have obtained written attestation, signed by a preceptor authorized user or a residency program director who represents a consensus of residency program faculties (as long as at least one member of the residency program faculty is an authorized individual in the same category designated by the applicant seeking authorized status) who meets the requirements in Rule 64E-5.657, 64E-5.652 or 64E-5.653, F.A.C., NRC or equivalent Aagreement Sstate requirements, that the individual has satisfactorily completed the requirements in paragraphs 64E-5.653(2)(a) and 64E-5.653(2)(b), F.A.C., of this section and have demonstrated the ability to function independently as an authorized user to fulfill the radiation safety related duties for a medical use licensee authorized for strontium-90 for ophthalmic use.

64E-5.654 Training for Use of Sealed Sources for Diagnosis.

Except as provided in Rule 64E-5.657, F.A.C., the licensee shall require the authorized user of a sealed source in a device specified in Rule 64E-5.631, F.A.C., to be a physician, dentist, or podiatrist:

(1) through (3) No change.

64E-5.655 Training for Use of Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units.

Except as provided in Rule 64E-5.657, F.A.C., the licensee shall require the authorized user of a sealed source specified in Rule 64E-5.634, F.A.C., to:

(1) No change.

(2)(a) Have completed a structured educational program in basic radionuclide techniques applicable to the use of a sealed source in a therapeutic medical unit that includes the following:

1. No change

2. 500 hours of work experience, under the supervision of an authorized user who meets the requirements in Rule 64E-5.657 or 64E-5.655, F.A.C., NRC or equivalent Aagreement Sstate requirements at a medical institution, clinic, or private practice facility, involving the following:

a. through f. No change.

(b) Have completed 3 years of supervised clinical experience in radiation therapy, under an authorized user who meets the requirements in Rule 64E-5.657 or 64E-5.655, F.A.C., NRC or equivalent Aagreement Sstate requirements as part of a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Committee on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required by subparagraph 64E-5.655(2)(a)2., F.A.C., of this section; and

(c) Have obtained written attestation that the individual has satisfactorily completed the requirements in paragraph 64E-5.655(1)(a) or 64E-5.655(2)(a) and 64E-5.655(2)(b) and subsection 64E-5.655(3), F.A.C., of this section, and have demonstrated the ability to function independently as an authorized user to fulfill the radiation safety related duties for a medical use licensee for each type of therapeutic medical unit for which the individual is requesting authorized user status. The written attestation must be signed by a preceptor authorized user or a residency program director who represents a consensus of residency program faculties (as long as at least one member of the residency program faculty is an authorized individual in the same category designated by the applicant seeking authorized status) who meets the requirements in Rule 64E-5.657 or 64E-5.655, F.A.C., NRC or equivalent Aagreement Sstate requirements for an authorized user for each type of therapeutic medical unit for which the individual is requesting authorized user status; and

(3) No change.

64E-5.656 Training for an Authorized Medical Physicist.

Except as provided in Rule 64E-5.657, F.A.C., the licensee shall require the authorized medical physicist to:

(1) No change.

(2)(a) No change.

(b) Have obtained written attestation that the individual has satisfactorily completed the requirements in subsection 64E-5.656(3) and paragraphs 64E-5.656(1)(a) and (b) or 64E-5.656(2)(a) and subsection 64E-5.656(3), F.A.C., of this section, and have demonstrated the ability to function independently as an authorized medical physicist to fulfill the radiation safety related duties for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status. The written attestation must be signed by a preceptor authorized user or a residency program director who represents a consensus of residency program faculties (as long as at least one member of the residency program faculty is an authorized individual in the same category designated by the applicant seeking authorized status) who meets the requirements in Rule 64E-5.656 or 64E-5.657, F.A.C., NRC or equivalent Aagreement Sstate requirements, for an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status; and

(3) No change.

64E-5.660 Training for Use of Unsealed Radioactive Material for Which a Written Directive Is Required in Rule 64E-5.626, 64E-5.627 or 64E-5.630, F.A.C.

Except as provided in Rule 64E-5.657, F.A.C., the licensee shall require the authorized user of unsealed radioactive materials specified in Rule 64E-5.626, 64E-5.627 or 64E-5.630, F.A.C., which require a written directive to:

(1) No change.

(2)(a) Have completed 700 hours of training and experience, including a minimum of 200 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed radioactive material requiring a written directive. The training and experience must include the following:

1. No change.

2. Work experience, under the supervision of an authorized user who meets the requirements in Rule 64E-5.657 or 4E-5.660, F.A.C., NRC or equivalent Aagreement Sstate requirements. A supervising authorized user, who meets the requirements in subsection 64E-5.660(2), F.A.C., must also have experience in administering dosages in the same dosage category or categories (i.e., sub-subparagraph 64E-5.660(2)(a)2.g., F.A.C.,) as the individual requesting authorized user status. The work experience must involve the following:

a. through g. No change.

(b) Have obtained written attestation that the individual has satisfactorily completed the requirements in paragraph 64E-5.660(1)(a), sub-subparagraph 64E-5.660(2)(a)2.g. or paragraph 64E-5.660(2)(a), F.A.C., of this section, and have demonstrated the ability to function independently as an authorized user to fulfill the radiation safety related duties for a medical use licensee authorized under Rule 64E-5.626, 64E-5.627 or 64E-5.630, F.A.C., that require a written directive. Have obtained written attestation, signed by a preceptor authorized user or a residency program director who represents a consensus of residency program faculties (as long as at least one member of the residency program faculty is an authorized individual in the same category designated by the applicant seeking authorized status) who meets the requirements in Rule 64E-5.657 or 64E-5.660, F.A.C., NRC or equivalent Aagreement Sstate requirements. The preceptor authorized user, who meets the requirements in subsection 64E-5.660(2), F.A.C., must have experience in administering dosages in the same dosage category or categories specified in sub-sub-subparagraph 64E-5.660(2)(a)2.g.(II), F.A.C., as the individual requesting authorized user status.

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).

Except as provided in Rule 64E-5.657, F.A.C., the licensee shall require an authorized user 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), to:

(1) through (2) No change.

(3)(a) No change.

(b) Have work experience, under the supervision of an authorized user who meets the requirements in Rule 64E-5.657, 64E-5.660, 64E-5.661 or 64E-5.662, F.A.C., NRC or equivalent Aagreement Sstate requirements. A supervising authorized user who meets the requirements in subsection 64E-5.660(2), F.A.C., must also have experience in administering dosages as specified in sub-sub-subparagraph 64E-5.660(2)(a)2.g.(I) or 64E-5.660(2)(a)2.g.(II), F.A.C. The work experience must involve the following:

1. through 6. No change.

(c) Have obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs 64E-5.661(3)(a) and 64E-5.661(3)(b), F.A.C., of this section, and have demonstrated the ability to function independently as an authorized user to fulfill the radiation safety related duties for a medical use licensee that required a written directive under Rule 64E-5.626, 64E-5.627 or 64E-5.630, F.A.C. Have obtained written attestation, signed by a preceptor authorized user or a residency program director who represents a consensus of residency program faculties (as long as at least one member of the residency program faculty is an authorized individual in the same category designated by the applicant seeking authorized status) who meets the requirements in Rule 64E-5.657, 64E-5.660, 64E-5.661 or 64E-5.662, F.A.C., NRC or equivalent Aagreement Sstate requirements. A preceptor authorized user, who meets the requirement in subsection 64E-5.660(2), F.A.C., must also have experience in administering dosages as specified in sub-sub-subparagraph 64E-5.660(2)(a)2.g.(I) or 64E-5.660(2)(a)2.g.(II), F.A.C.

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).

Except as provided in Rule 64E-5.657, F.A.C., the licensee shall require an authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 Gigabecquerels (33 millicuries), to:

(1) No change.

(2) Be an authorized user under Rule 64E-5.660, F.A.C., for uses listed in sub-sub-subparagraph 64E-5.660(2)(a)2.g.(II), F.A.C., NRC or equivalent Aagreement Sstate requirements; or

(3)(a) No change.

(b) Have work experience, under the supervision of an authorized user who meets the requirements in Rules 64E-5.657, 64E-5.660 or 64E-5.662, F.A.C., NRC or equivalent Aagreement Sstate requirements. A supervising authorized user, who meets the requirements in subsection 64E-5.660(2), F.A.C., must also have experience in administering dosages as specified in sub-sub-subparagraph 64E-5.660(2)(a)2.g.(II), F.A.C. The work experience must involve the following:

1. through 6. No change.

(c) Have obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs 64E-5.662(3)(a) and 64E-5.662(3)(b), F.A.C., of this section, and have demonstrated the ability to function independently as an authorized user to fulfill the radiation safety related duties for a medical use licensee authorized under Rule 64E-5.626, 64E-5.627 or 64E-5.630, F.A.C., that require written directives. Have obtained written attestation, signed by a preceptor authorized user or a residency program director who represents a consensus of residency program faculties (as long as at least one member of the residency program faculty is an authorized individual in the same category designated by the applicant seeking authorized status) who meets the requirements in Rule 64E-5.657, 64E-5.660 or 64E-5.662, F.A.C., NRC or equivalent Aagreement Sstate requirements. A preceptor authorized user, who meets the requirements in subsection 64E-5.660(2), F.A.C., must also have experience in administering dosages as specified in sub-sub-subparagraph 64E-5.660(2)(a)2.g.(II), F.A.C.

64E-5.663 Training for the Parenteral Administration of Unsealed Radioactive Material Requiring a Written Directive.

Except as provided in Rule 64E-5.657, F.A.C., the licensee shall require an authorized user for the parenteral administration requiring a written directive, to:

(1) Be an authorized user under Rule 64E-5.660, F.A.C., for uses listed in sub-sub-subparagraph 64E-5.660(2)(a)2.g.(III) or 64E-5.660(2)(a)2.g.(IV), F.A.C., NRC or equivalent Aagreement Sstate requirements; or

(2) Be an authorized user under Rule 64E-5.652 or 64E-5.655, F.A.C., NRC or equivalent Aagreement Sstate requirements and who meets the requirements in subsection 64E-5.663(4), F.A.C. of this section; or

(3) No change.

(4)(a) No change.

(b) Have work experience, under the supervision of an authorized user who meets the requirements in Rule 64E-5.657, 64E-5.660 or 64E-5.663, F.A.C., NRC or equivalent Aagreement Sstate requirements, in the parenteral administration, for which a written directive is required, of any beta emitter, or any photon-emitting radionuclide with a photon energy less than 150 keV, and/or parenteral administration of any other radionuclide for which a written directive is required. A supervising authorized user who meets the requirements in Rule 64E-5.660, F.A.C., NRC or equivalent Aagreement Sstate requirements, must have experience in administering dosages as specified in sub-sub-subparagraph 64E-5.660(2)(a)2.g.(III) or 64E-5.660(2)(a)2.g.(IV), F.A.C., NRC or equivalent Aagreement Sstate requirements. The work experience must involve the following:

1. through 6. No change.

(c) Have obtained written attestation that the individual has satisfactorily completed the requirements in subsection 64E-5.663(2) or 64E-5.663(3), F.A.C., of this section, and have demonstrated the ability to function independently as an authorized user to fulfill the radiation safety related duties for a medical use licensee authorized for the parenteral administration of unsealed radioactive material requiring a written directive. Have obtained written attestation, signed by a preceptor authorized user or a residency program director who represents a consensus of residency program faculties (as long as at least one member of the residency program faculty is an authorized individual in the same category designated by the applicant seeking authorized status) who meets the requirements in Rule 64E-5.657, 64E-5.660 or 64E-5.663, F.A.C., NRC or equivalent Aagreement Sstate requirements. A preceptor authorized user, who meets the requirements in Rule 64E-5.660, F.A.C., must have experience in administering dosages as specified in sub-sub-subparagraph 64E-5.660(2)(a)2.g.(III) or 64E-5.660(2)(a)2.g.(IV), F.A.C.

64E-5.810 Ventilation Systems.

(1) Means shall be provided to ensure that personnel entering any area where airborne radioactivity may be produced will not be exposed to concentrations in excess of the limits specified in State of Florida Bureau of Radiation Control ALIs, DACs, and Effluent Concentrations, June 2012 July 1993, Table I, Column 3.

(2) A registrant shall not vent, release or otherwise discharge airborne radioactive material to an uncontrolled area in concentrations which exceed the limits specified in State of Florida Bureau of Radiation Control ALIs, DACs, and Effluent Concentrations, June 2012 July 1993, Table II, Column 1, except as authorized pursuant to Rule 64E-5.329, F.A.C. For purposes of this paragraph, concentrations may be averaged over a period not greater than 1 year. Every reasonable effort should be made to maintain releases of radioactive material to uncontrolled areas as far below these limits as reasonably achievable.

Rulemaking Authority 404.051, 404.061, 404.081 FS. Law Implemented 404.022, 404.051(1), (4), 404.061(1), 404.081(1) FS. History–New 7-17-85, Amended 1-1-94, Formerly 10D-91.912, Amended________.

64E-5.1115 Subsurface Tracer Studies.

(1) through (2) No change.

(3) No licensee shall inject radioactive material into any well unless it can be demonstrated to the Department that the procedure will not result in any liquids or gases distributed to the public exceeding the following criteria:

(a) For gases, the air concentration in State of Florida Bureau of Radiation Control ALIs, DACs, and Effluent Concentrations, June 2012 July 1993, Table II, Column 1, shall apply.

(b) For liquids, the water concentration values in State of Florida Bureau of Radiation Control ALIs, DACs, and Effluent Concentrations, June 2012 July 1993, Table II, Column 2, shall apply.

Rulemaking Authority 404.051, 404.061 FS. Law Implemented 404.022, 404.031, 404.051(1), (4), 404.061(2) FS. History–New 7-17-85, Amended 1-1-94, Formerly 10D-91.1216, Amended________.

64E-5.1317 Storage and Control of Volatiles and Gases.

(1) No change.

(2) Unless otherwise specified in the license, a licensee shall store and use radioactive volatiles and gases in a properly functioning glove box or fume hood that will maintain airborne concentrations within the limits prescribed by State of Florida Bureau of Radiation Control ALIs, DACs, and Effluent Concentrations, June 2012 July 1993, Table I, Column 2, and Table II, Column 1.

(3) No change.

Rulemaking Authority 404.022, 404.042, 404.051, 404.061, 404.071, 404.081 FS. Law Implemented 404.022, 404.042, 404.051(1), (4), (6), (9), (10), 404.061(2), (3), 404.071(1), 404.081(1) FS. History–New 5-12-93, Amended 1-1-94, Formerly 10D-91.1423, Amended________.

64E-5.1419 Radiation Surveys.

(1) through (4) No change.

(5) Water from the irradiator pool or other potentially contaminated liquids and sediments from pool vacuuming must be monitored for radioactive contamination before release to unrestricted areas. Radioactive concentrations must not exceed those specified in State of Florida Bureau of Radiation Control ALIs, DACs, and Effluent Concentrations, June 2012 July 1993, Table II, Column 2, or Table III, as applicable. The lower limit of detection for the measurements must be below those concentrations.

(6) No change.

Rulemaking Authority 404.051(4) FS. Law Implemented 404.051(1), (5), (6), 404.061, 404.081, 404.141 FS. History–New 8-14-96, Formerly 10D-91.1519, Amended________.

64E-5.1420 Detection of Leaking or Contaminated Sources.

(1) through (3) No change.

(4) If a leaking source is detected, the licensee shall remove the leaking source from service and have it decontaminated, repaired, or disposed of by a licensee of the Ddepartment, NRC U.S. Nuclear Regulatory Commission, Aagreement Sstate or Llicensing Sstate authorized to perform these functions. The licensee shall check its personnel, equipment, facilities, and irradiated product promptly for radioactive contamination. No product shall be shipped until the product has been checked and found free of contamination. If a product has been shipped that could have been contaminated inadvertently, the licensee shall arrange to locate and survey that product for contamination. If any personnel are contaminated, decontamination must be performed promptly. If contaminated equipment, facilities, or products are found, the licensee shall have them decontaminated or disposed of by a licensee of the Ddepartment, NRC U.S. Nuclear Regulatory Commission, Aagreement Sstate or Llicensing Sstate authorized to perform these functions. If the pool water is contaminated, the licensee shall clean the pool water until the contamination levels do not exceed the appropriate concentration in State of Florida Bureau of Radiation Control ALIs, DACs, and Effluent Concentrations, June 2012 July 1993, Table II, Column 2.

Rulemaking Authority 404.051(4) FS. Law Implemented 404.051(1), (5), (6), 404.061, 404.081, 404.141 FS. History–New 8-14-96, Formerly 10D-91.1520, Amended________ .

64E-5.1501 Purpose and Scope.

(1) No change.

(2) Determinations and listings of A1 and A2 values are found in 10 C.F.R., Part 71, Appendix A as published on 01/01/2012 01/01/2007 which is herein incorporated by reference and can be obtained from the internet at ________ or at http://www.gpo.gov/fdsys/pkg/CFR-2012-title10-vol2/pdf/CFR-2012-title10-vol2-part71.pdf.

(3) through (4) No change.

Rulemaking Authority 404.051, 404.20 FS. Law Implemented 404.022, 404.051(1), (4), (6), (11), 404.20(1) FS. History–New 7-17-85, Amended 5-15-96, Formerly 10D-91.2001, Amended 2-28-08, ________.

64E-5.1502 Transportation of Radioactive Material.

(1) No change.

(2) Each licensee who transports radioactive material outside of the confines of his facility or other place of use, or who offers radioactive material to a carrier for transport shall:

(a) Comply with the current applicable requirements, appropriate to the mode of transport, of 49 C.F.R. Parts 107, 171-180, 383, 390-397 published on 10/01/2012 10/01/2007, which is herein incorporated by reference and can be obtained from the internet at ________ or at http://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR&searchPath=Title+49%2FSubtitle+B&oldPath=Title+49&isCollapsed=true&selectedYearFrom=2012&ycord=1546 and 10 C.F.R. Part 71 published on 01/01/201210/01/2007 which is herein incorporated by reference and can be obtained from the internet at ________ or at http://www.gpo.gov/fdsys/pkg/CFR-2012-title10-vol2/pdf/CFR-2012-title10-vol2-part71.pdf, and 10 C.F.R. Parts 73.72 through 73.74 published on 01/01/2012 which is herein incorporated by reference and can be obtained from the internet at ________ or at http://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR&searchPath=Title+10%2FChapter+I%2FPart+73%2FSubjgrp&oldPath=Title+10%2FChapter+I%2FPart+73%2FSubjgrp&isCollapsed=true&selectedYearFrom=2012&ycord=1772.

(b) through (e) No change.

(3) No change.

Rulemaking Authority 404.051, 404.061, 404.141, 404.20 FS. Law Implemented 404.022, 404.051(1), (4), (6), (11), 404.061(2), 404.141, 404.20(1) FS. History–New 7-17-85, Formerly 10D-91.2003, Amended 10-8-00, 9-28-06, 2-28-08,_______.

Posting of the American National Standards Institute (ANSI) Standard, ANSI-HPS N43.8-2008, “Classification of Industrial Ionizing Radiation Gauging Devices;” ANSI Standard, ANSI-HPS N43.4-2005, “Classification of Radioactive Self-Luminous Light Sources;” and ANSI Standard N432-1980, NBS Handbook 136, “Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography,” on the internet for purposes of public examination and inspection would constitute a violation of federal copyright law. These materials are available for public inspection and examination at the Florida Department of State, R.A. Gray Building, 507 South Bronough Street, Tallahassee, Florida 32399-0250, and the Florida Department of Health, Bureau of Radiation Control, 4042 Bald Cypress Way, Tallahassee, Florida 32399-1741.

NAME OF PERSON ORIGINATING PROPOSED RULE: Cynthia Becker, Bureau Chief, Bureau of Radiation Control

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: John H. Armstrong, MD, FACS, Surgeon General & Secretary

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: February 26, 2013

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: September 14, 2012

Document Information

Comments Open:: 4/19/2013
Summary:: 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 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 ...
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 ...
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.
Contact:: Brenda Andrews, 4052 Bald Cypress Way, Bin C21, Tallahassee, FL 32399-1741; (850) 245-4266; Brenda_Andrews@doh.state.fl.us.
Related Rules: (15): 64E-5.101. Definitions; 64E-5.1115. Subsurface Tracer Studies; 64E-5.1317. Storage and Control of Volatiles and Gases; 64E-5.1419. Radiation Surveys; 64E-5.1420. Detection of Leaking or Contaminated Sources; More ...