All changes described herein are needed to comply with the requirements of Florida’s agreement with the U.S. Nuclear Regulatory Commission (NRC) to regulate radioactive material. As an agreement state, many of Florida’s regulations governing the ...  

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    DEPARTMENT OF HEALTH
    Division of Environmental Health

    RULE NO: RULE TITLE
    64E-5.101: Definitions
    64E-5.11072: Energy Compensation Source
    64E-5.1501: Transportation of Radioactive Material
    64E-5.1502: Transportation of Radioactive Material
    64E-5.206: General Licenses - Radioactive Material Other Than Source Material
    64E-5.210: Special Requirements for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material
    64E-5.216: Reciprocal Recognition of Licenses for Byproduct, Source, Naturally Occurring and Accelerator Produced Radioactive Material, and Special Nuclear Material in Quantities Not Sufficient to Form a Critical Mass
    64E-5.350: Reports of Transactions Involving Nationally Tracked Sources
    64E-5.351: Nationally Tracked Source Thresholds
    64E-5.430: Inspection and Maintenance
    64E-5.440: Records
    64E-5.441: Reporting Requirements
    PURPOSE, EFFECT AND SUMMARY: All changes described herein are needed to comply with the requirements of Florida’s agreement with the U.S. Nuclear Regulatory Commission (NRC) to regulate radioactive material. As an agreement state, many of Florida’s regulations governing the possession and use of radioactive materials must be identical to the NRC’s regulations for federal radioactive materials licensees. The proposed rule specifies requirements for transportation of radioactive materials; national tracking of certain large radioactive sources; general license device transfers and export requirements; manufacturer or distributors of generally licensed devices requirements; reciprocity recognition of out of state licenses reporting requirements; technical changes in the use of energy compensation sources; and written procedures for inspection and maintenance of industrial radiography equipment.
    SPECIFIC AUTHORITY: 404.042, 404.051, 404.051(4), (11), 404.061, 404.061(2), 404.071, 404.081, 404.081(1), 404.141, 404.20 FS.
    LAW IMPLEMENTED: 404.022, 404.031, 404.051, 404.051(1), (2), (4), (6), (8), (9), (10), (11), 404.061, 404.061(2), 404.071(1), (3), 404.081, 404.081(1), 404.141, 404.20, 404.20(1), 404.22 FS.
    THIS RULEMAKING IS UNDERTAKEN PURSUANT TO SECTION
    120.54(6), F.S. WRITTEN COMMENTS MAY BE SUBMITTED WITHIN 14 DAYS OF THE DATE OF THIS NOTICE TO: Micheal N. Stephens, (Mike_Stephens@doh. state.fl.us) ENVIRONMENTAL HEALTH PROGRAM CONSULTANT, BUREAU OF RADIATION CONTROL, BIN C21, 4052 BALD CYPRESS WAY, TALLAHASSEE, FLORIDA 32399-1741
    SUBSTANTIALLY AFFECTED PERSONS MAY WITHIN 14 DAYS OF THE DATE OF THIS NOTICE, FILE AN OBJECTION TO THIS RULEMAKING WITH THE AGENCY. THE OBJECTION SHALL SPECIFY THE PORTIONS OF THE PROPOSED RULE TO WHICH THE PERSON OBJECTS AND THE SPECIFIC REASONS FOR THE OBJECTION.

    THE FULL TEXT OF THE PROPOSED RULE IS:

    PART I GENERAL PROVISIONS

    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 (78) No change.

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

    (a) Uranium or thorium ores and physical or chemical concentrates of these ores;

    (b) Unirradiated natural or depleted uranium or unirradiated natural thorium;

    (c) Tritium oxide in aqueous solutions provided the concentration does not exceed 5.0 millicuries (185 MBq) per milliliter;

    (d) Material in which the radioactivity is essentially uniformly distributed and in which the estimated average concentration of contents does not exceed:

    1. 0.0001 millicurie (3.7 kBq) per gram of radionuclides for which the A2 quantity is not more than 0.05 curie (1.85 GBq);

    2. 0.005 millicurie (185 kBq) per gram of radionuclides for which the A2 quantity is more than 0.05 curie (1.85 GBq), but not more than 1 curie (37 GBq); or

    3. 0.3 millicurie (11.1 MBq) per gram of radionuclides for which the A2 quantity is more than 1 curie (37 GBq).

    (e) Objects externally contaminated with radioactive material, provided that the radioactive material is not readily dispersible and the surface contamination, when averaged over an area of 1 square meter, does not exceed 0.0001 millicurie (3.7 kBq) per square centimeter for radionuclides of which the A2 quantity in Appendix A is not more than 0.05 curie (1.85 GBq), or, for all other radionuclides, 0.001 millicurie (37 kBq) per square centimeter.

    (80) through (99) No change.

    (100) “Package” means that as defined in 49 C.F.R. 173.403 (Pursuant to Section 120.54(6), Florida Statutes, subsection 64E-5.101(100), F.A.C., is substantively identical to 49 CFR 173.403 published on 10/01/2007.) the packaging, together with its radioactive contents, as presented for transport.

    (101) through (121) No change.

    (122) “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 that is used to make a radiographic exposure. It also is known as a camera or a projector. (Pursuant to Section 120.54(6), Florida Statutes, subsection 64E-5.101(122), F.A.C., is substantively identical to 10 CFR 34.3 published on 01/01/2007.)

    (123) through (132) No change.

    (133) “Sealed source” means radioactive material that is encased permanently bonded or fixed in a capsule or matrix designed to prevent release or escape and dispersal of the radioactive material under the most severe conditions which are likely to be encountered in normal use and handling. (Pursuant to Section 120.54(6), Florida Statutes, subsection 64E-5.101(133), F.A.C., is substantively identical to 10 CFR 30.4 published on 01/01/2007.)

    (134) through (193) No change.

    (194) “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), Florida Statutes, subsection 64E-5.101(194), F.A.C., is substantively identical to 10 CFR 20.1003 published on 01/01/2007.)

    Specific 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,________.

     

    PART II

    LICENSING OF RADIOACTIVE MATERIALS

    SUBPART B

    GENERAL LICENSES

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

    (1) through (3) No change.

    (4) Certain Measuring, Gauging and Controlling Devices.

    (a) No change.

    (b)1. The general license in paragraph (4)(a), above, applies only to radioactive material contained in devices which have been manufactured or initially transferred and labeled in accordance with the specifications contained in a specific license issued by the Department pursuant to subsection 64E-5.210(4), F.A.C., or in accordance with the specifications contained in a specific license issued by the NRC U.S. Nuclear Regulatory Commission, or an Agreement State or a Licensing State, which authorizes distribution of devices to persons granted a general license by the NRC U.S. Nuclear Regulatory Commission, or an Agreement State or a Licensing State. Regulations under the Federal Food, Drug, and Cosmetic Act authorizing the use of radioactive control devices in food production require certain additional labeling thereon which is found in Section 179.21 of 21 C.F.R. Part 179. (Pursuant to Section 120.54(6), Florida Statutes, subparagraph 64E-5.206(4)(b)1., F.A.C., is substantively identical to 10 CFR 31.5(b)(1) published on 01/01/2007.)

    2. 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 3. No change.

    4. Shall maintain records showing compliance with the requirements of subparagraphs (4)(c)2. and 3., above. The records shall show the results of tests. The records also shall show the dates of performance of, and the names of persons performing testing, installation, servicing and removal from installation concerning the radioactive material, its shielding or containment. Records of tests for leakage of radioactive material required by subparagraph (4)(c)2., above, shall be maintained for at least three a years after the next required leak test is performed or until the transfer or disposal of the sealed source. Records of tests of the on-off mechanism and indicator required by subparagraph (4)(c)2., above, shall be maintained for at least three a years after the next required test of the on-off mechanism and indicator is performed or until the sealed source is transferred or disposed. Records which are required by subparagraph (4)(c)3., above, shall be maintained for a period of at least three 2 years from the date of the recorded event or until the transfer or disposal of the device; (Pursuant to Section 120.54(6), Florida Statutes, subparagraph 64E-5.206(4)(c)4., F.A.C., is substantively identical to 10 CFR 31.5(c)(4)i published on 01/01/2007.)

    5. 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 subparagraph 15. below, transfer to a specific licensee of the Department, the NRC U.S. Nuclear Regulatory Commission, or an Agreement State or a Licensing State, whose specific license authorizes him to receive the device, and within 30 days after transfer of a device to a specific licensee, shall furnish to the Department 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. Shall transfer the device by export as provided by subparagraph 15. below, or to another general licensee only:

    a. Where the device remains in use at a particular location. In such case the transferor shall give the transferee a copy of this section, a copy of Rules 64E-5.103, 64E-5.343328, and 64E-5.344329, F.A.C., and any safety documents identified in the label on the device and within 30 days of the transfer, report to the Department the manufacturer’s or initial transferor’s name and model number and serial number of device transferred, the transferor’s name and mailing address for the location of use, and the name, title and phone number of the responsible individual identified by the transferee in accordance with subparagraph 64E-5.206(4)(c)11., F.A.C., to have knowledge of and authority to take actions to ensure compliance with these regulations; or

    b. Where the device is held in storage in the original shipping container at its intended location of use prior to initial use by a general licensee; and

    9. No change.

    10. Shall be required to obtain written Department authorization before transferring the device to any other specific license not specifically identified in subparagraph 64E-5.206(4)(c)7., F.A.C. The Department authorization is granted provided the specific license identifies the device.

    11. through 12. No change.

    13. Shall report to the Department changes in the general licensee name and the mailing address for each location of or use within 30 days of the effective date of the change. For a portable device, a report of address change is required for a change in the device’s primary place of storage.

    14. Shall May not hold devices that are not in use longer than 2 years. If the devices with shutters are not being used, the shutters must be locked in the closed position. The testing required by subparagraph 64E-5.206(4)(c)2., F.A.C., need not be performed during the period of storage only. However, when devices are put back into service or transferred to another person, and have not been tested within the required test interval, they must be tested for leakage before use or transfer and the shutter tested before use. Devices kept in standby for future use are excluded from the two year time limit if the general licensee performs physical inventories at intervals not to exceed three months while they are in standby. (Pursuant to Section 120.54(6), Florida Statutes, subpargraph 64E-5.206(4)(c)14., F.A.C., is substantively identical to 10 CFR 31.5(c)(15) published on 01/01/2007.)

    15. Shall not export the device containing radioactive material except in accordance with 10 C.F.R. Part 110;

    16. Shall respond to written requests from the Department to provide information relating to the general license within 30 calendar days of the date of the request, or other time specified in the request. If the general licensee cannot provide the requested information within the allotted time, it shall, within that same time period, request a longer period to supply the information by providing the Department, a written justification for the request for extension of time. (Pursuant to Section 120.54(6) Florida Statutes, subsections 64E-5.206(4)(c), (16), F.A.C., is substantively identical to 10 CFR 31.5(c)(11) published on 01/01/2007.)

    (d) through (e) No change.

    (5) through (10) No change

    Specific 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,________.

     

    SUBPART C

    SPECIFIC LICENSES

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

    (1) through (3) No change.

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

    (a) through (c) No change.

    (d) If a device containing radioactive material is transferred for use under the general license described in subsection 64E-5.206(4), F.A.C., each person that is licensed under subsection 64E-5.210(4), F.A.C., shall provide the information specified in this section to each person to whom a device is to be transferred. This information must be provided before the device may be transferred. In the case of a transfer through an intermediate person, the information must also be provided to the intended user prior to the initial transfer to the intermediate person. The required information includes the following:

    1. A copy of the general license contained in subsection 64E-5.206(4); subparagraphs 64E-5.206(4)(c)2., 3., and 4. or subparagraph 64E-5.206(4)(c)12., F.A.C., do not apply to the particular device, those paragraphs may be omitted;

    2. A copy of Rules 64E-5.103, 64E-5.343328, and 64E-5.344329, F.A.C.;

    3. through 5. No change.

    (e) If a device containing radioactive material is transferred for use under an equivalent general license of an Agreement State or the NRC U.S. Nuclear Regulatory Commission, each person that is licensed under subsection 64E-5.210(4), F.A.C., shall provide the information specified in this section to each person to whom a device is to be transferred. This information must be provided before the device may be transferred. In the case of a transfer through an intermediate person, the information must also be provided to the intended user prior to the initial transfer to the intermediate person. The required information includes the following:

    1. A copy of the Agreement States or NRC U.S. Nuclear Regulatory Commission equivalent to Rules 64E-5.103, 64E-5.343328, and 64E-5.344329, F.A.C. If a copy of the NRC U.S. Nuclear Regulatory Commission regulations is provided to a prospective general licensee in lieu of the Agreement State’s regulations, it shall be accompanied by a note explaining that the use of the device is regulated by the Agreement State. If certain parts of the regulations do not apply to the particular device, those regulations may be omitted;

    2. through 4. No change.

    (f) through (h) No change.

    (i) Each person licensed under subsection 64E-5.210(4), F.A.C., shall comply with the following additional reporting and record keeping requirements for transfers and receipt of devices to Agreement States or the NRC.

    1. Report all transfers of devices to persons for use under the general license in an Agreement State or the NRC, that are equivalent to subsection 64E-5.206(4), F.A.C., and all receipts of devices from persons licensed under a general license in Agreement State or the NRC jurisdiction to the responsible Agreement State or the NRC agency. This report must contain all of the information described in “Transfers of Industrial Devices Report 04/2007.”

    2. through 6. No change.

    7. If no transfers have been made to or from a particular Agreement State or the NRC during the reporting period, this information shall be reported to the responsible Agreement State or the NRC agency upon request of the agency.

    8. No change.

    (j) No change.

    (5) through (14) 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 120.54(6), Florida Statutes, subsection 64E-5.210(15), F.A.C., is substantively identical to 10 CFR 32.201 published on 01/01/2007.)

    Specific 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,________.

     

    RECIPROCITY SUBPART D

    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 U.S. Nuclear Regulatory Commission, or an Agreement State or a Licensing State 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 fFederal jurisdiction, for a period not in excess of 365 consecutive days provided that:

    (a) through (d) No change.

    (e) Shall not possess or use radioactive materials or engage in activities authorized in subsection 64E-5.216(1), F.A.C., above for more than a period in excess of 180 days in any calendar year. (Pursuant to Section 120.54(6), Florida Statutes, paragraph 64E-5.216(1)(e), F.A.C., is substantively identical to 10 CFR 150.20(b)(4) published on 01/01/2007.)

    (2) through (3) No change.

    Specific 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, ________.

     

    PART III

    STANDARDS FOR PROTECTION AGAINST RADIATION

    SUBPART L

    REPORTS

    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 subsections (1) through (5) of this section for each type of transaction. (Pursuant to Section 120.54(6), Florida Statutes, 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) Each licensee who manufactures a nationally tracked source shall complete and submit a National Source Tracking Transaction Report. The report must include the following information:

    (a) The name, address, and license number of the reporting licensee;

    (b) The name of the individual preparing the report;

    (c) The manufacturer, model, and serial number of the source;

    (d) The radioactive material in the source;

    (e) The initial source strength in becquerels (curies) at the time of manufacture; and

    (f) The manufacture date of the source.

    (2) Each licensee that transfers a nationally tracked source to another person shall complete and submit a National Source Tracking Transaction Report. The report must include the following information:

    (a) The name, address, and license number of the reporting licensee;

    (b) The name of the individual preparing the report;

    (c) The name and license number of the recipient facility and the shipping address;

    (d) The manufacturer, model, and serial number of the source or, if not available, other information to uniquely identify the source;

    (e) The radioactive material in the source;

    (f) The initial or current source strength in becquerels (curies);

    (g) The date for which the source strength is reported;

    (h) The shipping date;

    (i) The estimated arrival date; and

    (j) For nationally tracked sources transferred as waste under a Uniform Low-Level Radioactive Waste Manifest, the waste manifest number and the container identification of the container with the nationally tracked source.

    (3) Each licensee that receives a nationally tracked source shall complete and submit a National Source Tracking Transaction Report. The report must include the following information:

    (a) The name, address, and license number of the reporting licensee;

    (b) The name of the individual preparing the report;

    (c) The name, address, and license number of the person that provided the source;

    (d) The manufacturer, model, and serial number of the source or, if not available, other information to uniquely identify the source;

    (e) The radioactive material in the source;

    (f) The initial or current source strength in becquerels (curies);

    (g) The date for which the source strength is reported;

    (h) The date of receipt; and

    (i) For material received under a Uniform Low-Level Radioactive Waste Manifest, the waste manifest number and the container identification with the nationally tracked source.

    (4) Each licensee that disassembles a nationally tracked source shall complete and submit a National Source Tracking Transaction Report. The report must include the following information:

    (a) The name, address, and license number of the reporting licensee;

    (b) The name of the individual preparing the report;

    (c) The manufacturer, model, and serial number of the source or, if not available, other information to uniquely identify the source;

    (d) The radioactive material in the source;

    (e) The initial or current source strength in becquerels (curies);

    (f) The date for which the source strength is reported;

    (g) The disassemble date of the source.

    (5) Each licensee who disposes of a nationally tracked source shall complete and submit a National Source Tracking Transaction Report. The report must include the following information:

    (a) The name, address, and license number of the reporting licensee;

    (b) The name of the individual preparing the report;

    (c) The waste manifest number;

    (d) The container identification with the nationally tracked source.

    (e) The date of disposal; and

    (f) The method of disposal.

    (6) The National Source Tracking Transaction Report discussed in subsections (1) through (5) of this section must be submitted to the NRC by the close of the next business day after the transaction. A single report may be submitted for multiple sources and transactions. The reports must be submitted to the National Source Tracking System by using:

    (a) The on-line National Source Tracking System;

    (b) Electronically using a computer-readable format;

    (c) By facsimile;

    (d) By mail to the address on the NRC Form 748 National Source Tracking Transaction Report Form; or

    (e) By telephone with followup by facsimile or mail.

    (7)(a) Each licensee shall correct any error in previously filed reports or file a new report for any missed transaction within 5 business days of the discovery of the error or missed transaction. Such errors may be detected by a variety of methods such as administrative reviews or by physical inventories required by regulation.

    (b) In addition, every year each licensee shall reconcile the inventory of nationally tracked sources possessed by the licensee against that licensee's data in the National Source Tracking System. The reconciliation must be conducted during the month of January in each year. The reconciliation process must include resolving any discrepancies between the National Source Tracking System and the actual inventory by filing the reports identified by subsections (1) through (5) of this section. In order to reconcile each transaction, the licensee shall file a report for missed transactions or file a corrected report for previously submitted reports containing inaccuracies. By January 31 of each year, each licensee must submit to the National Source Tracking System confirmation that the data in the National Source Tracking System is correct.

    (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 (e) of this section. The initial inventory report must include the following information: (Pursuant to Section 120.54(6) Florida Statutes, subsection 64E-5.350(8), F.A.C., is substantively identical to 10 CFR 20.2207(h) effective 10/19/2007.)

    (a) The name, address, and license number of the reporting licensee;

    (b) The name of the individual preparing the report;

    (c) The manufacturer, model, and serial number of each nationally tracked source or, if not available, other information to uniquely identify the source;

    (d) The radioactive material in the sealed source;

    (e) The initial or current source strength in becquerels (curies); and

    (f) The date for which the source strength is reported.

    Specific Authority 404.051, 404.081 FS. Law Implemented 404.022, 404.051, 404.081 FS. History–New________.

     

    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), Florida Statutes, Rule 64E-5.351, F.A.C., is substantively identical to Appendix E to 10 CFR Part 20 effective 02/06/2007.)

    Table 1

    Radioactive material

    Category 1 (TBq)

    Category 1 (Ci)

    Category 2 (TBq)

    Category 2 (Ci)

    Actinium-227

    20

    540

    0 .2

    5 .4

    Americium-24

    60

    1,600

    0 .6

    16

    Americium-241/Be

    60

    1,600

    0 .6

    16

    Californium-252

    20

    540

    0 .2

    5 .4

    Cobalt-60

    30

    810

    0 .3

    8 .1

    Curium-244

    50

    1,400

    0 .5

    14

    Cesium-137

    100

    2,700

    1

    27

    Gadolinium-153

    1,000

    27,000

    10

    270

    Iridium-192

    80

    2,200

    0 .8

    22

    Plutonium-238

    60

    1,600

    0 .6

    16

    Plutonium-239/Be

    60

    1,600

    0 .6

    16

    Polonium-210

    60

    1,600

    0 .6

    16

    Promethium-147

    40,000

    1,100,000

    400

    11,000

    Radium-226

    40

    1,100

    0 .4

    11

    Selenium-75

    200

    5,400

    2

    54

    Strontium-90

    1,000

    27,000

    10

    270

    Thorium-228

    20

    540

    0 .2

    5 .4

    Thorium-229

    20

    540

    0 .2

    5 .4

    Thulium-170

    20,000

    540,000

    200

    5,400

    Ytterbium-169

    300

    8,100

    3

    81

    Specific Authority  404.051, 404.081 FS. Law Implemented 404.022, 404.051, 404.081 FS. History–New________.

     

    PART IV

    RADIATION SAFETY REQUIREMENTS FOR LICENSEES AND REGISTRANTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS

    SUBPART D

    EQUIPMENT CONTROL

    64E-5.430 Inspection and Maintenance.

    (1) No change.

    (2) Each licensee or registrant shall have written procedures and perform equipment inspection and maintenance as described below. (Pursuant to Section 120.54(6), Florida Statutes, subsection 64E-5.430(2), F.A.C., is substantively identical to 10 CFR 34.31(b) published on 01/01/2007.)

    (a) through (b) No change.

    Specific Authority 404.051 FS. Law Implemented 404.022, 404.051(1), (4), 404.081(1) FS. History–New 9-11-01, Amended ________.

     

    64E-5.440 Records.

    (1) No change.

    (2) Each licensee or registrant shall maintain the following records until the Department terminates the license or registration requiring the record:

    (a) through (c) No change.

    (d) Radiographer certification documents specified in paragraphs 64E-5.434(2)(d)(e)-(f), F.A.C., and verification of certification status;

    (e) through (h) No change.

    (3) No change.

    Specific Authority 404.051 FS. Law Implemented 404.022, 404.051(1), (4), 404.081(1), 404.20 FS. History–New 9-11-01, Amended 9-28-06, ________.

     

    64E-5.441 Reporting Requirements.

    (1) through (3) No change.

    (4) Any licensee conducting radiographic operations or storing radioactive material at any location not listed on the license for a period in excess of 180 days in a calendar year, shall notify the Department prior to exceeding the 180 days. (Pursuant to Section 120.54(6), Florida Statutes, subsection 64E-5.441(4), F.A.C., is substantively identical to 10 CFR 34.101(c) published on 01/01/2007.)

    Specific Authority 404.051 FS. Law Implemented 404.022, 404.051(1), (4), 404.081(1) FS. History–New 9-11-01, Amended 9-28-06,________.

     

    PART XI

    RADIATION SAFETY REQUIREMENTS FOR
    WIRELINE SERVICE OPERATIONS

    AND SUBSURFACE TRACER STUDIES

    SUBPART A

    EQUIPMENT CONTROL

    64E-5.11072 Energy Compensation Source.

    The licensee can use an ECS that is contained within a logging tool or other tool components only if the ECS contains 100 microcuries (3.7 MBq) or less of licensed material.

    (1) For well logging applications with a surface casing for protecting fresh water aquifers, use of the ECS is subject only to the requirements specified in Rules 64E-5.1104, 64E-5.11057, and 64E-5.1106, F.A.C., above.

    (2) No change.

    Specific Authority 404.051, 404.061, 404.071, 404.081 FS. Law Implemented 404.022, 404.051(1), (4), (6), 404.061(2), 404.071(1), 404.081(1) FS. History–New 9-28-06, Amended________.

     

    64E-5.1501 Purpose and Scope Transportation of Radioactive Material.

    (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 01/01/2007, which is herein incorporated by reference and is available from the department.

    (3) The regulations in this part apply to any licensee authorized by specific or general license issued by the department to receive, possess, use, or transfer licensed material, if the licensee delivers that material to a carrier for transport, transports the material outside the site of usage as specified in the license, or transports that material on public highways. No provision of this part authorizes possession of licensed material.

    (4) Definition of terms used in this part are those listed in Rule 64E-5.1502, F.A.C., as described in 49 C.F.R. and 10 C.F.R. 71.4, except that whenever a definition refers to evaluation or approval by the U.S. Department of Transportation or NRC, and such evaluation or approval is within the jurisdiction of the State of Florida as an Agreement State, the Department shall perform the evaluation or approval.

    Specific 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 _______.

     

    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, 171-180173, 177, 383, and 390-397 published on 10/01/2007, and 10 C.F.R. Part 71 published on 01/01/2007.

    (b) through (c) No change.

    (d) The licensee shall comply with U.S. Department of Transportation and NRC regulations in the following areas:

    1. Packaging, 49 C.F.R. part 173, subparts A, B, and I;

    2. Marking and labeling, 49 C.F.R. part 172, subpart D, §§172.400 through 172.407, §§172.436 through 172.441 of subpart E;

    3. Placarding, 49 C.F.R. part 172, subpart F, especially §§172.500 through 172.519 and 172.556, and appendices B and C;

    4. Accident reporting, 49 C.F.R. part 171, §§171.15 and 171.16;

    5. Shipping papers and emergency information, 49 C.F.R. part 172, subparts C and G;

    6. Hazardous material employee training, 49 C.F.R. part 172, subpart H;

    7. Security plans, 49 C.F.R. part 172, subpart I;

    8. Hazardous material shipper/carrier registration, 49 C.F.R. part 107, subpart G;

    9. Definitions, 10 C.F.R. 71.4;

    10. Transportation of licensed material, 10 C.F.R. 71.5;

    11. Exemptions for low level material, 10 C.F.R. 71.14(a);

    12. General license, NRC-approved package, 10 C.F.R. 71.17;

    13. Previously approved package, 10 C.F.R. 71.19(a) and (b);

    14. General license, U.S. Department of Transportation specification container material, 10 C.F.R. 71.20;

    15. General license, Use of foreign approved package, 10 C.F.R. 71.21;

    16. General license, Fissile material, 10 C.F.R. 71.22;

    17. External radiation standards for all packages, 10 C.F.R. 71.47;

    18. Assumptions as to unknown properties, 10 C.F.R. 71.83;

    19. Preliminary determinations, 10 C.F.R. 71.85;

    20. Routine determinations, 10 C.F.R. 71.87;

    21. Air transportation of plutonium, 10 C.F.R. 71.88;

    22. Opening instructions, 10 C.F.R. 71.89;

    23. Advance notification of shipment of irradiated reactor fuel and nuclear waste, 10 C.F.R. 71.97;

    24. Quality assurance requirements, 10 C.F.R. 71.101(a), (b), (c), (f) and (g);

    25. Quality assurance organization, 10 C.F.R. 71.103;

    26. Quality assurance program, 10 C.F.R. 71.105;

    27. Exemption of physicians, 10 C.F.R. 71.13;

    28. Handling storage and shipping control, 10 C.F.R. 71.127;

    29. Inspection tests and operating status, 10 C.F.R. 71.129;

    30. Nonconforming materials parts or components, 10 C.F.R. 71.131;

    31. Corrective action, 10 C.F.R. 71.13;

    32. Quality assurances records, 10 C.F.R. 71.135;

    33. Audits, 10 C.F.R. 71.137;

    34. Appendix A to Part 71; and

    35. General license plutonium beryllium special form material.

    (e) The licensee shall also comply with U.S. Department of Transportation regulations pertaining to the following modes of transportation:

    1. Rail, 49 C.F.R. part 174, subparts A through D and K;

    2. Air, 49 C.F.R. part 175;

    3. Vessel, 49 C.F.R. part 176, subparts A through F and M; and

    4. Public Highway, 49 C.F.R. part 177 and parts 390 through 397.

    (3) If U.S. Department of Transportation regulations are not applicable to a shipment of licensed material, the licensee shall conform to the standards and requirements of the U.S. Department of Transportation specified in paragraph (2) of this section to the same extent as if the shipment or transportation were subject to U.S. Department of Transportation regulations. A request for modification, waiver, or exemption from those requirements, and any notification referred to in those requirements, must be filed with, or made to, the Department.

    Specific 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,________.

     

    NAME OF PERSON ORIGINATING PROPOSED RULE: William A. Passetti

    NAME OF SUPERVISOR OR PERSON WHO APPROVED THE PROPOSED RULE: Lisa Conti

    DATE PROPOSED RULE APPROVED BY AGENCY HEAD: October 2, 2007

    DATE PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: October 5, 2007

Document Information

Comments Open:
1/18/2008
Summary:
Micheal N. Stephens, (Mike_Stephens@doh. state.fl.us) ENVIRONMENTAL HEALTH PROGRAM CONSULTANT, BUREAU OF RADIATION CONTROL, BIN C21, 4052 BALD CYPRESS WAY, TALLAHASSEE, FLORIDA 32399-1741
Purpose:
All changes described herein are needed to comply with the requirements of Florida’s agreement with the U.S. Nuclear Regulatory Commission (NRC) to regulate radioactive material. As an agreement state, many of Florida’s regulations governing the possession and use of radioactive materials must be identical to the NRC’s regulations for federal radioactive materials licensees. The proposed rule specifies requirements for transportation of radioactive materials; national tracking of certain large ...
Rulemaking Authority:
404.042, 404.051, 404.051(4), (11), 404.061, 404.061(2), 404.071, 404.081, 404.081(1), 404.141, 404.20 FS.
Law:
404.022, 404.031, 404.051, 404.051(1), (2), (4), (6), (8), (9), (10), (11), 404.061, 404.061(2), 404.071(1), (3), 404.081, 404.081(1), 404.141, 404.20, 404.20(1), 404.22 FS.
Related Rules: (12)
64E-5.101. Definitions
64E-5.11072. Energy Compensation Source
64E-5.1501. Transportation of Radioactive Material
64E-5.1502. Transportation of Radioactive Material
64E-5.206. General Licenses - Radioactive Material Other Than Source Material
More ...