The purpose of this proposed rule making is to update department rules regarding the use of x-rays in the healing arts; to establish provisions for the use of hand-held dental x-ray units; to correct the numbering of Rule 64E-5.210, F.A.C.; and to ...  

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    DEPARTMENT OF HEALTH
    Division of Environmental Health

    RULE NO: RULE TITLE
    64E-5.1003: Monitoring Fees
    64E-5.101: Definitions
    64E-5.1508: Inspection of Low-Level Radioactive Waste Shipments
    64E-5.204: Types of Licenses
    64E-5.210: Special Requirements for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material
    64E-5.502: General Requirements
    64E-5.504: Fluoroscopic X-Ray Systems
    64E-5.506: Intraoral Dental Radiographic Systems
    64E-5.511: Registration of Radiation Machines
    PURPOSE AND EFFECT: The purpose of this proposed rule making is to update department rules regarding the use of x-rays in the healing arts; to establish provisions for the use of hand-held dental x-ray units; to correct the numbering of Rule 64E-5.210, F.A.C.; and to update fees for environmental monitoring, inspections of low-level radioactive waste transportation shipments, and radioactive materials licenses. The effect will be to allow for the use of hand-held dental x-ray units; to clarify the requirements of x-ray use in the healing arts; and to cover the department’s operational costs.
    SUMMARY: This rulemaking will update department rules regarding the use of x-rays in the healing arts; establish provisions for the use of hand-held dental x-ray units; correct numbering, and update fees for environmental monitoring, inspections of low-level radioactive waste transportation shipments, and radioactive materials licenses.
    SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared.
    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.
    SPECIFIC AUTHORITY: 404.022, 404.051, 404.056, 404.081, 404.131, 404.141, 404.22 FS.
    LAW IMPLEMENTED: 404.022, 404.031, 404.056, 404.061, 404.081, 404.131, 404.141, 404.22, 404.051(1), (4), (5), (6), (8), (9), (10), (11), 404.061(2), (3), 404.071(1), 404.081(1), 404.22(1),(2),(3) FS.
    IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE HELD AT THE DATE,TIME AND PLACE SHOWN BELOW(IF NOT REQUESTED, THIS HEARING WILL NOT BE HELD):
    DATE AND TIME: June 25, 2007, 1:30 p.m. – 3:00 p.m.
    PLACE: Capital Circle Office Complex, Building 4042, Room 240P, 4042 Bald Cypress Way, Tallahassee, FL 32399
    Pursuant to the provisions of the Americans with Disabilities Act, any person requiring special accommodations to participate in this workshop/meeting is asked to advise the agency at least 7 days before the workshop/meeting by contacting: Michael Stephens, Environmental Health Program Consultant, Bin C21, 4052 Bald Cypress Way, Tallahassee, FL 32399-1741, (850)245-4266 or (850)245-4444, ext. 4043. If you are hearing or speech impaired, please contact the agency using the Florida Relay Service, 1(800)955-8771 (TDD) or 1(800)955-8770 (Voice).
    THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Michael Stephens, Environmental Health Program Consultant, Bin C21, 4052 Bald Cypress Way, Tallahassee, FL 32399-1741; (850)245-4266 or (850)245-4444, ext. 4043; email: mike_Stephens@doh.state.fl.us
    SECTION 286.0105, FLORIDA STATUTES, PROVIDES THAT, IF A PERSON DECIDES TO APPEAL ANY DECISION MADE BY THE DEPARTMENT WITH RESPECT TO ANY MATTER CONSIDERED AT THIS HEARING, THEY WILL NEED A RECORD OF PROCEEDINGS, AND FOR SUCH PURPOSES, THEY MAY NEED TO ENSURE THAT A VERBATIM RECORD OF THE PROCEEDINGS IS MADE, WHICH RECORD INCLUDES THE TESTIMONY AND EVIDENCE UPON WHICH THE APPEAL IS BASED.

    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 (22) No change.

    (23) “Cabinet x-ray system or Cabinet x-ray” means an x-ray system with the x-ray tube installed in an enclosure independent of existing architectural structures. A cabinet xray system is intended to contain the material being irradiated, and exclude personnel from its interior during generation of radiation. To be certified as a cabinet xray, the cabinet must be shielded so that every location on the exterior meets the conditions of 0.5 mRem (0.005 millisievert) in any one hour, at a distance of 5 cm. An x-ray tube used within a shielded part of a building or x-ray equipment that may temporarily or occasionally incorporate portable shielding is not considered a cabinet x-ray system. means an x-ray system with the x-ray tube installed in an enclosure or cabinet that, independently of existing architectural structures except the floor on which it is placed, is intended to contain at least the portion of the material being irradiated, to provide radiation attenuation, and to exclude persons from its interior during generation of x-radiation. An x-ray tube used within a shielded part of a building or x-ray equipment that temporarily or occasionally incorporates portable shielding is not considered a cabinet x-ray system.

    (24) through (191) No change.

    (192) “Mobile C-arm” means a mobile fluoroscopic machine that is designed for and used without a patient support device such as a radiographic table, cradle or radiolucent stretcher. This would include machines moved from room to room to assist in surgical procedures. Measurements of patient entrance exposure for this type of system will be measured in accordance with subparagraphs 64E-5.504(3)(e)2., 3., and 4.

    (193) “C-arm system” means a fluoroscopic C-arm routinely used with the same patient support device which will have interlocks, detents or positioning marks to allow reproducible geometry. Measurements of patient entrance exposure for this type of system will be measured in accordance with subparagraphs 64E-5.504(3)(e)2., 3., and 5.

    Specific Authority 404.042, 404.051, 404.061 FS. Law Implemented 404.031, 404.051, 404.061(2), 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,_________.

     

    PART II

    LICENSING OF RADIOACTIVE MATERIALS

    SUBPART A

    LICENSE TYPES AND FEES

    64E-5.204 Types of Licenses.

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

    (1) Some general licenses provided in this part may be effective without the filing of applications with the dDepartment or the issuance of licensing documents to the particular persons, although the filing of a certificate with the dDepartment for general licenses pursuant to subsections 64E-5.206(7) or (8), F.A.C., shall be required of the particular general licensee prior to the receipt of radioactive material and the dDepartment requires registration of certain general licenses described in subsection 64E-5.206(4), F.A.C. The payment of a fee is also required by all persons possessing general licensed material described in paragraph (1)(c), below. The general licensee is subject to all other applicable portions of these regulations and any limitations of the general license.

    (a) The annual registration fee set forth in this section for general licenses shall be payable every July 1, for as long as the license remains in effect.

    (b) The annual fee for a general license set forth in Rule 64E-5.216, F.A.C., under reciprocal agreement shall be paid before the first entrance into the sState and on each anniversary date thereafter, if applicable. Manufacturers, manufacturer's representatives, distributors, and waste treatment, storage or disposal companies servicing Florida radioactive materials license applicants or licensees are not exempt from this fee.

    (c) Payment of the indicated annual fee pursuant to paragraph (1)(a), above, is required for the following types of devices held or activities performed under a general license:

    1. Static elimination devices as described in paragraph 64E-5.206(1)(a), F.A.C.,$30.00 $25.00 per unit.

    2. Measuring, gauging, and control devices as described in subsection 64E-5.206(4), F.A.C.,$30.00 $25.00 per unit.

    3. In Vivo testing as described in subsection 64E-5.206(7), F.A.C.,$150.00 $125.00 per license.

    4. In Vitro testing as described in subsection 64E-5.206(8), F.A.C.,$150.00 $125.00 per license.

    5. Depleted uranium as described in subsection 64E-5.205(4), F.A.C.,$150.00 $125.00 per license.

    (d) No change.

    (2) Specific licenses require the submission of an application to the department and the issuance of a licensing document by the department. 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, Florida Statutes and as outlined below:

    (a) through (d) No change.

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

     

     

     

     

     

    Application

    Fee

    Annual

    Fee

     

    1. Source Material:.

     

     

     

    a. Licenses for concentration of uranium from phosphate ores for the production of uranium as “yellow cake” or powdered solid;

    $8,288 $6,907

    $14,330 11,942

     

    b. Licenses for concentration of uranium from phosphate ores for the production of “green cake” or equivalent, moist or solid;

    $4,522 $3,768

    $8,927 $7,439

     

    c. All other specific source material licenses excluding depleted uranium used as shielding and counterweights.

    $653 $544

    $275 $229

     

    2. Special Nuclear Material (SNM):.

     

     

     

    a. Licenses for use of SNM in sealed sources contained in devices used in measuring systems;

    $784 $653

    $622 $518

     

    b. Licenses for use of SNM not sufficient to form a critical mass, except as in 2.a., above, and 2.c. and 5.e., below;

    $1,608 $1,340

    $2,333 $1,944

     

    c. Licenses for use of SNM to be used as calibration

    and reference sources.

    $246 $205

    $131 $109

     

    3. Byproduct, naturally occurring or accelerator produced material:.

     

     

     

    a. Licenses for processing or manufacturing for commercial distribution or industrial uses;

    $3,508 $2,923

    $3,362 $2,802

     

    b. Licenses for processing or manufacturing and distribution of radiopharmaceuticals. This category includes radiopharmacies;

    $3,072 $2,560

    $4,608 $3,840

     

    c. Licenses for industrial radiography performed only in an approved shielded radiography installation;

    $1,870 $1,558

    $2,593 $2,161

     

    d. Licenses for industrial radiography performed only at the address indicated in the license, or at temporary job sites of the licensee;

    $1,972 $1,643

    $3,188 $2,657

     

    e. Licenses for possession and use of radioactive materials in sealed sources for irradiation of materials where the source is not removed from the shield and is less than 10,000 curies;

    $726 $605

    $726 $605

     

    f.(I) Licenses for possession and use of radioactive materials in sealed sources for irradiation of materials when the source is not removed from the shield and is greater than 10,000 curies and less than 100,000 curies, or where the source is less than 100,000 curies and is removed from the shield;

    $1,697 $1,414

    $1,956 $1,630

     

    (II) Licenses for possession and use of radioactive materials in sealed sources for irradiation of materials when the source is equal to or greater than 100,000 curies and less than 1,000,000 curies;

    $4,391 $3,659

    $4,753 $3,961

     

    (III) Licenses for possession and use of radioactive materials in sealed sources for irradiation of materials when the source is equal to or greater than 1,000,000 curies.

    $11,736 $9,780

    $5,278 $4,398

     

    g. Licenses issued to distribute items containing radioactive materials to persons under a general license;

    $1,972 $1,643

    $2,580 $2,150

     

    h. Fixed gauging devices; Licenses issued to distribute exempt quantities or items containing naturally occurring or accelerator produced material to persons exempt from licensing;

    $726 $1,643

    $1,159 $2,150

     

    i. Well logging:

     

     

     

    (I) Sealed sources or sub-surface tracer studies;

    $1,362 $1,135

    $1,798 $1,498

     

    (II) Sub-surface tracer studies and sealed sources;

    $1,723 $1,436

    $1,913 $1,594

     

    j. Nuclear laundry;

    $3,840 $3,200

    $6,781 $5,651

     

    k. Industrial or medical research and development;

    $1,421 $1,184

    $1,769 $1,474

     

    l(I) Fixed and Pportable gauging devices;

    $726 $605

    $1,159 $966

     

    (II) In Vitro and clinical laboratory;

    $870 $725

    $1,102

     

    (III) Academic;

    $1174 $978

    $1,405

     

    (IV) Possession of uranium or thorium, or their decay products as a result of mining or processing;

    $1174 $978

    $1,044 $870

     

    (V) All other specific licenses except as otherwise noted;

    $870 $725

    $1,202 $1,002

     

    m. Licenses of broad scope;

     

     

     

    (I) Academic;

    $3,840 $3,200

    $8,815 $7,346

     

    (II) Medical;

    $3,840 $3,200

    $6,569 $5,474

     

    (III) Industrial or Research and Development;

    $3,840 $3,200

    $5,482 $4,568

     

    n. Gas chromatography devices;

    $521 $434

    $377 $314

     

    o. Reference or calibration sources equal to or less than one millicurie total;

    $377 $314

    $158 $132

     

    p. Nuclear service licenses, such as, leak testing, instrument calibration, etc.;

    $622 $518

    $492 $410

     

    4. Waste disposal or processing:

     

     

     

    a. Commercial waste disposal or treatment facilities, including burial or incineration;

    $331,010 $275,842

    $300,666 $250,555

     

    b. All other commercial facilities involving compaction, repackaging, storage or transfer;

    $32,501 $27,084

    $29,965 $24,971

     

    c. Commercial treatment of radioactive materials for release to unrestricted areas.

    $6,913 $5,760

    $6,882.00 $5,735

     

    5. Medical use:.

     

     

     

    a.(I) Teletherapy or gamma stereotactic radiosurgery including gamma knife high dose rate remote afterloading devices;

    $1,838 $1,414

    $1,791 $1,378

     

    (II) High dose rate remote afterloading devices;

    $1,697

    $1,654

     

    (III) High dose rate remote afterloading devices and gamma stereotactic radiosurgery including gamma knife devices or teletherapy devices;

    $1,838

    $1,791

     

    b. Medical institutions, including hospitals, except category 5.a.(I), 5.a.(II), 5.a.(III), 5.e. and 5.f.;

    $1,972 $1,643

    $2,290 $1,908

     

    c. Private practice physicians except category 5.a.(I), 5.a.(II), 5.a.(III), 5.d. and 5.f.;

    $1,421 $1,184

    $1,608 $1,340

     

    d. Private practice physicians using only strontium 90 eye applicators, or materials authorized by Rule 64E-5.630, F.A.C., or and materials authorized by Rule 64E-5.6310, F.A.C.;

    $726 $605

    $898 $748

     

    e. Nuclear powered pacemakers;

    $521 $434

    $319 $266

     

    f.(I) Mobile nuclear medicine services;.

    $1,697 $1,414

    $1,950 $1,625

     

    (II) Mobile high dose rate remote afterloading therapy device when the treatment is only performed on the mobile vehicle.

    $2,970

    $3,308

     

    6. Civil defense.

    $653 $544

    $985 $821

     

    7. Device, product, or sealed source safety evaluation:.

     

     

     

    a. Safety evaluation of devices or products containing radioactive material, except reactor fuel devices, for commercial distribution or in accordance with the unique specifications of, and for use by, a single applicant; per device remaining in active status. Devices or products in inactive status more than 5 years must submit another application fee and be re-evaluated; Device evaluation, per device.

    $4,500 $1,208

     

    $2,570 NONE

     

    b. Safety evaluation of sealed sources containing radioactive material, for commercial distribution or in accordance with the unique specifications of, and for use by, a single applicant; per source remaining in active status. Sources in inactive  status more than 5 years must submit another application fee and be re-evaluated. Sealed source design, per source.

    $2,400 $528

    $2,900 NONE

     

    Specific Authority 404.051, 404.061, 404.131 FS. Law Implemented 404.031, 404.051(1), (4), (10), 404.061, 404.081(1), 404.131(1), 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,_________.

     

    PART II

    LICENSING OF RADIOACTIVE MATERIALS

    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 (f) No change.

    (g) If a notification of bankruptcy has been made under subsection 64E-5.213(3), F.A.C., or the license is to be terminated, each person licensed under subsection 64E-5.210(4), F.A.C., shall provide, upon request, to the dDepartment, U.S. Nuclear Regulatory Commission and to any appropriate Agreement State, records of final disposition required under paragraph 64E-5.210(4)(j)(k), F.A.C.

    (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 10/2003” herein incorporated by reference and is available at the address listed in paragraph 64E-5.204(2)(b), F.A.C., or at http://www.doh.state.fl.us/environment/radiation/.

    2. through 7. No changes.

    (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.

    1. Report all transfers of devices to persons for use under the general license in an Agreement State 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 jurisdiction to the responsible Agreement State agency. This report must contain all of the information described in “Transfers of Industrial Devices Report 04/2007 10/2003.”

    2. through 8. No change.

    (j)(k) The persons shall maintain all information concerning transfers and receipts of devices that supports the reports required by subsection 64E-5.210(4), F.A.C. Records and reports described in subsection 64E-5.210(4), F.A.C., shall be maintained for inspection by the dDepartment for a period of 3 years following the date of the recorded event.

    (5) through (14) No change.

    Specific Authority 404.051, 404.061, 404.071, 404.081, 404.141 FS. Law Implemented 404.022, 404.051(1), (4), (6), (9), (10), (11), 404.061(2), 404.081(1), 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,_________.

     

    PART V

    X-RAYS IN THE HEALING ARTS

    64E-5.502 General Requirements.

    (1) Administrative Controls.

    (a) Registrant. The registrant shall be responsible for directing the operation of the x-ray systems which are subject to registration as described in Rule 64E-5.511, F.A.C. The registrant or the registrant's agent shall assure that the following requirements are met in the operation of the x-ray system.

    1. through 7. No change.

    8. Exposure Procedures Designed to Minimize Patient and Personal Exposure.

    a. through d. No change.

    e. A person shall not perform fluoroscopic imaging or otherwise expose a human to x-rays from a fluoroscopic system unless the person is a:

    (I) Licensed practitioner as that term is defined in Section 468.301, Florida Statutes; or

    (II) Certified radiologist assistant practicing in accordance with the requirements of Chapter 468, Part IV, Florida Statutes; or

    (III) Certified general radiographer practicing in accordance with the requirements of Chapter 468, Part IV, Florida Statutes; and

    (A) The general radiographer has been trained and authorized in writing by the licensed practitioner in charge to perform the specified imaging; and

    (B) The specified imaging does not rely upon the general radiographer to provide any diagnostic interpretation, or to determine suspicious areas for additional imaging, or to otherwise modify the scope of authorization for the imaging; and

    (C) The specified imaging is designed to prevent or reduce exposure to patients by facilitating proper location and positioning for the authorized radiographic imaging.

    e. Persons who are not licensed to practice the healing arts shall not be permitted to perform fluoroscopic examinations or otherwise to expose humans to x-rays from fluoroscopic systems unless:

    (I) The individual is certified in accordance with the requirements of Chapter 468, Part IV, Florida Statutes;

    (II) Such persons have been trained and authorized in writing by the licensed practitioner in charge to perform specified procedures;

    (III) The specified procedures do not involve diagnostic interpretation by the unlicensed person; and

    (IV) The specified procedures are designed to prevent or reduce exposure to patients by facilitating proper location and positioning for radiographic procedures.

    9. through 10. No change.

    (b) through (c) No change.

    (2) through (3) No change.

    Specific Authority 404.051, 404.081, 404.141, 404.22 FS. Law Implemented 404.051(1), (4), (5), (6), 404.081(1), 404.141, 404.22(1), (2), (3) FS. History–New 7-17-85, Amended 4-4-89, 1-1-94, 11-20-94, 1-5-95, Formerly 10D-91.603, Amended 5-18-98,_________.

     

    64E-5.504 Fluoroscopic X-Ray Systems.

    All fluoroscopic x-ray systems shall meet the following requirements:

    (1) Limitation of the Useful Beam.

    (a) through (c) No change.

    (d) Limitation to the Imaging Surface.

    1. No change.

    2. The longitudinal and transverse dimensions of the x-ray field produced by image-intensified fluoroscopic equipment shall not extend beyond the corresponding dimensions of the visible area of the image receptor by more than 3 percent of the SID in either dimension in the plane of the image receptor and the sum of the excess shall be no greater than 4 percent of the SID. If the collimation is automatically accomplished between the tube and patient, the x-ray field dimension criteria above shall apply to all film sizes and portions thereof that the spot film device accommodates and to the dimensions of the input phosphor, as appropriate. If collimation is not automatic, the x-ray field dimension criteria shall apply to the useful area of the input phosphor.

    3. through 6. No change.

    (e) No change.

    (2) No change.

    (3) Allowable Entrance Exposure Rate Limits for Fluoroscopic Equipment.

    (a) through (d) No change.

    (e) Measuring Compliance of Entrance Exposure Rate Limits. Compliance with this subsection shall be determined as follows:

    1. No change.

    2. If the source can be operated is below the patient support device table, the exposure rate shall be measured at least 1 centimeter above the patient support device tabletop or cradle and corrected for distance to show the actual entrance exposure rate.

    3. If the source can be operated is above the patient support device table, the exposure rate shall be measured at 30 centimeters above the patient support device tabletop with the end of the beam-limiting device or spacer assembly positioned as closely as possible to the point of measurement.

    4. In a mobile C-arm type of fluoroscope, not associated with a specific patient support device, the exposure rate shall be measured at 30 centimeters from the input surface of the fluoroscopic imaging assembly with the source positioned at any available SID, provided that the end of the beam-limiting device or spacer is no closer than 30 centimeters from the input surface of the fluoroscopic imaging assembly.

    5. If the source can be operated laterally to the patient support device In a lateral type of fluoroscope, the exposure rate shall be measured at a point 15 centimeters from the centerline of the x-ray table and in the direction of the x-ray source with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement. If the tabletop is movable, it shall be positioned as closely as possible to the lateral x-ray source with the end of the beam-limiting device or spacer no closer than 15 centimeters to the centerline of the x-ray table.

    6. through 7. No change.

    (f) through (g) No change.

    (4) through (11) No change.

    (12) For remotely operated fluoroscopic systems:

    (a) The control panel shall be arranged or configured to allow the operator to have both auditory and visual communication with the patient during exposures.

    (b) The operator's protective barrier shall have a window or mirror system arranged so that the operator can keep the patient under constant visual surveillance during exposures.

    (c) Windows shall have lead equivalent shielding equal to that required in the operator's protective barrier.

    Specific Authority 404.051, 404.22 FS. Law Implemented 404.051(1), (4), 404.22(1), (3) FS. History–New 7-17-85, Amended 4-4-89, 3-17-92, 1-5-95, Formerly 10D-91.605, Amended 5-18-98,_________.

     

    64E-5.506 Intraoral Dental Radiologic Systems.

    (1) through (4) No change.

    (5) Operating Controls.

    (a) through (e) No change.

    (f) Each user of intraoral units that are specifically designed to be handheld shall:

    1. Have and use individual monitoring devices to document safe use practices; and

    2. Successfully complete training provided by the manufacturer using electronic media such as CD/DVD or a website. Training on the safe use of the unit shall be documented and include at a minimum:

    a. Proper positioning of the unit to ensure an adequate protected position;

    b. Limitations on the use of position indicating devices that require longer distances to the patients face;

    c. Diagrams (ie: drawings, illustrations, schematics, etc.) of protected position and location in relationship to the unit;

    d. Diagrams (ie, drawings, illustrations, schematics, etc.) of the effect of improper distance or removal of shielding device; and

    e. Diagrams (ie. drawings, illustrations, schematics, etc.) of common examples of improper positioning of the unit and or location of the operator.

    Specific Authority 404.051, 404.22 FS. Law Implemented 404.022, 404.051(1), (4), (6), 404.22(1), (3) FS. History–New 7-17-85, Amended 4-4-89, Formerly 10D-91.607, Amended_________.

     

    64E-5.511 Registration of Radiation Machines

    (1) Exemptions.

    (a) No change.

    (b) Radiation machines that are non-operational and under the control of a registered vendor prior to final installation while in transit or storage incident thereto are exempt from the registration and fee requirements of this section part.

    (2) Application and Fees for Registration of Radiation Machines.

    (a) Each person who acquires a radiation machine or an additional radiation machine shall:

    1. Apply for registration of the radiation machine with the department within 30 days after acquisition and before use. Application for registration shall be on DH DOH Form 1107, 3/07, which is herein incorporated by reference and available from the department at http://www.doh.state.fl.us/environment/radiation/.

    2. through 3. No change

    (b) No change.

    (2) through (7) No change.

    Specific Authority 404.051 FS. Law Implemented  404.071, 404.091, 404.101, 404.141, 404.161, 404.162, 404.163, 404.22(2) FS. History– New 12-12-96, Formerly 10D-91.612, Amended_________.

     

    PART X

    ENVIRONMENTAL RADIATION STANDARDS

    SUBPART B

    ENVIRONMENTAL MONITORING

    64E-5.1003 Monitoring Fees.

    (1) No change.

    (2) The annual fees paid by the mining companies shall be calculated by the following method:

    (a) Gamma radiation exposure measurements will be made at the rate of one per acre. An annual fee of $22.50 $7.50 per measurement shall be assessed the mining company by the department.

    (b) Soil characterization measurements will be made at the rate of one per 20 acres. An annual fee of $960 $320.00 per each 20 acres measured shall be assessed the mining company by the department.

    (c) Air monitoring measurements will be assessed at the rate of $495 $165.00 per measurement. The department shall prorate the cost of air monitoring measurements among the mining companies based on their share of the total acreage to be mined and reclaimed each year. The department will conduct no more than 272 air monitoring measurements per year for all mining companies for which a fee will be assessed.

    (d) No change.

    (3) through (4) No change.

    Specific Authority 404.022, 404.051, 404.056, 404.131 FS. Law Implemented 404.022(2), 404.051(4), 404.131(5) FS. History–New 11-13-85, Amended 9-26-91, Formerly 10D-91.1112, Amended_________.

     

    PART XV

    TRANSPORTATION OF RADIOACTIVE MATERIAL

    SUBPART A

    64E-5.1508  Inspection of Low-Level Radioactive Waste Shipments.

    (1) through (5) No change.

    (6) Each generator of radioactive waste whose shipment is inspected by the department's representative will be billed quarterly by the department a fee of $1.95 per cubic foot (0.02832 cubic meter) of waste shipped or $150.00 $50 per shipment inspected, whichever is greater. This quarterly billing will be paid to the department within 30 days of receipt of the bill.

    Specific Authority 404.051, 404.061, 404.071, 404.20, FS. Law Implemented 404.022, 404.051(1), (4), (6), (11), (15), 404.061(2), 404.071(1), 404.20(1), (2), (3), (4), (5) FS. History–New 7-17-85, Amended 7-5-88, Formerly 10D-91.2009, Amended_________.


    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: May 14, 2007
    DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: February 9, 2007

Document Information

Comments Open:
6/1/2007
Summary:
This rulemaking will update department rules regarding the use of x-rays in the healing arts; establish provisions for the use of hand-held dental x-ray units; correct numbering, and update fees for environmental monitoring, inspections of low-level radioactive waste transportation shipments, and radioactive materials licenses.
Purpose:
The purpose of this proposed rule making is to update department rules regarding the use of x-rays in the healing arts; to establish provisions for the use of hand-held dental x-ray units; to correct the numbering of Rule 64E-5.210, F.A.C.; and to update fees for environmental monitoring, inspections of low-level radioactive waste transportation shipments, and radioactive materials licenses. The effect will be to allow for the use of hand-held dental x-ray units; to clarify the requirements of ...
Rulemaking Authority:
404.022, 404.051, 404.056, 404.081, 404.131, 404.141, 404.22 FS.
Law:
404.022, 404.031, 404.056, 404.061, 404.081, 404.131, 404.141, 404.22, 404.051(1), (4), (5), (6), (8), (9), (10), (11), 404.061(2), (3), 404.071(1), 404.081(1), 404.22(1),(2),(3) FS.
Contact:
Michael Stephens, Environmental Health Program Consultant, Bin C21, 4052 Bald Cypress Way, Tallahassee, FL 32399-1741; (850)245-4266 or (850)245-4444, ext. 4043; email: mike_Stephens@doh.state.fl.us SECTION 286.0105, FLORIDA STATUTES, PROVIDES THAT, IF A PERSON DECIDES TO APPEAL ANY DECISION MADE BY THE DEPARTMENT WITH RESPECT TO ANY MATTER CONSIDERED AT THIS HEARING, THEY WILL NEED A RECORD OF PROCEEDINGS, AND FOR SUCH PURPOSES, THEY MAY NEED TO ENSURE THAT A VERBATIM RECORD OF THE ...
Related Rules: (9)
64E-5.1003. Monitoring Fees
64E-5.101. Definitions
64E-5.1508. Inspection of Low-Level Radioactive Waste Shipments
64E-5.204. Types of Licenses
64E-5.210. Special Requirements for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material
More ...