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 section 32.11.

(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, 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 section 32.11.

(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 section 32.11.

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

(a) An application for a specific license to manufacture or distribute devices containing radioactive material, excluding special nuclear material, to persons possessing a general license under subsection 64E-5.206(4), F.A.C., or equivalent regulations of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State will be approved if:

1. The applicant satisfies the general requirements of Rule 64E-5.208, F.A.C.;

2. The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control, labels, proposed uses, installation, servicing, leak testing, operating and safety instructions, and potential hazards of the device to provide reasonable assurance that:

a. The device can be safely operated by persons not having training in radiological protection,

b. Under ordinary conditions of handling, storage and use of the device, the radioactive material contained in the device will not be released or inadvertently removed from the device, and it is unlikely that any person will receive a dose in excess of 10 percent of the limits specified in Rule 64E-5.304, F.A.C., and

c. Under accident conditions such as fire and explosion associated with handling, storage and use of the device, it is unlikely that any person would receive an external radiation dose or dose commitment in excess of the following organ doses:

(I) Whole body; head and trunk; active blood-forming organs; gonads; or lens of eye – 15 rems (150 mSv)

(II) Hands and forearms; feet and ankles; localized areas of skin averaged over areas no larger than 1 square centimeter – 200 rems (2 Sv)

(III) Other organs – 50 rems (500 mSv); and

3. Each device bears a durable, legible, clearly visible label or labels approved by the Department which contain in a clearly identified and separate statement:

a. Instructions and precautions necessary to assure safe installation, operation and servicing of the device; documents such as operating and service manuals may be identified in the label and used to provide this information.

b. The requirement, or lack of requirement, for leak testing, or for testing any on-off mechanism and indicator, including the maximum time interval for such testing, and the identification of radioactive material by isotope, quantity of radioactivity, and date of determination of the quantity, and

c. The information called for in one of the following statements, as appropriate, in the same or substantially similar form. The model, serial number, and name of the manufacturer or distributor may be omitted from this label provided the information is elsewhere specified in labeling affixed to the device:

(I) The receipt, possession, use and transfer of this device, model ___, serial no. ___, are subject to a general license or the equivalent and the regulations of the U.S. Nuclear Regulatory Commission or a state with which the U.S. Nuclear Regulatory Commission has entered into an agreement for the exercise of regulatory authority. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited.

CAUTION – RADIOACTIVE MATERIAL

_____________________________

Name of manufacturer or distributor

(II) The receipt, possession, use and transfer of this device, model ___, serial no. ___, are subject to a general license or the equivalent, and the regulations of a Licensing State. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited.

CAUTION – RADIOACTIVE MATERIAL

_____________________________

Name of manufacturer or distributor

4. Each device having a separable source housing that provides the primary shielding for the source also bears, on the source housing, a durable label containing the device model number and serial number, the radioisotope and quantity, the words “Caution Radioactive Materials,” the radiation symbol described in Rule 64E-5.322, F.A.C., the name of the manufacturer or initial distributor.

5. Each device containing at least 10 millicuries (370 MBq) of cesium-137, 0.1 millicuries (3.7 MBq) of strontium-90, 1 millicurie (37 MBq) of cobalt-60, or 1 millicurie (37 MBq) of americium-241 or any other element with atomic numbers greater than 92, based on the activity indicated on the label, must bear a permanent label affixed to the source housing if separable, or the device if the source housing is not separable, that includes the words “Caution Radioactive Materials,” and if practical, the radiation symbol described in Rule 64E-5.322, F.A.C. Example of a permanent label include labels that are embossed, etched, stamped or engraved to the source housing or device as applicable.

(b) In the event the applicant desires that the device be required to be tested at intervals longer than 6 months, either for proper operation of the on-off mechanism and indicator, if any, or for leakage of radioactive material or for both, the applicant shall include in the application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the device or similar devices and by design features which have a significant bearing on the probability or consequences of leakage of radioactive material from the device or failure of the on-off mechanism and indicator. In determining the acceptable interval for the test for leakage of radioactive material, the Department will consider the following information:

1. Primary containment or source capsule;

2. Protection of primary containment;

3. Method of sealing containment;

4. Containment construction material;

5. Form of contained radioactive material;

6. Maximum temperature withstood during prototype tests;

7. Maximum pressure withstood during prototype tests;

8. Maximum quantity of contained radioactive material;

9. Radiotoxicity of contained radioactive material; and

10. Operating experience with identical devices or similarly designed and constructed devices.

(c) In the event the applicant desires that the general licensee under Rule 64E-5.206, F.A.C., or under equivalent regulations of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State be authorized to install the device, collect the sample to be analyzed by a specific licensee for leakage of radioactive material, service the device, test the on-off mechanism and indicator, or remove the device from installation, the applicant shall include in the application written instructions to be followed by the general licensee, estimated calendar quarter doses associated with such activity or activities, and bases for such estimates. The submitted information shall demonstrate that performance of such activity or activities by an individual untrained in radiological protection, in addition to other handling, storage, and use of devices under the general license, is unlikely to cause that individual to receive a dose in excess of 10 percent of the limits specified in Rule 64E-5.304, F.A.C.

(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-5.343, and 64E-5.344, F.A.C.;

3. A list of services that can only be performed by a specific licensee;

4. Information on acceptable disposal options including costs of disposal; and

5. An indication that department policy is to issue high civil penalties for improper disposal.

(e) If a device containing radioactive material is transferred for use under an equivalent general license of an Agreement State or the NRC, 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 State or NRC equivalent to Rules 64E-5.103, 64E-5.343, and 64E-5.344, F.A.C. If a copy of the NRC 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. A list of services that can only be performed by a specific licensee;

3. Information on acceptable disposal options including costs of disposal; and

4. The name or title, address, and phone number of the contact at the Agreement State regulatory agency or U.S. Nuclear Regulatory Commission, as applicable, from which additional information may be obtained.

(f) Each device that is transferred must meet the labeling requirements in subparagraphs 64E-5.210(4)(d)3. through 5., F.A.C.

(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 department, U.S. Nuclear Regulatory Commission and to any appropriate Agreement State, records of final disposition required under paragraph 64E-5.210(4)(j), 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 Department. 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 http://www.flrules.org/Gateway/reference.asp?No=Ref-03452 or at http://www.doh.state.fl.us/environment/radiation/regs/64e-5tab.htm.

2. This report must be clear and legible and contain the following data:

a. The identity of each general licensee by name and mailing address for the location of use; if no mailing address for the location of use, an alternative address for the general licensee shall be submitted along with information on the actual location of use;

b. The name, title, and phone number of the person identified by the general licensee as having knowledge of and authority to take required actions to ensure compliance with the appropriate regulations and requirements;

c. The date of transfer;

d. The type, model number, and serial number of the device transferred; and

e. The quantity and type of radioactive materials contained in the device.

3. If one or more intermediate persons will temporarily possess the device at the intended place of use before its possession by the user, the report must include the same information for both the intended user and each intermediate person and clearly designate the intermediate person(s).

4. For devices received from a subsection 64E-5.206(4), F.A.C., general licensee, the report must include the identity of the general licensee by name and address, the type, model number, and serial number of the device received, the date of receipt, and, in the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor.

5. If the licensee makes changes to the device possessed by a subsection 64E-5.206(4), F.A.C., general licensee, such that the label must be changed to update required information, this report must identify the general licensee, the device, and the changes to information on the device label.

6. The report must clearly identify the specific licensee submitting the report and include the licenses number of the specific licensee.

7. If no transfers have been made to or from persons generally licensed under subsection 64E-5.206(4), F.A.C., during the reporting period, the report must so indicate.

(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. The report must be clear and legible and contain the following data:

a. The identity of each general licensee by name and mailing address for the location of use; if no mailing address for the location of use, an alternative address for the general licensee shall be submitted along with information on the actual location of use;

b. The name, title, and phone number of the person identified by the general licensee as having knowledge of and authority to take required actions to ensure compliance with the appropriate regulations and requirements;

c. The date of transfer;

d. The type, model number, and serial number of the device transferred; and

e. The quantity and type of radioactive materials contained in the device.

3. If one or more intermediate persons will temporarily possess the device at the intended place of use before its possession by the user, the report must include the same information for both the intended user and each intermediate person and clearly designate the intermediate person(s).

4. For devices received from a general licensee, the report must include the identity of the general licensee by name and address, the type, model number, and serial number of the device received, the date of receipt, and, in the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor.

5. If the licensee makes changes to the device possessed by a general licensee, such that the label must be changed to update required information, this report must identify the general licensee, the device, and the changes to information on the device label.

6. The report must clearly identify the specific licensee submitting the report and include the license number of the specific licensee.

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. The report must cover each calendar quarter and must be filed within 30 days of the end of the calendar quarter and must clearly indicate the period covered by the report.

(j) 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 department for a period of 3 years following the date of the recorded event.

(5) Special Requirements for the Manufacture, Assembly or Repair of Luminous Safety Devices for Use in Aircraft. An application for a specific license to manufacture, assemble or repair luminous safety devices containing tritium or promethium 147 for use in aircraft, for distribution to general licensees under subsection 64E-5.206(5), F.A.C., will be approved if the requirements of Sections 32.53, 32.54, 32.55, 32.56 and 32.101 of 10 C.F.R., Part 32, or their equivalent and the general requirements specified in Rule 64E-5.208, F.A.C., are satisfied.

(6) Special Requirements for License to Manufacture Calibration Sources Containing Americium 241, Plutonium or Radium 226 for Distribution to Persons Generally Licensed Under subsection 64E-5.206(6), F.A.C. An application for a specific license to manufacture calibration and reference sources containing americium 241, plutonium or radium 226 to general licensees under subsection 64E-5.206(6), F.A.C., will be approved if the requirements of Sections 32.57, 32.58, 32.59 and 32.102 of 10 C.F.R., Part 32 and Section 70.39 of 10 C.F.R., Part 70, or their equivalent and the general requirements of Rule 64E-5.208, F.A.C., are satisfied.

(7) Manufacture and Distribution of Radioactive Material for Medical Use Under General License. In addition to requirements set forth in Rule 64E-5.208, F.A.C., a specific license authorizing the distribution of radioactive material for use by physicians under the general license in subsection 64E-5.206(7), F.A.C., will be issued if:

(a) The applicant submits evidence that the radioactive material is to be manufactured, labeled and packaged in accordance with a new drug application which the Commissioner of Food and Drugs, Food and Drug Administration, has approved, or in accordance with a license for a biological product issued by the Secretary, U.S. Department of Health and Human Services; and

(b) One of the following statements, as appropriate, or a substantially similar statement which contains the information called for in one of the following statements, appears on the label affixed to the container or appears in the leaflet or brochure which accompanies the package:

1. This radioactive drug may be received, possessed and used only by physicians licensed by the State of Florida to dispense drugs in the practice of medicine. Its receipt, possession, use and transfer are subject to the regulations and a general license or its equivalent of the U.S. Nuclear Regulatory Commission or of a state with which the Commission has entered into an agreement for the exercise of regulatory authority.

____________________

Name of Manufacturer

2. This radioactive drug may be received, possessed and used only by physicians licensed by the State of Florida to dispense drugs in the practice of medicine. Its receipt, possession, use and transfer are subject to the regulations and a general license or its equivalent of a Licensing State.

____________________

Name of Manufacturer

(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) The applicant satisfies the general requirements specified in Rule 64E-5.208, F.A.C.

(b) The radioactive material is to be prepared for distribution in prepackaged units of:

1. Carbon 14 in units not exceeding 10 microcuries (370 kBq) each.

2. Cobalt 57 in units not exceeding 10 microcuries (370 kBq) each.

3. Hydrogen 3 (tritium) in units not exceeding 50 microcuries (1.85 MBq) each.

4. Iodine 125 in units not exceeding 10 microcuries (370 kBq) each.

5. Mock iodine 125 in units not exceeding 0.05 microcurie (1.85 kBq) of iodine 129 and 0.005 microcurie (185 Bq) of americium 241 each.

6. Iodine 131 in units not exceeding 10 microcuries (370 kBq) each.

7. Iron 59 in units not exceeding 20 microcuries (740 kBq) each.

8. Selenium 75 in units not exceeding 10 microcuries (370 kBq) each.

(c) Each prepackaged unit bears a durable, clearly visible label:

1. Identifying the radioactive contents as to chemical form and radionuclide, and indicating that the amount of radioactivity does not exceed 10 microcuries (370 kBq) of iodine 125, iodine 131, carbon 14, cobalt 57 or selenium 75; 50 microcuries (1.85 MBq) of hydrogen 3 (tritium); 20 microcuries (740 kBq) of iron 59; or mock iodine 125 in units not exceeding 0.05 microcurie (1.85 kBq) of iodine 129 and 0.005 microcurie (185 Bq) of americium 241 each; and

2. Displaying the radiation caution symbol described in subsection 64E-5.322(1), F.A.C., and the words, “CAUTION, RADIOACTIVE MATERIAL”, and “Not for Internal or External Use in Humans or Animals”.

(d) One of the following statements, as appropriate, or a substantially similar statement which contains the information called for in one of the following statements, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package:

1. This radioactive material may be received, acquired, possessed and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use and transfer are subject to the regulations and a general license of the U.S. Nuclear Regulatory Commission or of a state with which the Commission has entered into an agreement for the exercise of regulatory authority.

____________________

Name of manufacturer

2. This radioactive material may be received, acquired, possessed and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation therefrom, to human beings or animals. Its receipt, acquisition, possession, use and transfer are subject to the regulations and a general license of a Licensing State.

____________________

Name of manufacturer

(e) The label affixed to the unit, or the leaflet or brochure which accompanies the package, contains adequate information as to the precautions to be observed in handling and storing such radioactive material. In the case of the mock iodine 125 reference or calibration source, the information accompanying the source must also contain directions to the licensee regarding the waste disposal requirements set out in Part III.

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

(9) Licensing the Manufacture and Distribution of Ice Detection Devices. An application for a specific license to manufacture and distribute ice detection devices to general licensees under subsection 64E-5.206(9), F.A.C., will be approved if:

(a) The applicant satisfies the general requirements of Rule 64E-5.208, F.A.C.; and

(b) The criteria of Sections 32.61, 32.62, and 32.103 of 10 C.F.R., Part 32, are met.

(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) The applicant satisfies the general requirements specified in Rule 64E-5.208, F.A.C.;

(b) The applicant submits evidence that:

1. The applicant is registered or licensed with the U.S. Food and Drug Administration as a drug manufacturer; or

2. The applicant is registered or licensed as a drug manufacturer as specified in Chapter 499, Florida Statutes; or

3. The applicant has a nuclear pharmacy permit and only authorized nuclear pharmacists compound or dispense radiopharmaceuticals as specified in Section 465.0193, F.S.

(c) The applicant submits information on the radionuclide, chemical and physical form, the maximum activity per vial, syringe, generator, or other container of the radioactive drug, 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) The applicant satisfies the following labeling requirements:

1. The label affixed to each transport radiation shield of any material of a radioactive drug transferred for commercial distribution includes the radiation symbol and the words “Caution, Radioactive Material” or “Danger, Radioactive Material”; the name of the radioactive drug or its abbreviation; and the quantity of the radioactive material at a specified date and time. The time can be omitted for radioactive drugs with a half life greater than 100 days.

2. A label affixed to each syringe, vial, or other container used to hold a radioactive drug transferred for commercial distribution includes the words “Caution, Radioactive Material” or “Danger, Radioactive Material” and an identifier that correlates the syringe, vial, or other container with the information on the transport radiation shield label; and

(e) A licensee shall possess and use instruments to measure the radioactivity of radioactive drugs. The licensee shall have procedures for use of the instruments. The licensee shall measure by direct measurements or by combination of measurements and calculations the amount of radioactivity in doses of alpha-emitting, beta-emitting, or photon-emitting radioactive drugs before transfer for commercial distribution. In addition, the licensee shall:

1. Perform tests before initial use, periodically, and following repair on each instrument for accuracy, linearity, and geometry dependence appropriate for the use of the instrument and make adjustments when needed; and

2. Check each instrument for constancy and proper operation at the beginning of each day of use.

(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) Manufacture and Distribution of Generators or Reagent Kits for Preparation of Radiopharmaceuticals Containing Radioactive Material. An application for a specific license to manufacture and distribute generators or reagent kits containing radioactive material for preparation of radiopharmaceuticals by persons licensed pursuant to Part VI for the uses listed in Rule 64E-5.627 or 64E-5.664, F.A.C., will be approved if:

(a) The applicant satisfies the general requirements specified in Rule 64E-5.208, F.A.C.;

(b) The applicant submits evidence that:

1. The generator or reagent kit is to be manufactured, labeled and packaged in accordance with the Federal Food, Drug and Cosmetic Act or the Public Health Service Act, such as a new drug application (NDA) approved by the Food and Drug Administration (FDA), or a “Notice of Claimed Investigational Exemption for a New Drug” (IND) that has been accepted by the FDA; or

2. The manufacture and distribution of the generator or reagent kit are not subject to the Federal Food, Drug and Cosmetic Act and the Public Health Service Act;

(c) The applicant submits information on the radionuclide, chemical and physical form, packaging including maximum activity per package, and shielding provided by the packaging of the radioactive material contained in the generator or reagent kit;

(d) The label affixed to the generator or reagent kit contains information on the radionuclide, quantity and date of assay; and

(e) The label affixed to the generator or reagent kit, or the leaflet or brochure which accompanies the generator or reagent kit, contains:

1. Adequate information pertaining to radiation safety on the procedures to be followed and the equipment and shielding to be used in eluting the generator or processing radioactive material with the reagent kit, and

2. A statement that this generator or reagent kit, as appropriate, is approved for use by persons licensed by the department pursuant to Part VI for uses listed in Rule 64E-5.627, F.A.C., or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an agreement state or a licensing state. The labels, leaflets, or brochures required by this section are in addition to the labeling required by the Food and Drug Administration (FDA) and they may be separate from or, with the approval of FDA, may be combined with the labeling required by FDA.

(12) Manufacture and Distribution of Sources or Devices Containing Radioactive Material for Medical Use.

(a) An application for a specific license to manufacture and distribute sources and devices containing radioactive material to persons licensed pursuant to Part VI for use as a calibration, transmission or reference source or for the uses listed in Rule 64E-5.631, 64E-5.634, 64E-5.664 or 64E-5.632, F.A.C., will be approved if:

1. The applicant satisfies the general requirements in Rule 64E-5.208, F.A.C.;

2. The applicant submits sufficient information regarding each type of source or device pertinent to an evaluation of its radiation safety, including:

a. The radioactive material contained, its chemical and physical form, and amount,

b. Details of design and construction of the source or device,

c. Procedures for, and results of, prototype tests to demonstrate that the source or device will maintain its integrity under stresses likely to be encountered in normal use and accidents,

d. For devices containing radioactive material, the radiation profile of a prototype device,

e. Details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests,

f. Procedures and standards for calibrating sources and devices,

g. Legend and methods for labeling sources and devices as to their radioactive content, and

h. Instructions pertaining to radiation safety for handling and storing the source or device; these instructions are to be included on a durable label attached to the source or device or attached to a permanent storage container for the source or device; provided, that instructions which are too lengthy for such label may be summarized on the label and printed in detail on a brochure which is referenced on the label;

3. The label affixed to the source or device, or to the permanent storage container for the source or device, contains information on the radionuclide, quantity, date of assay, and a statement that the name of source or device is licensed by the department for distribution to persons licensed pursuant to Part VI or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an agreement state or a licensing state, provided, that such labeling for sources which do not require long term storage may be on a leaflet or brochure which accompanies the source;

(b) In the event the applicant desires that the source or device be required to be tested for leakage of radioactive material at intervals longer than 6 months, he shall include in his application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the source or device or similar sources or devices and by design features that have a significant bearing on the probability or consequences of leakage of radioactive material from the source; and

(c) In determining the acceptable interval for test of leakage of radioactive material, the Department will consider the following information:

1. Primary containment or source capsule,

2. Protection of primary containment,

3. Method of sealing containment,

4. Containment construction materials,

5. Form of contained radioactive material,

6. Maximum temperature withstood during prototype tests,

7. Maximum pressure withstood during prototype tests,

8. Maximum quantity of contained radioactive material,

9. Radiotoxicity of contained radioactive material, and

10. Operating experience with identical sources or devices or similarly designed and constructed sources or devices.

(13) Requirements for License to Manufacture and Distribute Industrial Products Containing Depleted Uranium for Mass-Volume Applications.

(a) An application for a specific license to manufacture industrial products and devices containing depleted uranium for use pursuant to subsection 64E-5.205(4), F.A.C., or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State will be approved if:

1. The applicant satisfies the general requirements specified in Rule 64E-5.208, F.A.C.;

2. The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, proposed uses, and potential hazards of the industrial product or device to provide reasonable assurance that possession, use or transfer of the depleted uranium in the product or device is not likely to cause any individual to receive in any period of 1 calendar quarter a radiation dose in excess of 10 percent of the limits specified in Subpart III A of these rules; and

3. The applicant submits sufficient information regarding the industrial product or device and the presence of depleted uranium for a mass-volume application in the product or device to provide reasonable assurance that unique benefits will accrue to the public because of the usefulness of the product or device.

(b) In the case of an industrial product or device whose unique benefits have not been demonstrated, the Department will approve an application for a specific license under this subsection only if the product or device is found to combine a high degree of utility and low probability of uncontrolled disposal and dispersal of significant quantities of depleted uranium into the environment.

(c) Each person licensed pursuant to paragraph (13)(a), above, shall:

1. Maintain the level of quality control required by the license in the manufacture of the industrial product or device and in the installation of the depleted uranium into the product or device;

2. Label or mark each unit to:

a. Identify the manufacturer of the product or device and the number of the license under which the product or device was manufactured, the fact that the product or device contains depleted uranium and the quantity of depleted uranium in each product or device; and

b. State that receipt, possession, use and transfer of the product or device are subject to a general license or the equivalent and the regulations of the U.S. Nuclear Regulatory Commission or an Agreement State;

3. Assure that the depleted uranium before being installed in each product or device has been impressed with the following legend clearly legible through any plating or other covering: “Depleted Uranium”;

4.a. Furnish a copy of the general license described in subsection 64E-5.205(4), F.A.C., to each person to whom he transfers depleted uranium in a product or device for use pursuant to the general license described in subsection 64E-5.205(4), F.A.C., or

b. Furnish a copy of the general license certificate of the U.S. Nuclear Regulatory Commission’s or an Agreement State’s, or alternatively, furnish a copy of the general license described in subsection 64E-5.205(4), F.A.C., to each person to whom he transfers depleted uranium in a product or device for use pursuant to the general license of the U.S. Nuclear Regulatory Commission or an Agreement State, with a note explaining that use of the product or device is regulated by the U.S. Nuclear Regulatory Commission or an Agreement State under requirements substantially the same as those in subsection 64E-5.205(4), F.A.C.;

5. Report to the Department all transfers of industrial products or devices to persons for use under the general license described in subsection 64E-5.205(4), F.A.C. Such report shall identify each general licensee by name and address, an individual by name or position who may constitute a point of contact between the Department and the general licensee, the type and model number of device transferred, and the quantity of depleted uranium contained in the product or device. The report shall be submitted within 30 days after the end of each calendar quarter in which such a product or device is transferred to the general licensee. If no transfers have been made to general licensees under subsection 64E-5.205(4), F.A.C., during the reporting period, the report shall so indicate;

6.a. Report to the U.S. Nuclear Regulatory Commission all transfers of industrial products or devices to persons for use under the U.S. Nuclear Regulatory Commission general license in Section 40.25 of 10 C.F.R., Part 40,

b. Report to the responsible state agency all transfers of devices manufactured and distributed pursuant to subsection 64E-5.210(3), F.A.C., for use under a general license in that state’s rules equivalent to subsection 64E-5.205(4), F.A.C.,

c. Such report shall identify each general licensee by name and address, an individual by name or position who may constitute a point of contact between the agency and the general licensee, the type and model number of the device transferred, and the quantity of depleted uranium contained in the product or device. The report shall be submitted within 30 days after the end of each calendar quarter in which such product or device is transferred to the general licensee.

d. If no transfers have been made to U.S. Nuclear Regulatory Commission licensees during the reporting period, this information shall be reported to the U.S. Nuclear Regulatory Commission, and

e. If no transfers have been made to general licensees within a particular Agreement State during the reporting period, this information shall be reported to the responsible Agreement State agency upon the request of that agency; and

7. Keep records showing the name, address and point of contact for each general licensee to whom he transfers depleted uranium in industrial products or devices for use pursuant to the general license provided in subsection 64E-5.205(4), F.A.C., or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State. The records shall be maintained for a period of 2 years and shall show the date of each transfer, the quantity of depleted uranium in each product or device transferred and compliance with the report requirements of this section.

(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 Department.

(a) The request for review of a sealed source or device must be made in triplicate and include information about the design, manufacture, prototype testing, quality control and assurance program, labeling, leak testing and proposed uses. The licensee shall inform customers of current reasonable disposal options for the radioactive material.

(b) The request for review of a device must include information about installation, service and maintenance, operating and safety instructions, and its potential hazards. The information shall provide reasonable assurance that the radiation safety properties of the source or device are adequate to protect public health, safety and property.

(c) The Department 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 Department 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 https://www.flrules.org/gateway/reference.asp?No=Ref-03508 or at http://www.doh.state.fl.us/environment/radiation/matform.htm which is available from the department.

2. NRC 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 http://www.flrules.org/Gateway/reference.asp?No=Ref-03453 or at http://pbadupws.nrc.gov/docs/ML0037/ML003740220.pdf or at http://www.doh.state.fl.us/environment/radiation/.

3. NRC 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 http://www.flrules.org/Gateway/reference.asp?No=Ref-03454 or at http://pbadupws.nrc.gov/docs/ML0037/ML003740233.pdf or at http://www.doh.state.fl.us/environment/radiation/.

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

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

6. ANSI Standard N432-1980, NBS Handbook 136, as issued in January 1981, 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 http://www.flrules.org/Gateway/reference.asp?No=Ref-03455 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 Standard, ANSI-HPS N43.6-2007, Sealed Radioactive Sources Classification, which is herein incorporated by reference and can be obtained from the internet at http://hps.org/hpssc/documents/ansi_standards_order_form.pdf. The Ansi publications referenced in this rule section: ANSI-HPS N43.8-2008; ANSI-HPS N43.4-2005; ANSI-HPS N43.6-2007; are copyrighted materials. These materials are available for public inspection and examination at the Florida Department of State, Room 701, The Capitol, Tallahassee, Florida 32399-0250, and at the Florida Department of Health, Bureau of Radiation Control, 4042 Bald Cypress Way, Tallahassee, Florida 32399-1741.

(d) The licensee or applicant shall not distribute devices or products containing sealed sources unless the devices or sealed sources are manufactured and distributed in accordance with the registration and as authorized by a specific radioactive materials license issued by the department for such manufacture or distribution.

(e) The department shall not perform registration of devices or products containing sealed sources for persons outside the state.

(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.

Rulemaking Authority 404.051, 404.061, 404.071, 404.081 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, 12-26-13.