Florida Regulations 64E-5.210: Special Requirements for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material
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(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 C.F.R. § part 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 C.F.R. § part 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 C.F.R. § part 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 Fl. Admin. Code R. 64E-5.208,
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 Fl. Admin. Code R. 64E-5.304; 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
(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 C.F.R. § part 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 C.F.R. § part 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 Fl. Admin. Code R. 64E-5.208,
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 Fl. Admin. Code R. 64E-5.304; 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