Florida Administrative Code › 64 - DEPARTMENT OF HEALTH › 64E - Division of Environmental Health › Chapter 64E-5 - CONTROL OF RADIATION HAZARDS › Section 64E-5.210 - Special Requirements for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material

Current through Reg. 50, No. 138; July 16, 2024
(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.